Hydrotone (Generic)

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.

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. Keep 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).

Dizziness, drowsiness, 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 right away if you have any of these serious symptoms of dehydration or mineral loss: very dry mouth, extreme thirst, muscle cramps, weakness, vomiting, fast heartbeat, severe dizziness, confusion, fainting, seizures.

This product may rarely cause high potassium levels (hyperkalemia). This can lead to serious (rarely fatal) heart rhythm problems. Tell your doctor right away if you develop any symptoms of high potassium levels, including muscle weakness, slow/irregular heartbeat, numb/tingling skin.

Tell your doctor right away if you have any serious side effects, including: joint pain, breast pain, breast enlargement in men (gynecomastia), easy bruising/bleeding, signs of kidney problems (such as change in the amount of urine), 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, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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), decreased adrenal gland function (Addison's disease), skin cancer.

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 or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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. It may also increase your risk for skin cancer, especially if you take it for a long time. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned, have skin blisters/redness, or notice new or changed moles/skin lesions.

If you have diabetes, this product may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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.

Older adults may be more sensitive to the side effects of this drug, especially the effects on potassium (see Side Effects section), dizziness, or lightheadedness. Dizziness and lightheadedness can increase the risk of falling.

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.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

See also How to Use and Precautions sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: cisapride, dofetilide, lithium, 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).

Some products have ingredients that could raise your blood pressure or worsen your heart failure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

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.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting, confusion.

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. Take your next dose at the regular time. Do not double the dose to catch up.

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.