Zestoretic contains a combination of hydrochlorothiazide and lisinopril. 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 an ACE inhibitor. ACE stands for angiotensin converting enzyme. Lisinopril lowers blood pressure and also relieves symptoms of fluid retention.

Zestoretic is used to treat hypertension (high blood pressure). Lowering blood pressure may lower your risk of a stroke or heart attack.

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

Do not use Zestoretic if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

You should not use Zestoretic if you have ever had angioedema, if you are unable to urinate, or if you are allergic to sulfa drugs or to any ACE inhibitor. Do not take hydrochlorothiazide and lisinopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

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

Before taking this medicine

You should not use Zestoretic if you are allergic to hydrochlorothiazide or lisinopril, or if:

• you have hereditary angioedema;

• you are unable to urinate;

• you recently took a heart medicine called sacubitril;

• you have an allergy to sulfa drugs; or

• you have ever had a severe allergic reaction to any ACE inhibitor (benazepril, captopril, enalapril, fosinopril, moexipril, perindopril, quinapril, ramipril, trandolapril).

Do not take Zestoretic within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

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

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

To make sure Zestoretic is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);

• cirrhosis or other liver disease;

• glaucoma;

• heart disease or congestive heart failure;

• asthma or allergies;

• gout;

• lupus;

• an allergy to sulfa drugs or penicillin; or

• if you are on a low-salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Lisinopril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using hydrochlorothiazide and lisinopril.

Zestoretic is not approved for use by anyone younger than 18 years old.

Take Zestoretic 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.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

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

If you need surgery, tell your surgeon you currently use this medicine.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

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

Usual Adult Dose for Hypertension:

Initial dose: Hydrochlorothiazide 12.5 mg-Lisinopril 10 to 20 mg orally once a day, depending on the current monotherapy dose

Maximum dose: Hydrochlorothiazide 50 mg-Lisinopril 80 mg per day

Comments:
-May increase dose every 2 to 3 weeks.
-If blood pressure is controlled with monotherapy hydrochlorothiazide 25 mg per day, but significant potassium loss occurs, then similar or greater blood pressure control without electrolyte disturbance may be achieved with hydrochlorothiazide 12.5 mg-lisinopril 10 mg orally once a day.

You should not use Zestoretic if you are allergic to hydrochlorothiazide or lisinopril, or if:

• you have hereditary angioedema;

• you are unable to urinate;

• you recently took a heart medicine called sacubitril;

• you have an allergy to sulfa drugs; or

• you have ever had a severe allergic reaction to any ACE inhibitor (benazepril, captopril, enalapril, fosinopril, moexipril, perindopril, quinapril, ramipril, trandolapril).

Do not take Zestoretic within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

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

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

To make sure Zestoretic is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);

• cirrhosis or other liver disease;

• glaucoma;

• heart disease or congestive heart failure;

• asthma or allergies;

• gout;

• lupus;

• an allergy to sulfa drugs or penicillin; or

• if you are on a low-salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Lisinopril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using hydrochlorothiazide and lisinopril.

Zestoretic is not approved for use by anyone younger than 18 years old.

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.

Hydrochlorothiazide may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Your doctor may want you to have skin examinations on a regular basis.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of this medicine.

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

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

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. 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.

Get emergency medical help if you have signs of an allergic reaction to Zestoretic: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Call your doctor at once if you have:

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

• eye pain, vision problems;

• little or no urination;

• weakness, drowsiness, or feeling restless;

• fever, chills, sore throat, mouth sores, trouble swallowing;

• jaundice (yellowing of the skin or eyes);

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

• low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or

• low sodium - headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Common Zestoretic side effects may include:

• cough;

• headache;

• dizziness; or

• tired feeling.

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.

Tell your doctor about all your other medicines, especially:

• any other blood pressure medication;

• lithium;

• everolimus, sirolimus, temsirolimus; or

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

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