DEPO-MEDRONE WITH LIDOCAINE (40MG + 10MG)/ML INJECTION
Active substance(s): LIDOCAINE HYDROCHLORIDE / METHYLPREDNISOLONE ACETATE / LIDOCAINE HYDROCHLORIDE / METHYLPREDNISOLONE ACETATE / LIDOCAINE HYDROCHLORIDE / METHYLPREDNISOLONE ACETATE
PATIENT INFORMATION LEAFLET
Depo-Medrone® with Lidocaine
(40mg + 10mg)/ml Injection
(methylprednisolone acetate and
The name of your medicine is Depo-Medrone with Lidocaine
(40mg + 10mg)/ml Injection. Throughout this leaflet it will be
referred to as Depo-Medrone with Lidocaine.
Read all of this leaflet carefully before you start taking
• Keep this leaflet. You may need to read it again
• If you have any further questions please ask your doctor or
• 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
In this leaflet:
1. What Depo-Medrone with Lidocaine is and what it is
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
Depo-Medrone® with Lidocaine
(40mg + 10mg)/ml Injection
1. What Depo-Medrone with
1. Lidocaine is and what it is
2. 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, which is a
local anaesthetic. Lidocaine helps to reduce any
local pain caused by injecting this medicine.
This medicine will be injected by a doctor or
nurse to help treat the symptoms caused by the
• 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
• 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
Do not use Depo-Medrone with Lidocaine if:
• You think you have ever suffered an allergic
reaction, or any other type of reaction after
Depo-Medrone with Lidocaine, any other
medicine containing a corticosteroid or local
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).
(methylprednisolone acetate and
Undesirable effects may be minimized by using the lowest
effective dose for the minimum period (see Special warnings and
The name of the medicine is Depo-Medrone with Lidocaine (40mg + 10mg)/ml
Injection. Throughout this leaflet it will be referred to as Depo-Medrone with
Depo-Medrone with Lidocaine vials are intended for single dose
White, sterile aqueous suspension for injection contained in a clear glass vial
with a rubber cap and metal seal. There is a blue plastic tamper proof seal on
top of the metal seal. Each 1 ml of suspension contains 40mg per ml methylprednisolone and 10mg per ml Lidocaine Hydrochloride. Also contains
macrogol, sodium chloride, myristyl-gamma-picolinium chloride, benzyl
alcohol, sodium hydroxide, hydrochloric acid and water for injection.
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:
Osteo-arthritis with an inflammatory component
Tendon sheath administration
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
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).
Periarticular: Epicondylitis. Infiltrate 0.1-0.75 ml (4-30 mg of
steroid) into the affected area.
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
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.
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
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
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 with Lidocaine,
or having a family history of these illnesses.
• Diabetes (or if there is a family history of
• 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
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Joint infection - which is active and so
• Kidney or liver disease.
• Muscle problems (pain or weakness) have
happened while taking steroid medicines in
• Myasthenia gravis (a condition causing tired
and weak muscles).
• Osteoporosis (brittle bones).
• Skin abscess.
• Stomach ulcer or other serious stomach or
• 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.
You must tell your doctor before you take this
medicine if you have any of the conditions listed
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 Lidocaine 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
• Acetazolamide - used to treat glaucoma and
• Aminoglutethimide - used for treating
• 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, carbamazepine, phenytoin
and primidone - used to treat epilepsy.
• Carbenoxolone - used for heartburn and acid
• Ciclosporin - used to treat conditions such as
severe rheumatoid arthritis, severe psoriasis
or following an organ or bone marrow
• 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
• 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.
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 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 anaesthetist that you are taking this
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.
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
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.
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
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
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
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,
ENDOCRINE/METABOLIC - Suppression of the
hypothalamo-pituitary-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.
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
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).
1. Convulsions have been reported with concurrent use of
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
Side-effects for the Depo-Medrone component may be observed
PARENTERAL CORTICOSTEROID THERAPY - Anaphylactic
reaction or allergic reactions, hypopigmentation or
hyperpigmentation, subcutaneous and cutaneous atrophy, sterile
abscess, post injection flare (following intra-articular use),
GASTRO-INTESTINAL - Dyspepsia, peptic ulceration with
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.
Driving and Using Machines
There are no special precautions while you are
being treated with this medicine.
Important information about some of the
ingredients of Depo-Medrone with Lidocaine
3. How Depo-Medrone with
Lidocaine is given to you
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.
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.
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
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)
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
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,
CARDIOVASCULAR SYSTEM - Bradycardia, hypotension,
cardiovascular collapse, cardiac arrest.
ALLERGIC REACTIONS - Cutaneous lesions, urticaria, oedema,
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,
Extradural: Wound dehiscence, loss of sphincter control.
Intranasal: Permanent/temporary blindness, allergic reactions,
Ophthalmic (Subconjunctival): Redness and itching, abscess,
slough at injection site, residue at injection site, increased
intra-ocular pressure, decreased vision - blindness, infection.
Miscellaneous: Scalp, tonsillar fauces, sphenopalatine
Special warnings and precautions
Warnings and Precautions:
1. A Patient Information Leaflet is provided in the pack by the
2. Undesirable effects may be minimized by using the lowest
effective dose for the minimum period. Frequent patient
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.
