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DEPO-MEDRONE WITH LIDOCAINE (40MG + 10MG)/ML INJECTION

Active substance(s): LIDOCAINE HYDROCHLORIDE / METHYLPREDNISOLONE ACETATE

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500808/PL1g

PATIENT INFORMATION LEAFLET

Depo-Medrone
with Lidocaine
(40mg + 10mg)/ml Injection
®

(methylprednisolone acetate and
lidocaine hydrochloride)
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 this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Depo-Medrone with Lidocaine is and what it is used for
2. What you need to know before you use Depo-Medrone with Lidocaine
3. How to use Depo-Medrone with Lidocaine
4. Possible side effects
5. How to store Depo-Medrone with Lidocaine
6. Contents of the pack and other information

1. What Depo-Medrone with Lidocaine is and
what it is used for
Depo-Medrone with Lidocaine contains methylprednisolone acetate and
lidocaine hydrochloride.

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 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.

The following information is intended for healthcare
professionals only.

visually for particulate matter and discolouration 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 sections 4.3 and 4.8).

Depo-Medrone®
with Lidocaine
(40mg + 10mg)/ml Injection

Adults
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).

(methylprednisolone acetate and
lidocaine hydrochloride)
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.

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 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.
Paediatric population
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.

1. NAME OF THE MEDICINAL PRODUCT
Depo-Medrone with Lidocaine (40mg + 10mg)/ml Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Methylprednisolone 4%, Lidocaine Hydrochloride 1%
Excipients with known effect:
Also contains 8.7 mg/ml benzyl alcohol
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Suspension for Injection.
White, sterile aqueous suspension
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
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.
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
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.
4.2 Posology and method of administration
Depo-Medrone with Lidocaine should not be mixed with any other preparations as
flocculation of the product may occur. Parenteral drug products should be inspected

Elderly:
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 section 4.4).
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.
The usual sterile precautions should be observed with each injection.
4.3 Contraindications
Depo-Medrone with Lidocaine is contraindicated:
• in patients with known hypersensitivity to the active substances or to any of the
excipients listed in section 6.1
• in patients with known hypersensitivity to other local anaesthetics of the amide type
• in patients who have systemic infection unless specific anti-infective therapy is
employed

Your doctor may use this medicine to treat conditions other than those listed
above. You must talk to your doctor, if you do not feel better or if you feel worse.

2. What you need to know before you use
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, or any other
medicine containing a corticosteroid or local anaesthetic or any of the other
ingredients of this medicine (listed in section 6). 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.
• If you have recently had, or are about to have any vaccination.
• In premature babies or neonates.
See your doctor immediately if any of the above applies to you.
Do not inject this medicine:
• into the Achilles tendon (which is located behind the ankle joint)
• directly into a vein (intravenous), the spinal cord (intrathecal), into the
nostrils (intranasal), in the eye (intraocular).
Warnings and precautions
Talk to your doctor or nurse before taking Depo-Medrone with Lidocaine 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.
• Acute adrenal insufficiency (when your body cannot produce enough
corticosteroid due to problems with your adrenal glands).
• Acute pancreatitis (inflammation of the pancreas).
• Chickenpox, measles, shingles or a herpes eye infection. If you think
you have been in contact with someone with chickenpox, measles 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.
• Cushing’s disease (condition caused by an excess of cortisol hormone in
your body).
• Diabetes (or if there is a family history of diabetes).

• for use by the intrathecal route (due to its potential for neurotoxicity)
• for use by the intravenous route (see section 4.8)
Administration of live or live, attenuated vaccines is contraindicated in patients
receiving immunosuppressive doses of corticosteroids.
4.4 Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the
minimum period. Frequent patient review is required to appropriately titrate the dose
against disease activity (see section 4.2).
Depo-Medrone with Lidocaine vials are intended for single dose use only. Any
multidose use of the product may lead to contamination.
Depo-Medrone with Lidocaine is not recommended for intranasal, intra-ocular, or any
other unapproved route of administration.
Severe medical events have been reported in association with the intrathecal/epidural
routes of administration (see section 4.8). Appropriate measures must be taken to
avoid intravascular injection.
Due to the absence of a true tendon sheath, the Achilles tendon should not be
injected with Depo-Medrone with Lidocaine.
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 be
expected.
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.
The following precautions apply for parenteral corticosteroids:
Following intra-articular injection, the occurrence of 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.
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.
Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infections or contamination.
Immunosuppressant Effects/Increased Susceptibility to Infections
Corticosteroids may increase susceptibility to infection, 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

• Epilepsy, fits or seizures.
• 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).
• Hypotension (low 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).
• If you have recently had an operation.
• Osteoporosis (brittle bones).
• Pheochromocytoma (a rare tumour of adrenal gland tissue. The adrenal
glands are located above the kidneys).
• Skin abscess or other disorders of the skin.
• Stomach ulcer or other serious stomach or intestinal problems (ulcerative
colitis).
• Unusual stress.
• 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.
• Traumatic brain injury
You must tell your doctor before you take this medicine if you have any of the
conditions listed above.
Other medicines and Depo-Medrone with Lidocaine
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
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 and cyclophosphamide - used for treating cancer.
• Antibacterials (such as isoniazid, erythromycin, clarithromycin and
troleandomycin).

