Fosinopril Hydrochlorothiazide

Black Box Warnings

Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death

Contraindications

Hypersensitivity to ACE inhibitors, thiazides or sulfonamides

History of hereditary or angioedema associated with previous ACE inhibitor treatment

Coadministration of neprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hr of switching to or from sacubitril/valsartan

Anuria or renal artery stenosis

Do not coadminister with aliskiren in patients with diabetes mellitus or with renal impairment (ie, GFR <60 mL/min/1.73 m²)

Cautions

Begin combination therapy only after failed monotherapy

Severe renal impairment, hepatic impairment

Risk of hypotension, especially with CHF

Coadministration with mTOR inhibitors (eg, temsirolimus) may increased risk for angioedema

Renal impairment may occur

Neutropenia/agranulocytosis reported

Cough may occur within the first few months

Cholestatic jaundice may occur

Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy

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

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

Hydrochlorothiazide and fosinopril is a combination medicine used to treat hypertension (high blood pressure).

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

If you have diabetes, do not use hydrochlorothiazide and fosinopril together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant.

You should not use this medication if you are allergic to hydrochlorothiazide or fosinopril, or if:

• you are unable to urinate; or
• you are allergic to any other ACE inhibitor, such as benazepril, captopril, enalapril, lisinopril, quinapril, ramipril, trandolapril, and others.

If you have diabetes, do not use hydrochlorothiazide and fosinopril together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

You may also need to avoid taking hydrochlorothiazide and fosinopril with aliskiren if you have kidney disease.

To make sure hydrochlorothiazide and fosinopril is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);
• liver disease;
• congestive heart failure;
• gout;
• lupus;
• diabetes; or
• an allergy to sulfa drugs or penicillin.

FDA pregnancy category D. Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Hydrochlorothiazide and fosinopril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

Hydrochlorothiazide and fosinopril can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

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:

• a light-headed feeling, like you might pass out;
• pale skin, easy bruising or bleeding;
• fever, swollen gums, painful mouth sores, pain when swallowing, cold or flu symptoms;
• 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;
• low levels of sodium--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• headache, dizziness;
• cough; 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.

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.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

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

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

Other drugs may interact with hydrochlorothiazide and fosinopril, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking hydrochlorothiazide and fosinopril. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. Your blood and urine may also be tested if you have been vomiting or are dehydrated. Visit your doctor regularly.

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.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and fosinopril. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.