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inks on fils

I date: 3-FEB-12 11:57:05

Read all of this leaflet

carefully before you start

taking this medicine

•    Keep this leaflet. You may need to read it again

•    If you have any further questions please ask your doctor or pharmacist

•    This medicine has been prescribed for you. Do not pass it to others. It may harm them even if their symptoms are the same as yours

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist

In this leaflet:

1.    What Depo-Medrone with Lidocaine is and what it is used for

2.    Before you are given Depo-Medrone with Lidocaine

3.    How Depo-Medrone with Lidocaine is given to you

4.    Possible side effects

5.    How to Store Depo-Medrone with Liaocaine

6.    Further information

8R2075

478

1. What Depo-Medrone with Lidocaine is and what it is 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 anesthetic. 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, & tenosynovitis: Tennis elbow (epicondylitis), inflammation in a tendon (tendonitis), or a tendon’s covering sheath (tenosynovitis). For these conditions this medicine will be injected into the tendon or its tendon sheath.

Your doctor may use this medicine to treat conditions other than those listed above. Ask your doctor if you are unsure why you have been given this medicine.

2. Before you are given Depo-Medrone with Lidocaine

Do not use Depo-Medrone with Lidocaine if:

•    You think you have ever suffered an allergic reaction, or any other type of reaction after being given: Depo-Medrone with Lidocaine,

any other medicine containing a corticosteroid or local anaesthetic, any of the ingredients in this medicine (Section 6 of this leaflet contains a list of ingredients). An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath.

•    If you get a rash, or another symptom of an infection.

See your doctor immediately if you have any of the above.

Do not inject this medicine into:

•    the Achilles tendon (which is located behind the ankle joint), or

•    directly into a vein (intravenous), the spinal cord (intrathecal), into the nostrils (intranasal) or in the eye (intraocular).

Take special care before taking Depo-Medrone with Lidocaine:

You must tell your doctor before you take this medicine if you have any of the following conditions.

Your doctor may also have to monitor your treatment more closely, alter your dose or give you another medicine.

•    Chickenpox, shingles or a herpes eye infection. If you think you have been in contact with someone with chickenpox or shingles and you have not already had these illnesses, or if you are unsure if you have had them.

•    Severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Depo-Medrone with Lidocaine, or having a family history of these illnesses.

•    Diabetes (or if there is a family history of diabetes).

•    Epilepsy.

•    Glaucoma (increased pressure in the eye) or if there is a family history of glaucoma.

•    You have recently suffered a heart attack.

•    Heart problems, including heart failure or infections.

•    Hypertension (high blood

pressure).

•    Hypothyroidism (an under-active thyroid).

•    Joint infection - which is active and so requires treatment.

•    Kidney or liver disease.

•    Muscle problems (pain or weakness) have happened while taking steroid medicines in the past.

•    Myasthenia gravis (a condition causing tired and weak muscles).

•    Osteoporosis (brittle bones).

•    Skin abscess.

•    Stomach ulcer or other serious stomach or intestinal problems.

•    Thrombophlebitis - vein problems due to thrombosis (clots in the veins) resulting in phlebitis (red, swollen and tender veins).

•    Tuberculosis (TB) or if you have suffered tuberculosis in the past.

You must tell your doctor before you take this medicine if you have any of the conditions listed above.

Taking other medicines

Always tell your doctor or pharmacist if you are taking any medicines (including any you have bought without a prescription) as taking Depo-Medrone with 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 medicine works:

•    Acetazolamide - used to treat glaucoma and epilepsy.

•    Aminoglutethimide - used for treating cancer.

•    Anticoagulants - used to 'thin' the blood such as acenocoumarol, phenindione and warfarin.

•    Anticholinesterases - used to treat myasthenia gravis (a muscle condition) such as distigmine and neostigmine.

•    Antibiotics (such as erythromycin).

•    Aspirin and non-steroidal anti-inflammatory medicines (also called NSAIDs) such as ibuprofen used to treat mild to moderate pain.

•    Barbiturates, 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 or mibefradil - used for heart problems or high blood pressure.

•    Diuretics-sometimes called water tablets.

