Brand Name(s):

• Esidrix®¶
• Hydrodiuril®¶
• Microzide®
• Oretic®
• Zide®¶
• Amturnide®(as a combination product containing Aliskiren, Amlodipine, Hydrochlorothiazide)
• Apresazide®(as a combination product containing Hydralazine, Hydrochlorothiazide)
• Accuretic®(as a combination product containing Quinapril, Hydrochlorothiazide)
• Benicar®HCT (as a combination product containing Olmesartan, Hydrochlorothiazide)
• Diovan®HCT (as a combination product containing Valsartan, Hydrochlorothiazide)
• Dutoprol®(as a combination product containing Metoprolol, Hydrochlorothiazide)
• Exforge®HCT (as a combination product containing Amlodipine, Hydrochlorothiazide, Valsartan)
• Hydrap-ES®(as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
• Hydro-Reserp®(as a combination product containing Hydrochlorothiazide, Reserpine)
• Hydropres®(as a combination product containing Hydrochlorothiazide, Reserpine)
• Hydroserp®(as a combination product containing Hydrochlorothiazide, Reserpine)
• Hydroserpine®(as a combination product containing Hydrochlorothiazide, Reserpine)
• Hydra-Zide®(as a combination product containing Hydralazine, Hydrochlorothiazide)
• Inderide®(as a combination product containing Hydrochlorothiazide, Propranolol)
• Inderide®LA (as a combination product containing Hydrochlorothiazide, Propranolol)
• Lopressor®HCT (as a combination product containing Metoprolol, Hydrochlorothiazide)
• Mallopress®(as a combination product containing Hydrochlorothiazide, Reserpine)
• Marpres®(as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
• Monopril®HCT (as a combination product containing Fosinopril, Hydrochlorothiazide)
• Normozide®(as a combination product containing Labetalol, Hydrochlorothiazide)¶
• Quinaretic®(as a combination product containing Quinapril, Hydrochlorothiazide)
• Ser-Ap-Es®(as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
• Serathide®(as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
• Serpazide®(as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
• Serpex®(as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
• Tekturna®HCT (as a combination product containing Aliskiren, Hydrochlorothiazide)
• Teveten®HCT (as a combination product containing Eprosartan, Hydrochlorothiazide)
• Timolide®(as a combination product containing Timolol, Hydrochlorothiazide)
• Trandate HCT®(as a combination product containing Labetalol, Hydrochlorothiazide)¶
• Tri-Hydroserpine®(as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
• Tribenzor®(as a combination product containing Amlodipine, Hydrochlorothiazide, Olmesartan)
• Uni Serp®(as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
• Unipres®(as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
• Uniretic®(as a combination product containing Moexipril, Hydrochlorothiazide)
• Ziac®(as a combination product containing Bisoprolol, Hydrochlorothiazide)

IMPORTANT WARNING:

This MedWatch affects the following medications:

• Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
• Tekturna (aliskiren hemifumarate)
• Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
• Tekamlo (aliskiren hemifumarate and amlodipine besylate)
• Valturna (aliskiren hemifumarate and valsartan). Valturna will no longer be marketed after July 2012.

[Posted 04/20/2012]ISSUE:FDA notified healthcare professionals of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (i.e., where glomerular filtration rate [GFR] < 60 mL/min). The labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial, ''Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).''

BACKGROUND:Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension) by lowering blood pressure.

RECOMMENDATION:Concomitant use of aliskiren with ARBs or ACEIs in patients with diabetes is contraindicated because of the risk of renal impairment, hypotension, and hyperkalemia. Avoid use of aliskiren with ARBs or ACEIs in patients with renal impairment where GFR < 60 mL/min. Patients should not stop taking aliskiren without talking to your healthcare professional. Stopping aliskiren suddenly can cause problems if your high blood pressure (hypertension) is not treated.

WHY is this medicine prescribed?

Hydrochlorothiazide, a 'water pill,' is used to treat high blood pressure and fluid retention caused by various conditions, including heart disease. It causes the kidneys to get rid of unneeded water and salt from the body into the urine.

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

HOW should this medicine be used?

Hydrochlorothiazide comes as a tablet and liquid to take by mouth. It usually is taken once or twice a 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. Take this medication with a meal or snack. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take hydrochlorothiazide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Hydrochlorothiazide controls high blood pressure but does not cure it. Continue to take hydrochlorothiazide even if you feel well. Do not stop taking hydrochlorothiazide without talking to your doctor.

Are there OTHER USES for this medicine?

Hydrochlorothiazide may also be used to treat patients with diabetes insipidus and certain electrolyte disturbances and to prevent kidney stones in patients with high levels of calcium in their blood. Talk to your doctor about the possible risks of using this medicine for your condition.

What SPECIAL PRECAUTIONS should I follow?

Before taking hydrochlorothiazide,

• tell your doctor and pharmacist if you are allergic to hydrochlorothiazide, sulfa drugs, or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially other medicines for high blood pressure, anti-inflammatory medications such as ibuprofen (Motrin, Nuprin) or naproxen (Aleve), corticosteroids (e.g., prednisone), lithium (Eskalith, Lithobid), medications for diabetes, probenecid (Benemid), and vitamins. If you also are taking cholestyramine or colestipol, take it at least 1 hour after hydrochlorothiazide.
• tell your doctor if you have or have ever had diabetes, gout, or kidney, liver, thyroid, or parathyroid disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking hydrochlorothiazide, call your doctor immediately.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking hydrochlorothiazide.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• remember that alcohol can add to the drowsiness caused by this drug.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Hydrochlorothiazide may make your skin sensitive to sunlight.

What SPECIAL DIETARY instructions should I follow?

Follow your doctor's directions. They may include following a daily exercise program or a low-salt or low-sodium diet, potassium supplements, and increased amounts of potassium-rich foods (e.g., bananas, prunes, raisins, and orange juice) in your diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your 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.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

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). Do not allow the liquid to freeze. Throw away any medicine that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medicine.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

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.

¶This branded product is no longer on the market. Generic alternatives may be available.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 15, 2012.