atypical and may reach an advanced stage before being recognised.
With increasing doses of corticosteroids, the rate of occurrence of infectious
complications increases. Persons who are on drugs which suppress the immune
system are more susceptible to infections than healthy individuals. Chickenpox and
measles, for example, can have a more serious or even fatal course in non-immune
children or adults on corticosteroids.
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 immunoglobin (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 receive
chemoprophylaxis.
The role of corticosteroids in septic shock has been controversial, with early studies
reporting both beneficial and detrimental effects. More recently, supplemental
corticosteroids have been suggested to be beneficial in patients with established
septic shock who exhibit adrenal insufficiency. However, their routine use in septic
shock is not recommended. A systematic review of short-course, high-dose
corticosteroids did not support their use. However, meta-analyses, and a review
suggest that longer courses (5-11 days) of low-dose corticosteroids might reduce
mortality, especially in patients with vasopressor-dependent septic shock.
Immune System Effects
Allergic reactions may occur. Because rare instances of skin reactions and
anaphylactic/anaphylactoid reactions have occurred in patients receiving
corticosteroid therapy, appropriate precautionary measures should be taken prior to
administration, especially when the patient has a history of drug allergy.
Endocrine Effects
Pharmacologic doses of corticosteroids administered for prolonged periods may
result in hypothalamic-pituitary-adrenal (HPA) suppression (secondary adrenocortical
insufficiency). The degree and duration of adrenocortical insufficiency produced is
variable among patients and depends on the dose, frequency, time of administration,
and duration of glucocorticoid therapy.
Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to
3 weeks is appropriate if it is 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 systemic corticosteroid greater than 32 mg daily of
methylprednisolone.
• Patients repeatedly taking doses in the evening.
Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid
should be administered concurrently.
A steroid “withdrawal syndrome,” seemingly unrelated to adrenocortical insufficiency,
may also occur following abrupt discontinuance of glucocorticoids. This syndrome
includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever,
joint pain, desquamation, myalgia, weight loss, and/or hypotension. These effects are
thought to be due to the sudden change in glucocorticoid concentration rather than to
low corticosteroid levels.
Because glucocorticoids can produce or aggravate Cushing’s syndrome,
glucocorticoids should be avoided in patients with Cushing’s disease.
There is an enhanced effect of corticosteroids on patients with hypothyroidism.

• 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.
• Antidiabetics - medicines used to treat high blood sugar.
• Antiemetics (such as aprepitant and fosaprepitant).
• 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 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 - used for heart problems or high blood pressure.
• Ethinylestradiol and norethindrone - oral contraceptives.
• Indinavir and ritonavir - used to treat HIV infections.
• Ketoconazole or itraconazole - used to treat fungal infections.
• Pancuronium and vecuronium - or other medicines called
neuromuscular blocking agents which are used in some surgical
procedures.
• Potassium depleting agents - such as diuretics (sometimes called water
tablets), amphotericin B, xanthenes or beta2 agonists (e.g. medicines
used to treat asthma).
• Rifampicin and rifabutin - antibiotics used to treat tuberculosis (TB).
• Tacrolimus - used following an organ transplant to prevent rejection of the
organ.
• Vaccines - tell your doctor or nurse if you have recently had, or are about to
have any vaccination. You must 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 anaesthetist 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.

Metabolism and Nutrition
Corticosteroids, including methylprednisolone, can increase blood glucose, worsen
pre-existing diabetes, and predispose those on long-term corticosteroid therapy to
diabetes mellitus.
Psychiatric Effects
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 section 4.5), 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.
Nervous System Effects
Corticosteroids should be used with caution in patients with seizure disorders.
Corticosteroids should be used with caution in patients with myasthenia gravis (also
see myopathy statement in Musculoskeletal Effects section).
There have been reports of epidural lipomatosis in patients taking corticosteroids,
typically with long-term use at high doses.
Ocular Effects
Prolonged use of corticosteroids may produce posterior subcapsular cataracts and
nuclear cataracts (particularly in children), exophthalmos, or increased intraocular
pressure, which may result in glaucoma with possible damage to the optic nerves, and
may enhance the establishment of secondary ocular infections due to fungi or viruses.
Corticosteroids should be used cautiously in patients with ocular herpes simplex,
because of possible corneal perforation.
Corticosteroid therapy has been associated with central serous chorioretinopathy,
which may lead to retinal detachment.
Cardiac Effects
Adverse effects of glucocorticoids on the cardiovascular system, such as
dyslipidaemia and hypertension, may predispose treated patients with existing
cardiovascular risk factors to additional cardiovascular effects, if high doses and
prolonged courses are used. Accordingly, corticosteroids should be employed
judiciously in such patients and attention should be paid to risk modification and
additional cardiac monitoring if needed.
Systemic corticosteroids should be used with caution, and only if strictly necessary, in
cases of congestive heart failure.
Vascular Effects
Corticosteroids should be used with caution in patients with hypertension.
Thrombosis including venous thromboembolism has been reported to occur with
corticosteroids. As a result corticosteroids should be used with caution in patients
who have or may be predisposed to thromboembolic disorders.
Gastrointestinal Effects
There is no universal agreement on whether corticosteroids per se are responsible for
peptic ulcers encountered during therapy; however, glucocorticoid therapy may mask
the symptoms of peptic ulcer so that perforation or haemorrhage may occur without
significant pain. In combination with NSAIDs, the risk of developing gastrointestinal
ulcers is increased.
Corticosteroids should be used with caution in nonspecific ulcerative colitis, if there is
a probability of impending perforation, abscess or other pyogenic infection. Caution
must also be used in diverticulitis, fresh intestinal anastomoses, active or latent
peptic ulcer, when steroids are used as direct or adjunctive therapy.
Hepatobiliary Effects
Drug induced liver injury including acute hepatitis or liver enzyme increase can result from
cyclical pulsed IV methylprednisolone (usually at initial dose ≥ 1 g / day). Rare cases of
hepatotoxicity have been reported. The time to onset can be several weeks or longer. In
the majority of case reports resolution of the adverse events has been observed after
treatment was discontinued. Therefore, appropriate monitoring is required.