•    Ketoconazole or itraconazole -

used to treat fungal infections.

•    Pancuronium-or other medicines called neuromuscular blocking agents which are used in some surgical procedures.

•    Rifampicin and rifabutin - antibiotics used to treat tuberculosis (TB).

•    Vaccines - tell your doctor or nurse if you have recently had, or are about to have any vaccination. You should not have live’ vaccines while using this medicine. Other vaccines may be less effective.

If you are taking long term medication(s)

If you are being treated for diabetes, high blood pressure or water retention (oedema) tell your doctor as he/she may need to adjust the dose of the medicines used to treat these conditions.

Before you have any operation tell your doctor, dentist or anesthetist that you are taking this medicine.

If you require a test to be carried out by your doctor or in hospital it is important that you tell the doctor or nurse that you are taking Depo-Medrone with Lidocaine. This medicine can affect the results of some tests.

Pregnancy and breast feeding You must tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant as this medicine could slow the baby’s growth. Tell your doctor if you are breast feeding as small amounts of corticosteroid medicines may get into breast milk.

If you continue breast-feeding while you are having treatment, your baby will need extra checks to make sure he or she is not being affected by your medicine.

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

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.

3. How Depo-Medrone with Lidocaine is given to you

Steroid Cards Remember to always carry a Steroid Treatment Card. Make sure your doctor or pharmacist has filled out the details of your medicine, including the dose and how long you will require steroid treatment.

You should show your steroid card to anyone who gives you treatment (such as a doctor, nurse or dentist) while you are taking this medicine, and for 3 months after your last injection.

If you are admitted to hospital for any reason always tell your doctor or nurse that you are taking this medicine. You can also wear a medic-alert bracelet or pendant to let medical staff know that you are taking a steroid if you have an accident or become unconscious.

Dosage information

Your doctor will decide on the site of injection, how much of the medicine and how many injections you will receive depending on the condition being treated and its severity. Your doctor will inject you with the lowest dose for the shortest possible time to get effective relief of your symptoms.

Adults

Your doctor/nurse will tell you how many injections you will require for the condition you are being treated for, and when you will get them.

Joints - the normal dose for the injections into joint will depend on the size of the joint. Large joints (e.g. knee, ankle and shoulder) may require 20 - 80 mg (0.5 - 2 ml), medium sized joints (e.g. elbow or wrist) 10 - 40 mg (0.25 -1 ml) and small joints (e.g. finger or toe joints) may require a 4-10 mg (0.1 -0.25 ml) dose.

Joint injections may be given weekly over a period of several weeks, depending on how quickly you respond to treatment.

Bursitis, epicondylitis (tennis elbow) and tendonitis - the usual dose is between 4-30 mg (0.1 - 0.75 ml). In most cases repeat injections will not be needed for bursitis and epicondylitis. Repeat injections may be necessary to treat long standing tendonitis.

Elderly

Treatment will normally be the same as for younger adults. Flowever your doctor may want to see you more regularly to check how you are getting on with this medicine.    Continued overleaf...

PHYSICIAN LEAFLET

Depo-Medrone® with Lidocaine

methylprednisolone acetate and lidocaine hydrochloride

Presentation

White, sterile aqueous suspension for injection containing 40 mg per ml methylprednisolone acetate and 10 mg per ml lidocaine hydrochloride. Also contains macrogol, sodium chloride, myristyl-gamma-picolinium chloride, benzyl alcohol and sterile water for injections.

Uses

Corticosteroid (glucocorticoid). Depo-Medrone with Lidocaine is indicated in conditions requiring a glucocorticoid effect: e.g. anti-inflammatory or anti-rheumatic. It is recommended for local use where the added anaesthetic effect would be considered advantageous.

Therapy with Depo-Medrone with Lidocaine does not obviate the need for the conventional measures usually employed. Although this method of treatment will ameliorate symptoms, it is in no sense a cure and the hormone has no effect on the cause of the inflammation.

