Drug monograph for the active ingredient in Aldactone

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

DIURETICS, POTASSIUM-SPARING (Systemic)

Some commonly used brand names are:

In the U.S.—

• Aldactone ²
• Dyrenium ³
• Midamor ¹

In Canada—

• Aldactone ²
• Dyrenium ³
• Midamor ¹
• Novospiroton ²

Category

• Aldosterone antagonist—Spironolactone
• Antihypertensive—Amiloride; Spironolactone; Triamterene
• Antihypokalemic—Amiloride; Spironolactone; Triamterene
• Diagnostic aid, primary hyperaldosteronism—Spironolactone
• Diuretic—Amiloride; Spironolactone; Triamterene

Description

Potassium-sparing diuretics are commonly used to help reduce the amount of water in the body. Unlike some other diuretics, these medicines do not cause your body to lose potassium.

Amiloride and spironolactone are also used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If the condition continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Spironolactone is also used to help increase the amount of potassium in the body when it is getting too low.

Potassium-sparing diuretics help to reduce the amount of water in the body by acting on the kidneys to increase the flow of urine. This also helps to lower blood pressure.

These medicines can also be used for other conditions as determined by your doctor.

Potassium-sparing diuretics are available only with your doctor's prescription, in the following dosage forms:

Oral
• Amiloride
  • Tablets (U.S. and Canada)
• Spironolactone
  • Tablets (U.S. and Canada)
• Triamterene
  • Capsules (U.S.)
  • Tablets (Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For potassium-sparing diuretics, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to amiloride, spironolactone, or triamterene. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in pregnant women. However, this medicine has not been shown to cause birth defects or other problems in animals.

In general, diuretics are not useful for normal swelling of feet and hands that occurs during pregnancy. Diuretics should not be taken during pregnancy unless recommended by your doctor.

Breast-feeding—Although amiloride, spironolactone, and triamterene may pass into breast milk, these medicines have not been reported to cause problems in nursing babies.

Children—This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems in children than it does in adults.

Older adults—Signs and symptoms of too much potassium are more likely to occur in the elderly, who are more sensitive than younger adults to the effects of this medicine.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking potassium-sparing diuretics, it is especially important that your health care professional know if you are taking any of the following:

• Angiotensin-converting enzyme (ACE) inhibitors (benazepril [e.g., Lotensin], captopril [e.g., Capoten], enalapril [e.g., Vasotec], fosinopril [e.g., Monopril], lisinopril [e.g., Prinivil, Zestril], quinapril [e.g., Accupril], ramipril [e.g., Altace]) or
• Cyclosporine (e.g., Sandimmune) or
• Potassium-containing medicines or supplements—Use with potassium-sparing diuretics may cause high blood levels of potassium, which may increase the chance of side effects

• Digoxin—Use with spironolactone may cause high blood levels of digoxin, which may increase the chance of side effects

• Lithium (e.g., Lithane)—Use with potassium-sparing diuretics may cause high blood levels of lithium, which may increase the chance of side effects

Other medical problems—The presence of other medical problems may affect the use of potassium-sparing diuretics. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus or
• Kidney disease or
• Liver disease—Higher blood levels of potassium may occur, which may increase the chance of side effects

• Gout or
• Kidney stones (history of)—Triamterene may make these conditions worse

• Menstrual problems or breast enlargement—Spironolactone may make these conditions worse

Proper Use of This Medicine

This medicine may cause you to have an unusual feeling of tiredness when you begin to take it. You may also notice an increase in the amount of urine or in your frequency of urination. After you have taken the medicine for a while, these effects should lessen. In general, to keep the increase in urine from affecting your sleep:

• If you are to take a single dose a day, take it in the morning after breakfast.
• If you are to take more than one dose a day, take the last dose no later than 6 p.m., unless otherwise directed by your doctor.

However, it is best to plan your dose or doses according to a schedule that will least affect your personal activities and sleep. Ask your health care professional to help you plan the best time to take this medicine.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

If this medicine upsets your stomach, it may be taken with meals or milk. If stomach upset (nausea, vomiting, stomach pain or cramps) continues, check with your doctor.

For patients taking this medicine for high blood pressure :

• In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.
• Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.
• Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Dosing—The dose of potassium-sparing diuretics will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of potassium-sparing diuretics. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking potassium-sparing diuretics .

For amiloride
• For oral dosage form (tablets):
  • For high blood pressure or to lower the amount of water in the body:
    • Adults—5 to 10 milligrams (mg) once a day.
    • Children—Dose must be determined by your doctor.