Depo-Medrone with Lidocaine with drink
Do not drink grapefruit juice while taking this medicine.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine, as this
medicine could slow the baby’s growth.
Cataracts have been observed in infants born to mothers treated with long-term
corticosteroids during pregnancy.

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.

If you are breast-feeding, ask your doctor or pharmacist for advice before taking
this medicine, as small amounts of corticosteroid medicines may get into breast
milk.

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.

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.

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.

Driving and using machines
Undesirable effects, such as dizziness, vertigo, visual disturbances and fatigue
are possible after treatment with corticosteroids. If you are affected do not drive
or operate machinery.

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.

Depo-Medrone with Lidocaine contains benzyl alcohol and sodium.
This medicine contains benzyl alcohol. The amount of benzoyl alcohol per ml is
8.7 mg. It may cause toxic and allergic reactions. This medicine should not be
used in pre-term or full-term neonates unless strictly necessary because of the
risk of severe toxicity including abnormal respiration (”gasping syndrome”).
Talk to your doctor or pharmacist if you have liver or kidney problems or if you
are pregnant or breast-feeding as high volumes may lead to toxicity (metabolic
perturbation).
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e.
essentially ‘sodium-free’.

3. How to use Depo-Medrone with Lidocaine

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.

High doses of corticosteroids may produce acute pancreatitis.
Corticosteroids should be used with caution in patients with liver failure or cirrhosis.
Musculoskeletal Effects
An acute myopathy has been reported with the use of high doses of corticosteroids,
most often occurring in patients with disorders of neuromuscular transmission (e.g.
myasthenia gravis), or in patients receiving concomitant therapy with anticholinergics,
such as neuromuscular blocking drugs (e.g. pancuronium). This acute myopathy is
generalised, may involve ocular and respiratory muscles, and may result in
quadriparesis. Elevations of creatine kinase may occur. Clinical improvement or
recovery after stopping corticosteroids may require weeks to years.
Osteoporosis is a common but infrequently recognized adverse effect associated with
a long-term use of large doses of glucocorticoid.

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.
Children
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 doctor immediately.
Continued overleaf...
corticosteroids. Many other compounds are also substrates of CYP3A4, some of
which (as well as other drugs) have been shown to alter glucocorticoid metabolism by
induction (upregulation) or inhibition of the CYP3A4 enzyme.
CYP3A4 INHIBITORS – Drugs that inhibit CYP3A4 activity generally decrease hepatic
clearance and increase the plasma concentration of CYP3A4 substrate medications,
such as methylprednisolone. In the presence of a CYP3A4 inhibitor, the dose of
methylprednisolone may need to be titrated to avoid steroid toxicity.
CYP3A4 INDUCERS – Drugs that induce CYP3A4 activity generally increase hepatic
clearance, resulting in decreased plasma concentration of medications that are
substrates for CYP3A4. Coadministration may require an increase in
methylprednisolone dosage to achieve the desired result.

Renal and Urinary Disorders
Corticosteroids should be used with caution in patients with renal insufficiency.

CYP3A4 SUBSTRATES – In the presence of another CYP3A4 substrate, the hepatic
clearance of methylprednisolone may be affected, with corresponding dosage
adjustments required. It is possible that adverse events associated with the use of
either drug alone may be more likely to occur with coadministration.

Injury, Poisoning and Procedural Complications
Systemic corticosteroids are not indicated for, and therefore should not be used to
treat, traumatic brain injury, a multicentre study revealed an increased mortality at
2 weeks and 6 months after injury in patients administered methylprednisolone
sodium succinate compared to placebo. A causal association with
methylprednisolone sodium succinate treatment has not been established.

1. Convulsions have been reported with concurrent use of methylprednisolone and
ciclosporin (CYP3A4 inhibitor and substrate). Since concurrent administration of
these agents results in a mutual inhibition of metabolism (which may increase
the plasma concentrations of either or both drugs), it is possible that convulsions
and other adverse effects associated with the individual use of either drug may
be more apt to occur.

Investigations
Average and large doses of hydrocortisone or cortisone can cause elevation of blood
pressure, salt and water retention, and increased excretion of potassium. These
effects are less likely to occur with the synthetic derivatives except when used in
large doses. Dietary salt restriction and potassium supplementation may be
necessary. All corticosteroids increase calcium excretion.

2. Drugs that induce hepatic enzymes, such as rifampicin (antibiotic CYP3A4
inducer), rifabutin, carbamazepine (anticonvulsant CYP3A4 inducer and
substrate), phenobarbitone and phenytoin (anticonvulsants CYP3A4 inducers),
primidone, and aminoglutethimide (aromatase inhibitor) enhance the metabolism
of corticosteroids and its therapeutic effects may be reduced.
Aminoglutethimide- induced adrenal suppression may exacerbate endocrine
changes caused by prolonged glucocorticoid treatment.

