Inospiron Tablet 100mg

PRESENTATION

Inospiron 25: Each tablet contains Spironolactone BP 25 mg.

DESCRIPTION

Inospiron is a preparation of long-acting aldosterone antagonist, potassium-sparing Spironolactone. Spironolactone is a specific

pharmacologic antagonist of aldosterone, acting primarily through competitive binding of receptors at the aldosterone dependent

sodium-potassium exchange site in the distal convoluted renal tubule. Inospiron® causes increased amounts of sodium and water to

be excreted, while potassium and magnesium is retained.

INDICATIONS

• Congestive heart failure

• Hepatic cirrhosis with ascites and oedema

• Nephrotic syndrome

• Primary hyperaldosteronism

• Essential hypertension

• For the treatment of patients with hypokalemia

DOSAGE & ADMINISTRATION

Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome): An initial daily dosage of 100 mg of

Inospiron® administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. Combined therapy

with other diuretics is indicated when more rapid diuresis is desired.

Primary hyperaldosteronism: After the diagnosis of hyperaldosteronism has been established, Inospiron® may be administered in

doses of 100 to 400mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, Inospiron® may be

employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.

Essential hypertension: For adults, an initial daily dosage of 50 to 100 mg of Inospiron® administered in either single or divided

doses is recommended.

Hypokalemia: Inospiron® in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia.

SIDE EFFECTS

Gynaecomastia may develop in association with the use of Spironolactone. Other adverse reactions are: GI symptoms including

cramping and diarrhoea, drowsiness, lethargy, headache, urticaria, mental confusion, impotence, irregular menses or amenorrhoea

and post-menopausal bleeding.

PRECAUTIONS

All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance. Hyperkalemia may occur

in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities, which may be fatal.

USE IN PREGNANCY & LACTATION

Pregnancy: Spironolactone should not be used during pregnancy.

Lactation: Canrenone, an active metabolite of Spironolactone, appears in breast milk. If use of the drug is deemed essential an

alternative method of infant feeding should be instituted.

DRUG INTERACTION

ACE inhibitors: Concomitant administration of ACE inhibitors with potassium-sparing diuretics has been associated with severe

hyperkalemia.

Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.

Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, may occur.

Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a

high risk of lithium toxicity.

Digoxin: Spironolactone has been shown to increase the half-life of digoxin.

OVER DOSE

Symptoms of overdosage include drowsiness, mental confusion, dizziness, diarrhea and vomiting etc. Patients should induce vomiting

or evacuate the stomach by lavage during Spironolactone overdoasge.

COMMERCIAL PACK

Inospiron 25: Each box contains 10 blister strips of 10 tablets.