DEPO-MEDROL WITH LIDOCAINE

Active substance: METHYLPREDNISOLONE

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Transcript
Hormones and metabolic system
• Slowing of normal growth in infants, children and adolescents which may
be permanent.
• Irregular or no periods in women.
• Increased hair on the body and face in women (hirsutism).
• Round or moon-shaped face (Cushingoid facies).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of some hormones which in turn
can cause low blood pressure and dizziness. This effect may persist for
months.
• The amount of certain chemicals (enzymes) called alanine transaminase,
aspartate transaminase and alkaline phosphatase that help the body digest
drugs and other substances in your body may be raised after treatment
with a corticosteroid. The change is usually small and the enzyme levels
return to normal after your medicine has cleared naturally from your
system. You will not notice any symptoms if this happens, but it will show
up if you have a blood test.
Immune system
• Increased susceptibility to infections which can hide or change normal
reactions to skin tests, such as that for tuberculosis.
Muscles, bones and joints
• Muscle weakness or wasting.
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood, this causes pain in the
hip.
• Torn muscle tendons causing pain and/or swelling.
• Muscle cramps or spasms.
• Swollen or painful joints due to infection.
Nerves and mood issues
Steroids including methylprednisolone can cause serious mental health
problems. These are common in both adults and children. They can affect
about 5 in every 100 people taking medicines like methylprednisolone.
• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being
confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and
frightening thoughts, changing how you act or having feelings of being
alone.
• Other nervous system side effects may include breathing problems,
convulsions, dizziness, drowsiness, difficulty breathing, sensation of cold,
heat or numbness, tinnitus or unconsciousness.
Skin
• Abscess, especially near injection sites
• Acne.
• Poor wound healing.
• Thinning of skin with stretch marks.
• Bruising.
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or raised patches which are an
unusual color.

Depo-Medrone® with Lidocaine

If you experience any of the side effects listed above tell your doctor
immediately.

Ref:0926/260112/1/F

(methylprednisolone acetate and lidocaine hydrochloride)

Patient Information Leaflet
5

How to store Depo-Medrone with Lidocaine

Expiry Date
Do not use this medicine after the expiry date shown on the carton label or
vial label. Each vial is for single use only. After use your doctor should take
the container and syringe away. If anything is left over, take it to your
pharmacist (chemist) for safe disposal. If your medicine become
discoloured or shows any other signs of deterioration, consult your
pharmacist (chemist) who will tell you what to do.
Storing your Medication
• KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
• Store below 25°C.
• Protect from freezing.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to anyone, it may harm them, even if their symptoms are
the same as yours. This leaflet does not tell you everything about this
medicine, If you have any questions or are not sure about anything then ask
your doctor or pharmacist

Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions please ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it to others. It may
harm them even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist

In this leaflet:
1 What Depo-Medrone with Lidocaine is and what it is used for
2 Before you are given Depo-Medrone with Lidocaine
3 How Depo-Medrone with Lidocaine is given to you
4 Possible side effects
5 How to Store Depo-Medrone with Lidocaine
6 Further information

1
6

Further information

What Depo-Medrone with Lidocaine contains
Each 1ml vial contains 40mg methylprednisolone acetate and 10mg
Lidocaine hydrochloride. Each vial also contains sodium chloride,
myristyl-gamma-picolinium chloride, benzyl alcohol as 8.7mg per ml,
macrogol, sodium hydroxide, hydrochloric acid and water for injections.
What a Depo-Medrone with Lidocaine looks like
Depo-Medrone with Lidocaine is a white, sterile aqueous suspension for
injection. Depo-Medrone with Lidocaine is available in cartons of 1 x 1ml vial
or 3 x 1ml vial’s.
Manufacturer and Licence Holder
Depo-Medrone is manufactured by Pfizer Manufacturing Belgium NV.,
Rijksweg 12, B-2870 , Puurs Belgium and is procured from within the EU
and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

Depo-medrone with Lidocaine PL:15184/0926

Depo-Medrone witth lidocaine is a registered trademark of Pharmacia &
Upjohn Limited.
Leaflet revision date: 26/01/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

What Depo-Medrone with Lidocaine is and what it’s used
for

Depo-Medrone with Lidocaine contains Methylprednisolone Acetate and
Lidocaine.
Methylprednisolone belongs to a group of medicines called corticosteroids or
steroids. Corticosteroids are produced naturally in your body and are
important for many body functions. When injected into the body, such as in or
near a joint, corticosteroids help reduce symptoms caused by
inflammatory or rheumatic conditions.
This medicine also contains Lidocaine, a local anesthetic, which helps to
reduce any local pain caused by injecting the medicine.
This medicine will be injected by a doctor or nurse to help treat the
symptoms caused by the following conditions:
• Bursitis: inflammation in the fluid containing spaces around the shoulder,
knee and/or elbow joints. For this condition this medicine will be injected
directly into one or more of these spaces.
• Osteoarthritis and rheumatoid arthritis: inflammation located in
between the joints. For these conditions this medicine will be injected
directly into one or more joint spaces.
• Epicondylitis, tendonitis and tenosynovitis: Tennis elbow
(epicondylitis), inflammation in a tendon (tendonitis), or a tendon’s
covering sheath (tenosynovitis). For these conditions this medicine will be
injected into the tendon or its tendon sheath.
Your doctor may use this medicine to treat conditions other than those listed
above. Ask your doctor if you are unsure why you have been given this
medicine.

2

Before you are given Depo-Medrone with Lidocaine

Do not use Depo-Medrone with Lidocaine if:

• You think you have ever suffered an allergic reaction, or any other type



of reaction after being given:
Depo-Medrone with Lidocaine, any other medicine containing a
corticosteroid or local anaesthetic, any of the ingredients in this medicine
(Section 6 of this leaflet contains a list of ingredients). An allergic reaction
may cause a skin rash or reddening, swollen face or lips or shortness of
breath.
If you get a rash, or another symptom of an infection.

See your doctor immediately if you have any of the above.
Do not inject this medicine into:
• the Achilles tendon (which is located behind the ankle joint), or
• directly into a vein (intravenous), the spinal cord (intrathecal), into
the nostrils (intranasal) or in the eye (intraocular).
Take special care before taking Depo-Medrone with Lidocaine:
You must tell your doctor before you take this medicine if you have any of
the following conditions.
Your doctor may also have to monitor your treatment more closely, alter your
dose or give you another medicine.
• Chickenpox, shingles or a herpes eye infection. If you think
you have been in contact with someone with chickenpox or
shingles and you have not already had these illnesses, or if you are
unsure if you have had them.
• Severe depression or manic depression (bipolar disorder). This includes
having had depression before while taking steroid medicines like
Depo-Medrone, or having a family history of these illnesses.
• Diabetes (or if there is a family history of diabetes).
• Epilepsy.
• Glaucoma (increased pressure in the eye) or if there is a family history of
glaucoma.
• You have recently suffered a heart attack.
• Heart problems, including heart failure or infections.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Joint infection which is active and so requires treatment.
• Kidney or liver disease.
• Muscle problems (pain or weakness) have happened while taking steroid
medicines in the past.
• Myasthenia gravis (a condition causing tired and weak muscles).
• Osteoporosis (brittle bones).
• Skin abscess.
• Stomach ulcer or other serious stomach or intestinal problems.
• Thrombophlebitis - vein problems due to thrombosis (clots in the veins)
resulting in phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered tuberculosis in the past.
Page 1

You must tell your doctor before you take this medicine if you have any of
the conditions listed above.
Taking other medicines
Always tell your doctor or pharmacist if you are taking any medicines
(including any you have bought without a prescription) as taking
Depo-Medrone with other medicines could be harmful.
You should tell your doctor if you are taking any of the following medicines
which can affect the way Depo-Medrone with Lidocaine or the other medicine
works:
• Acetazolamide - used to treat glaucoma and epilepsy
• Aminoglutethimide – used for treating cancer
• Anticoagulants - used to ‘thin’ the blood such as acenocoumarol,
phenindione and warfarin
• Anticholinesterases - used to treat myasthenia gravis (a muscle
condition) such as distigmine and neostigmine
• Antibiotics (such as erythromycin)
• Aspirin and non-steroidal anti-inflammatory medicines (also called
NSAIDs) such as ibuprofen used to treat mild to moderate pain
• Barbiturates, carbamezipine, phenytoin and primidone – used to treat
epilepsy
• Carbenoxolone - used for heartburn and acid indigestion
• Ciclosporin - used to treat conditions such as severe rheumatoid
arthritis, severe psoriasis or following an organ or bone marrow transplant
• Digoxin - used for heart failure and/or an irregular heart beat
• Diltiazem or mibefradil – used for heart problems or high blood pressure
• Diuretics – sometimes called water tablets.
• Ketoconazole or itraconazole – used to treat fungal infections
• Pancuronium – or other medicines called neuromuscular blocking agents
which are used in some surgical procedures
• Rifampicin and rifabutin – antibiotics used to treat tuberculosis (TB)
• Vaccines - tell your doctor or nurse if you have recently had, or are about
to have any vaccination. You should not have ‘live’ vaccines while using
this medicine. Other vaccines may be less effective
If you are taking long term medication(s)
If you are being treated for diabetes, high blood pressure or water retention
(oedema) tell your doctor as he/she may need to adjust the dose of the
medicines used to treat these conditions.
Before you have any operation tell your doctor, dentist or anesthetist that
you are taking this medicine.
If you require a test to be carried out by your doctor or in hospital it is
important that you tell the doctor or nurse that you are taking Depo-Medrone
with Lidocaine. This medicine can affect the results of some tests.
Pregnancy and breast feeding
You must tell your doctor if you are pregnant, think you might be pregnant or
are trying to become pregnant as this medicine could slow the baby’s growth.
Tell your doctor if you are breast feeding as small amounts of corticosteroid
medicines may get into breast milk.
If you continue breast-feeding while you are having treatment, your baby will
need extra checks to make sure he or she is not being affected by your
medicine.
Page 2

Driving and Using Machines
There are no special precautions while you are being treated with this
medicine.