Care should be taken for patients receiving cardioactive drugs such as digoxin
because of steroid induced electrolyte disturbance/potassium loss (see section 4.8).
Other
Patients should carry 'Steroid Treatment' cards which give clear guidance on the
precautions to be taken to minimise risk and which provide details of prescriber,
drug, dosage and the duration of treatment.
Corticosteroids should be used with caution in patients with a predisposition to
thrombophlebitis.
Aspirin and nonsteroidal anti-inflammatory agents should be used cautiously in
conjunction with corticosteroids.
Pheochromocytoma crisis, which can be fatal, has been reported after administration of
systemic corticosteroids. Corticosteroids should only be administered to patients with
suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
Paediatric population
Intravenous administration of the preservative benzyl alcohol has been associated with
serious adverse event, and death in paediatric patients including neonates characterised
by central nervous system depression, metabolic acidosis, gasping respirations,
cardio-vascular failure and haematological anomalies (“gasping syndrome”). The
minimum amount of benzyl alcohol at which toxicity may occur is not known. Use only if
it is necessary and if there are no alternatives possible. If given in high volumes, should
be used with caution and preferably for short term treatment in subjects with liver or
kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis)
Premature and low-birth weight infants may be more likely to develop toxicity.
Benzyl Alcohol containing products should not be used in pre-term or full-term
neonates unless strictly necessary
Corticosteroids cause growth retardation in infancy, childhood and adolescence
which may be irreversible. Growth and development of infants and children on
prolonged corticosteroid therapy should be carefully observed. Treatment should be
limited to the minimum dosage for the shortest possible time. The use of such a
regimen should be restricted to those most serious indications.
Infants and children on prolonged corticosteroid therapy are at special risk from
raised intracranial pressure.
High doses of corticosteroids may produce pancreatitis in children.
4.5 Interaction with other medicinal products and other forms of interaction
Methylprednisolone is a cytochrome P450 enzyme (CYP) substrate and is mainly
metabolized by the CYP3A enzyme. CYP3A4 is the dominant enzyme of the most
abundant CYP subfamily in the liver of adult humans. It catalyzes 6β-hydroxylation of
steroids, the essential Phase I metabolic step for both endogenous and synthetic

3. Antibiotics/Antimycotics - Drugs such as erythromycin (macrolide antibacterial
CYP3A4 inhibitor and substrate), itraconazole and ketoconazole antifungal CYP3A4
inhibitors and substrates) may inhibit the metabolism of corticosteroids and thus
decrease their clearance. Troleandomycin (CYP3A4 inhibitor), as well as
clarithromycin, erythromycin, itraconazole and ketoconazole (CYP3A4 inhibitors and
substrates) increase the effects and the side effects of methylprednisolone.
The acetylation rate and clearance of isoniazid (CYP3A4 inhibitor), an
antibacterial drug, can be increased by methylprednisolone.
4. Steroids may reduce the effects of anticholinesterases in myasthenia gravis.
An acute myopathy has been reported with the concomitant use of high doses of
corticosteroids and anticholinergics, such as neuromuscular blocking drugs (see
section 4.4).
Antagonism of the neuromuscular blocking effects of pancuronium and
vecuronium has been reported in patients taking corticosteroids. This interaction
may be expected with all competitive neuromuscular blockers.
The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives
and diuretics are antagonised by corticosteroids, and the hypokalaemic effects of
acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced.
5. The effect of methylprednisolone on oral anticoagulants is variable. 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 and to maintain the desired anticoagulant effects.
There are also reports of diminished effects of anticoagulants when given
concurrently with corticosteroids.
6. There may be increased incidence of gastrointestinal bleeding and ulceration
when corticosteroids are given with NSAIDs. Methylprednisolone may increase
the clearance of high-dose aspirin, which can lead to decreased salicylate serum
levels. Discontinuation of methylprednisolone treatment can lead to raised
salicylate serum levels, which could lead to an increased risk of salicylate
toxicity. Salicylates and non-steroidal anti-inflammatory agents should be used
cautiously in conjunction with corticosteroids in hypothrombinaemia.
7. Antidiabetics - Because corticosteroids may increase blood glucose
concentrations, dosage adjustments of antidiabetic agents may be required.
8. Antiemetics - Aprepitant and fosaprepitant (CYP3A4 inhibitors and substrates).
9. Antivirals - HIV protease inhibitors: Indinavir and ritonavir (CYP3A4 inhibitors and
substrates) may increase plasma concentrations of corticosteroids.
Continued overleaf.....

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.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, 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.

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.
• 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.
• Peritonitis, an inflammation (irritation) of the peritoneum, the thin tissue
that lines the inner wall of the abdomen and covers most of the abdominal
organs. Symptoms are, the stomach (abdomen) being very painful or tender,
the pain may become worse when the stomach is touched or when you
move.
• 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.

not known
• 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, cardiac arrest.
• Low blood pressure, symptoms may include dizziness, fainting,
lightheadedness, blurred vision, a rapid or irregular heartbeat (palpitations).
• Increase of white blood cells (leukocytosis).
• Increased clotting of the blood.
Body water and salts
common
• 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).

If you experience any of the following side effects, or notice any other
unusual effects not mentioned in this leaflet, tell your doctor immediately.

Digestive system
common
• Ulcers.
• Vomiting (being sick).
not known
• Nausea (feeling sick).
• Thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Diarrhoea.
• Bloated stomach.
• Abdominal pain.
• Hiccups.

The side effects may occur with certain frequencies, which are defined as follows:
• common: may affect up to 1 in 10 people.
• not known: frequency cannot be estimated from the available data.

Ears
not known
• A feeling of dizziness or spinning (vertigo).

Blood, heart and circulation
common
• High blood pressure, symptoms of which are headaches, or generally feeling
unwell.
• Slowing heart rate (bradycardia).

Eyes
common
• Glaucoma (raised pressure within the eye, causing pain in the eyes and
headaches).
• Cataracts (indicated by failing eyesight).

not known
• Swollen optic nerve (causing a condition called papilloedema, and which
may cause sight disturbance).
• Increased intra-ocular pressure, with possible damage to the optic nerve
(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).
• Blindness, blurred or double vision.
• Blurred or distorted vision (due to disease of the retina and choroid
membrane).

