Zestoretic

DRUG DESCRIPTION

ZESTORETIC® (Lisinopril and Hydrochlorothiazide) combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide.

Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-l-[N2-(l-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5•2H2O and its structural formula is:

Lisinopril Structural Formula Illustration

Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8C1N3O4S2 and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

ZESTORETIC (lisinopril and hydrochlorothiazide) is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: ZESTORETIC (lisinopril and hydrochlorothiazide) 10-12.5 containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; ZESTORETIC (lisinopril and hydrochlorothiazide) 20-12.5 containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and, ZESTORETIC (lisinopril and hydrochlorothiazide) 20-25 containing 20 mg lisinopril and 25 mg hydrochlorothiazide.

Inactive Ingredients

10-12.5 Tablets - calcium phosphate, magnesium stearate, mannitol, red ferric oxide, starch, yellow ferric oxide.

20-12.5 Tablets - calcium phosphate, magnesium stearate, mannitol, starch.

20-25 Tablets - calcium phosphate, magnesium stearate, mannitol, red ferric oxide, starch, yellow ferric oxide.

What are the possible side effects of hydrochlorothiazide and lisinopril (Prinzide, Zestoretic)?

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

Call your doctor at once if you have any of these serious side effects:

  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • dry...

Read All Potential Side Effects and See Pictures of Zestoretic »

What are the precautions when taking lisinopril and hydrochlorothiazide (Zestoretic)?

Before taking this product, tell your doctor or pharmacist if you are allergic to lisinopril or hydrochlorothiazide; or to other ACE inhibitors (such as captopril, benazepril); 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: history of an allergic reaction that included swelling of the face/lips/tongue/throat (angioedema), blood filtering procedures (such as LDL apheresis, dialysis), desensitizing treatment for bee/wasp sting allergy, gout, kidney disease, liver disease, collagen vascular disease (such as lupus, scleroderma).

This drug may make you...

Read All Potential Precautions of Zestoretic »


Zestoretic Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, tiredness, or headache may occur as your body adjusts to the medication. Dry cough may also occur. 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, signs of infection (such as fever, chills, persistent sore throat), slow/fast/irregular heartbeat, unusual decreased urination, unusual dry mouth/thirst.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of these rare but serious side effects: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, 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 product, tell your doctor or pharmacist if you are allergic to lisinopril or hydrochlorothiazide; or to other ACE inhibitors (such as captopril, benazepril); 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: history of an allergic reaction that included swelling of the face/lips/tongue/throat (angioedema), blood filtering procedures (such as LDL apheresis, dialysis), desensitizing treatment for bee/wasp sting allergy, gout, kidney disease, liver disease, collagen vascular disease (such as lupus, scleroderma).

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


Zestoretic Patient Information Including Side Effects

Brand Names: Prinzide, Zestoretic

Generic Name: hydrochlorothiazide and lisinopril (Pronunciation: HYE droe KLOR oh THYE a zide and lye SIN oh pril)

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

What is hydrochlorothiazide and lisinopril (Zestoretic)?

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

Lisinopril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme. Lisinopril lowers blood pressure and also relieves symptoms of fluid retention.

The combination of hydrochlorothiazide and lisinopril is used to treat hypertension (high blood pressure).

Hydrochlorothiazide and lisinopril may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hydrochlorothiazide and lisinopril (Zestoretic)?

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

Call your doctor at once if you have any of these serious side effects:

  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • dry mouth, thirst, nausea, vomiting;
  • feeling weak, drowsy, restless, or light-headed;
  • a red, blistering, peeling skin rash;
  • jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • swelling, weight gain, feeling short of breath; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • cough;
  • dizziness, tired feeling, depressed mood;
  • headache, blurred vision;
  • diarrhea, constipation, upset stomach; or
  • mild skin rash, increased sweating.

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 lisinopril (Zestoretic)?

Do not use this medication if you are unable to urinate.

You should not use this medication if you are allergic to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik).

Before taking hydrochlorothiazide and lisinopril, tell your doctor if you have kidney disease (or are on dialysis), liver disease, congestive heart failure, gout, lupus, diabetes, or an allergy to sulfa drugs.

Lisinopril can cause birth defects in the baby if you take the medication during pregnancy. Do not use hydrochlorothiazide and lisinopril without telling your doctor if you are pregnant or planning a pregnancy.

Avoid the regular use of salt substitutes in your diet, and do not take potassium supplements while taking hydrochlorothiazide and lisinopril, unless your doctor has told you to.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking other diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking hydrochlorothiazide and lisinopril. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

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