U.S. Brand Names

Aldactone®

Canadian Brand Names

Aldactone®; Novo-Spiroton

Mexican Brand Names

Aldactone; Vivitar

Dosage Forms

• This medicine is available as a tablet.

• Some pharmacies may make a liquid.

Pharmacologic Category

Diuretic, Potassium-Sparing; Selective Aldosterone Blocker

What key warnings should I know about before giving this medicine to my child?

Spironolactone can cause tumors in animals. These were long-term studies using larger doses than would be used in humans.

Is it safe for my child to take this medicine?

• Not if your child has an allergy to spironolactone or any other part of this medicine.

• Be sure to let healthcare provider know if your child has any allergies or reactions to medicine, food preservatives, or dyes. Make sure to tell about the allergy and how it affected your child. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• Not if your child has any of the following conditions: High potassium levels or kidney disease.

Why does my child need this medicine?

• This medicine is used to get rid of extra fluid.

• This medicine is used to increase potassium stores in the body.

• This medicine is used to treat high blood pressure.

• This medicine is used to improve a weakened heart.

How does this medicine work?

• Spironolactone lowers blood pressure and gets rid of extra salt and water in the body through the kidneys.

• It prevents potassium loss.

How is this medicine given?

• Give this medicine with food.

• A liquid (suspension) is available if your child cannot swallow pills. Shake well before use.

• Children who have feeding tubes can also use the liquid. Flush the feeding tube before and after medicine is given.

• Measure liquid doses carefully. Use measuring device that comes with the medicine. If none is available, get an oral syringe, a medicine dropper, a medicine spoon, or a medicine cup (only for older children) from your pharmacist.

• Have your child follow diet plan and exercise program as recommended by healthcare provider.

How long does this medicine take to work?

• Your child may start feeling better soon after starting this medicine.

What do I do if my child misses a dose? (does not apply to patients in the hospital)

• Give a missed dose as soon as possible.

• If it is almost time for the next dose, skip the missed dose and return to your child's regular schedule.

• Do not give a double dose or extra doses.

• Do not change dose or stop your child's medicine. Talk with healthcare provider.

What safety measures should I take while my child is using this medicine?

• Check your child's medicines with healthcare provider. This medicine may not mix well with other medicines.

• If your child is taking potassium-containing salt substitutes, potassium-saving water pills, or extra potassium, talk with healthcare provider.

What are some possible side effects of this medicine?

• High potassium level. Signs include feeling weak, lightheaded, dizzy, feel like passing out, or have numbness or tingling.

• Feeling dizzy. Rising slowly over several minutes from sitting or lying position is recommended. Children should be extra careful climbing stairs.

• Nausea or vomiting. Small frequent meals and frequent mouth care may help. Older children may suck hard, sugar-free candy.

What should I monitor?

• Change in condition being treated. Is it better, worse, or about the same?

• For the occurrence of side effects.

• Check blood pressure and heart rate regularly. Talk with healthcare provider.

• Check blood work (potassium) regularly. Talk with healthcare provider.

When should I call my child's healthcare provider?

• If any of this information causes you to be concerned, any of the common side effects occur, or if your child's symptoms do not improve after taking this medicine.

• If you suspect an overdose, call your local poison control center or emergency department immediately.

• If your child shows signs of a life-threatening reaction, call healthcare provider or emergency department immediately. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; swelling of face, lips, tongue, or throat; or if your child exhibits any other unusual behavior.

• If your child shows signs of high potassium.

• If your child shows signs of severe dizziness or passes out.

• If your child has severe nausea or vomiting.

• If your child has severe diarrhea.

• If your child develops a rash.

• No improvement in condition or if you believe your child's condition is worse.

How should I store and/or dispose of this medicine?

• Store tablets at room temperature.

• Protect tablets from light.

• Protect tablets from moisture. Do not store in a bathroom or kitchen.

• Store liquid (suspension) in a refrigerator. Throw away any unused portion after expiration date on bottle.

General statements

• If your child has a life-threatening allergy, he/she should wear an allergy identification bracelet at all times.

• This medicine is available by prescription only. If there are refills, contact your pharmacy. If no refills remain, you may need to contact your child's healthcare provider.

• This medicine should be thrown out when your child no longer needs it or if the medicine becomes outdated.

• Do not share your child's medicine with others and do not give anyone else's medicine to your child.

• Keep all medicine out of the reach of children and pets.

• Many medications interact with other medications. Keep a list of all your child's medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to your child's healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or in Canada to Health Canada's Canada Vigilance Program at 1-866-234-2345.

• Talk with your child's healthcare provider before giving him/her any new medicine, including over-the-counter, natural products, or vitamins.

• Medicine can be dangerous if used incorrectly. Follow directions given by healthcare provider.

Created: 2009-01-13 14:01:23.0

Modified: 2009-05-06 12:51:11.0

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