• 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.

• Other nervous system side effects may include convulsions (seizures),
amnesia (loss of memory), cognitive disorder (mental changes), tremor,
dizziness and headache, drowsiness, difficulty breathing, sensation of cold,
heat or numbness, tinnitus or unconsciousness.
• Back pain or weakness (due to Epidural Lipomatosis, a rare disorder in
which an abnormal amount of fat is deposited on or outside the lining of the
spine).

6. Contents of the pack and other information

Immune system
common
• Increased susceptibility to infections which can hide or change normal
reactions to skin tests, such as that for tuberculosis.

Hepatobiliary disorders
• Methylprednisolone can damage your liver, hepatitis and increase of liver
enzymes have been reported.

Metabolism and nutrition disorders
• Accumulation of fat tissue on localised parts of the body.

Skin
common
• Acne.
• Bruising.
not known
• Abscess, especially near injection sites.
• Thinning of skin, stretch marks.
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or raised patches which are an unusual
colour.
• Increased hair on the body and face (hirsutism).
• Rash, skin redness, itching, hives.
• Increased sweating.

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 pack containing
1 vial.

General disorders
common
• Poor wound healing.
• Irritability.
not known
• Feeling tired or unwell.
• Skin reactions at the site of injection.
Hormones and metabolic system
common
• Slowing of normal growth in infants, children and adolescents which may be
permanent.
• Round or moon-shaped face (Cushingoid facies).
• Diabetes or worsening of existing diabetes.
not known
• Irregular or no periods in women.
• Increased appetite and weight gain.
• Abnormal localised or tumour-like accumulations of fat in the tissues.
• 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.

In certain medical conditions medicines like Depo-Medrone with
Lidocaine (steroids) should not be stopped abruptly. If you suffer from
any of the following symptoms seek IMMEDIATE medical attention.

Corticosteroids may induce the metabolism of HIV-protease inhibitors resulting in
reduced plasma concentrations.
10. Calcium channel blocker - Diltiazem (CYP3A4 inhibitor and substrate).

the relative potency of the drug, dosage, timing of administration and duration of
treatment (See section 4.4).

MedDRA
System Organ Class

Frequency

Undesirable Effects

Side effects for the Depo-Medrone component may be observed including:

Gastrointestinal
disorders

Common

11. Contraceptives (oral) - Ethinylestradiol/norethindrone (CYP3A4 inhibitors and
substrate).

MedDRA
System Organ Class

Frequency

12. Other immunosuppressants like cyclophosphamide and tacrolimus are
substrates of CYP3A4.

Infections and
infestations

Common

13. Potassium-depleting agents - When corticosteroids are administered
concomitantly with potassium-depleting agents (i.e. diuretics), patients should be
observed closely for development of hypokalaemia. There is also an increased
risk of hypokalaemia with concurrent use of corticosteroids with amphotericin B,
xanthenes, or beta2 agonists.
14. Grapefruit juice - CYP3A4 inhibitor.
4.6 Fertility, pregnancy and lactation

Not Known
Immune system
disorders

Not Known

Blood and lymphatic
system disorders

Not Known

Endocrine disorders

Fertility
There is no evidence showing that corticosteroids impair fertility (see section 5.3).

Common
Not Known

Pregnancy
Methylprednisolone
The ability of corticosteroids to cross the placenta varies between individual drugs,
however, methylprednisolone does cross the placenta. One retrospective study found
an increased incidence of low birth weights in infants born of mothers receiving
corticosteroids.
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. Although neonatal
adrenal insufficiency appears to be rare in infants who were exposed in utero to
corticosteroids, those exposed to substantial doses of corticosteroids must be carefully
observed and evaluated for signs of adrenal insufficiency. 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.

Metabolism and
nutrition disorders

Common

Not Known
Psychiatric disorders Common
Not Known

Cataracts have been observed in infants born to mothers treated with long-term
corticosteroids during pregnancy.
Lidocaine
Adequate human reproductive studies have not been done with Lidocaine.
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.

Nervous system
disorders

Eye disorders

Not Known

Common
Not Known

Benzyl alcohol can cross the placenta
Breast-feeding
Methylprednisolone
Corticosteroids are distributed in small amounts in breast milk and may suppress
growth and interfere with endogenous glucocorticoid production in nursing infants.
However, doses of up to 40 mg 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. Since adequate reproductive studies have not
been performed in humans with glucocorticoids, these drugs should be administered
to nursing mothers only if the benefits of therapy are judged to outweigh the potential
risks to the infant.
Lidocaine
It is not known whether lidocaine is excreted in human breast milk.
4.7 Effects on ability to drive and use machines
The effect of corticosteroids on the ability to drive or use machinery has not been
systematically evaluated. Undesirable effects, such as dizziness, vertigo, visual
disturbances, and fatigue are possible after treatment with corticosteroids. If affected,
patients should not drive or operate machinery.
4.8 Undesirable effects
The incidence of predictable undesirable side effects associated with the use of
corticosteroids, including hypothalamic-pituitary-adrenal suppression correlates with

Ear and labyrinth
disorders

Not Known

Cardiac disorders

Not Known

Vascular disorders

Common
Not Known

Respiratory, thoracic
and mediastinal
disorders

Not Known

Hepatobiliary
disorders

Not Known

Peptic ulcer (with possible Peptic
ulcer perforation and Peptic ulcer haemorrhage)
Gastric haemorrhage; Intestinal perforation;
Pancreatitis; Oesophagitis ulcerative;
Oesophagitis; Oesophageal candidiasis;
Abdominal pain; Abdominal distension;
Diarrhoea; Dyspepsia; Nausea
Hepatitis, Increase of liver enzymes

