Techno Drugs Ltd.31,Segun Bagicha,Dhaka1000

Welcome to the training program

Pro-MedrolMethylprednisolone Sodium Succinate for injection, USP

Product Profile:

• Brand Name: Pro-Medrol

• Generic Name: Methylprednisolone Sodium Succinate

• Therapeutic Class : Glucocorticoids

• Strength : 500 mg and 1 gm vials.

Description:

Pro-Medrol®is an l.M.and l.V. Injectable form ofMethylprednisolone, synthetic glucocorticoids. This highly concentrated aqueous solution is particularly suitable for the treatment of pathologic conditions, in which an effective and rapid hormonal effect is required. Methylprednisolone has a strong anti-inflammatory,immunosuppressive and anti-allergic activity.

Indications:Intravenous administration of PRO-MEDROL (methylprednisolone sodiumsuccinate) is indicated in situations in which a rapid and intense hormonal effect is required. These include the following: * Hypersensitivity and dermatologic conditions :- Status asthmaticus - Anaphylactic reactions- Drug reactions - Contact dermatitis - Urticaria - Generalized neurodermatitis - Reactions to insect bites - Pemphigus foliaceous and vulgaris - Exfoliative dermatitis - Erythema multiforme

Cont..

*As Adjunctive therapy in:- Acute systemic lupus erythematosus - Acute rheumatic fever - Acute gout

*Ulcerative colitis *In anaphylactic reactions *In severe hemorrhagic or traumatic shock *Organ transplants *Cerebral oedema of non traumatic origin

Dosage & Administration:

As adjunctive therapy in life threatening conditions (e.g., shock states), therecommended dose of PRO-MEDROL (methylprednisolone sodium succinate) is 30 mg per kg, given intravenously over a period of at least 30 minutes. The large doses may be repeated every 4 - 6 hours for up to 48 hours.

• In other indications, initial dosage will vary from 10 to 500 mg depending on the clinical problem being treated. Larger doses may be required forshort-term management of severe, acute conditions. Therapy may be initiated byadministering PRO-MEDROL intravenously over a period of at least 5 minutes (e.g., doses up to 250 mg) to at least 30 minutes (e.g., doses greater than 250 mg). Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient's response and clinical condition. Corticosteroid therapy is an adjunct to, and not replacement for, conventional therapy.

Contraindication:• Except when used for short-term or emergency therapy as in acute

sensitivity reactions, PRO-MEDROL (methylprednisolone sodium succinate) is contraindicated in patients with arrested tuberculosis, herpes simplex keratitis, acute psychoses, Cushing's syndrome, peptic ulcer, markedly elevated serum creatinine, vaccinia and varicella. PRO-MEDROL is also contraindicated for systemic fungal infections and known hypersensitivity to the ingredients.

• PRO-MEDROL is contraindicated for intrathecal or epidural administration. Reports of serious medical events have been associated with these routes of administration.

• Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

• PRO-MEDROL is contraindicated for use in premature infants because the formulation contains benzyl alcohol.

Side Effects:

The following are typical for all systemic corticosteroids. Their inclusion in this list does not necessarily indicate that the

specific event has been observed with this particular formulation.• Fluid and Electrolyte Disturbances:sodium retention,fluid retention,congestive heart failure in

susceptible patients, potassium loss, hypokalaemic alkalosis, hypertension.• Musculoskeletal: muscle weakness, steroid myopathy, vertebral compression fractures, asepticnecrosis,

pathologicfractures, osteoporosis, Tendon rupture, particularly of the Archilles tendon.• Gastrointestinal: Peptic ulcer with possible perforation and heamorrhage, gastric haemorrhage,

pancreatitis, oesophagitis, perforation of the bowel.• Dermatologic: Impaired wound healing, thin fragile skin,petechiae and ecchymoses.• Neurological: increased intracranial pressure, pseudotumor cerebri, psychic derangements,seizures. • Endocrine: menstrual irregularities, development of cushingoid state, suppression of growth in children

suppression of pituitary-adrenal axis, decreased carbohydrate tolerance.• -manifestations of latent diabetes mellitus• -increased requirements for insulin or oral hypoglycaemic agents in diabetes.• Opthalmic: posterior subcapsular cataracts, increasedintraocularpressure, exophthalmos• Metabolic: negative nitrogen balance due to protein catabolism • Immune System: masking of infections, latent infections becoming active, opportunistic infections • Hypersensitivity reactions including anaphylaxis may suppress reactions to skin tests.• The following additional reactions are related to parenteral corticosteroidtherapy:• Anaphylactic reaction with or without circulatory collapse, cardiac arrest, bronchospasm, cardiac

arrhythmias, hypotension or hypertension.

Drug Interactions:• Aminoglutethimide• Amphotericin B injection and potassium-depleting agents• Macrolide antibiotics• Anticholinesterases• Anticoagulants, oral• Antidiabetics• Antitubercular drugs• Estrogens, including oral contraceptives• Hepatic Enzyme Inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin)• Hepatic Enzyme Inhibitors (e.g., ketoconazole, macrolide antibiotics such as

erythromycin and troleandomycin)• Ketoconazole• Nonsteroidal anti-inflammatory agents (NSAIDs)• Vaccines

Storage :

Protect from light. Store unreconstituted product at controlled room temperature (20° to 25°C). Store solution at controlled room temperature (20° to 25° C). Use solution within 48 hours after mixing.

How supplied :

Pro-Medrol® 500 mg injection: 1 vial of 500 mg Lyophilized powder with 1vial of 8 ml diluent in a box.

Pro-Medrol® 1 gm injection: 1 vial of 1 gm Lyophilized powder with 1 vial of16 ml diluent in a box.

Brand Competitors:

Have a Good Day