Pronunciation:

loe-SAR-tan

Brand Names:

• Cozaar

Dosage Forms:

• Tablet

Warnings:

When pregnancy is detected, discontinue losartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus .

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Angiotensin II Receptor Antagonist

Uses of This Medicine:

Losartan is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure may reduce the risk of strokes and heart attacks.

Losartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, losartan relaxes the blood vessels. A lower blood pressure will increase the supply of the blood and oxygen to the heart.

Losartan is also used to decrease the risk of stroke in patients with high blood pressure and enlargement of the heart. It is also used to treat kidney problems in patients with type 2 diabetes and a history of hypertension.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of losartan to treat high blood pressure in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

No information is available on the relationship of age to the effects of losartan to treat other indications in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of losartan combination in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aliskiren
• Sparsentan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Benazepril
• Capecitabine
• Captopril
• Carbamazepine
• Ceritinib
• Cilazapril
• Cyclosporine
• Enalapril
• Enalaprilat
• Entacapone
• Fosinopril
• Furosemide
• Lisinopril
• Lithium
• Mavacamten
• Moexipril
• Perindopril
• Phenobarbital
• Potassium Citrate
• Potassium Phosphate
• Primidone
• Quinapril
• Ramipril
• Spirapril
• Tacrolimus
• Trandolapril
• Trimethoprim
• Zofenopril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rifampin
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angioedema (an allergic reaction) with other blood pressure medicines (eg, benazepril, enalapril, lisinopril, Lotrel®, Vasotec®, Zestoretic®, Zestril®), history of—Use may cause this condition to reoccur.

• Congestive heart failure, severe—Use may lead to kidney problems.

• Diabetic patients who are also taking aliskiren (Tekturna®) or
• Patients with kidney disease who are also taking aliskiren (Tekturna®)—Should not be used in patients with these conditions.

• Electrolyte imbalances (eg, high or low potassium or sodium in the body)—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease (including cirrhosis)—Use with caution. The effects may be increased because of slower removal of losartan from the body.

Proper Use of This Medicine:

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine may be taken with or without food.

If you are unable to swallow tablets, ask your pharmacist about preparing an oral suspension for you.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—At first, 50 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    • Children 6 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 0.7 milligram (mg) per kilogram (kg) of body weight per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For lowering risk of stroke in patients with high blood pressure and enlargement of the heart:
    • Adults—At first, 50 milligrams (mg) once a day. Your doctor may adjust your dose and add another medicine based on your blood pressure response.
    • Children—Use and dose must be determined by your doctor.
  • For diabetic nephropathy:
    • Adults—At first, 50 milligrams (mg) once a day. Your doctor may adjust your dose based on your blood pressure response.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness or lightheadedness may occur after the first dose of this medicine, especially if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Check with your doctor right away if you become sick while taking this medicine, especially if you have severe or continuing nausea, vomiting, or diarrhea that does not stop. These conditions may cause you to lose too much water and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

Avoid alcoholic beverages until you have discussed their use with your doctor. Alcohol may make the low blood pressure effect worse or increase the possibility of dizziness or fainting.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

confusion

difficult breathing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast or irregular heartbeat

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

stomach pain

sweating

unusual tiredness or weakness

weakness or heaviness of the legs

Incidence not known

Black, tarry stools

bleeding gums

blood in the urine or stools

coma

convulsions

cough

decreased urine output

difficulty swallowing

headache

hives, itching, skin rash

increased thirst

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

muscle pain or cramps

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

tightness in the chest

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Body aches or pain

chills

continuing ringing or buzzing or other unexplained noise in the ears

decreased interest in sexual intercourse

difficulty having a bowel movement (stool)

ear congestion

feeling of constant movement of self or surroundings

feeling sad or empty

headache, severe and throbbing

hearing loss

inability to have or keep an erection

increased sensitivity of the skin to sunlight

irritability

lack of appetite

loss in sexual ability, desire, drive, or performance

loss of interest or pleasure

loss of voice

redness or other discoloration of the skin

sensation of spinning

severe sunburn

sneezing

sore throat

stuffy or runny nose

trouble concentrating

trouble sleeping

Incidence not known

Change or loss of taste

dark urine

general tiredness and weakness

light-colored stools

yellow eyes and skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.