Children
Corticosteroids can affect growth in children so your doctor will prescribe the
lowest dose that will be effective for your child.

Important information about some of the ingredients of Depo-Medrone
with Lidocaine
This medicine contains benzyl alcohol. This medicine must not be given to
premature babies or neonates. It may cause toxic reactions and allergic
reactions in infants and children up to 3 years old.

If you are given more Depo-Medrone with Lidocaine than you should
If you think you have been given too many injections of this medicine please
speak to your doctor immediately.

3

How Depo-Medrone with Lidocaine is given to you

Steroid Cards
Remember to always carry a Steroid Treatment Card. Make sure your
doctor or pharmacist has filled out the details of your medicine,
including the dose and how long you will require steroid treatment.
You should show your steroid card to anyone who gives you treatment (such
as a doctor, nurse or dentist) while you are taking this medicine, and for 3
months after your last injection.
If you are admitted to hospital for any reason always tell your doctor or nurse
that you are taking this medicine. You can also wear a medic-alert bracelet or
pendant to let medical staff know that you are taking a steroid if you have an
accident or become unconscious.
Dosage information
Your doctor will decide on the site of injection, how much of the medicine and
how many injections you will receive depending on the condition being
treated and its severity. Your doctor will inject you with the lowest dose for the
shortest possible time to get effective relief of your symptoms.
Adults
Your doctor/nurse will tell you how many injections you will require for the
condition you are being treated for, and when you will get them.
Joints - the normal dose for the injections into joint will depend on the size of
the joint. Large joints (e.g. knee, ankle and shoulder) may require 20 - 80 mg
(0.5 – 2 ml), medium sized joints (e.g. elbow or wrist) 10 - 40 mg (0.25 – 1
ml) and small joints (e.g. finger or toe joints) may require a 4 - 10 mg
(0.1 -0.25 ml) dose.
Joint injections may be given weekly over a period of several weeks,
depending on how quickly you respond to treatment.
Bursitis, epicondylitis (tennis elbow) and tendonitis – the usual dose is
between 4-30 mg (0.1 - 0.75 ml). In most cases repeat injections will not be
needed for bursitis and epicondylitis. Repeat injections may be necessary to
treat long standing tendonitis.
Elderly
Treatment will normally be the same as for younger adults. However your
doctor may want to see you more regularly to check how you are getting on
with this medicine.

Stopping/reducing the dose of your Depo-Medrone with Lidocaine
Your doctor will decide when it is time to stop your treatment.
You will need to come off this treatment slowly if you:
• have been given more than 6 mg (0.15 ml) Depo-Medrone with Lidocaine
for more than 3 weeks;
• have been given high doses of Depo-Medrone with Lidocaine, over 32 mg
(0.8 ml) daily, even if it was only for 3 weeks or less;
• have already had a course of corticosteroid tablets or injections in the last
year;
• already have problems with your adrenal glands (adrenocortical
insufficiency) before you started this treatment.
You will need to come off this medicine slowly to avoid withdrawal
symptoms. These symptoms may include itchy skin, fever, muscle and joint
pains, runny nose, sticky eyes, sweating and weight loss.
If your symptoms seem to return or get worse as your dose of this medicine
is reduced tell your doctor immediately.
Mental problems while taking Depo-Medrone with Lidocaine
Mental health problems can happen while taking steroids like Depo-Medrone
with Lidocaine (see also section 4, Possible Side Effects).
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is
stopped. However if the problems do happen they might need treatment.
Talk to a doctor if you (or someone using this medicine) show any signs of
mental problems. This is particularly important if you are depressed, or might
be thinking about suicide. In a few cases mental problems have happened
when doses are being lowered or stopped.

4

Possible side effects

Like all steroids this medicine can cause side-effects, although not everybody
gets them. Your doctor will have given you this medicine for a condition which
if not treated properly could become serious.
In certain medical conditions medicines like Depo-Medrone and
Lidocaine (steroids) should not be stopped abruptly, if you suffer from
any of the following symptoms seek IMMEDIATE medical attention, your
doctor will then decide whether you should continue taking your
medicine:
• Allergic reactions, such as skin rash, swelling of the face or wheezing
and difficulty breathing. This type of side effect is rare, but can be serious.
• Acute pancreatitis, stomach pain which may spread through to your back,
possibly accompanied by vomiting, shock and loss of consciousness.








Burst or bleeding ulcers, symptoms of which are severe stomach pain
which may go through to the back and could be associated with bleeding
from the back passage, black or bloodstained stools and/or vomiting blood.
Infections, This medicine can hide or change the signs and symptoms of
some infections, or reduce your resistance to the infection, so that they are
hard to diagnose at an early stage. Symptoms might include a raised
temperature and feeling unwell. Symptoms of a flare up of a previous TB
infection could be coughing blood or pain in the chest. This medicine may
also make you more likely to develop a severe infection.
Pulmonary embolus (blood clot in the lung) symptoms include sudden
sharp chest pain, breathlessness and coughing up blood.
Raised pressure within the skull of children (pseudotumour cerebri)
symptoms of which are headaches with vomiting, lack of energy and
drowsiness. This side-effect usually occurs after treatment is stopped.
Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of
which include painful swollen, red and tender veins.

If you experience any of the following side effects, or notice any other
unusual effects not mentioned in this leaflet, tell your doctor straight
away.
Blood, heart and circulation
Problems with the pumping of your heart (heart failure) symptoms of which
are swollen ankles, difficulty in breathing and palpitations (awareness of
heart beat) or irregular beating of the heart, irregular or very fast or slow
pulse.
• High blood pressure, symptoms of which are headaches, or generally
feeling unwell.
• Increased numbers of white blood cells (leucocytosis).



Body water and salts
• Swelling and high blood pressure, caused by increased levels of water and
salt content.
• Cramps and spasms, due to the loss of potassium from your body. In rare
cases this can lead to congestive heart failure (when the heart cannot
pump properly).
Digestive system
Nausea (feeling sick) or vomiting (being sick).
Ulcers or thrush in the gullet (discomfort on swallowing).
Indigestion.
Bloated stomach.
Persistent hiccups, especially when high doses are taken.







Eyes
• Glaucoma (raised pressure within the eye, causing pain in the eyes and
headaches).
• Swollen optic nerve (causing a condition called papilloedema, and which
may cause sight disturbance).
• Damage to the optic nerve or cataracts (indicated by failing eyesight).
• Thinning of the clear part at the front of the eye (cornea) or of the white
part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or double vision.

Ref:0926/260112/1/B

Page 3

Hormones and metabolic system
• Slowing of normal growth in infants, children and adolescents which may
be permanent.
• Irregular or no periods in women.
• Increased hair on the body and face in women (hirsutism).
• Round or moon-shaped face (Cushingoid facies).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of some hormones which in
turn can cause low blood pressure and dizziness. This effect may persist
for months.
• The amount of certain chemicals (enzymes) called alanine transaminase,
aspartate transaminase and alkaline phosphatase that help the body digest
drugs and other substances in your body may be raised after treatment
with a corticosteroid. The change is usually small and the enzyme levels
return to normal after your medicine has cleared naturally from your
system. You will not notice any symptoms if this happens, but it will show
up if you have a blood test.
Immune system
• Increased susceptibility to infections which can hide or change normal
reactions to skin tests, such as that for tuberculosis.
Muscles, bones and joints
• Muscle weakness or wasting.
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood, this causes pain in the
hip.
• Torn muscle tendons causing pain and/or swelling.
• Muscle cramps or spasms.
• Swollen or painful joints due to infection.
Nerves and mood issues
Steroids including methylprednisolone can cause serious mental health
problems. These are common in both adults and children. They can affect
about 5 in every 100 people taking medicines like methylprednisolone.
• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being
confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and
frightening thoughts, changing how you act or having feelings of being
alone.
• Other nervous system side effects may include breathing problems,
convulsions, dizziness, drowsiness, difficulty breathing, sensation of cold,
heat or numbness, tinnitus or unconsciousness.
Skin
• Abscess, especially near injection sites
• Acne.
• Poor wound healing.
• Thinning of skin with stretch marks.
• Bruising.
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or raised patches which are an
unusual color.

®

Depo-Medrol with Lidocaine

If you experience any of the side effects listed above tell your doctor
immediately.

Ref:0926/260112/2/F

(methylprednisolone acetate and lidocaine hydrochloride)

Patient Information Leaflet
5

How to store Depo-Medrol with Lidocaine

Expiry Date
Do not use this medicine after the expiry date shown on the carton label or
vial label. Each vial is for single use only. After use your doctor should take
the container and syringe away. If anything is left over, take it to your
pharmacist (chemist) for safe disposal. If your medicine become
discoloured or shows any other signs of deterioration, consult your
pharmacist (chemist) who will tell you what to do.
Storing your Medication
• KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
• Store below 25°C.
• Protect from freezing.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to anyone, it may harm them, even if their symptoms are
the same as yours. This leaflet does not tell you everything about this
medicine, If you have any questions or are not sure about anything then ask
your doctor or pharmacist

Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions please ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it to others. It may
harm them even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist

In this leaflet:
1 What Depo-Medrol with Lidocaine is and what it is used for
2 Before you are given Depo-Medrol with Lidocaine
3 How Depo-Medrol with Lidocaine is given to you
4 Possible side effects
5 How to Store Depo-Medrol with Lidocaine
6 Further information

1
6

Further information

What Depo-Medrol with Lidocaine contains
Each 1ml vial contains 40mg methylprednisolone acetate and 10mg
Lidocaine hydrochloride. Each vial also contains sodium chloride,
myristyl-gamma-picolinium chloride, benzyl alcohol as 8.7mg per ml,
macrogol, sodium hydroxide, hydrochloric acid and water for injections.
What a Depo-Medrol with Lidocaine looks like
Depo-Medrol with Lidocaine is a white, sterile aqueous suspension for
injection. Depo-Medrol with Lidocaine is available in cartons of 1 x 1ml vial or
3 x 1ml vial’s.
Manufacturer and Licence Holder
Depo-Medrol is manufactured by Pfizer Manufacturing Belgium NV., Rijksweg
12, B-2870 , Puurs Belgium and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

