Losartan is used alone or in combination with other medications to treat high blood pressure in adults and children at least 6 years old.

Losartan is also used to decrease the risk of stroke in people who have high blood pressure and a heart condition called left ventricular hypertrophy (enlargement of the walls of the left side of the heart).

Losartan may not decrease the risk of stroke in African Americans who have these conditions.

Losartan is also used to treat kidney disease in people who have type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) and high blood pressure.

Losartan belomgs to a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.

Do not use losartan if you are pregnant, and tell your doctor right away if you become pregnant. It can cause injury or death to the unborn baby during your second or third trimester.

If you have diabetes, do not use losartan together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking losartan with aliskiren if you have kidney disease.

In rare cases, this medicine can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Take losartan exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Losartan is usually taken once per day.

You may take losartan with or without food.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking losartan. This can lead to very low blood pressure, a serious electrolyte imbalance, or kidney failure.

Your blood pressure will need to be checked often and you may need frequent blood tests.

If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms.

Store tightly closed at room temperature, away from moisture, heat, and light.

Usual Adult Dose for Diabetic Nephropathy:

Initial dose: 50 mg orally once a day
Maximum dose: 100 mg orally once a day

Comments:
-If hypertensive patients with left ventricular hypertrophy or type 2 diabetic nephropathy patients require titration from initial dose, increase to 100 mg orally once a day.
-Antihypertension is substantially present within 1 week but in some studies the maximal effect occurred in 3 to 6 weeks.

Uses:
-Treatment of hypertension.
-To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
-Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio 300 mg/g or greater) in patients with type 2 diabetes and a history of hypertension.

Usual Adult Dose for Hypertension:

Initial dose: 50 mg orally once a day
Maximum dose: 100 mg orally once a day

Comments:
-If hypertensive patients with left ventricular hypertrophy or type 2 diabetic nephropathy patients require titration from initial dose, increase to 100 mg orally once a day.
-Antihypertension is substantially present within 1 week but in some studies the maximal effect occurred in 3 to 6 weeks.

Uses:
-Treatment of hypertension.
-To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
-Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio 300 mg/g or greater) in patients with type 2 diabetes and a history of hypertension.

Usual Pediatric Dose for Hypertension:

6 Years or Older:
Initial dose: 0.7 mg/kg orally once a day (up to 50 mg total)

Comments:
-May be given as a tablet or suspension.
-Doses above 1.4 mg/kg (or 100 mg) daily have not been studied in pediatric patients.

You should not use losartan if you are allergic to it.

If you have diabetes, do not take losartan with any medication that contains aliskiren (a blood pressure medicine).

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart disease or congestive heart failure;

• an electrolyte imbalance (such as high levels of potassium in your blood);

• if you are on a low-salt diet;

• liver disease; or

• kidney disease.

You may also need to avoid taking losartan with aliskiren if you have kidney disease.

Stop using this medicine and tell your doctor right away if you become pregnant. Losartan can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Tell your doctor if you are breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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, light, and moisture (not in the bathroom).

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. http://www.upandaway.org

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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Get emergency medical help if you have signs of an allergic reaction to losartan: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Losartan may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• high blood potassium - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or

• kidney problems - swelling, urinating less, feeling tired or short of breath.

Common losartan side effects may include:

• dizziness, tiredness;

• low blood pressure;

• low blood sugar;

• diarrhea;

• back pain; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• a diuretic or "water pill" that may increase blood potassium such as spironolactone, triamterene, amiloride;

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

• heart or blood pressure medication.

This list is not complete. Other drugs may affect losartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to losartan.

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.

• Hyzaar® (containing Hydrochlorothiazide, Losartan)