Maxtar Bio-genics


Bell-Kenz Pharma
Concise Prescribing Info
Management of primary hyperaldosteronism, edematous conditions for patients w/ CHF, cirrhosis of the liver accompanied by edema &/or ascites, nephrotic syndrome, essential HTN, severe heart failure (NYHA class III-IV); treatment/prophylaxis of hypokalemia; in pregnancy when edema is due to pathologic causes.
Dosage/Direction for Use
Long-term therapy for primary hyperaldosteronism 400 mg daily for 3-4 wk. Short-term therapy for primary hyperaldosteronism 400 mg daily for 4 days. In preparation for surgery 100-400 mg daily. Edema in adults (CHF, hepatic cirrhosis or nephrotic syndrome) Initially 100 mg daily as single or divided doses, but may range from 25-200 mg daily, then continue for at least 5 days. Essential HTN Initially 50-100 mg as single or divided doses, then continue for at least 2 wk. Hypokalemia 25-100 mg daily. Severe heart failure (NYHA class III-IV) Patient w/ serum K of ≤5 mEq/L & serum creatinine ≤2.5 mg/dL Initially 25 mg once daily, may increase to 50 mg once daily. Patients who do not tolerate 25 mg once daily may reduce dosage to 25 mg every other day.
May be taken with or without food: Do not take together w/ potassium rich foods & potassium supplements, including salt substitutes.
Anuria, acute renal insufficiency, significant impairment of renal excretory function or hyperkalemia.
Special Precautions
K supplementation, excessive K intake. Do not administer concurrently w/ other K-sparing diuretics, or lithium. Concomitant use w/ ACE inhibitors or indomethacin. Patients w/ severe heart failure, impaired hepatic function. Monitor K & creatinine 1 wk after initiation of therapy or increase in dose, mthly for the 1st 3 mth, then quarterly for a year, & then every 6 mth. Observe for evidence of fluid or electrolyte imbalance eg, hypomagnesemia, hyponatremia, hypochloremic alkalosis & hyperkalemia. Discontinue if hyperkalemia is present. Reversible hyperchloremic metabolic acidosis in some patients w/ decompensated hepatic cirrhosis. Dilutional hyponatremia. Transient elevation of BUN in patient w/ preexisting renal impairment. Mild acidosis. Gynecomastia may develop. Avoid K supplements & foods containing high levels of K. Periodic determination of serum electrolytes particularly in elderly & patient w/ renal or hepatic impairment. Pregnancy & lactation. Childn.
Adverse Reactions
Gastric bleeding, ulceration, gastritis, diarrhea & cramping, nausea, vomiting; gynecomastia, inability to achieve or maintain erection, irregular menses or amenorrhea, post-menopausal bleeding, carcinoma of the breast; agranulocytosis; fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis; mental confusion, ataxia, headache, drowsiness, lethargy; renal dysfunction (including renal failure).
Drug Interactions
Severe hyperkalemia w/ ACE inhibitors. Potentiation of orthostatic hypotension w/ alcohol, barbiturates or narcotics. Intensified electrolyte depletion particularly hypokalemia w/ corticosteroids, ACTH. Reduced vascular responsiveness to pressor amines (eg, norepinephrine) especially in patients subjected to regional or general anesth. Increased responsiveness to nondepolarizing skeletal muscle relaxants (eg, tubocurarine). High risk of lithium toxicity. Reduced diuretic, natriuretic & antihypertensive effect w/ NSAIDs eg, indomethacin. Increased serum digoxin levels & subsequent digitalis toxicity.
MIMS Class
ATC Classification
C03DA01 - spironolactone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Spirofar tab 25 mg
10 × 10's (P15/tab, P1,500/box)
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