Aldactone Tablets (Generic Spironolactone Tablets)

1. Aldactone Tablets (Generic Spironolactone Tablets) © The Swiss Pharmacy

2. Aldactone Tablets (Generic Spironolactone Tablets) Aldactone (Generic Spironolactone Tablets) is used to treat high blood pressure as well as heart failure. Lowering high blood pressure helps to prevent strokes, heart attacks, and kidney problems. This medicine is also used to treat swelling (edema) caused by certain conditions (such as heart failure, liver disease) by removing excess fluid and improving symptoms such as breathing problems. © The Swiss Pharmacy

3. Aldactone Tablets (Generic Spironolactone Tablets) Aldactone Tablets are manufactured by RPG Life Sciences Limited, India in the strengths of 25 mg, 50 mg and 100 mg. © The Swiss Pharmacy

4. Aldactone Tablets (Generic Spironolactone Tablets) Chemical Structure © The Swiss Pharmacy

5. Aldactone Tablets (Generic Spironolactone Tablets) The active ingredient contained in Aldactone tablets is Spironolactone. Each Aldactone tablet contains 25 mg, 50 mg or 100 mg of Spironolactone. © The Swiss Pharmacy

6. Aldactone Tablets (Generic Spironolactone Tablets) Uses of Aldactone 25 mg, 50 mg and 100 mg Tablets: Aldactone (Spironolactone tablets) is used in combination with other medicines to treat high blood pressure (hypertension) and heart failure. Lowering blood pressure can reduce the risk of strokes and heart attacks. Spironolactone is also used to lessen the need for hospitalization for heart failure. Spironolactone is also used to diagnose and treat hyperaldosteronism, a condition in which the adrenal gland produces too much hormone called aldosterone. This medicine may also be used to treat fluid retention (edema) in patients with congestive heart failure, liver cirrhosis, or a kidney disorder called nephrotic syndrome. Spironolactone is a potassium-sparing diuretic (water pill). It prevents your body from absorbing too much salt and keeps your potassium levels from getting too low. This medicine is also used to treat or prevent hypokalemia (low potassium levels in the blood). © The Swiss Pharmacy

7. Aldactone Tablets (Generic Spironolactone Tablets) Recommended Adult Dosage The dosage of Aldactone tablets Aldactone tablets (Spironolactone tablets) for various indications is given below: Heart Failure: Start treatment at 25 mg once daily. Hypertension: Start treatment at 25 to 100 mg daily in either single or divided doses Edema: Start therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses. Primary hyperaldosteronism: Initiate treatment at 100 mg to 400 mg in preparation for surgery. In patients unsuitable for surgery use the lowest effective dosage determined for the individual patient. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html © The Swiss Pharmacy

8. Aldactone Tablets (Generic Spironolactone Tablets) Contraindications ➔Aldactone is contraindicated in patients with a known hypersensitivity to Spironolactone or any component of the tablet. ➔Administration of Spironolactone is coontraindicated in patients with Hyperkalemia and Addison’s disease. ➔Concomitant use of Eplerenone is contraindicated. ➔Acute renal insufficiency, significant impairment of renal function, anuria URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html © The Swiss Pharmacy

9. Aldactone Tablets (Generic Spironolactone Tablets) Storage Instructions Aldactone (Spironolactone tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html © The Swiss Pharmacy

10. Aldactone Tablets (Generic Spironolactone Tablets) Warnings Hyperkalemia: Spironolactone tablets (Aldactone) can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as angiotensin converting enzyme inhibitors and angiotensin receptor blockers. Monitor serum potassium within 1 week of initiation or titration of spironolactone tablets and regularly thereafter. 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. Worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSAIDs). Monitor volume status and renal function periodically. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html © The Swiss Pharmacy

11. Aldactone Tablets (Generic Spironolactone Tablets) Warnings Electrolyte and Metabolic Abnormalities: In addition to causing hyperkalemia, spironolactone tablets 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. Gynecomastia: Spironolactone tablets can cause gynecomastia. In the Randomized Spironolactone Evaluation Study, patients with heart failure treated with a mean dose of 26 mg of Spironolactone once daily, about 9% of the male subjects developed gynecomastia. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html © The Swiss Pharmacy

12. Aldactone Tablets (Generic Spironolactone Tablets) Possible Side Effects The most common adverse reaction with Spironolactone tablets (Aldactone) treatment is gynecomastia The following side effects associated with the use of Spironolactone tablets (Aldactone) were identified in clinical trials or postmarketing reports. 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. Metabolism: Hyperkalemia, electrolyte disturbances, hyponatremia, hypovolemia. © The Swiss Pharmacy

13. Aldactone Tablets (Generic Spironolactone Tablets) Possible Side Effects The following side effects associated with the use of Spironolactone tablets (Aldactone) were identified in clinical trials or postmarketing reports. 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: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritis. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html © The Swiss Pharmacy

14. Aldactone Tablets (Generic Spironolactone Tablets) Overdosage Acute overdosage of Spironolactone tablets (Aldactone) may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html © The Swiss Pharmacy

15. Aldactone Tablets (Generic Spironolactone Tablets) Treatment of Overdosage Induce vomiting or evacuate the stomach by lavage. There is no specific antidote for Spironolactone tablets (Aldactone). Treatment is supportive to maintain hydration, electrolyte balance, and vital functions. Patients who have renal impairment may develop hyperkalemia. In such cases, discontinue Spironolactone tablets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html © The Swiss Pharmacy

16. Aldactone Tablets (Generic Spironolactone Tablets) Aldactone Tablets During Pregnancy Spironolactone (Aldactone tablets) has been classified by the US FDA as Pregnancy Category C. Based on mechanism of action and findings in animal studies, Spironolactone may affect sex differentiation of the male during embryogenesis. Rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to Spironolactone in utero. There are risks to the mother and fetus associated with heart failure, cirrhosis and poorly controlled hypertension during pregnancy. Because of the potential risk to the male fetus due to anti-androgenic properties of Spironolactone and animal data, avoid Spironolactone in pregnant women or advise a pregnant woman of the potential risk to a male fetus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html © The Swiss Pharmacy

17. Aldactone Tablets (Generic Spironolactone Tablets) Aldactone tablets Aldactone tablets are manufactured by RPG Life Sciences Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9478_Aldactone-Tablets.html © The Swiss Pharmacy