IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
SPIRONOLACTONE/HYDROCHLOROTHIAZIDE – ORAL
COMMON BRAND NAME(S): Aldactazide
USES: This product is used to treat high blood pressure (hypertension), heart failure, or extra fluid in the body (edema). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.
This product contains two medications: spironolactone and hydrochlorothiazide. Both medications are “water pills” (diuretics) and cause your body to get rid of extra salt and water. This effect helps to relax the blood vessels so that blood can flow more easily and may increase the amount of urine you make when you first start the product. Spironolactone also helps to treat or prevent low blood potassium levels and block the activity of a certain natural substance (aldosterone) that can cause edema.
Your doctor may direct you to start taking the individual medications first, and then switch you over to this combination product if this is the best dose combination for you.
HOW TO USE: Take this medication by mouth with or without food, usually once or twice daily or as directed by your doctor.
If you take this drug too close to bedtime, you may need to wake up to urinate. Therefore, it is best to take this medication at least 4 hours before your bedtime. If you have any questions about how and when to take this medication, ask your doctor or pharmacist.
The dosage is based on your medical condition and response to treatment.
Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.
If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 4 hours before or at least 4 to 6 hours after these medications.
Tell your doctor if your condition does not improve or if it worsens (such as your blood pressure readings remain high or increase).
SIDE EFFECTS: Dizziness, lightheadedness, loss of appetite, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, extreme thirst, muscle cramps, weakness, vomiting, fast heartbeat, severe dizziness, confusion, unusual decrease in the amount of urine, fainting, seizures.
This product may infrequently cause high potassium levels (hyperkalemia). This can lead to serious (rarely fatal) heart rhythm problems. Tell your doctor immediately if you develop any symptoms of high potassium levels, including muscle weakness, slow/irregular heartbeat, numb/tingling skin.
Tell your doctor immediately if any of these unlikely but serious side effects occur: joint pain, breast enlargement in men (gynecomastia).
Tell your doctor immediately if any of these rare but serious side effects occur: unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), yellowing eyes/skin, dark urine, severe stomach/abdominal pain, decrease in vision, eye pain.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to either spironolactone or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: untreated salt/mineral imbalance (such as high potassium, low sodium level), kidney disease, liver disease, diabetes, loss of too much body water (dehydration), lupus, gout, high levels of fats in the blood (cholesterol/triglycerides).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Significant loss of body water from too much sweating, vomiting, or diarrhea can also lower your blood pressure and worsen dizziness. Drink plenty of fluids to prevent dehydration/loss of too much body water. If you are on restricted fluid intake, consult your doctor for further instructions. Contact your doctor if you are unable to drink fluids or if you have persistent diarrhea/vomiting.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.
This product may affect the potassium levels in your blood. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness and lightheadedness.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
Spironolactone and hydrochlorothiazide both pass into breast milk but are unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use and Precautions sections.
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor’s approval.
Some products that may interact with this drug include: cisapride, dofetilide, lithium, sodium phosphate products, other products that may affect potassium levels (such as eplerenone, tacrolimus, cyclosporine, birth control pills containing drospirenone, other diuretics like amiloride/triamterene, ACE inhibitors like benazepril/captopril, angiotensin receptor antagonists like losartan/valsartan).
Check the labels on all your medicines (such as cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs for pain/fever reduction) because they may contain ingredients that could increase your blood pressure (such as pseudoephedrine, phenylephrine) or reduce the effect of this medication (such as ibuprofen, naproxen). Ask your pharmacist about using those products safely.
This medication may interfere with certain laboratory tests (including parathyroid test, protein-bound iodide test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting, confusion.
NOTES: Do not share this medication with others.
Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.
Laboratory and/or medical tests (including kidney function, blood mineral levels such as potassium) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.
Check your blood pressure regularly while taking this medication, especially when you first start this drug or when your dose is changed. Learn how to monitor your own blood pressure at home, and share the results with your doctor.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised June 2012. Copyright(c) 2012 First Databank, Inc.