Tumorigenic in chronic toxicity studies in rats. Use for FDA-approved indications; avoid unnecessary use.
Spironolactone/hydrochlorothiazide fixed combination not indicated for initial therapy of edema or hypertension. Individualize dosage. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension and edema is not static but must be reevaluated as conditions in each patient warrant. (See Dosage and Administration.)
SPIRONOLACTONE (speer on oh LAK tone) is a diuretic. It helps you make more urine and to lose excess water from your body. This medicine is used to treat high blood pressure, and edema or swelling from heart, kidney, or liver disease. It is also used to treat patients who make too much aldosterone or have low potassium.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth with a drink of water. Follow the directions on your prescription label. You may take this medicine with or without food. If it upsets your stomach, take it with food or milk. Do not take your medicine more often than directed. Remember that you will need to pass more urine after taking this medicine. Do not take your doses at a time of day that will cause you problems. Do not take at bedtime.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
eplerenone
This medicine may also interact with the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. Check your blood pressure as directed. Ask your doctor what your blood pressure should be, and when you should contact them.
You may need to be on a special diet while taking this medicine. Ask your doctor. Also, ask how many glasses of fluid you need to drink a day. You must not get dehydrated.
This medicine may make you feel confused, dizzy or lightheaded. Drinking alcohol and taking some medicines can make this worse. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not sit or stand up quickly.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store below 25 degrees C (77 degrees F). Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.