Depo-medrol with Lidocaine PL:15184/0926

Depo-Medrol witth lidocaine is a registered trademark of Pharmacia & Upjohn
Limited.
Leaflet revision date: 26/01/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

What Depo-Medrol with Lidocaine is and what it’s used
for

Depo-Medrol with Lidocaine contains Methylprednisolone Acetate and
Lidocaine.
Methylprednisolone belongs to a group of medicines called corticosteroids or
steroids. Corticosteroids are produced naturally in your body and are
important for many body functions. When injected into the body, such as in or
near a joint, corticosteroids help reduce symptoms caused by
inflammatory or rheumatic conditions.
This medicine also contains Lidocaine, a local anesthetic, which helps to
reduce any local pain caused by injecting the medicine.
This medicine will be injected by a doctor or nurse to help treat the
symptoms caused by the following conditions:
• Bursitis: inflammation in the fluid containing spaces around the shoulder,
knee and/or elbow joints. For this condition this medicine will be injected
directly into one or more of these spaces.
• Osteoarthritis and rheumatoid arthritis: inflammation located in
between the joints. For these conditions this medicine will be injected
directly into one or more joint spaces.
• Epicondylitis, tendonitis and tenosynovitis: Tennis elbow
(epicondylitis), inflammation in a tendon (tendonitis), or a tendon’s
covering sheath (tenosynovitis). For these conditions this medicine will be
injected into the tendon or its tendon sheath.
Your doctor may use this medicine to treat conditions other than those listed
above. Ask your doctor if you are unsure why you have been given this
medicine.

2

Before you are given Depo-Medrol with Lidocaine

Do not use Depo-Medrol with Lidocaine if:

• You think you have ever suffered an allergic reaction, or any other type



of reaction after being given:
Depo-Medrol with Lidocaine, any other medicine containing a
corticosteroid or local anaesthetic, any of the ingredients in this medicine
(Section 6 of this leaflet contains a list of ingredients). An allergic reaction
may cause a skin rash or reddening, swollen face or lips or shortness of
breath.
If you get a rash, or another symptom of an infection.

See your doctor immediately if you have any of the above.
Do not inject this medicine into:
• the Achilles tendon (which is located behind the ankle joint), or
• directly into a vein (intravenous), the spinal cord (intrathecal), into
the nostrils (intranasal) or in the eye (intraocular).
Take special care before taking Depo-Medrol with Lidocaine:
You must tell your doctor before you take this medicine if you have any of
the following conditions.
Your doctor may also have to monitor your treatment more closely, alter your
dose or give you another medicine.
• Chickenpox, shingles or a herpes eye infection. If you think
you have been in contact with someone with chickenpox or
shingles and you have not already had these illnesses, or if you are
unsure if you have had them.
• Severe depression or manic depression (bipolar disorder). This includes
having had depression before while taking steroid medicines like
Depo-Medrol, or having a family history of these illnesses.
• Diabetes (or if there is a family history of diabetes).
• Epilepsy.
• Glaucoma (increased pressure in the eye) or if there is a family history of
glaucoma.
• You have recently suffered a heart attack.
• Heart problems, including heart failure or infections.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Joint infection which is active and so requires treatment.
• Kidney or liver disease.
• Muscle problems (pain or weakness) have happened while taking steroid
medicines in the past.
• Myasthenia gravis (a condition causing tired and weak muscles).
• Osteoporosis (brittle bones).
• Skin abscess.
• Stomach ulcer or other serious stomach or intestinal problems.
• Thrombophlebitis - vein problems due to thrombosis (clots in the veins)
resulting in phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered tuberculosis in the past.
Page 1

You must tell your doctor before you take this medicine if you have any of
the conditions listed above.
Taking other medicines
Always tell your doctor or pharmacist if you are taking any medicines
(including any you have bought without a prescription) as taking
Depo-Medrol with other medicines could be harmful.
You should tell your doctor if you are taking any of the following medicines
which can affect the way Depo-Medrol with Lidocaine or the other medicine
works:
• Acetazolamide - used to treat glaucoma and epilepsy
• Aminoglutethimide – used for treating cancer
• Anticoagulants - used to ‘thin’ the blood such as acenocoumarol,
phenindione and warfarin
• Anticholinesterases - used to treat myasthenia gravis (a muscle
condition) such as distigmine and neostigmine
• Antibiotics (such as erythromycin)
• Aspirin and non-steroidal anti-inflammatory medicines (also called
NSAIDs) such as ibuprofen used to treat mild to moderate pain
• Barbiturates, carbamezipine, phenytoin and primidone – used to treat
epilepsy
• Carbenoxolone - used for heartburn and acid indigestion
• Ciclosporin - used to treat conditions such as severe rheumatoid
arthritis, severe psoriasis or following an organ or bone marrow transplant
• Digoxin - used for heart failure and/or an irregular heart beat
• Diltiazem or mibefradil – used for heart problems or high blood pressure
• Diuretics – sometimes called water tablets.
• Ketoconazole or itraconazole – used to treat fungal infections
• Pancuronium – or other medicines called neuromuscular blocking agents
which are used in some surgical procedures
• Rifampicin and rifabutin – antibiotics used to treat tuberculosis (TB)
• Vaccines - tell your doctor or nurse if you have recently had, or are about
to have any vaccination. You should not have ‘live’ vaccines while using
this medicine. Other vaccines may be less effective
If you are taking long term medication(s)
If you are being treated for diabetes, high blood pressure or water retention
(oedema) tell your doctor as he/she may need to adjust the dose of the
medicines used to treat these conditions.
Before you have any operation tell your doctor, dentist or anesthetist that
you are taking this medicine.
If you require a test to be carried out by your doctor or in hospital it is
important that you tell the doctor or nurse that you are taking Depo-Medrol
with Lidocaine. This medicine can affect the results of some tests.
Pregnancy and breast feeding
You must tell your doctor if you are pregnant, think you might be pregnant or
are trying to become pregnant as this medicine could slow the baby’s growth.
Tell your doctor if you are breast feeding as small amounts of corticosteroid
medicines may get into breast milk.
If you continue breast-feeding while you are having treatment, your baby will
need extra checks to make sure he or she is not being affected by your
medicine.
Page 2

Driving and Using Machines
There are no special precautions while you are being treated with this
medicine.

Children
Corticosteroids can affect growth in children so your doctor will prescribe the
lowest dose that will be effective for your child.

Important information about some of the ingredients of Depo-Medrol
with Lidocaine
This medicine contains benzyl alcohol. This medicine must not be given to
premature babies or neonates. It may cause toxic reactions and allergic
reactions in infants and children up to 3 years old.

If you are given more Depo-Medrol with Lidocaine than you should
If you think you have been given too many injections of this medicine please
speak to your doctor immediately.

3

How Depo-Medrol with Lidocaine is given to you

Steroid Cards
Remember to always carry a Steroid Treatment Card. Make sure your
doctor or pharmacist has filled out the details of your medicine,
including the dose and how long you will require steroid treatment.
You should show your steroid card to anyone who gives you treatment (such
as a doctor, nurse or dentist) while you are taking this medicine, and for 3
months after your last injection.
If you are admitted to hospital for any reason always tell your doctor or nurse
that you are taking this medicine. You can also wear a medic-alert bracelet or
pendant to let medical staff know that you are taking a steroid if you have an
accident or become unconscious.
Dosage information
Your doctor will decide on the site of injection, how much of the medicine and
how many injections you will receive depending on the condition being
treated and its severity. Your doctor will inject you with the lowest dose for the
shortest possible time to get effective relief of your symptoms.
Adults
Your doctor/nurse will tell you how many injections you will require for the
condition you are being treated for, and when you will get them.
Joints - the normal dose for the injections into joint will depend on the size of
the joint. Large joints (e.g. knee, ankle and shoulder) may require 20 - 80 mg
(0.5 – 2 ml), medium sized joints (e.g. elbow or wrist) 10 - 40 mg (0.25 – 1
ml) and small joints (e.g. finger or toe joints) may require a 4 - 10 mg
(0.1 -0.25 ml) dose.
Joint injections may be given weekly over a period of several weeks,
depending on how quickly you respond to treatment.
Bursitis, epicondylitis (tennis elbow) and tendonitis – the usual dose is
between 4-30 mg (0.1 - 0.75 ml). In most cases repeat injections will not be
needed for bursitis and epicondylitis. Repeat injections may be necessary to
treat long standing tendonitis.
Elderly
Treatment will normally be the same as for younger adults. However your
doctor may want to see you more regularly to check how you are getting on
with this medicine.

Stopping/reducing the dose of your Depo-Medrol with Lidocaine
Your doctor will decide when it is time to stop your treatment.
You will need to come off this treatment slowly if you:
• have been given more than 6 mg (0.15 ml) Depo-Medrol with Lidocaine
for more than 3 weeks;
• have been given high doses of Depo-Medrol with Lidocaine, over 32 mg
(0.8 ml) daily, even if it was only for 3 weeks or less;
• have already had a course of corticosteroid tablets or injections in the last
year;
• already have problems with your adrenal glands (adrenocortical
insufficiency) before you started this treatment.
You will need to come off this medicine slowly to avoid withdrawal
symptoms. These symptoms may include itchy skin, fever, muscle and joint
pains, runny nose, sticky eyes, sweating and weight loss.
If your symptoms seem to return or get worse as your dose of this medicine
is reduced tell your doctor immediately.
Mental problems while taking Depo-Medrol with Lidocaine
Mental health problems can happen while taking steroids like Depo-Medrol
with Lidocaine (see also section 4, Possible Side Effects).
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is
stopped. However if the problems do happen they might need treatment.
Talk to a doctor if you (or someone using this medicine) show any signs of
mental problems. This is particularly important if you are depressed, or might
be thinking about suicide. In a few cases mental problems have happened
when doses are being lowered or stopped.

