Lactone - Spironolactone tablets

Before taking this medicine

Before taking spironolactone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

You should use spironolactone with caution if you have kidney problems, high levels of potassium in your blood, Addison's disease, if you are unable to urinate, or if you are also taking eplerenone.

Potassium intake:

This drug can cause hyperkalemia (high potassium levels). While taking this drug, you should watch your potassium intake. You shouldn’t take potassium supplements, eat a diet rich in potassium, or consume salt substitutes containing potassium. Having too much potassium in your body can lead to severe problems. This can even be fatal. Talk to your doctor or a nutritionist if you’re concerned about your potassium intake.

You should not use spironolactone if you are allergic to it, or if you have:

• Addison's disease (an adrenal gland disorder);
• High levels of potassium in your blood (hyperkalemia);
• If you are unable to urinate; or
• If you are also taking eplerenone.

To make sure spironolactone is safe for you, tell your doctor if you have:

• An electrolyte imbalance (such as low levels of calcium, magnesium, or sodium in your blood);
• Kidney disease;
• Liver disease; or
• Heart disease.

Tell your doctor if you are pregnant or plan to become pregnant. Having congestive heart failure, cirrhosis, or uncontrolled high blood pressure during pregnancy may lead to medical problems in the mother or the baby. Your doctor should decide whether you take spironolactone if you are pregnant.

It may not be safe to breastfeed while using spironolactone. Ask your doctor about any risk.

Spironolactone dosing information

Usual Adult Dose for Edema:

• 25 to 200 mg orally per day in single or divided doses
• Duration of therapy: When given as the sole diuretic, continue the initial dose for at least 5 days, after which the initial dose may be adjusted to an optimal maintenance dose.

A second diuretic that acts more proximally at the renal tubule may be added if adequate diuresis has not been achieved after 5 days. The dose of this drug should remain unchanged if a second diuretic is added.

Usual Adult Dose for Hypertension:

• Initial dose: 50 to 100 mg orally per day in single or divided doses
• Duration of therapy: Treatment should be continued for at least 2 weeks to achieve maximum response. Subsequently, the dose may be adjusted according to patient response.

Usual Adult Dose for Congestive Heart Failure:

• Initial dose: 25 mg orally once a day assuming serum potassium is less than or equal to 5 mEq/L and serum creatinine is less than or equal to 2.5 mg/dL
• Patients tolerant of initial dose: May increase to 50 mg orally once a day as clinically indicated
• Patients intolerant of initial dose: May decrease to 25 mg orally every other day: To increase survival and reduce the need for hospitalization of severe heart failure patients

Usual Adult Dose for Primary Hyperaldosteronism:

This serves an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets and for:

• Short-term preoperative treatment of patients with primary hyperaldosteronism
• Long-term maintenance therapy for patients deemed unsuitable for surgery or those with idiopathic hyperaldosteronism.

Diagnostic dose:

Long test: 400 mg orally per day for 3 to 4 weeks-Short test: 400 mg orally per day for 4 days

Maintenance dose: 100 to 400 mg orally per day until surgery

May be used long-term at the lowest effective dose in patients deemed unsuitable for surgery.

For the long test, correction of hypokalemia and hypertension provides presumptive evidence of primary hyperaldosteronism.-For the short test, increased serum potassium with this drug and a decrease upon discontinuation provide presumptive evidence of primary hyperaldosteronism.

Short-term preoperative treatment of patients with primary hyperaldosteronism.

Side effects

Spironolactone oral tablet may cause drowsiness. You shouldn’t drive, use machinery, or do similar tasks that require alertness until you know how this drug affects you.

Common side effects that can occur with spironolactone include:

• Diarrhoea and abdominal cramping
• Nausea and vomiting
• High potassium levels
• Leg cramps
• Headache
• Dizziness
• Drowsiness
• Itching
• Irregular menstrual cycles or bleeding after menopause

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Serious side effects and their symptoms can include the following:

• Allergic reactions. Symptoms can include:
• skin rash
• hives
• fever
• trouble breathing
• swelling of your lips, mouth, tongue, or throat
• Electrolyte and/or fluid problems. Symptoms can include:
• mouth dryness
• extreme thirst
• extreme weakness and tiredness
• fast heart rate and dizziness
• not being able to urinate
• Dangerously high potassium levels. Symptoms can include:
• muscle weakness
• not being able to move your legs and arms
• extreme tiredness
• tingling or numb feeling in your hands or feet
• slow heart rate
• Breast enlargement (gynecomastia). Symptoms can include:
• growth of breast tissue in males and females
• Severe skin reactions. Symptoms can include:
• redness, blistering, peeling or loosening of your skin, including inside of your mouth