Spironolactone and Hydrochlorothiazide

Spironolactone has caused tumors in laboratory animals. Talk to your doctor about the risks and benefits of using this medicine for your condition.

This medication should not be used when you first begin your treatment. You should take this medication only after the appropriate dosages of spironolactone and hydrochlorothiazide are individually established by your doctor.

The combination of spironolactone and hydrochlorothiazide is used to treat high blood pressure. This medication is also used to treat patients with edema (fluid retention) caused by various conditions, including heart, liver, or kidney disease. Spironolactone is in a class of medications called aldosterone receptor antagonists. It causes the kidneys to eliminate unneeded water and sodium from the body into the urine, but reduces the loss of potassium from the body. Hydrochlorothiazide is in a class of medications called diuretics (''water pills''). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine.

High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

The combination of spironolactone and hydrochlorothiazide comes as a tablet to take by mouth. It usually is taken once or twice a day. To help you remember to take spironolactone and hydrochlorothiazide, take it around the same time(s) every day. If you are to take it once a day, take it in the morning; if you are to take it twice a day, take it in the morning and in the late afternoon to avoid going to the bathroom during the night. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take spironolactone and hydrochlorothiazide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

This medication controls high blood pressure and edema, but does not cure these conditions. Continue to take spironolactone and hydrochlorothiazide even if you feel well. Do not stop taking spironolactone and hydrochlorothiazide without talking to your doctor.

This medicine is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking spironolactone and hydrochlorothiazide,

• tell your doctor and pharmacist if you are allergic to spironolactone, hydrochlorothiazide, thiazide diuretics (''water pills''), sulfa-based medications, penicillin, other medications, or any of the ingredients in spironolactone and hydrochlorothiazide tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking spironolactone and hydrochlorothiazide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. )
• the following nonprescription products may interact with spironolactone and hydrochlorothiazide: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (Advil, Motrin), naproxen (Naprosyn); potassium supplements. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking spironolactone and hydrochlorothiazide. Do not start any of these medications while taking spironolactone and hydrochlorothiazide without discussing with your healthcare provider.
• tell your doctor if you have high blood levels of calcium or potassium or have or ever had Addison's disease or other conditions that may cause high blood levels of potassium, or kidney or liver disease. Your doctor may tell you not to take spironolactone and hydrochlorothiazide.
• tell your doctor if you have or have ever had asthma, systemic lupus erythematosus (SLE, a chronic inflammatory condition), diabetes, or gout.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking spironolactone and hydrochlorothiazide, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking spironolactone and hydrochlorothiazide.
• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication.

Follow your doctor's directions for a low-salt or low-sodium diet and daily exercise program. Avoid potassium-containing salt substitutes. Limit your intake of potassium-rich foods (e.g., bananas, prunes, raisins, and orange juice). Ask your doctor for advice on how much of these foods you may have.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Spironolactone and hydrochlorothiazide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• loss of appetite
• stomach pain
• frequent urination
• dizziness
• headache
• enlarged or painful breasts
• irregular menstrual periods
• difficulty maintaining or achieving an erection
• vaginal bleeding in post-menopausal ('after the change of life', the end of monthly menstrual periods) women
• drowsiness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• muscle weakness or cramps
• changes in vision or eye pain
• rapid, excessive weight loss
• fatigue
• slow or irregular heartbeat
• unusual bruising or bleeding
• yellowing of the skin or eyes
• skin rash
• itching
• fever
• confusion

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medicine in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly, and blood tests should be done occasionally.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Aldactazide^® (containing Spironolactone, Hydrochlorothiazide)