Hyles

Hyles

spironolactone

Manufacturer:

Berlin Pharm

Distributor:

Berlin Pharm
Concise Prescribing Info
Contents
Spironolactone
Indications/Uses
Management of edema associated w/ excessive aldosterone excretion eg, idiopathic edema & edema accompanying liver cirrhosis, nephrotic syndrome, & CHF in conjunction w/ other diuretics. Essential HTN in combination w/ other drugs. Severe CHF in conjunction w/ ACE inhibitors, loop diuretics & cardiac glycosides. Short-term pre-op treatment of primary aldosteronism; long-term maintenance therapy for patients w/ discrete aldosterone-producing adrenal adenomas who cannot undergo adrenalectomy or who decline surgery & bilateral micronodular or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Severe heart failure NYHA class III-IV. Prophylaxis of hypokalemia.
Dosage/Direction for Use
Edema Usual dose: 25-200 mg daily. Initially 100 mg once daily or in divided doses for at least 5 days. Essential HTN Initially 50-100 mg once daily or in divided doses continued for at least 2 wk. CHF Initially 12.5-25 mg daily, may be increased to 50 mg daily after 8 wk of therapy in patients w/ signs & symptoms of progressive heart failure & who had no hyperkalemia (serum K conc 5.5 mEq/L). Decreased to 25 mg every other day if hyperkalemia occurs. Primary hyperaldosteronism Usual dose: 100-400 mg daily in prep for surgery. Long term: 400 mg daily for 3-4 wk; short term: 400 mg daily for 4 days. Hypokalemia Usual dose: 25-100 mg daily. Severe heart failure (NYHA class III-IV) Initially 25 mg once daily in patient w/ serum K ≤5 mEq/L & serum creatinine ≤2.5 mg/dL, may be increased to 50 mg once daily if tolerated. Reduced to 25 mg every other day, if not tolerated.
Administration
Should be taken with food.
Contraindications
Anuria, acute renal insufficiency, significant renal excretory function impairment, hyperkalemia. Patients w/ rapidly deteriorating renal function; whose serum creatinine or BUN conc is more than twice the normal. Renal or hepatic impairment.
Special Precautions
Discontinue if hyperkalemia occur. Not to be given w/ K supplements, either in medication form or as diet rich in K. Dermatologic & sensitivity reactions; fluid & electrolyte imbalance; reversible hyperchloremic metabolic acidosis; hyponatremia; gynecomastia; GI & nervous system effects. Transient elevation of serum BUN. Dilutional hyponatremia in edematous patients in hot weather. Patients receiving K supplements; primary aldosteronism. Concomitant use w/ other diuretics. Decompensated hepatic cirrhosis. Hepatic & preexisting renal impairment. Pregnancy. Not to be used during lactation.
Adverse Reactions
Mental confusion, ataxia, headache, drowsiness, lethargy; gynecomastia, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding; breast carcinoma; diarrhea & cramping, gastric bleeding, gastritis, nausea, ulceration, vomiting; mixed cholestatic/hepatocellular toxicity; anaphylactic reactions, fever, maculopapular or erythematous cutaneous eruptions, urticaria, vasculitis; agranulocytosis, hyperkalemia, renal dysfunction including renal failure.
Drug Interactions
Increased risk of hyperkalemia w/ K-sparing agents eg, amiloride, triamterene; K supplements or K-containing prep. Increased serum K conc w/ indomethacin. Concomitant use w/ ACE inhibitor eg, captopril. Potentiated action of other diuretics or hypotensive agents. Increased digoxin t½. Slightly reduced natriuretic effect w/ aspirin. Decreased hypoprothrombinemic effect of anticoagulants eg, warfarin. Reduced lithium renal clearance & increased risk of lithium toxicity. Blocked adrenolytic effects of mitotane. Potentiated orthostatic hypotension w/ alcohol, barbiturates, narcotics. Decreased effect & severe hyperkalemia w/ NSAIDs. Intensified electrolyte depletion w/ corticosteroids, corticotropin (ACTH). Reduced vascular responsiveness to norepinephrine & regional/general anesth.
MIMS Class
Diuretics
ATC Classification
C03DA01 - spironolactone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Presentation/Packing
Form
Hyles tab 100 mg
Packing/Price
10 × 10's
Form
Hyles tab 25 mg
Packing/Price
10 × 10's;50 × 10's
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