Spironolactone

What is Spironolactone?

• Spironolactone (Aldactone) is an aldosterone antagonist used to treat certain patients with hyperaldosteronism (the body produces too much aldosterone, a naturally occurring hormone); low potassium levels; heart failure; and in patients with edema (fluid retention) caused by various conditions, including liver, or kidney disease.

Spironolactone

Spironolactone 3D ball

What are the uses of this medicine?

Spironolactone (Aldactone) is used in the treatment of:

• Heart Failure
• Hypertension
• Edema Associated with Hepatic Cirrhosis or Nephrotic Syndrome
• Primary Hyperaldosteronism

How does this medicine work?

• Spironolactone, is an aldosterone antagonist.
• It acts primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule.
• Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained.
• Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism.
• It may be given alone or with other diuretic agents that act more proximally in the renal tubule.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

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

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed below:

• aminoglycoside antibiotics such as amikacin, gentamicin, kanamycin, neomycin (Neo-Rx, Neo-Fradin), streptomycin, and tobramycin (Tobi)
• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten), enalapril (Vasotec), fosinopril, lisinopril (in Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril, (Aceon), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka)
• angiotensin II antagonists (angiotensin receptor blockers; ARBs) such as azilsartan (Edarbi, Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten, in Teveten HCT), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, Benicar HCT, Tribenzor), telmisartan (Micardis, in Micardis HCT), and valsartan (Diovan, in Diovan HCT, Exforge)
• aspirin and other nonsteroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (Advil, Motrin), indomethacin (Indocin, Tivorbex), and naproxen (Aleve, Naprosyn)
• barbiturates such as phenobarbital
• cholestyramine (Prevalite)
• cisplatin
• digoxin (Lanoxin)
• diuretics ('water pills') including potassium-sparing diuretics such as amiloride (Midamor) and triamterene (Dyrenium, in Dyazide, in Maxzide); heparin or low-molecular-weight heparin enoxaparin (Lovenox)
• lithium (Lithobid)
• medications to treat high blood pressure; narcotic medications for pain
• oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos)
• potassium supplements
• trimethoprim (Primsol, in Bactrim).

Is this medicine FDA approved?

• Spironolactone was discovered in 1957, and was introduced in 1959.
• It was FDA aprroved in the year of 1960.

How should this medicine be used?

Recommended dosage: Heart Failure:

• Initiate treatment at 25 mg once daily.

Hypertension:

• Initiate treatment at 25 to 100 mg daily in either single or divided doses.

Edema:

• Initiate 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 to 400 mg in preparation for surgery.
• In patients unsuitable for surgery use the lowest effective dosage determined for the individual patient.

Administration:

• Spironolactone comes as a tablet and suspension to take by mouth.
• It usually is taken once or twice a day.
• Take spironolactone suspension consistently either with food or without food each time.
• Take spironolactone at around the same time(s) every day.
• Shake the oral suspension well before each use to mix the medication evenly.
• Your doctor may start you on a low dose of spironolactone and gradually increase your dose.
• Spironolactone tablets and suspension release the medication differently in your body and cannot be substituted for one another.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As tablet and suspension

This medicine is available in fallowing brand namesː

• Aldactone

What side effects can this medication cause?

The most common side effects of this medicine include:

• Hyperkalemia
• Hypotension and Worsening Renal Function
• Electrolyte and Metabolic Abnormalities
• Gynecomastia
• Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites
• Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting
• Decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain
• Leukopenia (including agranulocytosis), thrombocytopenia
• Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis
• Hyperkalemia, electrolyte disturbances , hyponatremia, hypovolemia
• Leg cramps
• Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness
• Renal dysfunction
• Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritis

What special precautions should I follow?

• ALDACTONE can cause hyperkalemia. Monitor serum potassium within one week of initiation and regularly thereafter.
• 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. Monitor volume status and renal function periodically.
• In addition to causing hyperkalemia, ALDACTONE can cause hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia. Monitor serum electrolytes, uric acid and blood glucose periodically.
• ALDACTONE can cause 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• drowsiness
• mental confusion
• maculopapular or erythematous rash
• nausea
• vomiting
• dizziness
• diarrhea
• hyponatremia
• hyperkalemia
• hepatic coma

Management of overdosage:

• 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 ALDACTONE.

Can this medicine be used in 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.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• SPIRONOLACTONE

Inactives ingredients:

• STARCH, CORN
• FERRIC OXIDE RED
• MAGNESIUM STEARATE
• POVIDONE, UNSPECIFIED
• TITANIUM DIOXIDE
• HYPROMELLOSE
• CALCIUM SULFATE DIHYDRATE
• PEPPERMINT
• POLYETHYLENE GLYCOL 400
• CARNAUBA WAX
• STEARIC ACID

Who manufactures and distributes this medicine?

Distributed By:

• Pfizer Laboratories Div Pfizer Inc

What should I know about storage and disposal of this medication?

• Store below 77°F (25°C).

• Dailymed label info on Spironolactone
• FDA Spironolactone

Medical uses

Pharmacodynamics