Skin and
subcutaneous
tissue disorders

Common

Ecchymosis; Acne

Not Known

Undesirable Effects
Infection (including increased susceptibility
and severity of infections with suppression of
clinical symptoms and signs)
Opportunistic infection; Injection site infection;
Peritonitis; Recurrence of dormant tuberculosis
Drug hypersensitivity, Anaphylactic reaction

Not Known

Leukocytosis
Cushingoid
Hypopituitarism; 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 section 4.4). A
'withdrawal syndrome' may also occur including,
fever, myalgia, arthralgia, rhinitis, conjunctivitis,
painful itchy skin nodules and loss of weight.
Glucose tolerance impaired; Sodium retention;
Fluid retention; Increased requirements for
insulin (or oral hypoglycemic agents in
diabetics).
Alkalosis hypokalaemic; Dyslipidaemia,
Increased appetite (which may result in Weight
increased); Epidural lipomatosis
Affective disorder (including Depressed mood,
Euphoric mood). Mood swings; Abnormal
behaviour; Insomnia
Affective disorder (including Affect lability,
psychological dependence [not a MedDRA PT],
Suicidal ideation), Psychotic disorder (including
Mania, Delusion, Hallucination, and
Schizophrenia [aggravation of]); Confusional
state; Mental disorder; Anxiety; Personality
change
Intracranial pressure increased (with
Papilloedema [Benign intracranial
hypertension]); Convulsion; Amnesia; Cognitive
disorder; Dizziness; Headache; Epidural
lipomatosis
Cataract; Glaucoma
Exophthalmos; chorioretinopathy; Rare
instances of blindness associated with
intralesional therapy around the face and head
[not a MedDRA PT]; Increased intra-ocular
pressure, with possible damage to the optic
nerve; Corneal or scleral thinning; Exacerbation
of ophthalmic viral or fungal disease
Vertigo
Cardiac failure congestive (in susceptible
patients)
Hypertension
Hypotension; Embolism arterial, Thrombotic
events
Pulmonary embolism, Hiccups

Musculoskeletal and
connective tissue
disorders

Common
Not Known

Reproductive system Not Known
and breast disorders
General disorders
and administration
site conditions
Investigations

Osteonecrosis; Pathological fracture; Muscle
atrophy; Myopathy; Neuropathic arthropathy;
Arthralgia; Myalgia
Menstruation irregular
Impaired healing; Oedema
peripheral; Irritability

Not Known

Injection site reaction; Abscess sterile; Fatigue;
Malaise
Blood potassium decreased

Common

Not Known

Alanine aminotransferase increased; Aspartate
aminotransferase increased; Blood alkaline
phosphatase increased; Carbohydrate tolerance
decreased; Urine calcium increased;
suppression of reactions to skin tests [not a
MedDRA PT]; Blood urea increased; Nitrogen
balance negative (due to protein catabolism)
Tendon rupture (particularly of the
Achilles tendon); Spinal
compression fracture. Systemic corticosteroids
are not indicated for, and therefore should not
be used to treat, traumatic brain injury.

† Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare
(≥1/10,000 to <1/1,000); Not known (frequency cannot be estimated from the
available data)
Side effects for the Lidocaine component include:
MedDRA
Frequency
System Organ Class
Immune system
Not known
Psychiatric disorders Common

Undesirable Effects

Nervous System
disorders

Common

Loss of consciousness; Convulsion;
Hypoaesthesia; Tremor; Somnolence; Dizziness

Eye disorders
Ear and labyrinth
disorders
Cardiac disorders

Common
Common

Diplopia; Vision blurred;
Tinnitus

Common

Bradycardia

Vascular disorders

Common

Hypotension

Not Known

Circulatory collapse; Cardiac arrest

Common

Respiratory arrest; Respiratory depression

Respiratory, thoracic
and mediastinal
disorders

Undesirable Effects

Gastrointestinal
disorders

Common

Vomiting

Skin and
subcutaneous
disorders

Not Known

Skin lesion; Urticaria

Musculoskeletal and Common
connective tissue
disorders

Muscle twitching

General disorders
and administration
site conditions

Oedema; Feeling cold;
Feeling hot

Common

CERTAIN SIDE EFFECTS REPORTED WITH SOME NON RECOMMENDED ROUTES OF
ADMINISTRATION:
Intrathecal/Epidural: Usual systemic corticoid adverse reactions, headache,
meningismus, meningitis, paraparesis/paraplegia, spinal fluid abnormalities, nausea,
vomiting, sweating, arachnoiditis, functional gastrointestinal disorder/bladder
dysfunction, convulsions, sensory disturbances. The frequency of these adverse
reactions is not known.
Extradural: Wound dehiscence, loss of sphincter control.

