Depomed Injection 80 mg/2 ml

৳ 100.30

Drug International Limited

Methyl Prednisolone Acetate

Indications

For Intramuscular Administration: When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of Methylprednisolone acetate Sterile Aqueous Suspension is indicated as follows:

  • Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions.
  • Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme(Stevens-Johnson syndrome).
  • Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.
  • Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.
  • Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia.
  • Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
  • Neoplastic Diseases: For palliative management of leukemias and lymphomas.
  • Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.
  • Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
  • Renal Diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus.
  • Respiratory Diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
  • Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, andsystemic lupus erythematosus.

For Intra-Articular Or Soft Tissue Administration: Methylprednisolone acetate is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.

For Intralesional Administration: Methylprednisolone acetate is indicated for intralesional use in alopecia areata, discoid lupus erythematosus, keloids, localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques, necrobiosis lipoidica diabeticorum. Methylprednisolone acetate acetate also may be useful in cystic tumors of an aponeurosis or tendon(ganglia).

Therapeutic Class

Glucocorticoids

Pharmacology

Methylprednisolone binds to and activates intracellular glucocorticoid receptors. Activated glucocorticoid receptors bind to promoter regions of DNA (which may activate or suppress transcription).

Unbound glucocorticoids cross cell membranes and bind with high affinity to specific cytoplasmic receptors, modifying transcription and protein synthesis. By this mechanism, glucocorticoids can inhibit leukocyte infiltration at the site of inflammation, interfere with mediators of inflammatory response, and suppress humoral immune responses. The antiinflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.

Dosage & Administration

Intra-articular-
Anti-inflammatory or immunosuppressive

  • Adult: As methylprednisolone acetate: 4-10 mg (small joints); 10-40 mg (medium joints); 20-80 mg (large joints). May be repeated every 1-5 wk depending on patient’s response.

Intralesional-
Corticosteroid-responsive dermatoses

  • Adult: As methylprednisolone acetate: 20-60 mg; 1-4 inj may be given at intervals depending on the type of lesion and the duration of improvement from the initial inj.

Intralesional-
Anti-inflammatory or immunosuppressive

  • Adult: As methylprednisolone acetate: 20-60 mg every 1-5 wk depending on patient’s response.

Interaction

Loss of corticosteroid-induced adrenal suppression with aminoglutethimide. Risk of hypokalaemia with K-depleting agents (e.g. amphotericin B, diuretics). Decreased clearance with macrolide antibiotics. May decrease serum levels of isoniazid. Increased clearance with cholestyramine. Risk of convulsions with ciclosporin. Increased risk of arrhythmias with digitalis glycosides. Decreased metabolism with oestrogens, including OCs. Enhanced metabolism with CYP3A4 inducers (e.g. rifampicin, barbiturates). Increased plasma concentrations with CYP3A4 inhibitors (e.g. ketoconazole, erythromycin). Risk of GI effects with aspirin or other NSAIDs. May increase the anticoagulant effect of warfarin. May reduce the therapeutic effect of antidiabetics.

Contraindications

Systemic fungal infections unless specific anti-infective therapy is employed; IM admin in idiopathic thrombocytopenic purpura. Intrathecal admin. Concurrent admin of live or live, attenuated vaccines (in patients receiving immunosuppressive doses).

Side Effects

Adrenal suppression, anaphylactoid reactions, immunosuppression, acute myopathy, Kaposi’s sarcoma, psychiatric disturbances (e.g. depression, euphoria, insomnia, mood swings, personality changes), increased susceptibility and severity of infections, impaired healing, HTN, Na and fluid retention, CV collapse (high dose), peptic ulcer, cataract subcapsular, skin atrophy, acne, muscular weakness, growth retardation, decreased blood K; dermal/subdermal skin depression at inj site. Topical: Itching, burning erythema, vesiculation; rarely, folliculitis, hypertrichosis, perioral dermatitis, skin discolouration, allergic skin reactions.

Pregnancy & Lactation

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Precautions

Patient with heart failure, HTN, DM, GI disease (e.g. diverticulitis, intestinal anastomoses, peptic ulcer, ulcerative colitis), multiple sclerosis, myasthenia gravis, acute MI, cataracts, glaucoma, osteoporosis, history of seizure disorder, thyroid disease. Avoid abrupt withdrawal. Renal and hepatic impairment (including cirrhosis). Childn. Pregnancy and lactation.

Storage Conditions

Store between 20-25° C.

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