For spironolactone
• For oral dosage form (tablets):
  • To lower the amount of water in the body:
    • Adults—At first, 25 to 200 milligrams (mg) a day. This is divided into two to four doses. Your doctor may increase your dose as needed.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mg per kilogram (kg) (0.45 to 1.36 mg per pound) of body weight a day. The dose may be taken as a single dose or divided into two to four doses. Your doctor may increase your dose as needed.
  • For high blood pressure:
    • Adults—At first, 50 to 100 milligrams (mg) a day. This may be taken as a single dose or divided into two to four doses. Your doctor may gradually increase your dose up to 200 mg a day.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mg per kg (0.45 to 1.36 mg per pound) of body weight a day. The dose may be taken as a single dose or divided into two to four doses. Your doctor may increase your dose as needed.
  • To treat high aldosterone levels in the body:
    • Adults—100 to 400 mg a day. This is divided into two to four doses and taken until you have surgery. If you are not having surgery, your doses may be smaller.
  • For detecting high aldosterone levels in the body:
    • Adults—400 mg a day, taken in two to four divided doses. Your doctor may want you to take this dose for as little as four days or as long as three to four weeks. Follow your doctor's instructions.
  • To treat low potassium levels in the blood:
    • Adults—25 to 100 mg a day. This may be taken as a single dose or divided into two to four doses.

For triamterene
• For oral dosage form (capsules or tablets):
  • To lower the amount of water in the body:
    • Adults— 100 mg twice a day. Your doctor may gradually increase your dose.
    • Children—Dose is based on body weight and must be determined by your doctor. To start, the usual dose is 2 to 4 mg per kilogram (kg) (0.9 to 1.82 mg per pound) of body weight a day or every other day. This is divided into smaller doses. Your doctor may increase your dose as needed.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly.

This medicine does not cause a loss of potassium from your body as some other diuretics (water pills) do. Therefore, it is not necessary for you to get extra potassium in your diet, and too much potassium could even be harmful. Since salt substitutes and low-sodium milk may contain potassium, do not use them unless told to do so by your doctor.

Check with your doctor if you become sick and have severe or continuing nausea, vomiting, or diarrhea. These problems may cause you to lose additional water, which could be harmful, or to lose potassium, which could lessen the medicine's helpful effects.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

For patients taking this medicine for high blood pressure :

• Do not take other medicines unless they have been discussed with your doctor . This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since these medicines may tend to increase your blood pressure.

For patients taking triamterene :

• This medicine may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:
  • Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
  • Wear protective clothing, including a hat. Also, wear sunglasses.
  • Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
  • Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
  • Do not use a sunlamp or tanning bed or booth.
  • If you have a severe reaction from the sun, check with your doctor.

Side Effects of This Medicine

In rats, spironolactone has been found to increase the risk of tumors. It is not known if spironolactone increases the chance of tumors in humans.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

For amiloride, spironolactone, and triamterene

Skin rash or itching; shortness of breath

For spironolactone and triamterene only (in addition to effects listed above)

Cough or hoarseness; fever or chills; lower back or side pain; painful or difficult urination

For triamterene only (in addition to effects listed above)

Black, tarry stools; blood in urine or stools; bright red tongue; burning, inflamed feeling in tongue; cracked corners of mouth; lower back pain (severe); pinpoint red spots on skin; unusual bleeding or bruising; weakness

Signs and symptoms of too much potassium

Confusion; irregular heartbeat; nervousness; numbness or tingling in hands, feet, or lips; shortness of breath or difficult breathing; unusual tiredness or weakness; weakness or heaviness of legs

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common (less common with amiloride and triamterene)

Nausea and vomiting; stomach cramps and diarrhea

Less common

For amiloride, spironolactone, and triamterene

Dizziness; headache

For amiloride and spironolactone only (in addition to effects listed above)

Decreased sexual ability

For amiloride only (in addition to effects listed above)

Constipation; muscle cramps

For spironolactone only (in addition to effects listed above for spironolactone)

Breast tenderness in females; clumsiness; deepening of voice in females; enlargement of breasts in males; inability to have or keep an erection; increased hair growth in females; irregular menstrual periods; sweating

For triamterene only (in addition to effects listed above for triamterene)

Increased sensitivity of skin to sunlight

Signs and symptoms of too little sodium

Drowsiness; dryness of mouth; increased thirst; lack of energy

For male patients :

• Spironolactone sometimes causes enlarged breasts in males, especially when they take large doses of it for a long time. Breasts usually decrease in size gradually over several months after this medicine is stopped. If you have any questions about this, check with your doctor.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, spironolactone is used in certain patients with the following medical conditions:

• Polycystic ovary syndrome
• Hirsutism, female (increased hair growth)
• Congestive heart failure, severe

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 04/26/2000

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