Common

Not Known

Injury, poisoning
and procedural
complications

Angioedema; Petechiae; Skin atrophy; Skin
striae; Skin hyperpigmentation; Skin
hypopigmentation; Hirsutism; Rash; Erythema;
Pruritus; Urticaria; Hyperhidrosis
Growth retardation; Osteoporosis;
Muscular weakness

MedDRA
Frequency
System Organ Class

Anaphylactic reaction
Confusional state; Euphoric mood;
Nervousness; Anxiety

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.
Miscellaneous: Scalp, tonsillar fauces, sphenopalatine ganglion: blindness.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse
reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Methylprednisolone
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.
Reports of acute toxicity and/or death following overdosage of corticosteroids are
rare. In the event of overdosage, no specific antidote is available; treatment is
supportive and symptomatic.
Methylprednisolone is dialysable.
Lidocaine
Overdose with lidocaine can manifest itself in a transient stimulation of the central
nervous system with early symptoms: yawning, restlessness, dizziness, nausea,
vomiting, dysarthria, ataxia, hearing and visual disturbances. With moderate
intoxication also twitching and convulsions can occur. This can be followed by
unconsciousness, respiratory depression and coma. In very severe intoxication due to
decreased myocardial contractility and delayed impulse conduction, hypotension and
cardiovascular collapse can be expected to be followed by a complete heart block
and cardiac arrest. Convulsions, hypotension and respiratory depression and cardiac
events should be treated as necessary. Continual optimal oxygenation and ventilation
and circulatory support as well as treatment of acidosis are of vital importance.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Glucocorticoids, ATC Code: H02AB04
Pharmacotherapeutic group: Anaesthetics, ATC Code: N01BB02
Methylprednisolone
Methylprednisolone acetate is a synthetic glucocorticoid with the actions and use of
natural corticosteroids. However the slower metabolism of the synthetic corticosteroid
with their lower protein-binding affinity may account for their increased potency
compared with the natural corticosteroids.
Lidocaine
Lidocaine has the actions of a local anaesthetic.

Muscles, bones and joints
common
• Muscle weakness.
• Muscle twitching.
• Brittle bones (bones that break easily).
not known
• Broken bones or fractures.
• Muscle wasting.
• Breakdown of bone due to poor circulation of blood, this causes pain in the
hip.
• Joint pain.
• Torn muscle tendons causing pain and/or swelling.
• Muscle cramps or spasms.
• Swollen or painful joints due to infection.
Nerves and mood issues
common
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.

5.2 Pharmacokinetic properties
No pharmacokinetic studies have been performed with the combination product of
methylprednisolone and lidocaine, however, data are provided from pharmacokinetic
studies performed with the individual product components methylprednisolone and
lidocaine.
Absorption:
Methylprednisolone:
One in-house study of eight volunteers determined the pharmacokinetics of a single
40 mg intramuscular dose of Depo-Medrone. The average of the individual peak
plasma concentrations was 14.8 ± 8.6 ng/mL, the average of the individual peak
times (tmax) was 7.25 ± 1.04 hours, and the average area under the curve (AUC)
was 1354.2 ± 424.1 ng/mL x hrs (Day 1-21).
Lidocaine:
Pharmacokinetics of lidocaine after synovial absorption following intra-articular bolus
injection in patients with knee joint arthroscopy was studied with different maximum
concentration (Cmax) values reported. The Cmax values are 2.18 μg/mL at 1 hour
(serum) and 0.63 μg/mL at 0.5 hour (plasma) following administration of lidocaine
doses of 7 mg/kg and 400 mg, respectively. Other reported serum Cmax values are
0.69 μg/mL at 5 minutes and 0.278 μg/mL at 2 hours following administration of
lidocaine doses of 25 mL of 1% and 20 mL of 1.5%, respectively.
Pharmacokinetic data of lidocaine after intra-bursa and intra-cyst administrations for
local effect are not available.
Distribution:
Methylprednisolone:
Methylprednisolone is widely distributed into the tissues, crosses the blood-brain
barrier, and is secreted in breast milk. Its apparent volume of distribution is
approximately 1.4 L/kg. The plasma protein binding of methylprednisolone in humans
is approximately 77%.
Lidocaine:
The plasma protein binding of lidocaine is concentration-dependent, and binding
decreases as concentration increases. At concentrations of 1 to 5 μg/mL, 60%-80%
lidocaine is protein bound. Binding is also dependent on the plasma concentration of
the α1-acid glycoprotein.
Lidocaine has a volume of distribution at steady state of 91 L.
Lidocaine readily crosses the placenta, and equilibrium of unbound drug
concentration is rapidly reached. The degree of plasma protein binding in the foetus
is less than in the mother, which results in lower total plasma concentrations in the
foetus.
Metabolism:
Methylprednisolone:
In humans, methylprednisolone is metabolized in the liver to inactive metabolites; the
major ones are 20α-hydroxymethylprednisolone and
20β-hydroxymethylprednisolone. Metabolism in the liver occurs primarily via the
CYP3A4. (For a list of drug interactions based on CYP3A4-mediated metabolism, see
section 4.5.)
Methylprednisolone, like many CYP3A4 substrates, may also be a substrate for the
ATP-binding cassette (ABC) transport protein p-glycoprotein, influencing tissue
distribution and interactions with other medicines modulated by P-gp.
Lidocaine:
Lidocaine is mainly metabolized by the liver. The main metabolites of lidocaine are
monoethylglycine xylidide, glycinexylidide, 2,6-dimethylaniline, and
4-hydroxy-2,6-dimethylaniline. The lidocaine N-dealkylation to monoethylglycine
xylidide is considered to be mediated by both CYP1A2 and CYP3A4. The metabolite
2,6-dimethylaniline is converted to 4-hydroxy-2,6-dimethylaniline by CYP2A6 and
CYP2E1.
Elimination:
Methylprednisolone:
The mean elimination half-life for total methylprednisolone is in the range of 1.8 to
5.2 hours. Total clearance is approximately 5 to 6 mL/min/kg.
Lidocaine:
The clearance of lidocaine in plasma following intravenous bolus administration is
9 to 10 mL/min/kg.
The elimination half life of lidocaine following intravenous bolus injection is typically
1.5 to 2 hours.

If you experience any of the side effects listed above tell your doctor
immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Depo-Medrone with Lidocaine
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.