4

Possible side effects

Like all steroids this medicine can cause side-effects, although not everybody
gets them. Your doctor will have given you this medicine for a condition which
if not treated properly could become serious.
In certain medical conditions medicines like Depo-Medrol and Lidocaine
(steroids) should not be stopped abruptly, if you suffer from any of the
following symptoms seek IMMEDIATE medical attention, your doctor
will then decide whether you should continue taking your
medicine:
• Allergic reactions, such as skin rash, swelling of the face or wheezing
and difficulty breathing. This type of side effect is rare, but can be serious.
• Acute pancreatitis, stomach pain which may spread through to your back,
possibly accompanied by vomiting, shock and loss of consciousness.








Burst or bleeding ulcers, symptoms of which are severe stomach pain
which may go through to the back and could be associated with bleeding
from the back passage, black or bloodstained stools and/or vomiting blood.
Infections, This medicine can hide or change the signs and symptoms of
some infections, or reduce your resistance to the infection, so that they are
hard to diagnose at an early stage. Symptoms might include a raised
temperature and feeling unwell. Symptoms of a flare up of a previous TB
infection could be coughing blood or pain in the chest. This medicine may
also make you more likely to develop a severe infection.
Pulmonary embolus (blood clot in the lung) symptoms include sudden
sharp chest pain, breathlessness and coughing up blood.
Raised pressure within the skull of children (pseudotumour cerebri)
symptoms of which are headaches with vomiting, lack of energy and
drowsiness. This side-effect usually occurs after treatment is stopped.
Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of
which include painful swollen, red and tender veins.

If you experience any of the following side effects, or notice any other
unusual effects not mentioned in this leaflet, tell your doctor straight
away.
Blood, heart and circulation
Problems with the pumping of your heart (heart failure) symptoms of which
are swollen ankles, difficulty in breathing and palpitations (awareness of
heart beat) or irregular beating of the heart, irregular or very fast or slow
pulse.
• High blood pressure, symptoms of which are headaches, or generally
feeling unwell.
• Increased numbers of white blood cells (leucocytosis).



Body water and salts
• Swelling and high blood pressure, caused by increased levels of water and
salt content.
• Cramps and spasms, due to the loss of potassium from your body. In rare
cases this can lead to congestive heart failure (when the heart cannot
pump properly).
Digestive system
Nausea (feeling sick) or vomiting (being sick).
Ulcers or thrush in the gullet (discomfort on swallowing).
Indigestion.
Bloated stomach.
Persistent hiccups, especially when high doses are taken.







Eyes
• Glaucoma (raised pressure within the eye, causing pain in the eyes and
headaches).
• Swollen optic nerve (causing a condition called papilloedema, and which
may cause sight disturbance).
• Damage to the optic nerve or cataracts (indicated by failing eyesight).
• Thinning of the clear part at the front of the eye (cornea) or of the white
part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or double vision.

Ref:0926/260112/2/B

Page 3

Special precautions:
Particular care is required when considering the use of systemic
corticosteroids in patients with the following conditions and frequent patient
monitoring is necessary.
1. Osteoporosis (post-menopausal females are particularly at risk).
2. Hypertension or congestive heart failure.
3. Existing or previous history of severe affective disorders (especially
previous steroid psychosis).
4. Diabetes mellitus (or a family history of diabetes).
5. History of tuberculosis.
6. Glaucoma (or a family history of glaucoma).
7. Previous corticosteroid-induced myopathy.
8. Liver failure or cirrhosis
9. Renal insufficiency.
10. Epilepsy.
11. Peptic ulceration.
12. Fresh intestinal anastomoses.
13. Predisposition to thrombophlebitis.
14. Abscess or other pyogenic infections.
15. Ulcerative colitis.
16. Diverticulitis.
17. Myasthenia gravis.
18. Ocular herpes simplex, for fear of corneal perforation.
19. Hypothyroidism.
20. Patients and/or carers should be warned that potentially severe
psychiatric adverse reactions may occur with systemic steroids (see
section 4.8). Symptoms typically emerge within a few days or weeks of
starting treatment. Risks may be higher with high doses/systemic
exposure (see also section 4.5 Interaction with Other Medicaments and
Other Forms of Interaction that can increase the risk of side effects),
although dose levels do not allow prediction of the onset, type, severity
or duration of reactions. Most reactions recover after either dose
reduction or withdrawal, although specific treatment may be necessary.
Patients/carers should be encouraged to seek medical advice if worrying
psychological symptoms develop, especially if depressed mood or
suicidal ideation is suspected. Patients/carers should be alert to possible
psychiatric disturbances that may occur either during or immediately after
dose tapering/withdrawal of systemic steroids, although such reactions
have been reported infrequently.
Particular care is required when considering the use of systemic
corticosteroids in patients with existing or previous history of severe affective
disorders in themselves or in their first degree relatives. These would include
depressive or manic-depressive illness and previous steroid psychosis.

neonate following prenatal exposure to corticosteroids but usually resolves
spontaneously following birth and is rarely clinically important. As with all
drugs, corticosteroids should only be prescribed when the benefits to the
mother and child outweigh the risks. When corticosteroids are essential,
however, patients with normal pregnancies may be treated as though they
were in the non-gravid state.
The use of local anaesthetics such as lidocaine during labour and delivery
may be associated with adverse effects on mother and foetus. Lidocaine
readily crosses the placenta.
Lactation
Corticosteroids are excreted in small amounts in breast milk, however, doses
of up to 40mg daily of methylprednisolone are unlikely to cause systemic
effects in the infant. Infants of mothers taking higher doses than this may
have a degree of adrenal suppression, but the benefits of breastfeeding are
likely to outweigh any theoretical risk.
It is not known whether lidocaine is excreted in human breast milk.
Use in children: Corticosteroids cause growth retardation in infancy,
childhood and adolescence which may be irreversible. Treatment should be
limited to the minimum dosage for the shortest possible time.
Use in the elderly: The common adverse effects of systemic corticosteroids
may be associated with more serious consequences in old age, especially
osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection
and thinning of the skin. Close clinical supervision is required to avoid
life-threatening reactions.
Overdosage: There is no clinical syndrome of acute overdosage with
Depo-Medrone with Lidocaine. Following overdosage the possibility of
adrenal suppression should be guarded against by gradual diminution of
dose levels over a period of time. In such event the patient may require to be
supported during any further traumatic episode.
Incompatibilities (major): None stated.
Pharmaceutical precautions
Depo-Medrone with Lidocaine should not be stored above 25° C and
protected from freezing.
Depo-Medrone with Lidocaine should not be mixed with any other fluid.
Discard any remaining suspension after use.

Use in children: Corticosteroids cause growth retardation in infancy,
childhood and adolescence which may be irreversible. Treatment should be
limited to the minimum dosage for the shortest possible time.
Use in the elderly: The common adverse effects of systemic corticosteroids
may be associated with more serious consequences in old age, especially
osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection
and thinning of the skin. Close clinical supervision is required to avoid
life-threatening reactions.
Use in Pregnancy and Lactation:
Pregnancy
The ability of corticosteroids to cross the placenta varies between individual
drugs, however, methylprednisolone does cross the placenta.
Administration of corticosteroids to pregnant animals can cause abnormalities
of foetal development including cleft palate, intra-uterine growth retardation
and affects on brain growth and development. There is no evidence that
corticosteroids result in an increased incidence of congenital abnormalities,
such as cleft palate in man, however, when administered for long periods or
repeatedly during pregnancy, corticosteroids may increase the risk of
intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the

Legal Category:
POM
Package quantities:
1 x 1ml vial pack or 3 x 1ml packs.
Manufacturer and Licence Holder
This mediciene is manufactured by Pfizer manufacturing Belgium NV,
Rijksweg 12, 2870 Puurs, Belgium and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL:15184/0926 - Depo-Medrone with Lidocaine
Depo-Merdone is a registered trademark of Pharmacia & Upjohn Limited.
Leaflet revision date: 26/01/12

Depo-Medrone ® with Lidocaine

Ref:0926/260112/1P-F

(methylprednisolone acetate and lidocaine hydrochloride)

PHYSICIAN LEAFLET
Presentation
White, sterile aqueous suspension for injection containing 40 mg per ml
methylprednisolone acetate and 10 mg per ml lidocaine hydrochloride. Also
contains macrogol, sodium chloride, myristyl-gamma-picolinium chloride,
benzyl alcohol and sterile water for injections.
Uses
Corticosteroid (glucocorticoid). Depo-Medrone with Lidocaine is indicated in
conditions requiring a glucocorticoid effect: e.g. anti-inflammatory or
anti-rheumatic. It is recommended for local use where the added anaesthetic
effect would be considered advantageous.
Therapy with Depo-Medrone with Lidocaine does not obviate the need for the
conventional measures usually employed. Although this method of treatment
will ameliorate symptoms, it is in no sense a cure and the hormone has no
effect on the cause of the inflammation.
Depo-Medrone with Lidocaine may be used as follows:
Intra-articular administration
Rheumatoid arthritis
Osteo-arthritis with an inflammatory component
Periarticular administration
Epicondylitis
Intrabursal administration
Subacromial bursitis
Prepatellar bursitis
Olecranon bursitis
Tendon sheath administration
Tendinitis
Tenosynovitis
Epicondylitis
Dosage and administration
Depo-Medrone with Lidocaine should not be mixed with any other
preparation as flocculation of the product may occur. Parenteral drug
products should be inspected visually for particulate matter and discoloration
prior to administration whenever suspension and container permit.
Depo-Medrone with Lidocaine may be used by any of the following routes:
intra-articular, periarticular, intrabursal, and into the tendon sheath. It must
not be used by the intrathecal or intravenous routes. (See Contra-indications
and Side-effects).
Undesirable effects may be minimized by using the lowest effective dose for
the minimum period (see Special warnings and precautions).
Depo-Medrone with Lidocaine vials are intended for single dose use only.
Intra-articular: Rheumatoid arthritis, osteo-arthritis. The dose of
Depo-Medrone with Lidocaine depends on the size of the joint and the
severity of the condition. Repeated injections, if needed, may be given at
intervals of one to five or more weeks depending upon the degree of relief
obtained from the initial injection. A suggested dosage guide is: large joint
(knee, ankle, shoulder), 0.5 - 2 ml (20 - 80 mg of steroid); medium joint
(elbow, wrist), 0.25 - 1 ml (10 - 40 mg of steroid); small joint
(metacarpophalangeal, interphalangeal, sternoclavicular, acromioclavicular),
0.1 - 0.25 ml (4 - 10 mg of steroid).

