Carospir Suspension

General Considerations

CAROSPIR is not therapeutically equivalent to Aldactone. Follow dosing instructions given here. In patients requiring a dose greater than 100 mg, use another formulation. Doses of the suspension greater than 100 mg may result in spironolactone concentrations higher than expected [see Clinical Pharmacology (12.3)].

CAROSPIR can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology (12.3)].

Treatment of Heart Failure

In patients with serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73m2, initiate treatment at 20 mg (4 mL) once daily. Patients who tolerate 20 mg (4 mL) once daily may have their dosage increased to 37.5 mg (7.5 mL) once daily as clinically indicated. Patients who develop hyperkalemia on 20 mg (4 mL) once daily may have their dosage reduced to 20 mg (4 mL) every other day [see Warning and Precautions 5.1)]. In patients with an eGFR between 30 and 50 mL/min/1.73m2, consider initiating treatment at 10 mg (2 mL) because of the risk of hyperkalemia [see Use in Specific Populations (8.6)].

Treatment of Essential Hypertension

The recommended initial daily dose is 20 mg (4 mL) to 75 mg (15 mL) administered in either single or divided doses. Dosage can be titrated at two-week intervals. Doses >75 mg/day generally do not provide additional reductions in blood pressure.

Treatment of Edema associated with Hepatic Cirrhosis

In patients with cirrhosis, initiate therapy in a hospital setting and titrate slowly [see Use in Specific Populations (8.6)] and Clinical Pharmacology (12.3)]. The recommended initial daily dose is 75 mg (15 mL) administered in either single or divided doses. In patients requiring titration above 100 mg, use another formulation [see Dosage and Administration (2.1)]. When given as the sole agent for diuresis, administer for at least five days before increasing dose to obtain desired effect.

CAROSPIR is contraindicated for patients with the following conditions:

• Hyperkalemia
• Addison’s disease
• Concomitant use of eplerenone

Get emergency medical help if you have any signs of an allergic reaction to spironolactone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using spironolactone and call your doctor at once if you have:

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• high potassium--slow heart rate, weak pulse, muscle weakness or limp feeling, tingly feeling;

• low sodium--confusion, slurred speech, hallucinations, severe weakness, loss of coordination, feeling unsteady, seizure (convulsions), fainting, shallow breathing (breathing may stop); or

• symptoms of any electrolyte imbalance--dry mouth, increased thirst, drowsiness, lack of energy, restless feeling, confusion, nausea, vomiting, increased urination, muscle cramps or weakness, fast heart rate, little or no urinating, or feeling like you might pass out.

Common spironolactone side effects may include:

• mild nausea or vomiting, diarrhea;

• breast swelling or tenderness;

• dizziness, headache, mild drowsiness;

• leg cramps; or

• impotence, difficulty having an erection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking this medicine with other drugs that make you dizzy or lower your blood pressure can worsen these effects. Ask your doctor before taking spironolactone with a narcotic pain medicine, muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with spironolactone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to spironolactone: oral tablet

Along with its needed effects, spironolactone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking spironolactone:

• Abdominal or stomach cramping, burning, or tenderness
• bleeding gums
• bloody or black, tarry stools
• bloody urine
• breast pain
• chest pain
• chills
• clay-colored stools
• clear or bloody discharge from the nipple
• cloudy urine
• coma
• confusion
• constipation
• convulsions
• cough or hoarseness
• dark urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• difficulty with swallowing
• dimpling of the breast skin
• dizziness
• drowsiness
• fast or irregular heartbeat
• fever with or without chills
• general feeling of tiredness or weakness
• headache
• heartburn
• hives, itching, or skin rash
• increased thirst
• indigestion
• inverted nipple
• loss of appetite
• lower back or side pain
• lump in the breast or under the arm
• muscle pain or cramps
• muscle spasms or twitching
• nausea and vomiting
• painful or difficult urination
• persistent crusting or scaling of the nipple
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness or swelling of the breast
• severe stomach pain
• shakiness and unsteady walk
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, fingers, feet, ankles, or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tightness in the chest
• trembling
• troubled breathing
• unpleasant breath odor
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight gain
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking spironolactone:

• Irregular heartbeat
• nervousness
• numbness or tingling in the hands, feet, or lips
• rash with flat lesions or small raised lesions on the skin
• reddened skin
• weakness or heaviness of the legs

Some side effects of spironolactone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning feeling in the chest or stomach
• hair loss or thinning of the hair
• leg cramps
• sores, welting, or blisters
• stomach upset
• swelling of the breasts or breast soreness in both females and males
• unusual dullness or feeling of sluggishness

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 a maximum response. Subsequently, the dose may be adjusted according to patient response.

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.

Comments:
-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.

Uses:
-Initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.
-Short-term preoperative treatment of patients with primary hyperaldosteronism.
-Long-term maintenance therapy for patients deemed unsuitable for surgery or those with idiopathic hyperaldosteronism.

Contraindicated in patients with anuria, acute renal insufficiency, or significant impairment of renal excretory function.

Data not available

• Removes excess fluid from the body and may be used in the treatment of heart failure, cirrhosis of the liver, and in nephrotic syndrome (a type of kidney disease). Has been shown to increase survival and reduce the need for hospitalization in people with severe heart failure.
• May be used in the treatment of high blood pressure (hypertension) in conjunction with other medications and lifestyle measures (such as lipid control, diabetes management, smoking cessation, blood thinning medications, exercise and a reduction in sodium intake). Reducing blood pressure is associated with an improvement in survival in people with cardiovascular disease.
• May be used in the diagnosis or treatment of primary hyperaldosteronism (a hormonal disorder characterized by over-production of aldosterone that leads to high blood pressure).
• May be used long-term in some people with inoperable aldosterone-producing tumors.
• May occasionally be used to treat hypokalemia (low potassium levels) when other treatments are inappropriate or ineffective.
• Spironolactone does not cause potassium loss nor is it likely to precipitate gout, unlike several other diuretics.
• Generic spironolactone is available.