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.
Corticosteroids can affect growth in children so
your doctor will prescribe the lowest dose that
will be effective for your child.
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
Stopping/reducing the dose of your
Depo-Medrone with Lidocaine
Your doctor will decide when it is time to stop
You will need to come off this treatment slowly if
• have been given more than 6 mg (0.15 ml)
Depo-Medrone with Lidocaine for more than
• 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
• 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
If your symptoms seem to return or get worse
review is required to appropriately titrate the dose against
disease activity (see Dosage and administration).
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.
Depo-Medrone with Lidocaine vials are intended for single
dose use only. Any multidose use of the product may lead
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.
Due to the absence of a true tendon sheath, the Achilles
tendon should not be injected with Depo-Medrone with
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.
Systemic absorption of methylprednisolone occurs
following intra-articular injection of Depo-Medrone with
Lidocaine. Systemic as well as local effects can therefore
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.
as your dose of this medicine is reduced tell
your doctor immediately.
Mental problems while taking Depo-Medrone
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
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
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
• 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
10. Following a single dose of Depo-Medrone with Lidocaine,
plasma cortisol levels are reduced and there is evidence of
hypothalamic-pituitary-adrenal 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
withdrawal 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
• When a short course has been prescribed within one
year of cessation of long-term therapy (months or
• Patients who may have reasons for adrenocortical
insufficiency other than exogenous corticosteroid
• 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
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 sideeffects, or notice any other unusual effects
not mentioned in this leaflet, tell your doctor
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
• High blood pressure, symptoms of which are
headaches, or generally feeling unwell.
• Increased numbers of white blood cells
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).
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers or thrush in the gullet (discomfort on
• Bloated stomach.
and/or a mineralocorticoid should be administered
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.
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.
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.
Live vaccines should not be given to individuals with
impaired immune responsiveness. The antibody response to
other vaccines may be diminished.
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
This product contains benzyl alcohol. Benzyl alcohol has
been reported to be associated with a fatal “Gasping
Syndrome” in premature infants.
Care should be taken for patients receiving cardioactive
drugs such as digoxin because of steroid induced
electrolyte disturbance/potassium loss (see Side-effects).
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
• Persistent hiccups, especially when high
doses are taken.
• 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
• 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
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or double vision.
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
• Round or moon-shaped face (Cushingoid
• 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.
• 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).
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
Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infections or
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
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.
11. Peptic ulceration.
12. Fresh intestinal anastomoses.
13. Predisposition to thrombophlebitis.
14. Abscess or other pyogenic infections.
15. Ulcerative colitis.
17. Myasthenia gravis.
18. Ocular herpes simplex, for fear of corneal perforation.
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
• 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
• 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
• Feeling high (mania) or moods that go up and
• 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
• Abscess, especially near injection sites
• Poor wound healing.
• Thinning of skin with stretch marks.
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or raised
patches which are an unusual colour.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more
information on the safety of this medicine.
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
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
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
Use in Pregnancy and Lactation:
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 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
5. How to store Depo-Medrone with
This medicine must not be used after the expiry date ‘EXP’
shown on the container.
Do not store above 25°C.
Do not freeze.
Keep out of the sight and reach of children.
If you notice any sign of discolouration or deterioration of this
medicine, please tell your pharmacist immediately.
6. Further information
What Depo-Medrone with Lidocaine contains
Each 1 ml of suspension contains 40mg of methyl-prednisolone
and 10mg of Lidocaine Hydrochloride.
This medicine also contains macrogol, sodium chloride,
myristyl-gamma-picolinium chloride, benzyl alcohol, sodium
hydroxide, hydrochloric acid and water for injection.
What Depo-Medrone with Lidocaine looks like
Depo-Medrone with Lidocaine is a white, sterile aqueous
suspension for injection contained in a clear glass vial with a
rubber cap and metal seal. There is a blue plastic tamper proof
seal on top of the metal seal.
Depo-Medrone with Lidocaine is available in a packs containing
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd,
repackaged by Ginova UK Ltd both at St James’ House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by Pfizer Manufacturing Belgium NV/SA, Rijksweg
12, Puurs, B-2870, Belgium
Depo-Medrone with Lidocaine (40mg+10mg)/ml Injection
PL No: 18067/0293
Date leaflet last revised on 27th July 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.
Depo-Medrone® is a registered trademark.
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.
Corticosteroids are excreted in small amounts in breast milk, however, doses of
up to 40 mg daily of methylprednisolone are unlikely to cause systemic effects in
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
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
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.
Depo-Medrone with Lidocaine should be stored below 25°C and protected from
Depo-Medrone with Lidocaine should not be mixed with any other fluid. Discard
any remaining suspension after use.
Depo-Medrone with Lidocaine is available in packs containing 1 vial.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd, repackaged by
Ginova UK Ltd both at St James’ House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by Pfizer Manufacturing Belgium NV/SA, Rijksweg 12, Puurs,
Depo-Medrone with Lidocaine (40mg + 10mg)/ml Injection
PL No: 18067/0293
Date leaflet last revised on 27th July 2015.
Depo-Medrone® is a registered trademark.
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.