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Al-Tinez Dexamethasone Tablet

Al-Tinez Pharmaceuticals Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Tel: 01-4826452; 0802-307-7320, 0803-305-7978

Brand Name

Al-Tinez Dexamethasone Tablet

Manufacturer

Medipharco 8 Nguyen Truong To St., Hue City, Vietnam.

Therapeutic Class

Corticosteroids, Systemic

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: A4- 4420): Dexamethasone acetate 0.5 mg.

Pack size: Box of 10/50 blisters x 30 tablets.

Pharmacology

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have sodium-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs including dexamethasone are primarily used for their anti-inflammatory effects in disorders of many organ systems.

At equipotent anti-inflammatory doses, Dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

Indications

Treatment of all conditions in which corticosteroid therapy is indicated:

Allergic disorders and autoimmunologic diseases, associated treatment in well-controlled infections, bronchial asthma, nephritic syndrome, arthritis.

Contra-indications

Hypersensitivity to any component of the product.

Any bacterial or fungal infections which are poorly controlled by a specific therapy.

Active viral infections, especially herpes and zona with ocular manifestations.

Gout, active gastroduodenal ulcer, certain psychiatric states, alcoholic cirrhosis with ascites, acute hepatitis A or B, or non-A, non-B.

Precautions/Warnings

Congestive heart failure, diabetes, infectious diseases, chronic renal failure, uraemia, quiescent tuberculosis. Prolonged use. Prophylactic immunoglobulin may be necessary in children. Reduce Na intake & give K supplement.

Elderly.

Pregnancy and lactation:

Use in pregnancy: In women, retrospetive studies reveal no teratogenic effect of corticosteroid therapy in the 1st trimester.

Use in lactation: Dexamethasone should not be administered during breastfeeding.

Interactions

Aminoglutethimide: Aminoglutethimide may diminish adrenal suppression by corticosteroids.

Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.

Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.

Anticoagulants, oral: Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.

Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.

Antitubercular drugs: Serum concentrations of isoniazid may be decreased.

Cholestyramine: Cholestyramine may increase the clearance of corticosteroids

Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.

Dexamethasone suppression test (DST): False-negative results in the Dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.

Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

Ephedrine: Ephedrine may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring an increase in corticosteroid dosage.

Adverse Effects

Fluid and hydroelectrolytes disorders: Hypokalemia, hypokalemic alkalosis, water and sodium retention sometimes causing arterial hypertension and congestive heart failure.

Endocrinal and metabolic effects: Cushing's syndrome, ACTH secretion inertia, cortico-suprarenal atrophy, diminution of glucose tolerance, latent diabetic manifestations, growth retardation in children, sometimes menstrual irregularities.

Digestive effects: Gastro-duodenal ulcers, ulcerous hemorrhage, intestinal ulcer, acute pancreatitis.

Cutaneous effects: cutaneous atrophy, purpura, ecchymosis, hypertrichosis.

Neuropsychic effects: Usually euphoria, sleeping trouble.

Inform your doctor of any adverse reaction related to drug use.

Dosage & Administration

This drug must be used under the prescription of a doctor.

Adults: 0.5-9 mg daily in divided doses

Children: 0.024 - 0.34 mg/kg/day

Administration: Should be taken with food.

Storage/Handling Recommendations

Store in a cool dry place below 30ºC. Protect from sunlight.

Review Date

2016-12-02 19:24:48