Depo-Medrone with Lidocaine may be used as follows:

Intra-articular administration Rheumatoid arthritis

Osteo-arthritis with an inflammatory component Periarticular administration Epicondylitis

Intrabursal administration Subacromial bursitis Prepatellar bursitis Olecranon bursitis Tendon sheath administration Tendinitis Tenosynovitis Epicondylitis

Dosage and administration

Depo-Medrone with Lidocaine should not be mixed with any other preparation as flocculation of the product may occur. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever suspension and container permit. Depo-Medrone with Lidocaine may be used by any of the following routes: intra-articular, periarticular, intrabursal, and into the tendon sheath. It must not be used by the intrathecal or intravenous routes. (See Contra-indications and Side-effects).

Undesirable effects may be minimized by using the lowest effective dose for the minimum period (see Special warnings and precautions).

Depo-Medrone with Lidocaine vials are intended for single dose use only.

Intra-articular: Rheumatoid arthritis, osteo-arthritis. The dose of Depo-Medrone with Lidocaine depends on the size of the joint and the severity of the condition. Repeated injections, if needed, may be given at intervals of one to five or more weeks depending upon the degree of relief obtained from the initial injection. A suggested dosage guide is: large joint (knee, ankle, shoulder), 0.5 - 2 ml (20 -80 mg of steroid); medium joint (elbow, wrist),

0.25 -1 ml (10 - 40 mg of steroid); small joint (metacarpophalangeal, interphalangeal, sternoclavicular, acromioclavicular), 0.1 - 0.25 ml (4-10 mg of steroid).

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.

Special precautions should be observed when administering Depo-Medrone with Lidocaine: Intra-articular injections should be made using precise, anatomical localisation into the synovial space of the joint involved. The injection site for each joint is determined by that location where the synovial cavity is most superficial and most free of large vessels and nerves. Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal and hip joints. The spinal joints, unstable joints and those devoid of synovial space are not suitable. Treatment failures are most frequently the result of failure to enter the joint space. Intra-articular injections should be made with care as follows: ensure correct positioning of the needle into the synovial space and aspirate a few drops of joint fluid. The aspirating syringe should then be replaced by another containing Depo-Medrone with Lidocaine. To ensure position of the needle synovial fluid should be aspirated and the injection made.

After injection the joint is moved slightly to aid mixing of the synovial fluid and the suspension. Subsequent to therapy care should be taken for the patient not to overuse the joint in which benefit has been obtained. Negligence in this matter may permit an increase in joint deterioration that will more than offset the beneficial effects of the steroid. Intrabursal injections should be made as follows: the area around the injection site is prepared in a sterile way and a wheal at the site made with 1 percent procaine hydrochloride solution. A 20 to 24 gauge needle attached to a dry syringe is inserted into the bursa and the fluid aspirated. The needle is left in place and the aspirating syringe changed for a small syringe containing the desired dose. After injection, the needle is withdrawn and a small dressing applied.

In the treatment of tenosynovitis and tendinitis, care should be taken to inject Depo-Medrone with Lidocaine into the tendon sheath rather than into the substance of the tendon. Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with Depo-Medrone with Lidocaine. Children: For infants and children, the recommended dosage should be reduced, but dosage should be governed by the severity of the condition rather than by strict adherence to the ratio indicated by age or body weight.

Elderly patients: When used according to instructions, there is no information to suggest that a change in dosage is warranted in the elderly. However, treatment of elderly patients, particularly if long-term, should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age and close clinical supervision is required (see special warnings and precautions).

Contra-indications, warnings, etc.

Contra-indications: Depo-Medrone with Lidocaine is contra-indicated where there is known hypersensitivity to components or to any local anaesthetics of the amide type and in systemic infection unless anti-infective therapy is employed. Due to its potential for neurotoxicity,

Depo-Medrone with Lidocaine must not be given by the intrathecal route. In addition, as the product is a suspension it must not be given by the intravenous route (see Side-effects).

Interactions

1. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Since concurrent administration of these agents results in

a mutual inhibition of metabolism, it is possible that convulsions and other adverse effects associated with the individual use of either drug may be more apt to occur.

2.    Drugs that induce hepatic enzymes, such as ritampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, and aminoglutethimide enhance the metabolism of corticosteroids and their therapeutic effects may be reduced.

3.    Drugs such as erythromycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance.

4.    Steroids may reduce the effects of anticholinesterases in myasthenia gravis. The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives and diuretics are antagonized by corticosteroids, and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced.

