Losartan and Hydrochlorothiazide

(loe sar' tan) (hye droe klor oh thye' a zide)

Brand Name(s): Hyzaar^® (as a combination product containing Losartan Potassium and Hydrochlorothiazide); also available generically

IMPORTANT NOTICE:

ISSUE: A recently published study - a meta-analysis combining cancer-related findings from several clinical trials - suggested use of angiotensin receptor blockers (ARBs) may be associated with a small increased risk of cancer.

BACKGROUND: ARBs are used in patients with high blood pressure and other conditions. Brand names include Atacand (candesartan), Avapro (irbesartan), Benicar (olmesartan), Cozaar (losartan), Diovan (valsartan), Micardis (telmisartan), and Teveten (eprosartan).

The meta-analysis included data from over 60,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs for which adverse events related to cancer were captured during the study. The mean duration of follow-up ranged from 1.7 to 4.8 years.

The study reported the frequencies of new cancer occurrence to be 7.2% for patients receiving ARBs compared to 6.0% for those not receiving ARBs (risk ratio = 1.08, 95% Confidence Interval: 1.01-1.15). No statistically significant difference in cancer deaths was noted.

RECOMMENDATION: FDA has not concluded that ARBs increase the risk of cancer. The Agency is reviewing information related to this safety concern and will update the public when additional information is available. FDA believes the benefits of ARBs continue to outweigh their potential risks. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

WHY is this medicine prescribed?

The combination of losartan and hydrochlorothiazide is used to treat high blood pressure. Losartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain chemicals that tighten the blood vessels, so blood flows more smoothly. 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.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of losartan and hydrochlorothiazide comes as a tablet to take by mouth. It is usually taken once a day with or without food. To help you remember to take losartan and hydrochlorothiazide, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take losartan and hydrochlorothiazide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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

What SPECIAL PRECAUTIONS should I follow?

Before taking losartan and hydrochlorothiazide,

• tell your doctor and pharmacist if you are allergic to losartan (Cozaar), hydrochlorothiazide (HCTZ, Hydrodiuril, Microzide), sulfa drugs, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as indomethacin (Indocin); cholestyramine (Questran); colestipol (Colestid); insulin or oral medications for diabetes; lithium (Eskalith, Lithobid); narcotic pain medications; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); other diuretics; other medications for high blood pressure; phenobarbital (Luminal, Solfoton); and potassium supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had gout; lupus; asthma; allergies; heart failure; diabetes; high blood levels of cholesterol or other fats (triglycerides); or liver or kidney disease.
• tell your doctor if you plan to become pregnant or are breast-feeding.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking losartan and hydrochlorothiazide.
• ask your doctor about the safe use of alcoholic beverages while you are taking losartan and hydrochlorothiazide. Alcohol can make the side effects from losartan and hydrochlorothiazide worse.
• you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor before using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet or an exercise program, follow these directions carefully.

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 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.

What SIDE EFFECTS can this medicine cause?

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

• dizziness
• runny nose
• sore throat
• back pain

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• hives
• dry mouth
• thirst
• weakness
• drowsiness
• restlessness
• confusion
• seizures
• muscle pains or cramps
• infrequent urination
• upset stomach
• vomiting
• lightheadedness
• fainting
• rapid, pounding, or irregular heartbeat

Losartan and hydrochlorothiazide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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 [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What STORAGE CONDITIONS are needed for this medicine?

Keep this medication 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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

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.

Symptoms of overdose may include:

• dizziness
• lightheadedness
• fainting
• rapid or pounding heartbeat

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to losartan and hydrochlorothiazide. Your doctor may order certain blood tests to check your body's response to losartan and hydrochlorothiazide.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking losartan and hydrochlorothiazide.

Do not let anyone else take your medication. 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.