Intrabursal: Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis. For
administration directly into bursae, 0.1 - 0.75 ml (4 - 30 mg of steroid). In
most acute cases, repeat injections are not needed.
Into the tendon sheath: Tendinitis, tenosynovitis, epicondylitis. For
administration directly into the tendon sheath, 0.1 - 0.75 ml (4 - 30 mg of
steroid). In recurrent or chronic conditions, repeat injections may be
necessary.
Special precautions should be observed when administering Depo-Medrone
with Lidocaine: Intra-articular injections should be made using precise,
anatomical localisation into the synovial space of the joint involved. The
injection site for each joint is determined by that location where the synovial
cavity is most superficial and most free of large vessels and nerves. Suitable
sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder,
phalangeal and hip joints. The spinal joints, unstable joints and those devoid
of synovial space are not suitable. Treatment failures are most frequently the
result of failure to enter the joint space. Intra-articular injections should be
made with care as follows: ensure correct positioning of the needle into the
synovial space and aspirate a few drops of joint fluid. The aspirating syringe
should then be replaced by another containing Depo-Medrone with
Lidocaine. To ensure position of the needle synovial fluid should be aspirated
and the injection made.
After injection the joint is moved slightly to aid mixing of the synovial fluid and
the suspension. Subsequent to therapy care should be taken for the patient
not to overuse the joint in which benefit has been obtained. Negligence in
this matter may permit an increase in joint deterioration that will more than
offset the beneficial effects of the steroid. Intrabursal injections should be
made as follows: the area around the injection site is prepared in a sterile
way and a wheal at the site made with 1 percent procaine hydrochloride
solution. A 20 to 24 gauge needle attached to a dry syringe is inserted into
the bursa and the fluid aspirated. The needle is left in place and the
aspirating syringe changed for a small syringe containing the desired dose.
After injection, the needle is withdrawn and a small dressing applied. In the
treatment of tenosynovitis and tendinitis, care should be taken to inject
Depo-Medrone with Lidocaine into the tendon sheath rather than into the
substance of the tendon. Due to the absence of a true tendon sheath, the
Achilles tendon should not be injected with Depo-Medrone with Lidocaine.
Children: For infants and children, the recommended dosage should be
reduced, but dosage should be governed by the severity of the condition
rather than by strict adherence to the ratio indicated by age or body weight.
Elderly patients: When used according to instructions, there is no information
to suggest that a change in dosage is warranted in the elderly. However,
treatment of elderly patients, particularly if long-term, should be planned
bearing in mind the more serious consequences of the common side-effects
of corticosteroids in old age and close clinical supervision is required (see
special warnings and precautions).
Contra-indications, warnings, etc.
Contra-indications: Depo-Medrone with Lidocaine is contra-indicated where
there is known hypersensitivity to components or to any local anaesthetics of
the amide type and in systemic infection unless anti-infective therapy is
employed.
Due to its potential for neurotoxicity, Depo-Medrone with Lidocaine must not
be given by the intrathecal route. In addition, as the product is a suspension
it must not be given by the intravenous route (see Side-effects).

Periarticular: Epicondylitis. Infiltrate 0.1 - 0.75 ml (4 - 30 mg of steroid) into
the affected area.
Page 1

Interactions
1. Convulsions have been reported with concurrent use of
methylprednisolone and cyclosporin. Since concurrent administration of
these agents results in a mutual inhibition of metabolism, it is possible that
convulsions and other adverse effects associated with the individual use of
either drug may be more apt to occur.
2. Drugs that induce hepatic enzymes, such as rifampicin, rifabutin,
carbamazepine, phenobarbitone, phenytoin, primidone, and
aminoglutethimide enhance the metabolism of corticosteroids and their
therapeutic effects may be reduced.
3. Drugs such as erythromycin and ketoconazole may inhibit the metabolism
of corticosteroids and thus decrease their clearance.
4. Steroids may reduce the effects of anticholinesterases in myasthenia
gravis. The desired effects of hypoglycaemic agents (including insulin),
anti-hypertensives and diuretics are antagonized by corticosteroids, and
the hypokalaemic effects of acetazolamide, loop diuretics, thiazide
diuretics and carbenoxolone are enhanced.
5. The efficacy of coumarin anticoagulants may be enhanced by concurrent
corticosteroid therapy and close monitoring of the INR or prothrombin time
is required to avoid spontaneous bleeding.
6. The renal clearance of salicylates is increased by corticosteroids and
steroid withdrawal may result in salicylate intoxication. Salicylates and
non-steroidal anti-inflammatory agents should be used cautiously in
conjunction with corticosteroids in hypothrombinaemia.
7. Steroids have been reported to interact with neuromuscular blocking
agents such as pancuronium with partial reversal of the neuromuscular
block.
Effects on ability to drive and to use machines: None stated.
Other undesirable effects (frequency and seriousness)
Side-effects: The incidence of predictable undesirable side-effects associated
with the use of corticosteroids, including hypothalamic-pituitary-adrenal
suppression correlates with the relative potency of the drug, dosage, timing
of administration and duration of treatment (see Special warnings and
precautions).
Side-effects for the Depo-Medrone component may be observed including:
PARENTERAL CORTICOSTEROID THERAPY - Anaphylactic reaction or
allergic reactions, hypopigmentation or hyperpigmentation, subcutaneous and
cutaneous atrophy, sterile abscess, post injection flare (following
intra-articular use), Charcot-like arthropathy.
GASTRO-INTESTINAL - Dyspepsia, peptic ulceration with perforation and
haemorrhage, abdominal distension, oesophageal ulceration, oesophageal
candidiasis, acute pancreatitis, perforation of bowel.
Increases in alanine transaminase (ALT, SGPT) aspartate transaminase
(AST, SGOT) and alkaline phosphatase have been observed following
corticosteroid treatment. These changes are usually small, not associated
with any clinical syndrome and are reversible upon discontinuation.
ANTI-INFLAMMATORY AND IMMUNOSUPPRESSIVE EFFECTS - Increased
susceptibility and severity of infections with suppression of clinical symptoms
and signs, opportunistic infections, may suppress reactions to skin tests,
recurrence of dormant tuberculosis (see Special warnings and precautions).
MUSCULOSKELETAL - Proximal myopathy, osteoporosis, vertebral and long
bone fractures, avascular osteonecrosis, tendon rupture, aseptic necrosis,
muscle weakness.
FLUID AND ELECTROLYTE DISTURBANCE - Sodium and water retention,
potassium loss, hypertension, hypokalaemic alkalosis, congestive heart
failure in susceptible patients.
DERMATOLOGICAL - Impaired healing, petechiae and ecchymosis, thin
fragile skin, skin atrophy, bruising, striae, telangiectasia, acne.
Page 2

ENDOCRINE/METABOLIC - Suppression of the hypothalamopituitary-adrenal axis, growth suppression in infancy, childhood and
adolescence, menstrual irregularity and amenorrhoea. Cushingoid facies,
hirsutism, weight gain, impaired carbohydrate tolerance with increased
requirement for antidiabetic therapy, negative nitrogen and calcium balance.
Increased appetite.
NEUROPSYCHIATRIC - A wide range of psychiatric reactions including
affective disorders (such as irritable, euphoric, depressed and labile mood
psychological dependence and suicidal thoughts), psychotic reactions
(including mania, delusions, hallucinations and aggravation of schizophrenia),
behavioural disturbances, irritability, anxiety, sleep disturbances, and
cognitive dysfunction including confusion and amnesia have been reported
for all corticosteroids. Reactions are common and may occur in both adults
and children. Psychological effects have been reported on withdrawal of
corticosteroids; the frequency is unknown. Increased intra-cranial pressure
with papilloedema in children (pseudotumour cerebri) has been reported,
usually after treatment withdrawal of methylprednisolone.
OPHTHALMIC - Increased intra-ocular pressure, glaucoma, papilloedema,
cataracts with possible damage to the optic nerve, corneal or scleral thinning,
exacerbation of ophthalmic viral or fungal disease, exophthalmos.
GENERAL - Leucocytosis, hypersensitivity including anaphylaxis,
thrombo-embolism, nausea, vertigo.
WITHDRAWAL SYMPTOMS - Too rapid a reduction of corticosteroid dosage
following prolonged treatment can lead to acute adrenal insufficiency,
hypotension and death. However, this is more applicable to corticosteroids
with an indication where continuous therapy is given (see Special warnings
and precautions).
A ’withdrawal syndrome’ may also occur including, fever, myalgia, arthralgia,
rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.
Side-effects for the Lidocaine component include:
CENTRAL NERVOUS SYSTEM - Light-headedness, nervousness,
apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or
double vision, vomiting, sensation of heat, cold, numbness, twitching,
tremors, convulsions, loss of consciousness, respiratory depression,
respiratory arrest.
CARDIOVASCULAR SYSTEM - Bradycardia, hypotension, cardiovascular
collapse, cardiac arrest.
ALLERGIC REACTIONS - Cutaneous lesions, urticaria, oedema,
anaphylactic reactions.
CERTAIN SIDE-EFFECTS REPORTED WITH SOME NON
RECOMMENDED ROUTES OF ADMINISTRATION:
Intrathecal: Usual systemic corticoid adverse reactions, headache,
meningismus, meningitis, paraplegia, spinal fluid abnormalities, nausea,
vomiting, sweating, arachnoiditis, convulsions.
Extradural: Wound dehiscence, loss of sphincter control.
Intranasal: Permanent/temporary blindness, allergic reactions, rhinitis.
Ophthalmic (Subconjunctival): Redness and itching, abscess, slough at
injection site, residue at injection site, increased intra-ocular pressure,
decreased vision - blindness, infection.