5.    The efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.

6.    The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication. Salicylates and non-steroidal anti-inflammatory agents should be used cautiously in conjunction with corticosteroids in hypothrombinaemia.

7.    Steroids have been reported to interact with neuromuscular blocking agents such as pancuronium with partial reversal of the neuromuscular block.

Effects on ability to drive and to use machines: None stated.

Other undesirable effects (frequency and seriousness)

Side-effects: The incidence of predictable undesirable side-effects associated with the use of corticosteroids, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and duration of treatment (see Special warnings and precautions). Side-effects for the Depo-Medrone component may be observed including:

PARENTERAL CORTICOSTEROID THERAPY -Anaphylactic reaction or allergic reactions, hypopigmentation or hyperpigmentation, subcutaneous and cutaneous atrophy, sterile abscess, post injection flare (following intra-articular use), Charcot-like arthropathy. GASTRO-INTESTINAL - Dyspepsia, peptic ulceration with perforation and haemorrhage, abdominal distension, oesophageal ulceration, oesophageal candidiasis, acute pancreatitis, perforation of bowel.

Increases in alanine transaminase (ALT, SGPT) aspartate transaminase (AST, SGOT) and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation. ANTI-INFLAMMATORY AND IMMUNOSUPPRESSIVE EFFECTS - Increased susceptibility and severity of infections with suppression ot clinical symptoms and signs, opportunistic infections, may suppress reactions to skin tests, recurrence of dormant tuberculosis (see Special warnings and precautions). MUSCULOSKELETAL - Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, aseptic necrosis, muscle weakness.

FLUID AND ELECTROLYTE DISTURBANCE -Sodium and water retention, potassium loss, hypertension, hypokalaemic alkalosis, congestive heart failure in susceptible patients. DERMATOLOGICAL - Impaired healing, petechiae and ecchymosis, thin fragile skin, skin atrophy, bruising, striae, telangiectasia, acne. 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 tor antidiabetic therapy, negative nitrogen and calcium balance. Increased appetite. NEUROPSYCHIATRIC "A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood psychological dependence and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported for all corticosteroids.. Reactions are common and may occur in both adults and children. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown. Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri) has been reported, usually after treatment withdrawal of methylprednisolone. OPHTHALMIC - Increased intra-ocular pressure, glaucoma, papilloedema, cataracts with possible damage to the optic nerve, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal disease, exophthalmos.

GENERAL - Leucocytosis, hypersensitivity including anaphylaxis, thrombo-embolism, nausea, vertigo. WITHDRAWAL SYMPTOMS - Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. However, this is more applicable to corticosteroids with an indication where continuous therapy is given (see Special warnings and precautions).

A 'withdrawal syndrome' may also occur including, tever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight. Side-effects for the Lidocaine component include: CENTRAL NERVOUS SYSTEM - Light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensation of heat, cold, numbness, twitching, tremors, convulsions, loss of consciousness, respiratory depression, respiratory arrest.

CARDIOVASCULAR SYSTEM - Bradycardia, hypotension, cardiovascular collapse, cardiac arrest. ALLERGIC REACTIONS - Cutaneous lesions, urticaria, oedema, anaphylactic reactions.

CERTAIN SIDE-EFFECTS REPORTED WITH SOME NON RECOMMENDED ROUTES OF ADMINISTRATION:

Intrathecal: Usual systemic corticoid adverse reactions, headache, meningismus, meningitis, paraplegia, spinal fluid abnormalities, nausea, vomiting, sweating, arachnoiditis, convulsions. Extradural: Wound dehiscence, loss of sphincter control.

Intranasal: Permanent/temporary blindness, allergic reactions, rhinitis.

Ophthalmic (Subconjunctival): Redness and itching, abscess, slough at injection site, residue at injection site, increased intra-ocular pressure, decreased vision - blindness, infection.

Miscellaneous: Scalp, tonsillar fauces, sphenopalatine ganglion: blindness.

