Aldactone

2 ). 3 ). • Edema: Initiate therapy in a hospital setting and titrate slowly. 4 ). • Primary hyperaldosteronism: Initiate treatment at 100 to 400 mg in preparation for surgery. 5 ). 3) ] . 73 m 2 , initiate treatment at 25 mg once daily. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated.

1) ] . 6) ]. 3 Treatment of Essential Hypertension The recommended initial daily dose is 25 to 100 mg of ALDACTONE administered in either single or divided doses is recommended. Dosage can be titrated at two-week intervals. Doses greater than 100 mg/day generally do not provide additional reductions in blood pressure.

7) ] . The recommended initial daily dosage is 100 mg of ALDACTONE administered in either single or divided doses, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, administer for at least five days before increasing dose to obtain desired effect.

5 Treatment of Primary Hyperaldosteronism Administer ALDACTONE in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, ALDACTONE can be used as long-term maintenance therapy at the lowest effective dosage determined for the individual patient.

7) ] The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

Digestive:

Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.

Reproductive:

Decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain.

Hematologic:

Leukopenia (including agranulocytosis), thrombocytopenia.

Hypersensitivity:

Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis. 3) ] , hyponatremia, hypovolemia.

Musculoskeletal:

Leg cramps.

Nervous system/psychiatric:

Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness.

Liver/biliary:

A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.

Renal:

Renal dysfunction (including renal failure).

Skin:

1 ). 2 ). 3 ). 4 ). 1 Hyperkalemia ALDACTONE can cause hyperkalemia. 1) ] . Monitor serum potassium within 1 week of initiation or titration of ALDACTONE and regularly thereafter. More frequent monitoring may be needed when ALDACTONE is given with other drugs that cause hyperkalemia or in patients with impaired renal function.

If hyperkalemia occurs, decrease the dose or discontinue ALDACTONE and treat hyperkalemia. 2 Hypotension and Worsening Renal Function Excessive diuresis may cause symptomatic dehydration, hypotension and worsening renal function, particularly in salt-depleted patients or those taking angiotensin converting enzyme inhibitors and angiotensin II receptor blockers.

, aminoglycosides, cisplatin, and NSAIDs). Monitor volume status and renal function periodically. 3 Electrolyte and Metabolic Abnormalities In addition to causing hyperkalemia, ALDACTONE can cause hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia.

Asymptomatic hyperuricemia can occur and rarely gout is precipitated. Monitor serum electrolytes, uric acid and blood glucose periodically. 4 Gynecomastia ALDACTONE can cause gynecomastia. In RALES, patients with heart failure treated with a mean dose of 26 mg of spironolactone once daily, about 9% of the male subjects developed gynecomastia.

The risk of gynecomastia increases in a dose-dependent manner with an onset that varies widely from 1–2 months to over a year. Gynecomastia is usually reversible.

4 CONTRAINDICATIONS ALDACTONE is contraindicated in the patients with: • Hyperkalemia • Addison's disease • Concomitant use of eplerenone ALDACTONE is contraindicated in patients with ( 4 ): ▪ Hyperkalemia ▪ Addison's disease ▪ Concomitant use of eplerenone