Special warnings and precautions
Warnings and Precautions:
1. A Patient Information Leaflet is provided in the pack by the manufacturer.
2. Undesirable effects may be minimized by using the lowest effective dose
for the minimum period. Frequent patient review is required to
appropriately titrate the dose against disease activity (see Dosage and
administration).
3. Patients should carry ’Steroid Treatment’ cards which give clear guidance
on the precautions to be taken to minimize risk and which provide details
of prescriber, drug, dosage and the duration of treatment.
4. Depo-Medrone with Lidocaine vials are intended for single dose use only.
Any multidose use of the product may lead to contamination.
5. Depo-Medrone with Lidocaine is not recommended for epidural,
intranasal, intra-ocular, or any other unapproved route of administration.
See Side-effects section for details of side-effects reported from some
non-recommended routes of administration.
6. Due to the absence of a true tendon sheath, the Achilles tendon should
not be injected with Depo-Medrone with Lidocaine.
7. While crystals of adrenal steroids in the dermis suppress inflammatory
reactions, their presence may cause disintegration of the cellular
elements and physiochemical changes in the ground substance of the
connective tissue. The resultant infrequently occurring dermal and/or
subdermal changes may form depressions in the skin at the injection site
and the possibility of depigmentation. The degree to which this reaction
occurs will vary with the amount of adrenal steroid injected. Regeneration
is usually complete within a few months or after all crystals of the adrenal
steroid have been absorbed. In order to minimize the incidence of dermal
and subdermal atrophy, care must be exercised not to exceed
recommended doses in injections. Multiple small injections into the area
of the lesion should be made whenever possible. The technique of
intra-articular injection should include precautions against injection or
leakage into the dermis.
8. Systemic absorption of methylprednisolone occurs following intra-articular
injection of Depo-Medrone with Lidocaine. Systemic as well as local
effects can therefore be expected.
9. Intra-articular corticosteroids are associated with a substantially increased
risk of inflammatory response in the joint, particularly bacterial infection
introduced with the injection. Charcot-like arthropathies have been
reported particularly after repeated injections. Appropriate examination of
any joint fluid present is necessary to exclude any bacterial infection, prior
to injection.
10. Following a single dose of Depo-Medrone with Lidocaine, plasma cortisol
levels are reduced and there is evidence of hypothalamic-pituitaryadrenal axis (HPA) suppression. This suppression lasts for a variable
period of up to 4 weeks. The usual dynamic tests of HPA axis function
can be used to diagnose evidence of impaired activity (e.g. Synacthen
test).
11. Adrenal cortical atrophy develops during prolonged therapy and may
persist for months after stopping treatment. In patients who have received
more than physiological doses of systemic corticosteroids (approximately
6 mg methylprednisolone) for greater than 3 weeks, withdrawal should not
be abrupt. How dose reduction should be carried out depends largely on
whether the disease is likely to relapse as the dose of systemic
corticosteroids is reduced. Clinical assessment of disease activity may be
needed during withdrawal. If the disease is unlikely to relapse on with
drawal of systemic corticosteroids, but there is uncertainty about HPA
suppression, the dose of systemic corticosteroid may be reduced rapidly
to physiological doses. Once a daily dose of 6 mg methylprednisolone is
reached, dose reduction should be slower to allow the HPA-axis to
recover.

Abrupt withdrawal of systemic corticosteroid treatment, which has continued
up to 3 weeks is appropriate if it considered that the disease is unlikely to
relapse. Abrupt withdrawal of doses up to 32 mg daily of methylprednisolone
for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in
the majority of patients. In the following patient groups, gradual withdrawal of
systemic corticosteroid therapy should be considered even after courses
lasting 3 weeks or less:
• Patients who have had repeated courses of systemic corticosteroids,
particularly if taken for greater than 3 weeks.
• When a short course has been prescribed within one year of cessation
of long-term therapy (months or years).
• Patients who may have reasons for adrenocortical insufficiency other
than exogenous corticosteroid therapy.
• Patients receiving doses of corticosteroid greater than 32 mg daily of
methylprednisolone.
• Patients repeatedly taking doses in the evening.
12. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
13. Because rare instances of anaphylactic reactions have occurred in
patients receiving parenteral corticosteroid therapy, appropriate
precautionary measures should be taken prior to administration,
especially when the patient has a history of drug allergy.
14. Corticosteroids may mask some signs of infection, and new infections
may appear during their use. Suppression of the inflammatory response
and immune function increases the susceptibility to fungal, viral and
bacterial infections and their severity. The clinical presentation may often
be atypical and may reach an advanced stage before being recognized.
15. Chickenpox is of serious concern since this normally minor illness may
be fatal in immunosuppressed patients. Patients (or parents of children)
without a definite history of chickenpox should be advised to avoid close
personal contact with chickenpox or herpes zoster and if exposed they
should seek urgent medical attention. Passive immunization with
varicella/zoster immunoglobulin (VZIG) is needed by exposed
non-immune patients who are receiving systemic corticosteroids or who
have used them within the previous 3 months; this should be given within
10 days of exposure to chickenpox. If a diagnosis of chickenpox is
confirmed, the illness warrants specialist care and urgent treatment.
Corticosteroids should not be stopped and the dose may need to be
increased.
16. Live vaccines should not be given to individuals with impaired immune
responsiveness. The antibody response to other vaccines may be
diminished.
17. If corticosteroids are indicated in patients with latent tuberculosis or
tuberculin reactivity, close observation is necessary as reactivation of the
disease may occur. During prolonged corticosteroid therapy, these
patients should receive chemoprophylaxis.
18. This product contains benzyl alcohol. Benzyl alcohol has been reported
to be associated with a fatal "Gasping Syndrome" in premature infants.
19. Care should be taken for patients receiving cardioactive drugs such as
digoxin because of steroid induced electrolyte disturbance/potassium
loss (see Side-effects).
20. The following precautions apply for parenteral corticosteroids: Following
intra-articular injection, a marked increase in pain accompanied by local
swelling, further restriction of joint motion, fever, and malaise are
suggestive of septic arthritis. If this complication occurs and the
diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should
be instituted.
No additional benefit derives from the intramuscular administration of
Depo-Medrone with Lidocaine. Where parenteral corticosteroid therapy for
sustained systemic effect is desired, plain Depo-Medrone should be used.
Local injection of a steroid into a previously infected joint is to be avoided.

Miscellaneous: Scalp, tonsillar fauces, sphenopalatine ganglion: blindness.
Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infections or contamination.
Ref:0926/260112/1P-B

Page 3

Special precautions:
Particular care is required when considering the use of systemic
corticosteroids in patients with the following conditions and frequent patient
monitoring is necessary.
1. Osteoporosis (post-menopausal females are particularly at risk).
2. Hypertension or congestive heart failure.
3. Existing or previous history of severe affective disorders (especially
previous steroid psychosis).
4. Diabetes mellitus (or a family history of diabetes).
5. History of tuberculosis.
6. Glaucoma (or a family history of glaucoma).
7. Previous corticosteroid-induced myopathy.
8. Liver failure or cirrhosis
9. Renal insufficiency.
10. Epilepsy.
11. Peptic ulceration.
12. Fresh intestinal anastomoses.
13. Predisposition to thrombophlebitis.
14. Abscess or other pyogenic infections.
15. Ulcerative colitis.
16. Diverticulitis.
17. Myasthenia gravis.
18. Ocular herpes simplex, for fear of corneal perforation.
19. Hypothyroidism.
20. Patients and/or carers should be warned that potentially severe
psychiatric adverse reactions may occur with systemic steroids (see
section 4.8). Symptoms typically emerge within a few days or weeks of
starting treatment. Risks may be higher with high doses/systemic
exposure (see also section 4.5 Interaction with Other Medicaments and
Other Forms of Interaction that can increase the risk of side effects),
although dose levels do not allow prediction of the onset, type, severity
or duration of reactions. Most reactions recover after either dose
reduction or withdrawal, although specific treatment may be necessary.
Patients/carers should be encouraged to seek medical advice if worrying
psychological symptoms develop, especially if depressed mood or
suicidal ideation is suspected. Patients/carers should be alert to possible
psychiatric disturbances that may occur either during or immediately after
dose tapering/withdrawal of systemic steroids, although such reactions
have been reported infrequently.
Particular care is required when considering the use of systemic
corticosteroids in patients with existing or previous history of severe affective
disorders in themselves or in their first degree relatives. These would include
depressive or manic-depressive illness and previous steroid psychosis.

neonate following prenatal exposure to corticosteroids but usually resolves
spontaneously following birth and is rarely clinically important. As with all
drugs, corticosteroids should only be prescribed when the benefits to the
mother and child outweigh the risks. When corticosteroids are essential,
however, patients with normal pregnancies may be treated as though they
were in the non-gravid state.
The use of local anaesthetics such as lidocaine during labour and delivery
may be associated with adverse effects on mother and foetus. Lidocaine
readily crosses the placenta.
Lactation
Corticosteroids are excreted in small amounts in breast milk, however, doses
of up to 40mg daily of methylprednisolone are unlikely to cause systemic
effects in the infant. Infants of mothers taking higher doses than this may
have a degree of adrenal suppression, but the benefits of breastfeeding are
likely to outweigh any theoretical risk.
It is not known whether lidocaine is excreted in human breast milk.
Use in children: Corticosteroids cause growth retardation in infancy,
childhood and adolescence which may be irreversible. Treatment should be
limited to the minimum dosage for the shortest possible time.
Use in the elderly: The common adverse effects of systemic corticosteroids
may be associated with more serious consequences in old age, especially
osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection
and thinning of the skin. Close clinical supervision is required to avoid
life-threatening reactions.
Overdosage: There is no clinical syndrome of acute overdosage with
Depo-Medrol with Lidocaine. Following overdosage the possibility of
adrenal suppression should be guarded against by gradual diminution of
dose levels over a period of time. In such event the patient may require to be
supported during any further traumatic episode.
Incompatibilities (major): None stated.
Pharmaceutical precautions
Depo-Medrol with Lidocaine should not be stored above 25° C and protected
from freezing.
Depo-Medrol with Lidocaine should not be mixed with any other fluid.
Discard any remaining suspension after use.