Special warnings and precautions Warnings and Precautions:

1.    A Patient Information Leaflet is provided in the pack by the manufacturer.

2.    Undesirable effects may be minimized by using the lowest effective dose for the minimum period. Frequent patient review is required to appropriately titrate the dose against disease activity (see Dosage and administration).

3.    Patients should carry 'Steroid Treatment' cards which give clear guidance on the precautions to be taken to minimize risk and which provide details of prescribes drug, dosage and the duration of treatment.

4.    Depo-Medrone with Lidocaine vials are intended for single dose use only. Any multidose use ot the product may lead to contamination.

Continued overleaf...

5.    Depo-Medrone with Lidocaine is not recommended for epidural, intranasal, intra-ocular, or any other unapproved route of administration. See Side-effects section for details of side-effects reported from some non-recommended routes of administration.

6.    Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with Depo-Medrone with Lidocaine.

7.    While crystals of adrenal steroids in the dermis suppress inflammatory reactions, their presence may cause disintegration of the cellular elements and physiochemical changes in the ground substance of the connective tissue. The resultant infrequently occurring dermal and/or subdermal changes may form depressions in the skin at the injection site and the possibility of depigmentation. The degree to which this reaction occurs will vary with the amount of adrenal steroid injected. Regeneration is usually complete within a few months or after all crystals of the adrenal steroid have been absorbed. In order to minimize the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections. Multiple small injections into the area of the lesion should be made whenever possible. The technique of intra-articular injection should include precautions against injection or leakage into the dermis.

8.    Systemic absorption of methylprednisolone occurs following intra-articular injection of Depo-Medrone with Lidocaine. Systemic as well as local effects can therefore be expected.

9.    Intra-articular corticosteroids are associated with a substantially increased risk of inflammatory response in the joint, particularly bacterial infection introduced with the injection. Charcot-like arthropathies have been reported particularly after repeated injections. Appropriate examination of any joint fluid present is necessary to exclude any bacterial infection, prior to injection.

10.    Following a single dose of Depo-Medrone with Lidocaine, plasma cortisol levels are reduced and there is evidence of hypothalamic-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 3 weeks.

•    When a short course has been prescribed within one year of cessation of long-term therapy (months or years).

•    Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy.

•    Patients receiving doses of corticosteroid greater than 32 mg daily of methylprednisolone.

•    Patients repeatedly taking doses in the evening.

12.    Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

13.    Because rare instances of anaphylactic reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of drug allergy.

14.    Corticosteroids may mask some signs of infection, and new infections may appear during their use. Suppression of the inflammatory response and immune function increases the susceptibility to fungal, viral and bacterial infections and their severity. The clinical presentation may often be atypical and may reach an advanced stage before being recognized.

15.    Chickenpox is of serious concern since this normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. Passive immunization with varicella/zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.

16.    Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished.

17.    If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

18.    This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.

19.    Care should be taken for patients receiving cardioactive drugs such as digoxin because of steroid induced electrolyte disturbance/potassium loss (see Side-effects).

20.    The following precautions apply for parenteral corticosteroids: Following intra-articular injection, a marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.

No additional benefit derives from the intramuscular administration of Depo-Medrone with Lidocaine. Where parenteral corticosteroid therapy for sustained systemic effect is desired, plain Depo-Medrone should be used.

Local injection of a steroid into a previously infected joint is to be avoided.

Corticosteroids should not be injected into unstable joints.

Sterile technique is necessary to prevent infections or contamination.

Special precautions:

Particular care is required when considering the use

of systemic corticosteroids in patients with the

following conditions and frequent patient

monitoring is necessary.

1.    Osteoporosis (post-menopausal females are particularly at risk).

2.    Hypertension or congestive heart failure.

3.    Existing or previous history of severe affective disorders (especially previous steroid psychosis).

4.    Diabetes mellitus (or a family history of diabetes).

5.    History of tuberculosis.

6.    Glaucoma (or a family history of glaucoma).

7.    Previous corticosteroid-induced myopathy.

8.    Liver failure or cirrhosis.

9.    Renal insufficiency.

10.    Epilepsy.

11.    Peptic ulceration.

12.    Fresh intestinal anastomoses.

13.    Predisposition to thrombophlebitis.

14.    Abscess or other pyogenic infections.

15.    Ulcerative colitis.

16.    Diverticulitis.

17.    Myasthenia gravis.

18.    Ocular herpes simplex, for fear of corneal perforation.

19.    Hypothyroidism.

20.    Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5 Interaction with Other Medicaments and Other Forms of Interaction that can increase the risk of side effects), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

Use in children. Corticosteroids cause growth retardation in infancy, childhood and adolescence which may be irreversible. Treatment should be limited to the minimum dosage for the shortest possible time.

