Lisinopril

Pregnancy category: D

Discontinue as soon as pregnancy detected; during the second and third trimesters of pregnancy, drugs that act directly on the renin-angiotensin system have been associated with fetal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible and irreversible renal failure, and death

Lactation: Not known if excreted into breast milk; not recommended

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Talk to your doctor before using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Included as part of the PRECAUTIONS section.

Lisinopril is a prescription medication used:

• alone or with other medications for the treatment of hypertension (high blood pressure)
• with other medications in the management of congestive heart failure
• to improve survival following a heart attack

Lisinopril is not recommended in children less than 6 years of age.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• potassium-sparing diuretics such as:
  • spironolactone (Aldactone)
  • triamterene (Dyrenium)
  • amiloride (Midamor)
• other diuretics such as:
  • furosemide (Lasix)
  • hydrochlorothiazide
  • torsemide (Demadex)
• aliskiren (Tekturna)
• angiotensin receptor blockers such as candesartan (Atacand), losartan (Cozaar), and telmisartan (Micardis, Twynsta)
• aspirin and other NSAIDs (non-steroidal anti-inflammatory drugs) such as:
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin, Nuprin)
  • indomethacin (Indocin, Indocin SR)
  • ketoprofen (Orudis, Actron, Oruvail)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
• lithium (Eskalith, Lithobid)
• potassium supplements
• injectable gold (sodium aurothiomalate)

This is not a complete list of lisinopril drug interactions. Ask your doctor or pharmacist for more information.

Store this medication at room temperature, away from excess heat and moisture. Keep this and all medicines out of the reach of children.

Do not use lisinopril if you are pregnant. It could harm the unborn baby. Stop using this medication and tell your doctor right away if you become pregnant.

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

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

Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking lisinopril. Drink plenty of water each day while you are taking this medication.

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.

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

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

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.

Non-sulfhydryl ACE inhibitor.1 2 3 4 5

Storage

Oral

1-mg/mL preparation of lisinopril tablets in syrup (Ora-Sweet SF) (see Oral Administration under Dosage and Administration): Stable up to 4 weeks at ≤25°C.1 2 67 69

Conventional tablets: 15–30°C.1 2 Protect from moisture, freezing, and excessive heat.1 2

Fixed combination tablets: 15–30°C.3 Protect from excessive light and moisture.3

Lisinopril is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Lisinopril works by blocking a substance in the body that causes the blood vessels to tighten. As a result, lisinopril relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Lisinopril is also used to help treat heart failure. It is also used in some patients after a heart attack. After a heart attack, some of the heart muscle is damaged and weakened. The heart muscle may continue to weaken as time goes by. This makes it more difficult for the heart to pump blood. Lisinopril may be started within 24 hours after a heart attack to increase survival rate.

lisinopril is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• cloudy urine
• confusion
• decrease in urine output or decrease in urine-concentrating ability
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating
• unusual tiredness or weakness

• Abdominal or stomach pain
• body aches or pain
• chest pain
• chills
• common cold
• cough
• diarrhea
• difficulty breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• nausea
• runny nose
• sneezing
• sore throat
• vomiting

• Arm, back, or jaw pain
• chest discomfort, tightness, or heaviness
• fast or irregular heartbeat
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• muscle aches and pains
• shivering
• trouble sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• rash

• Acid or sour stomach
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• feeling of constant movement of self or surroundings
• heartburn
• indigestion
• muscle cramps
• sensation of spinning
• stomach discomfort or upset
• swelling

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Hypertension

Initial Therapy in adults: The recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 mg to 40 mg per day administered in a single daily dose. Doses up to 80 mg have been used but do not appear to give greater effect.

Use with diuretics in adults

If blood pressure is not controlled with Lisinopril tablets alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of Lisinopril tablets.

The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day.

Pediatric Patients 6 years of age and older with hypertension

For pediatric patients with glomerular filtration rate > 30 mL/min/1.73 m2, the recommended starting dose is 0.07 mg per kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg per kg (up to 40 mg) once daily. Doses above 0.61 mg per kg (or in excess of 40 mg) have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].

Lisinopril tablets is not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73 m2 [see Use in Specific Populations (8.4) and Clinical Studies (14.1)].

Heart Failure

The recommended starting dose for Lisinopril tablets, when used with diuretics and (usually) digitalis as adjunctive therapy for systolic heart failure, is 5 mg once daily. The recommended starting dose in these patients with hyponatremia (serum sodium < 130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.

Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension [see Warnings and Precautions (5.4), and Drug Interactions (7.1)]. The appearance of hypotension after the initial dose of Lisinopril tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

Reduction of Mortality in Acute Myocardial Infarction

In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give Lisinopril tablets 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Dosing should continue for at least six weeks.

Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (≤ 120 mmHg and > 100 mmHg) during the first 3 days after the infarct [see Warnings and Precautions (5.4)]. If hypotension occurs (systolic blood pressure ≤ 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) Lisinopril tablets should be withdrawn.

