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Solu-Medrol Solucion INJECTION 500mg 8ml 1 AMP

THIS IS A BRAND MEDICATION

* Solu-Medrol (Methylprednisolone)
INJECTABLE SOLUTION
Parenteral corticosteroid action antishock
PFIZER, Inc.

- FORMULA
- NOTES
- Contraindications
- WARNINGS
- PRECAUTIONS
- Adverse Reactions
- LIMITATIONS dosage
- STORAGE
- PRESENTATIONS

FORMULA:

SOLU-Medrol * 500 mg:

Each bottle vial contains:

Methylprednisolone sodium succinate
    ........................................... equivalent to 500 mg
    methylprednisolone

Solu-Medrol 1000 mg *:

Each bottle vial contains:

Methylprednisolone sodium succinate
    equivalent to 1.000 mg ...........................................
    methylprednisolone

INDICATIONS: Corticosteroids are generally indicated for the treatment of inflammatory disorders, when conventional therapy is unsuccessful or during acute exacerbations of chronic disease, such as rheumatic disorders, collagen diseases or gastrointestinal inflammatory diseases. Although no clinical studies with good controls (double blind placebo), data from experimental animal models indicate that SOLU-MEDROL * may be useful in haemorrhagic, traumatic or surgical shock that is unresponsive to routine therapy (for example, replacement fluid, etc.). See Warnings, compared to septic shock.

Prevention of nausea and vomiting associated with cancer chemotherapy: SOLU-Medrol * may be used alone or in combination with phenothiazine, butyrophenone or metoclopramide to prevent nausea and vomiting associated with cancer chemotherapy.

Acute spinal cord injury: For treatment of acute spinal cord injury, administered intravenously methylprednisolone 30 mg per kg body weight in a bolus dose, in a period of 15 minutes, followed by a pause of 45 minutes and then a continuous infusion of 5.4 mg / kg / hour for 23 hours. It should be used besides a vein for the infusion pump. Treatment should be initiated at the end of 8 hours of the injury.

Contraindications

q systemic fungal infections.

q Cases known hypersensitivity.

WARNINGS: When patients receiving steroids will be subjected to unusual stress, is indicated steroids quick action before, during and after stress. Steroids may mask the signs of infection and altered host defenses. Susceptibility to infection is increased can be reduced and the ability to locate the same. Prolonged use may produce subcapsular cataracts, glaucoma with possible damage to the optic nerves, allergic reactions, eg, angioedema and eye infections. Steroids can cause increased blood pressure, increased salt and water retention, increased excretion of potassium and calcium and osteoporosis. Patients who are receiving steroids should not receive smallpox vaccine or other kind of immunization. TB patients should only receive steroids in conjunction with appropriate antituberculous therapy. Patients with latent tuberculosis or tuberculin exhibit activity require close monitoring, as reactivation of the disease may occur. Steroids may mask the symptoms of a peptic ulcer; perforation or bleeding can occur without significant pain manifest. Recent studies have established the efficacy of Solu-Medrol * in cases of septic shock and suggest that higher risk subgroups may present increased mortality (eg creatinine concentrations higher than 2.0 mg or to secondary infections). Because in rare circumstances have appeared anaphylactic reactions (eg, bronchospasm) in patients receiving therapy parenteral corticosteroid appropriate before administration precautions, especially when the patient has a history of allergy to any medicine should be taken. There have been reports of cardiac arrhythmias and / or circulatory collapse and / or arrest / heart after rapid IV administration of large doses methylprednisolone sodium succinate (0.5 g administered over for a period of less than 10 minutes). Bradycardia has been reported during or after the administration of large doses of methylprednisolone sodium succinate, which may be unrelated to the speed or duration of infusion. This product contains benzyl alcohol. An association has been reported between benzyl alcohol and the "choking syndrome" fatal in premature infants. (This clarification applies only to countries where benzyl alcohol is included in the formula).

Pregnancy: Studies in animals have demonstrated fetal malformations. This drug should only be used during pregnancy only if clearly needed. Children born to mothers receiving steroids or who were breastfed by them, must be carefully watched for adrenal deficiency occurs.

PRECAUTIONS: Use with caution in patients with ocular herpes simplex because of the risk of perforation. Use the lowest possible dose. Psychic disturbances may occur, and emotional instability or psychotic tendencies may be aggravated. Hypoprothrombinemia patients must use steroids with great caution, when administered in conjunction with aspirin or other nonsteroidal antiinflammatory agents. Use cautiously in cases of nonspecific ulcerative colitis if there was risk of complications. Complications observed during treatment depend on the magnitude and duration of dosing. In each individual case must be taken a decision about risk vs. benefits.

Nursing Mothers: Steroids are excreted in breast milk.

ADVERSE REACTIONS:

q Fluid and Electrolyte Disturbances: Caused by sodium retention and potassium depletion.

q musculoskeletal effects: For example, myopathy, osteoporosis and pathological fractures.

q Gastrointestinal: peptic ulcer, pancreatitis and esophagitis. Increase in liver enzyme values ​​aminotransaminase alanine (ALT) and aspartate aminotransaminase (ASAT).

q Dermatological reactions: impaired wound healing, thin fragile skin, bruising.

q protein catabolism. Neurological reactions: Increased intracranial pressure, psychological disorders.

q endocrine reactions: Growth suppression, menstrual irregularities, reduced tolerance to carbohydrates, like state Cushing, suppression of pituitary-adrenal axis.

q ophthalmic reactions: Niagara, increased intraocular pressure.

q immune system: Concealment of infection, latent infection becomes active, opportunistic pathogens infection, hypersensitivity reactions including anaphylaxis, suppression of reactions to skin tests.

LIMITATIONS Dosage: The dosage requirements are variable and must be individualized based on the disease being treated and patient response.

STORAGE: unreconstituted product stored at controlled room temperature (15 to 30 ° C), the solution made ​​lasts 48 hours after mixing.

PRESENTATIONS flask-ampoules containing 40 mg (1 ml), 500 mg (8 ml) and 1000 mg (16 ml).