Use in the elderly. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

Use in Pregnancy and Lactation:

Prennancv

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 treated as though they were in the non-gravid state.

The use of local anaesthetics such as lidocaine during labour and delivery may be associated with adverse effects on mother and foetus. Lidocaine readily crosses the placenta.

Lactation

Corticosteroids are excreted in small amounts in breast milk, however, doses of up to 40mg daily of methylprednisolone are unlikely to cause systemic effects in the infant.

Infants of mothers taking higher doses than this may have a degree of adrenal suppression, but the benefits of breastfeeding are likely to outweigh any theoretical risk.

It is not known whether lidocaine is excreted in human breast milk.

Use in children: Corticosteroids cause growth retardation in infancy, childhood and adolescence which may be irreversible. Treatment should be limited to the minimum dosage for the shortest possible time.

Use in the elderly: The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

Overdosage: There is no clinical syndrome of acute overdosage with Depo-Medrone with Lidocaine. Following overdosage the possibility of adrenal suppression should be guarded against by gradual diminution of dose levels over a period of time. In such event the patient may require to be supported during any further traumatic episode. Incompatibilities (major): None stated. Pharmaceutical precautions Depo-Medrone with Lidocaine should be stored below 25° C and protected from freezing. Depo-Medrone with Lidocaine should not be mixed with any other fluid. Discard any remaining suspension after use.

Legal category POM

Packaging quantities

1 ml and 2 ml vials packed singly and in 10 vial packs.

Product licence number

PL 00057/0964 Product licence holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ.

Date of preparation or last review: 02/2012 Ref: DM 6_0 UK

® Depo-Medrone with Lidocaine is a registered trademark

8R2075

review is required to appropriately titrate the dose against disease activity (see Dosage and administration).

3.    Patients should carry 'Steroid Treatment’ cards which give clear guidance on the precautions to be taken to minimize risk and which provide details of prescriber, drug, dosage and the duration of treatment.

4.    Depo-Medrone with Lidocaine vials are intended for single dose use only. Any multidose use of the product may lead to contamination.

5.    Depo-Medrone with Lidocaine is not recommended for epidural, intranasal, intra-ocular, or any other unapproved route of administration. See Side-effects section for details of side-effects reported from some non-recommended routes of administration.

6.    Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with Depo-Medrone with Lidocaine.

7.    While crystals of adrenal steroids in the dermis suppress inflammatory reactions, their presence may cause disintegration of the cellular elements and physiochemical changes in the ground substance of the connective tissue. The resultant infrequently occurring dermal and/or subdermal changes may form depressions in the skin at the^-injection siteand"the-possibtt%'OfdeptgmefilationrThe degree to which this reaction occurs will vary with the amount of adrenal steroid injected. Regeneration is usually complete within a few months or after all crystals of the adrenal steroid have been absorbed. In order to minimize the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections. Multiple small injections into the area of the lesion should be made whenever possible. The technique of intra-articular injection should include precautions against injection or leakage into the dermis.

8.    Systemic absorption of methylprednisolone occurs following intra-articular injection of Depo-Medrone with Lidocaine. Systemic as well as local effects can therefore

9. Intra-articular corticosteroids are associated with a substantially increased risk of inflammatory response in the joint, particularly bacterial infection introduced with the injection. Charcot-like arthropathies have been reported particularly after repeated injections. Appropriate examination of any joint fluid present is necessary to exclude any bacterial infection, prior to injection.

