Hyzaar

DRUG DESCRIPTION

HYZAAR® 50-12.5 (losartan potassium-hydrochlorothiazide), HYZAAR® 100-12.5 (losartan potassium-hydrochlorothiazide) and HYZAAR® 100-25 (losartan potassium-hydrochlorothiazide) combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide.

Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is:

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.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

HYZAAR is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. HYZAAR 50-12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. HYZAAR 100-12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. HYZAAR 100-25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are microcrystalline cellulose, lactose hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. HYZAAR 50-12.5 and HYZAAR 100-25 also contain D&C yellow No. 10 aluminum lake. HYZAAR 5012.5, HYZAAR 100-12.5, and HYZAAR 100-25 may also contain carnauba wax.

HYZAAR 50-12.5 contains 4.24 mg (0.108 mEq) of potassium, HYZAAR 100-12.5 contains 8.48 mg (0.216 mEq) of potassium, and HYZAAR 100-25 contains 8.48 mg (0.216 mEq) of potassium.

What are the possible side effects of hydrochlorothiazide and losartan (Hyzaar)?

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, hydrochlorothiazide and 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.

Stop using this medication and call your doctor at...

Read All Potential Side Effects and See Pictures of Hyzaar »

What are the precautions when taking losartan potassium-hydrochlorothiazide (Hyzaar)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to losartan or hydrochlorothiazide; 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: gout, kidney disease, liver disease, lupus.

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.

Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or a serious loss of body water (dehydration). Report prolonged...

Read All Potential Precautions of Hyzaar »


Hyzaar 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, muscle cramps/weakness, slow/fast/irregular heartbeat, unusual decrease in the amount of urine, unusual dry mouth/thirst, decrease in vision, eye pain.

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 this medication, tell your doctor or pharmacist if you are allergic to losartan or hydrochlorothiazide; 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: gout, kidney disease, liver disease, lupus.

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.

Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or a serious loss of body water (dehydration). Report prolonged diarrhea or vomiting to your doctor. To prevent dehydration, drink plenty of fluids unless your doctor directs you otherwise.

If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

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

Older adults may be more sensitive to the effects of this drug, especially dizziness.

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 losartan passes into breast milk. Hydrochlorothiazide passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Hyzaar Patient Information Including Side Effects

Brand Names: Hyzaar

Generic Name: hydrochlorothiazide and losartan (Pronunciation: HYE droe KLOR oh THYE a zide and loe SAR tan)

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

What is hydrochlorothiazide and losartan (Hyzaar)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

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.

The combination of hydrochlorothiazide and 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.

Hydrochlorothiazide and losartan may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of hydrochlorothiazide and losartan (Hyzaar)?

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, hydrochlorothiazide and 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.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • feeling light-headed, fainting;
  • swelling, rapid weight gain;
  • fast or pounding heartbeats;
  • pale skin, easy bruising or bleeding;
  • urinating less than usual, or not at all;
  • jaundice (yellowing of the skin or eyes); or
  • dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, fainting, or seizure (convulsions).

Less serious side effects may include:

  • stomach pain;
  • back pain;
  • dizziness, tired feeling;
  • skin rash;
  • runny or stuffy nose, sore throat; or
  • dry cough.

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 hydrochlorothiazide and losartan (Hyzaar)?

Do not use this medication if you are allergic to hydrochlorothiazide or losartan, or if you are unable to urinate.

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.

Before using hydrochlorothiazide and losartan, tell your doctor if you have congestive heart failure, kidney or liver disease, asthma, low or high blood levels of potassium, gout, lupus, diabetes, or an allergy to sulfa drugs.

Hydrochlorothiazide and losartan can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

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

In rare cases, hydrochlorothiazide and 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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