Hyles

Hyles

spironolactone

Manufacturer:

Berlin Pharm

Distributor:

Berlin Pharm
Concise Prescribing Info
Contents
Spironolactone
Indications/Uses
Edema, essential HTN, CHF (in patients receiving ACE inhibitors & a loop diuretic, w/ or w/o a cardiac glycoside), primary aldosteronism, hypokalemia, severe heart failure (NYHA class III-IV).
Dosage/Direction for Use
Edema Usual dosage: 25-200 mg daily. Essential HTN Initially 50-100 mg daily in single or divided doses. CHF Initially 12.5-25 mg daily. Dose may be increased to 50 mg daily after 8 wk of therapy in patients who exhibited signs & symptoms of progressive heart failure & who had no hyperkalemia (serum K conc of 5.5 mEq/L). If hyperkalemia occurs, decrease to 25 mg every other day. Primary hyperaldosteronism Usual dosage: 100-400 mg daily in prep for surgery. Hypokalemia Usual dosage: 25-100 mg daily. Severe heart failure (NYHA class III to IV) Initially 25 mg once daily if the patient's serum K is ≤5 mEq/L & the patient's serum creatinine is ≤2.5 mg/dL.
Administration
Should be taken with food.
Contraindications
Anuria, acute renal insufficiency, significant impairment of renal excretory function, hyperkalemia, impaired renal function or hepatic disease, patients w/ rapidly deteriorating renal function, whose serum creatinine or BUN conc is more than twice the normal.
Special Precautions
Hyperkalemia, fluid & electrolyte imbalance, hyperchloremic metabolic acidosis, hyponatremia, gynecomastia, renal effects, hepatic function impairment, GI effects, nervous system effects, dermatologic & sensitivity reactions, mutagenicity & carcinogenicity.
Adverse Reactions
Mental confusion, ataxia, headache, drowsiness, lethargy; gynecomastia, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding; carcinoma of the breast; 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
K-sparing agents, K-containing prep, antihypertensive & hypotensive agents, cardiac glycosides, aspirin, anticoagulants, lithium, mitotane, alcohol, barbiturates, narcotics, NSAIDs, corticosteroids, corticotropin (ACTH). 
MIMS Class
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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