Use in children: Corticosteroids cause growth retardation in infancy,
childhood and adolescence which may be irreversible. Treatment should be
limited to the minimum dosage for the shortest possible time.
Use in the elderly: The common adverse effects of systemic corticosteroids
may be associated with more serious consequences in old age, especially
osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection
and thinning of the skin. Close clinical supervision is required to avoid
life-threatening reactions.
Use in Pregnancy and Lactation:
Pregnancy
The ability of corticosteroids to cross the placenta varies between individual
drugs, however, methylprednisolone does cross the placenta.
Administration of corticosteroids to pregnant animals can cause abnormalities
of foetal development including cleft palate, intra-uterine growth retardation
and affects on brain growth and development. There is no evidence that
corticosteroids result in an increased incidence of congenital abnormalities,
such as cleft palate in man, however, when administered for long periods or
repeatedly during pregnancy, corticosteroids may increase the risk of
intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the

Legal Category:
POM
Package quantities:
1 x 1ml vial pack or 3 x 1ml packs.
Manufacturer and Licence Holder
This mediciene is manufactured by Pfizer manufacturing Belgium NV,
Rijksweg 12, 2870 Puurs, Belgium and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL:15184/0926 - Depo-Medrol with Lidocaine
Depo-Medrol is a registered trademark of Pharmacia & Upjohn Limited.
Leaflet revision date: 26/01/12

Depo-Medrol ® with Lidocaine

Ref:0926/260112/2P-F

(methylprednisolone acetate and lidocaine hydrochloride)

PHYSICIAN LEAFLET
Presentation
White, sterile aqueous suspension for injection containing 40 mg per ml
methylprednisolone acetate and 10 mg per ml lidocaine hydrochloride. Also
contains macrogol, sodium chloride, myristyl-gamma-picolinium chloride,
benzyl alcohol and sterile water for injections.
Uses
Corticosteroid (glucocorticoid). Depo-Medrol with Lidocaine is indicated in
conditions requiring a glucocorticoid effect: e.g. anti-inflammatory or
anti-rheumatic. It is recommended for local use where the added anaesthetic
effect would be considered advantageous.
Therapy with Depo-Medrol with Lidocaine does not obviate the need for the
conventional measures usually employed. Although this method of treatment
will ameliorate symptoms, it is in no sense a cure and the hormone has no
effect on the cause of the inflammation.
Depo-Medrol with Lidocaine may be used as follows:
Intra-articular administration
Rheumatoid arthritis
Osteo-arthritis with an inflammatory component
Periarticular administration
Epicondylitis
Intrabursal administration
Subacromial bursitis
Prepatellar bursitis
Olecranon bursitis
Tendon sheath administration
Tendinitis
Tenosynovitis
Epicondylitis
Dosage and administration
Depo-Medrol with Lidocaine should not be mixed with any other
preparation as flocculation of the product may occur. Parenteral drug
products should be inspected visually for particulate matter and discoloration
prior to administration whenever suspension and container permit.
Depo-Medrol with Lidocaine may be used by any of the following routes:
intra-articular, periarticular, intrabursal, and into the tendon sheath. It must
not be used by the intrathecal or intravenous routes. (See Contra-indications
and Side-effects).
Undesirable effects may be minimized by using the lowest effective dose for
the minimum period (see Special warnings and precautions).
Depo-Medrol with Lidocaine vials are intended for single dose use only.
Intra-articular: Rheumatoid arthritis, osteo-arthritis. The dose of
Depo-Medrol with Lidocaine depends on the size of the joint and the
severity of the condition. Repeated injections, if needed, may be given at
intervals of one to five or more weeks depending upon the degree of relief
obtained from the initial injection. A suggested dosage guide is: large joint
(knee, ankle, shoulder), 0.5 - 2 ml (20 - 80 mg of steroid); medium joint
(elbow, wrist), 0.25 - 1 ml (10 - 40 mg of steroid); small joint
(metacarpophalangeal, interphalangeal, sternoclavicular, acromioclavicular),
0.1 - 0.25 ml (4 - 10 mg of steroid).

Intrabursal: Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis. For
administration directly into bursae, 0.1 - 0.75 ml (4 - 30 mg of steroid). In
most acute cases, repeat injections are not needed.
Into the tendon sheath: Tendinitis, tenosynovitis, epicondylitis. For
administration directly into the tendon sheath, 0.1 - 0.75 ml (4 - 30 mg of
steroid). In recurrent or chronic conditions, repeat injections may be
necessary.
Special precautions should be observed when administering Depo-Medrol
with Lidocaine: Intra-articular injections should be made using precise,
anatomical localisation into the synovial space of the joint involved. The
injection site for each joint is determined by that location where the synovial
cavity is most superficial and most free of large vessels and nerves. Suitable
sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder,
phalangeal and hip joints. The spinal joints, unstable joints and those devoid
of synovial space are not suitable. Treatment failures are most frequently the
result of failure to enter the joint space. Intra-articular injections should be
made with care as follows: ensure correct positioning of the needle into the
synovial space and aspirate a few drops of joint fluid. The aspirating syringe
should then be replaced by another containing Depo-Medrol with Lidocaine.
To ensure position of the needle synovial fluid should be aspirated and the
injection made.
After injection the joint is moved slightly to aid mixing of the synovial fluid and
the suspension. Subsequent to therapy care should be taken for the patient
not to overuse the joint in which benefit has been obtained. Negligence in
this matter may permit an increase in joint deterioration that will more than
offset the beneficial effects of the steroid. Intrabursal injections should be
made as follows: the area around the injection site is prepared in a sterile
way and a wheal at the site made with 1 percent procaine hydrochloride
solution. A 20 to 24 gauge needle attached to a dry syringe is inserted into
the bursa and the fluid aspirated. The needle is left in place and the
aspirating syringe changed for a small syringe containing the desired dose.
After injection, the needle is withdrawn and a small dressing applied. In the
treatment of tenosynovitis and tendinitis, care should be taken to inject
Depo-Medrol with Lidocaine into the tendon sheath rather than into the
substance of the tendon. Due to the absence of a true tendon sheath, the
Achilles tendon should not be injected with Depo-Medrol with Lidocaine.
Children: For infants and children, the recommended dosage should be
reduced, but dosage should be governed by the severity of the condition
rather than by strict adherence to the ratio indicated by age or body weight.
Elderly patients: When used according to instructions, there is no information
to suggest that a change in dosage is warranted in the elderly. However,
treatment of elderly patients, particularly if long-term, should be planned
bearing in mind the more serious consequences of the common side-effects
of corticosteroids in old age and close clinical supervision is required (see
special warnings and precautions).
Contra-indications, warnings, etc.
Contra-indications: Depo-Medrol with Lidocaine is contra-indicated where
there is known hypersensitivity to components or to any local anaesthetics of
the amide type and in systemic infection unless anti-infective therapy is
employed.
Due to its potential for neurotoxicity, Depo-Medrol with Lidocaine must not be
given by the intrathecal route. In addition, as the product is a suspension it
must not be given by the intravenous route (see Side-effects).

Periarticular: Epicondylitis. Infiltrate 0.1 - 0.75 ml (4 - 30 mg of steroid) into
the affected area.
Page 1

Interactions
1. Convulsions have been reported with concurrent use of
methylprednisolone and cyclosporin. Since concurrent administration of
these agents results in a mutual inhibition of metabolism, it is possible that
convulsions and other adverse effects associated with the individual use of
either drug may be more apt to occur.
2. Drugs that induce hepatic enzymes, such as rifampicin, rifabutin,
carbamazepine, phenobarbitone, phenytoin, primidone, and
aminoglutethimide enhance the metabolism of corticosteroids and their
therapeutic effects may be reduced.
3. Drugs such as erythromycin and ketoconazole may inhibit the metabolism
of corticosteroids and thus decrease their clearance.
4. Steroids may reduce the effects of anticholinesterases in myasthenia
gravis. The desired effects of hypoglycaemic agents (including insulin),
anti-hypertensives and diuretics are antagonized by corticosteroids, and
the hypokalaemic effects of acetazolamide, loop diuretics, thiazide
diuretics and carbenoxolone are enhanced.
5. The efficacy of coumarin anticoagulants may be enhanced by concurrent
corticosteroid therapy and close monitoring of the INR or prothrombin time
is required to avoid spontaneous bleeding.
6. The renal clearance of salicylates is increased by corticosteroids and
steroid withdrawal may result in salicylate intoxication. Salicylates and
non-steroidal anti-inflammatory agents should be used cautiously in
conjunction with corticosteroids in hypothrombinaemia.
7. Steroids have been reported to interact with neuromuscular blocking
agents such as pancuronium with partial reversal of the neuromuscular
block.
Effects on ability to drive and to use machines: None stated.
Other undesirable effects (frequency and seriousness)
Side-effects: The incidence of predictable undesirable side-effects associated
with the use of corticosteroids, including hypothalamic-pituitary-adrenal
suppression correlates with the relative potency of the drug, dosage, timing
of administration and duration of treatment (see Special warnings and
precautions).
Side-effects for the Depo-Medrol component may be observed including:
PARENTERAL CORTICOSTEROID THERAPY - Anaphylactic reaction or
allergic reactions, hypopigmentation or hyperpigmentation, subcutaneous and
cutaneous atrophy, sterile abscess, post injection flare (following
intra-articular use), Charcot-like arthropathy.
GASTRO-INTESTINAL - Dyspepsia, peptic ulceration with perforation and
haemorrhage, abdominal distension, oesophageal ulceration, oesophageal
candidiasis, acute pancreatitis, perforation of bowel.
Increases in alanine transaminase (ALT, SGPT) aspartate transaminase
(AST, SGOT) and alkaline phosphatase have been observed following
corticosteroid treatment. These changes are usually small, not associated
with any clinical syndrome and are reversible upon discontinuation.
ANTI-INFLAMMATORY AND IMMUNOSUPPRESSIVE EFFECTS - Increased
susceptibility and severity of infections with suppression of clinical symptoms
and signs, opportunistic infections, may suppress reactions to skin tests,
recurrence of dormant tuberculosis (see Special warnings and precautions).
MUSCULOSKELETAL - Proximal myopathy, osteoporosis, vertebral and long
bone fractures, avascular osteonecrosis, tendon rupture, aseptic necrosis,
muscle weakness.
FLUID AND ELECTROLYTE DISTURBANCE - Sodium and water retention,
potassium loss, hypertension, hypokalaemic alkalosis, congestive heart
failure in susceptible patients.
DERMATOLOGICAL - Impaired healing, petechiae and ecchymosis, thin
fragile skin, skin atrophy, bruising, striae, telangiectasia, acne.
Page 2

