Finished product reference
Lisinopril
Tablet · Oral · 20 mg
- List code
- 765
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue lisinopril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. WARNING: FETAL TOXICITY When pregnancy is detected, discontinue lisinopril as soon as possible .
What it is and how it works
Mechanism of Action Lisinopril inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of lisinopril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium.
Indications
Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older Adjunct therapy for heart failure Treatment of Acute Myocardial Infarction Hypertension Lisinopril tablet USP is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals.
Dosage and administration (summary)
Hypertension: Initial adult dose is 10 mg once daily. Titrate up to 40 mg daily based on blood pressure response. Initiate patients on diuretics at 5 mg once daily Pediatric patients with glomerular filtration rate > 30 mL/min/1.73m 2 : Initial dose in patients 6 years of age and older is 0.07 mg per kg (up to 5 mg total) once daily Heart Failure: Initiate with 5 mg once daily. Increase dose as tolerated to 40 mg daily Acute Myocardial Infarction (MI): Give 5 mg within 24 hours of MI. Followed by 5 mg after 24 hours, then 10 mg once daily Renal Impairment: For patients with creatinine clearance > 10 mL/min and < 30 mL/min, halve usual initial dose.
Contraindications
Angioedema or a history of hereditary or idiopathic angioedema Hypersensitivity Co-administration of aliskiren with lisinopril in patients with diabetes ( 4 , 7.4 ) Lisinopril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lisinopril tablet USP within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor .
Warnings and precautions
Angioedema: Discontinue lisinopril, provide appropriate therapy and monitor until resolved Renal impairment: Monitor renal function periodically Hypotension: Patients with other heart or renal diseases have increased risk, monitor blood pressure after initiation Hyperkalemia: Monitor serum potassium periodically Cholestatic jaundice and hepatic failure: Monitor for jaundice or signs of liver failure Fetal Toxicity Lisinopril can cause fetal harm when administered to a pregnant woman.
Pregnancy
Pregnancy Risk Summary Lisinopril can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Storage and supply
Lisinopril tablet USP is available as uncoated biconvex tablets in bottles of below mentioned pack size Strength Color Shape Scored Side 1/Side 2 NDC 2.5 mg White to off-white Round No LUPIN/Bottles of 90: 68180-512-09 Bottles of 100: 68180-512-01 Bottles of 500: 68180-512-02 Bottles of 1000: 68180-512-03 5 mg Pink Round Yes 5/Breakline Bottles of …
Source: Lisinopril (Lisinopril) — US FDA prescribing information, 2023-08-18, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.