Spironolactone

1.1 Heart Failure
Spironolactone tablets are indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure.
Spironolactone tablets are usually administered in conjunction with other heart failure therapies.
1.2 Hypertension
Spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
1.3 Edema Associated with Hepatic Cirrhosis or Nephrotic Syndrome
Spironolactone tablets are indicated for the management of edema in the following settings:
Cirrhosis of the liver when edema is not responsive to fluid and sodium restriction.
Nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response.
Because it increases serum potassium, spironolactone tablets may be useful for treating edema when administration of other diuretics has caused hypokalemia.
1.4 Primary Hyperaldosteronism
Spironolactone tablets are indicated in the following settings:
Short-term preoperative treatment of patients with primary hyperaldosteronism.
Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery.
Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).

2.1 General Considerations
Spironolactone tablets can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology (12.3)].
2.2 Treatment of Heart Failure
In patients with serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73 m², 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. Patients who develop hyperkalemia on 25 mg once daily may have their dosage reduced to 25 mg every other day [see Warnings and Precautions (5.1)]. In patients with an eGFR between 30 and 50 mL/min/1.73 m2, consider initiating therapy at 25 mg every other day because of the risk of hyperkalemia [see Use in Specific Populations (8.6)].
2.3 Treatment of Essential Hypertension
The recommended initial daily dose is 25 to 100 mg of spironolactone tablets 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.
2.4 Treatment of Edema
In patients with cirrhosis, initiate therapy in a hospital setting and titrate slowly [see Use in Specific Populations (8.7)]. The recommended initial daily dosage is 100 mg of spironolactone tablets 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.
2.5 Treatment of Primary Hyperaldosteronism
Administer spironolactone tablets in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone tablets can be used as long-term maintenance therapy at the lowest effective dosage determined for the individual patient.

The oral LD50 of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits.
Acute overdosage of spironolactone 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.
Treatment: Induce vomiting or evacuate the stomach by lavage. There is no specific antidote. Treatment is supportive to maintain hydration, electrolyte balance, and vital functions. Patients who have renal impairment may develop hyperkalemia. In such cases, discontinue spironolactone.

8.1 Pregnancy: Based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis (see Data). Rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero. Limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone. There are risks to the mother and fetus associated with heart failure, cirrhosis and poorly controlled hypertension during pregnancy (see Clinical Considerations). 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.
8.2 Lactation: Spironolactone is not present in breastmilk; however, limited data from a lactating woman at 17 days postpartum reports the presence of the active metabolite, canrenone, in human breast milk in low amounts that are expected to be clinically inconsequential. In this case, there were no adverse effects reported for the breastfed infant after short term exposure to spironolactone; however, long term effects on a breastfed infant are unknown. There are no data on spironolactone effects on milk production. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for spironolactone and any potential adverse effects on the breastfed child from spironolactone or from the underlying maternal condition.

Spironolactone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
vomiting
diarrhea
stomach pain or cramps
enlarged or painful breasts in men or women
irregular menstrual periods
vaginal bleeding in post-menopausal ('after the change of life', the end of monthly menstrual periods) women
difficulty maintaining or achieving an erection
deepening of voice
increased hair growth on parts of the body
drowsiness
tiredness
restlessness

It usually is taken once or twice a day. Take spironolactone at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take spironolactone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Spironolactone controls high blood pressure, edema, heart failure, and hyperaldosteronism but does not cure these conditions. It may take about 2 weeks or longer before the full effect of spironolactone occurs. Continue to take spironolactone even if you feel well. Do not stop taking spironolactone without talking to your doctor.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking spironolactone.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to spironolactone.