ENDOCRINE/METABOLIC - Suppression of the hypothalamopituitary-adrenal axis, growth suppression in infancy, childhood and
adolescence, menstrual irregularity and amenorrhoea. Cushingoid facies,
hirsutism, weight gain, impaired carbohydrate tolerance with increased
requirement for antidiabetic therapy, negative nitrogen and calcium balance.
Increased appetite.
NEUROPSYCHIATRIC - A wide range of psychiatric reactions including
affective disorders (such as irritable, euphoric, depressed and labile mood
psychological dependence and suicidal thoughts), psychotic reactions
(including mania, delusions, hallucinations and aggravation of schizophrenia),
behavioural disturbances, irritability, anxiety, sleep disturbances, and
cognitive dysfunction including confusion and amnesia have been reported
for all corticosteroids. Reactions are common and may occur in both adults
and children. Psychological effects have been reported on withdrawal of
corticosteroids; the frequency is unknown. Increased intra-cranial pressure
with papilloedema in children (pseudotumour cerebri) has been reported,
usually after treatment withdrawal of methylprednisolone.
OPHTHALMIC - Increased intra-ocular pressure, glaucoma, papilloedema,
cataracts with possible damage to the optic nerve, corneal or scleral thinning,
exacerbation of ophthalmic viral or fungal disease, exophthalmos.
GENERAL - Leucocytosis, hypersensitivity including anaphylaxis,
thrombo-embolism, nausea, vertigo.
WITHDRAWAL SYMPTOMS - Too rapid a reduction of corticosteroid dosage
following prolonged treatment can lead to acute adrenal insufficiency,
hypotension and death. However, this is more applicable to corticosteroids
with an indication where continuous therapy is given (see Special warnings
and precautions).
A ’withdrawal syndrome’ may also occur including, fever, myalgia, arthralgia,
rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.
Side-effects for the Lidocaine component include:
CENTRAL NERVOUS SYSTEM - Light-headedness, nervousness,
apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or
double vision, vomiting, sensation of heat, cold, numbness, twitching,
tremors, convulsions, loss of consciousness, respiratory depression,
respiratory arrest.
CARDIOVASCULAR SYSTEM - Bradycardia, hypotension, cardiovascular
collapse, cardiac arrest.
ALLERGIC REACTIONS - Cutaneous lesions, urticaria, oedema,
anaphylactic reactions.
CERTAIN SIDE-EFFECTS REPORTED WITH SOME NON
RECOMMENDED ROUTES OF ADMINISTRATION:
Intrathecal: Usual systemic corticoid adverse reactions, headache,
meningismus, meningitis, paraplegia, spinal fluid abnormalities, nausea,
vomiting, sweating, arachnoiditis, convulsions.
Extradural: Wound dehiscence, loss of sphincter control.
Intranasal: Permanent/temporary blindness, allergic reactions, rhinitis.
Ophthalmic (Subconjunctival): Redness and itching, abscess, slough at
injection site, residue at injection site, increased intra-ocular pressure,
decreased vision - blindness, infection.

Special warnings and precautions
Warnings and Precautions:
1. A Patient Information Leaflet is provided in the pack by the manufacturer.
2. Undesirable effects may be minimized by using the lowest effective dose
for the minimum period. Frequent patient review is required to
appropriately titrate the dose against disease activity (see Dosage and
administration).
3. Patients should carry ’Steroid Treatment’ cards which give clear guidance
on the precautions to be taken to minimize risk and which provide details
of prescriber, drug, dosage and the duration of treatment.
4. Depo-Medrol with Lidocaine vials are intended for single dose use only.
Any multidose use of the product may lead to contamination.
5. Depo-Medrol with Lidocaine is not recommended for epidural,
intranasal, intra-ocular, or any other unapproved route of administration.
See Side-effects section for details of side-effects reported from some
non-recommended routes of administration.
6. Due to the absence of a true tendon sheath, the Achilles tendon should
not be injected with Depo-Medrol with Lidocaine.
7. While crystals of adrenal steroids in the dermis suppress inflammatory
reactions, their presence may cause disintegration of the cellular
elements and physiochemical changes in the ground substance of the
connective tissue. The resultant infrequently occurring dermal and/or
subdermal changes may form depressions in the skin at the injection site
and the possibility of depigmentation. The degree to which this reaction
occurs will vary with the amount of adrenal steroid injected. Regeneration
is usually complete within a few months or after all crystals of the adrenal
steroid have been absorbed. In order to minimize the incidence of dermal
and subdermal atrophy, care must be exercised not to exceed
recommended doses in injections. Multiple small injections into the area
of the lesion should be made whenever possible. The technique of
intra-articular injection should include precautions against injection or
leakage into the dermis.
8. Systemic absorption of methylprednisolone occurs following intra-articular
injection of Depo-Medrol with Lidocaine. Systemic as well as local
effects can therefore be expected.
9. Intra-articular corticosteroids are associated with a substantially increased
risk of inflammatory response in the joint, particularly bacterial infection
introduced with the injection. Charcot-like arthropathies have been
reported particularly after repeated injections. Appropriate examination of
any joint fluid present is necessary to exclude any bacterial infection, prior
to injection.
10. Following a single dose of Depo-Medrol with Lidocaine, plasma cortisol
levels are reduced and there is evidence of hypothalamic-pituitaryadrenal axis (HPA) suppression. This suppression lasts for a variable
period of up to 4 weeks. The usual dynamic tests of HPA axis function
can be used to diagnose evidence of impaired activity (e.g. Synacthen
test).
11. Adrenal cortical atrophy develops during prolonged therapy and may
persist for months after stopping treatment. In patients who have received
more than physiological doses of systemic corticosteroids (approximately
6 mg methylprednisolone) for greater than 3 weeks, withdrawal should not
be abrupt. How dose reduction should be carried out depends largely on
whether the disease is likely to relapse as the dose of systemic
corticosteroids is reduced. Clinical assessment of disease activity may be
needed during withdrawal. If the disease is unlikely to relapse on with
drawal of systemic corticosteroids, but there is uncertainty about HPA
suppression, the dose of systemic corticosteroid may be reduced rapidly
to physiological doses. Once a daily dose of 6 mg methylprednisolone is
reached, dose reduction should be slower to allow the HPA-axis to
recover.

Abrupt withdrawal of systemic corticosteroid treatment, which has continued
up to 3 weeks is appropriate if it considered that the disease is unlikely to
relapse. Abrupt withdrawal of doses up to 32 mg daily of methylprednisolone
for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in
the majority of patients. In the following patient groups, gradual withdrawal of
systemic corticosteroid therapy should be considered even after courses
lasting 3 weeks or less:
• Patients who have had repeated courses of systemic corticosteroids,
particularly if taken for greater than 3 weeks.
• When a short course has been prescribed within one year of cessation
of long-term therapy (months or years).
• Patients who may have reasons for adrenocortical insufficiency other
than exogenous corticosteroid therapy.
• Patients receiving doses of corticosteroid greater than 32 mg daily of
methylprednisolone.
• Patients repeatedly taking doses in the evening.
12. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
13. Because rare instances of anaphylactic reactions have occurred in
patients receiving parenteral corticosteroid therapy, appropriate
precautionary measures should be taken prior to administration,
especially when the patient has a history of drug allergy.
14. Corticosteroids may mask some signs of infection, and new infections
may appear during their use. Suppression of the inflammatory response
and immune function increases the susceptibility to fungal, viral and
bacterial infections and their severity. The clinical presentation may often
be atypical and may reach an advanced stage before being recognized.
15. Chickenpox is of serious concern since this normally minor illness may
be fatal in immunosuppressed patients. Patients (or parents of children)
without a definite history of chickenpox should be advised to avoid close
personal contact with chickenpox or herpes zoster and if exposed they
should seek urgent medical attention. Passive immunization with
varicella/zoster immunoglobulin (VZIG) is needed by exposed
non-immune patients who are receiving systemic corticosteroids or who
have used them within the previous 3 months; this should be given within
10 days of exposure to chickenpox. If a diagnosis of chickenpox is
confirmed, the illness warrants specialist care and urgent treatment.
Corticosteroids should not be stopped and the dose may need to be
increased.
16. Live vaccines should not be given to individuals with impaired immune
responsiveness. The antibody response to other vaccines may be
diminished.
17. If corticosteroids are indicated in patients with latent tuberculosis or
tuberculin reactivity, close observation is necessary as reactivation of the
disease may occur. During prolonged corticosteroid therapy, these
patients should receive chemoprophylaxis.
18. This product contains benzyl alcohol. Benzyl alcohol has been reported
to be associated with a fatal "Gasping Syndrome" in premature infants.
19. Care should be taken for patients receiving cardioactive drugs such as
digoxin because of steroid induced electrolyte disturbance/potassium
loss (see Side-effects).
20. The following precautions apply for parenteral corticosteroids: Following
intra-articular injection, a marked increase in pain accompanied by local
swelling, further restriction of joint motion, fever, and malaise are
suggestive of septic arthritis. If this complication occurs and the
diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should
be instituted.
No additional benefit derives from the intramuscular administration of
Depo-Medrol with Lidocaine. Where parenteral corticosteroid therapy for
sustained systemic effect is desired, plain Depo-Medrol should be used.
Local injection of a steroid into a previously infected joint is to be avoided.

Miscellaneous: Scalp, tonsillar fauces, sphenopalatine ganglion: blindness.
Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infections or contamination.
Ref:0926/260112/2P-B

Page 3

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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