The pharmacological actions of monoethylglycine xylidide and glycinexylidide are
similar to but less potent than those of lidocaine. Monoethylglycine xylidide has a half
life of approximately 2.3 hours and glycinexylidide has a half life of about 10 hours
and may accumulate after long-term administration.
Only 3% of lidocaine is excreted unchanged by the kidneys. About 73% of lidocaine
appears in the urine as 4-hydroxy-2,6-dimethylaniline metabolite.
Special Population
Methylprednisolone:
No pharmacokinetic studies have been performed for methylprednisolone in special
populations.

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.

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.
Manufacturer
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: 12th October 2017

POM

To request a copy of this leaflet
in Braille, large print or audio
please call 01622 690172.
Depo-Medrone® is a registered trademark.

Mutagenic potential:
Genotoxicity studies were carried out with lidocaine and its metabolites. The
Salmonella microsomal assay (Salmonella typhimurium strains TA100, TA98,
and TA1538 with 1, 10, 100 and 500 mg/plate), with or without metabolic
activation, with lidocaine and its metabolites monoethylglycinexylidine,
N-hydroxylidocaine, N-hydroxy-monoethylglycinexylidine, 2,6-xylidine,
2,6-dimethylphenylhydroxylamine, did not reveal any mutagenic activity.
However, metabolite 2,6-dimethylaniline, has been shown to have mutagenic
and carcinogenic potential.
Reproductive toxicity:
Lidocaine has not been shown to affect male or female fertility.

Special Population
Lidocaine:
Hepatic impairment
Following intravenous administration, the half life of lidocaine has approximately
3-fold increase in patients with liver impairment. Pharmacokinetic data of lidocaine
after intra-articular, intra-bursa and intra-cyst administrations for local effect are not
available in hepatic impairment.

Methylprednisolone plus Lidocaine
Carcinogenic potential:
Long-term studies in animals have not been performed to evaluate
carcinogenic potential.

Renal impairment
Mild to moderate renal impairment (CLcr 30-60 mL/min) does not affect lidocaine
pharmacokinetics but may increase the accumulation of glycinexylidide metabolite
following intravenous administration. However, lidocaine clearance decreases about half
and its half life is approximately doubled with increased accumulation of glycinexylidide
metabolite in patients with severe renal impairment (Clcr <30 mL/min).

Mutagenic potential:
Genotoxicity studies have not been conducted with the combination of
methylprednisolone and lidocaine (see above for genotoxicity as it pertains to the
individual drugs).

The pharmacokinetics of lidocaine and its main metabolite of monoethylglycine
xylidide are not altered significantly in haemodialysis patients who receive an
intravenous dose of lidocaine.
Pharmacokinetic data of lidocaine after intra-articular, intra-bursa and intra-cyst
administrations for local effect are not available in renal impairment.
No dosing adjustments are necessary in renal failure. Methylprednisolone is
haemodialysable.
5.3 Preclinical safety data
Methylprednisolone
Based on conventional studies of safety pharmacology and repeated dose toxicity, no
unexpected hazards were identified. The toxicities seen in the repeated-dose studies
were those expected to occur with continued exposure to exogenous adrenocortical
steroids.
Mutagenic potential:
There was no evidence of a potential for genetic and chromosome mutations when
tested in limited studies performed in bacteria and mammalian cells.
Carcinogenic potential:
Long-term studies in animals have not been performed to evaluate carcinogenic
potential, as the drug is indicated for short-term treatment only. There were no signs
indicative of carcinogenic activity in studies conducted to date.
Reproductive toxicity:
Reproductive fertility studies in animals have not been performed to evaluate
specifically the potential of impairment of fertility. There is no evidence that
corticosteroids impair fertility.
An increased frequency of cleft palate was observed among the offspring of mice
treated during pregnancy with methylprednisolone in doses similar to those typically
used for oral therapy in humans.
An increased frequency of cardiovascular defects and decreased body weight were
observed among the offspring of pregnant rats treated with methylprednisolone in a
dose that was similar to that used for oral therapy in humans but was toxic to the
mothers. In contrast, no teratogenic effect was noted in rats with doses
<1-18 times those typically used for oral therapy in humans in another study. High
frequencies of foetal death and a variety of central nervous system and skeletal
anomalies were reported in the offspring of pregnant rabbits treated with
methylprednisolone in doses less than those used in humans. The relevance of
these findings to the risk of malformations in human infants born to mothers treated
with methylprednisolone in pregnancy is unknown. Safety margins for the reported
teratogenic effects are unknown.
Lidocaine
Carcinogenic potential:
Long-term studies in animals have not been performed to evaluate carcinogenic
potential.

The toxicity of lidocaine was not significantly altered in rats that were treated with the
combination of lidocaine and methylprednisolone.

Reproductive toxicity:
Reproductive toxicity studies have not been conducted with the combination of
methylprednisolone and lidocaine (see above for reproductive toxicity as it pertains to
the individual drugs).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Macrogol
Sodium chloride
Myristyl-gamma-picolinium chloride
Benzyl alcohol
Sodium hydroxide
Hydrochloric acid
Water for injection.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
See package for expiry date.
6.4 Special precautions for storage
Do not store above 25°C.
Do not freeze.
6.5 Nature and contents of container
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 pack containing 1
vial.
6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed off in
accordance with local requirements.
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.
Depo-Medrone with Lidocaine (40mg+10mg)/ml Injection
PL No: 18067/0293

POM

Date leaflet last revised: 12th October 2017.
Depo-Medrone® is a registered trademark.

500808/PL1g

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