10.    Following a single dose of Depo-Medrone with Lidocaine, plasma cortisol levels are reduced and there is evidence of hypothalamic-pituitary-adrenal axis (MPA) 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. Mow 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 withdrawaPof systemic uorttcostefoidTreatment; which has continued up to 3 weeks is appropriate if it considered that the disease is unlikely to relapse. Abrupt withdrawal of doses up to 32 mg daily of methylprednisolone for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less:

•    Patients who have had repeated courses of systemic corticosteroids, particularly if taken for greater than 3 weeks.

•    When a short course has been prescribed within one year of cessation of long-term therapy (months or years).

•    Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy.

•    Patients receiving doses of corticosteroid greater than 32 mg daily of methylprednisolone.

•    Patients repeatedly taking doses in the evening.

12.    Since mineralocorticoid secretion may be impaired, salt

and/or a mineralocorticoid should be administered concurrently.

13. Because rare instances of anaphylactic reactions have occurred in patients receiv ng parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administratiejn, especially when the patient has a history of drug allergy.

Corticosteroids may mask some signs of infection, and new infections may appear duri lg their use. Suppression of the inflammatory response and immune function increases the susceptibility to fungal, virhl and bacterial infections and their severity. The clinical presentation may often be atypical and may reach an advance i stage before being recognized. 15. Chickenpox is of serious concern since this normally minor

(or parents of children) without a definite history of chickenpox should be advised to avoid close personal immunization with varicella/zoster immunoglobulin (VZIG) is needed by exposed non-iimmune patients who are receiving systemic cortico: teroids or who have used them within the previous 3 months; this should be given within 1-0-days-ofexpesurete eht jkenpoxrlfa-diagnosis of chickenpox is confirmed, t le illness warrants specialist care and urgent treatment. Cort costeroids should not be stopped and the dose may need to oe increased.

i to individuals with

impaired immune responsiveness. The antibody response to other vaccines may be dim nished.

17.    If corticosteroids are indicated in patients with latent tuberculosis or tuberculin feactivity, close observation is necessary as reactivation t|f the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis

18.    This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.

19.    Care should be taken for patients receiving cardioactive drugs such as digoxin because of steroid induced electrolyte disturbance/pot^ssium loss (see Side-effects).

20.    The following precautions ppply for parenteral corticosteroids: Following intra-articular injection, a marked increase in pain accompanied by local swelling, further restriction of joint motion, tever, and malaise are suggestive of septic arthritis. If this complication occurs ind the diagnosis of sepsis is confirmed, appropriate therapy should be instituted.

No additional benefit derives from the intramuscular administration of Depo-Medrone with Lidocaine, parenteral corticosteroid therapy for sustained sys desired, plain Depo-Medrone should be used.

Local injection of a steroid into a previously infectfed joint is to be avoided.

Corticosteroids should not be injected into unstab i Sterile technique is necessary to prevent infection: contamination.

Special precautions:

Particular care is required when considering the uie of systemic corticosteroids in patients with the following cond tions and frequent patient monitoring is necessary.

1.    Osteoporosis (post-menopausal females are particularly at risk).

2.    Hypertension or congestive heart failure.

3.    Existing or previous history of severe affective; disorders (especially previous steroid psychosis).

4.    Diabetes mellitus (or a family history of diabe es).

5.    History of tuberculosis.

_S_ fthnnnrm fnr t fTmilu hicttnrv/ nf nlaunnma^ u. urauuuirta (ut ct iatttiiy itroioty ut y lauLiUiiia/.

7.    Previous corticosteroid-induced myopathy.

8.    Liver failure or cirrhosis.

9.    Renal insufficiency.

10.    Epilepsy.

11.    Peptic ulceration.

12.    Fresh intestinal anastomoses.

13.    Predisposition to thrombophlebitis.

14.    Abscess or other pyogenic infections.

15.    Ulcerative colitis.

16.    Diverticulitis.

17.    Myasthenia gravis.

18.    Ocular herpes simplex, for fear of corneal perforation.

19.    Hypothyroidism.

20.    Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occi r 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 M jdicaments and Other Forms of Interaction that can increase the risk of side effects), although dose levels do not allo^f 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.

Use in children: Corticosteroids cause growth retardation in infancy, childhood and adolescence which may be irreversible. Treatment should be limited to the minimum dosage for the shortest possible time.

Use in the elderly: The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

Use in Pregnancy and Lactation:

Preonancv

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