Cozaar

DRUG DESCRIPTION

COZAAR (losartan potassium) is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5ylphenyl)benzyl]imidazole-5-methanol monopotassium salt.

Its empirical formula is C22H22ClKN6O, and its structural formula is:

COZAAR® (Losartan potassium) Structural Formula Illustration

Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.

COZAAR is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide.

COZAAR 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. COZAAR 25 mg, COZAAR 50 mg, and COZAAR 100 mg may also contain carnauba wax.

What are the possible side effects of losartan (Cozaar)?

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

In rare cases, losartan 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 muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have a serious side effect such as:

  • feeling like...

Read All Potential Side Effects and See Pictures of Cozaar »

What are the precautions when taking losartan potassium (Cozaar)?

Before taking losartan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not...

Read All Potential Precautions of Cozaar »


Cozaar Consumer (continued)

SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, slow/irregular heartbeat, unusual decrease in the amount of urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking losartan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Cozaar Patient Information Including Side Effects

Brand Names: Cozaar

Generic Name: losartan (Pronunciation: loe SAR tan)

  • What is losartan (Cozaar)?
  • What are the possible side effects of losartan (Cozaar)?
  • What is the most important information I should know about losartan (Cozaar)?
  • What should I discuss with my healthcare provider before taking losartan (Cozaar)?
  • How should I take losartan (Cozaar)?
  • What happens if I miss a dose (Cozaar)?
  • What happens if I overdose (Cozaar)?
  • What should I avoid while taking losartan (Cozaar)?
  • What other drugs will affect losartan (Cozaar)?
  • Where can I get more information?

What is losartan (Cozaar)?

Losartan is in a group of drugs called angiotensin II receptor antagonists. Losartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Losartan is used to treat high blood pressure (hypertension). It is also used to lower the risk of stroke in certain people with heart disease.

Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure.

Losartan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of losartan (Cozaar)?

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

In rare cases, losartan 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 muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • painful or difficult urination;
  • chest pain;
  • numbness or tingly feeling;
  • pale skin, easy bruising or bleeding;
  • swelling in your hands or feet; or
  • slow heart rate, weak pulse, tingly feeling.

Less serious side effects may include:

  • runny or stuffy nose, sore throat, cough;
  • muscle, leg, or back pain;
  • stomach pain, diarrhea;
  • headache, dizziness;
  • tired feeling; or
  • sleep problems (insomnia).

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.

What is the most important information I should know about losartan (Cozaar)?

Do not use this medication without telling your doctor if you are pregnant. Losartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

You should not use this medication if you are allergic to losartan.

Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of losartan.

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

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

Keep using this medication even if you feel fine. High blood pressure often has no symptoms.

In rare cases, losartan 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 muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

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