Dose in Patients with Renal Impairment

No dose adjustment of Lisinopril tablets is required in patients with creatinine clearance > 30 mL/min. In patients with creatinine clearance ≥ 10 mL/min and ≤ 30 mL/min, reduce the initial dose of Lisinopril tablets to half of the usual recommended dose i.e., hypertension, 5 mg; systolic heart failure, 2.5 mg and acute MI, 2.5 mg. Up titrate as tolerated to a maximum of 40 mg daily. For patients on hemodialysis or creatinine clearance < 10 mL/min, the recommended initial dose is 2.5 mg once daily [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Oral:

Qbrelis: 1 mg/mL (150 mL) [contains sodium benzoate]

Tablet, Oral:

Prinivil: 5 mg, 10 mg, 20 mg [scored]

Zestril: 2.5 mg

Zestril: 5 mg [scored]

Zestril: 10 mg, 20 mg, 30 mg, 40 mg

Generic: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg

Heart Failure (New York Heart Association class II through IV): Vd is slightly smaller.

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Use potassium-containing salt substitutes cautiously in patients with diabetes, patients with renal impairment, or those maintained on potassium supplements or potassium-sparing diuretics.

Lisinopril is an ACE inhibitor. ACE stands for angiotensin converting enzyme.

Lisinopril is used to treat high blood pressure (hypertension) in adults and children who are at least 6 years old.

Lisinopril is also used to treat congestive heart failure in adults, or to improve survival after a heart attack.

Initial dose: 2.5 to 5 mg orally once a day
Maintenance dose: Dosage should be increased as tolerated
Maximum dose: 40 mg orally once a day

Comments:
-The diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension. The appearance of hypotension after the initial dose of lisinopril does not preclude subsequent careful dose titration with the drug.

Pediatric patients greater than or equal to 6 years of age:
Initial dose: 0.07 mg/kg orally once a day (Maximum initial dose is 5 mg once a day)
Maintenance dose: Dosage should be adjusted according to blood pressure response at 1 to 2 week intervals.
Maximum dose: Doses above 0.61 mg/kg or greater than 40 mg have not been studied in pediatric patients

Comments:
-This drug is not recommended in pediatric patients less than 6 years old or in pediatric patients with glomerular filtration rate less than 30 mL/min.

CrCl greater than 30 mL/min: No adjustment recommended
CrCl 10 mL/min to less than or equal to 30 mL/min: Recommended initial dose is half of the usual recommended dose (i.e., hypertension, 5 mg; systolic heart failure, 2.5 mg, and acute MI, 2.5 mg. Up titrate as tolerated to a maximum of 40 mg daily)
CrCl less than 10 mL/min or on hemodialysis: Recommended initial dose is 2.5 mg orally once a day

US BOXED WARNINGS:
-FETAL TOXICITY: Angiotensin converting enzyme (ACE) inhibitor use during pregnancy can cause morbidity and death to the developing fetus. When used during the second and third trimesters, ACE inhibitors have been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Exposure to ACE inhibitors during the first trimester of pregnancy has been associated with prematurity, intrauterine growth retardation, patent ductus arteriosus, other structural cardiac malformations, and neurological malformations. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible. If no alternative to ACE inhibitor therapy is available, patients should be made aware of the risks to their fetuses and the intra-amniotic environment should be evaluated by serial ultrasound examinations. If oligohydramnios develops, this drug should be discontinued unless it is considered lifesaving for the mother. Depending on the week of pregnancy, contraction stress testing, a nonstress test, or biophysical profiling may be appropriate. Oligohydramnios may not show until after the fetus has suffered irreversible injury.

Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.

• Lisinopril inhibits an enzyme called angiotensin-converting enzyme (ACE). This enzyme is involved in the production of angiotensin II, a powerful vasoconstrictor (narrows the arteries), which also stimulates the release of the hormone aldosterone from the adrenal glands (aldosterone increases blood pressure). By inhibiting this enzyme, lisinopril dilates (opens up) the arteries, reduces how hard the heart has to work to pump blood around the body, and lowers blood pressure.
• Lisinopril belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors.

• Can be taken without regard to meals.
• Treatments that lower blood pressure, such as lisinopril, should always be part of a comprehensive cardiovascular risk reduction plan that also targets, if appropriate, cholesterol lowering, diabetes risk reduction, exercise, weight loss, and smoking cessation.
• Ensure adequate hydration before starting lisinopril.
• Lisinopril may make you feel dizzy, especially in the first few weeks of therapy and when going from a sitting or lying down position to standing. Always take your time when standing up. Talk with your doctor if this feeling persists.
• Call emergency services if your throat, face or lips show signs of swelling.
• Your doctor should monitor your kidney function and potassium levels regularly.
• For high blood pressure, continue this medication even if you feel well. High blood pressure does not usually have symptoms.
• Do not use salt substitutes or potassium supplements while taking lisinopril, unless recommended by your doctor.
• If you also have diabetes, you may need to monitor your blood sugar levels more closely during the first few weeks of lisinopril therapy.
• Do not use lisinopril if you are pregnant or trying to become pregnant.

Substance Name

Lisinopril

CAS Registry Number

83915-83-7

Drug Class

Antihypertensive Agents

Angiotensin-Converting Enzyme Inhibitors

Lisinopril is an ACE inhibitor. ACE stands for angiotensin converting enzyme.

Lisinopril is used to treat high blood pressure (hypertension) in adults and children who are at least 6 years old.

Lisinopril is also used to treat congestive heart failure in adults, or to improve survival after a heart attack.

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

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Drink plenty of water each day while you are taking this medicine.

Lisinopril can be taken with or without food.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

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

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 while you are taking lisinopril.

If you need surgery, tell the surgeon ahead of time that you are using lisinopril.

If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture and heat. Do not freeze the oral liquid.