Lisinopril - Dosage TABLET

LISINOPRIL (tablet) comes in different strengths and amounts, which is referred to as the dosing of Lisinopril. The appearance of Lisinopril can differ based on the dosing. Your doctor may change the dosage and prescription of Lisinopril to get you the best results possible.

Dosage & Administration

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 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.

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/1.73m 2, 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 tablet USP is not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m 2 [see USE IN SPECIFIC POPULATIONS ( 8.4) and CLINICAL STUDIES ( 14.1)] .

heart failure

The recommended starting dose for lisinopril, 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 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 USP 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 mm Hg) 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 should be withdrawn.

dose in patients with renal impairment

No dose adjustment of lisinopril 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 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)] .

Dosage Form & Strengths

2.5 mg tablet is a white to off-white, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "2.5" on other side.

5 mg tablet is a pink coloured, round, biconvex, uncoated tablet with "5" debossed on one side and breakline on other side.

10 mg tablet is a pink coloured, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "10" on other side.

20 mg tablet is a pink coloured, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "20" on other side.

30 mg tablet is a red coloured, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "30" on other side.

40 mg tablet is a yellow coloured, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "40" on other side.

Overdosage

Following a single oral dose of 20 g/kg no lethality occurred in rats, and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution.

Lisinopril can be removed by hemodialysis [see CLINICAL PHARMACOLOGY ( 12.3)] .

Storage & Handling

5 mg tablet is a pink coloured, round, biconvex uncoated tablet with "5" debossed on one side and breakline on other side. They are available as follows:

Bottles of 30: (NDC 55289-884-30) and Bottles of 90: (NDC 55289-884-90).

Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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