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Lisinopril (Prinivil)

Trade Name : PRINIVIL

Merck Sharp & Dohme Corp.

TABLET

Strength 5 mg/1

LISINOPRIL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Lisinopril (Prinivil) which is also known as PRINIVIL and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 5 mg/1 per ml. Read more

Lisinopril (Prinivil) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • When pregnancy is detected, discontinue PRINIVIL as soon as possible n- [see ]n- .
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
  • WARNING: FETAL TOXICITY
  • See full prescribing information for complete boxed warning.
  • When pregnancy is detected, discontinue PRINIVIL as soon as possible ().
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ().
  • PRINIVIL is an angiotensin converting enzyme (ACE) inhibitor indicated for:
  • Treatment of hypertension in adults and pediatric patients u22656 years of age ()
  • Adjunctive therapy for heart failure ()
  • Treatment of acute myocardial infarction ()
  • No data
  • Hypertension: Initiate adults at 10 mg (monotherapy) or 5 mg (on a diuretic) once daily. Titrate up to 40 mg daily based on response. Initial dose in patients 6 years of age and older is 0.07 mg/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 10-30 mL/min, halve the usual initial dose. For creatinine clearance <10 mL/min or on hemodialysis, initiate at 2.5 mg ()
  • Tablets PRINIVIL, 5 mg, are white, oval-shaped compressed tablets with code MSD 19 on one side and scored on the other side.
  • Tablets PRINIVIL, 10 mg, are light yellow, oval-shaped compressed tablets with code MSD 106 on one side and scored on the other side.
  • Tablets PRINIVIL, 20 mg, are peach, oval-shaped compressed tablets with code MSD 207 on one side and scored on the other side.
  • Tablets (lisinopril content): 5 mg; 10 mg; and 20 mg ()
  • PRINIVIL is contraindicated in patients with:
  • Do not coadminister aliskiren with PRINIVIL in patients with diabetes .
  • PRINIVIL is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer PRINIVIL within 36 hours of switching to or from sacubitril/valsartan, a product containing a neprilysin inhibitor . tttttt
  • Angioedema or a history of hereditary or idiopathic angioedema ()
  • Hypersensitivity ()
  • Coadministration of aliskiren with PRINIVIL in patients with diabetes (, )
  • PRINIVIL is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer PRINIVIL within 36 hours of switching to or from sacubitril/valsartan, a product containing a neprilysin inhibitor ()
  • No data
  • Angioedema: Discontinue PRINIVIL ()
  • Renal impairment: Monitor renal function periodically ()
  • Hypotension: Monitor blood pressure after initiation ()
  • Hyperkalemia: Monitor serum potassium periodically ()
  • Cholestatic jaundice and hepatic failure: Discontinue PRINIVIL ()
  • Common adverse reactions (events 2% greater than on placebo):
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Hypertension: headache, dizziness and cough ()
  • Heart Failure: hypotension and chest pain ()
  • Acute Myocardial Infarction: hypotension ()
  • No data
  • Diuretics: Excessive drop in blood pressure ()
  • NSAIDs: Increased risk of renal impairment and loss of antihypertensive efficacy ()
  • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, syncope, and hyperkalemia ()
  • Lithium: Symptoms of lithium toxicity ()
  • Gold: Nitritoid reactions ()
  • No data
  • Pregnancy: Discontinue PRINIVIL if pregnancy is detected (, )
  • Pediatrics: Safety and effectiveness have not been established in patients <6 years of age or with glomerular filtration rate <30 mL/min/1.73 m ()
  • Race: Less antihypertensive effect in Blacks than non-Blacks ()
  • 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 .
  • PRINIVIL contains lisinopril, a synthetic peptide derivative, and an oral, long-acting angiotensin converting enzyme inhibitor. Lisinopril is chemically described as ()-1-[-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is CHNOu22192HO and its structural formula is:
  • Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol.
  • PRINIVIL is supplied as 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient, lisinopril, each tablet contains the following inactive ingredients: calcium phosphate, mannitol, magnesium stearate, and starch. The 10 mg and 20 mg tablets also contain iron oxide.
  • No data
  • There was no evidence of a tumorigenic effect when lisinopril was administered for 105 weeks to male and female rats at doses up to 90 mg per kg per day or for 92 weeks to male and female mice at doses up to 135 mg per kg per day. These doses are 10 times and 7 times, respectively, the MRHDD when compared on a body surface area basis.
  • Lisinopril was not mutagenic in the Ames microbial mutagen test with or without metabolic activation. It was also negative in a forward mutation assay using Chinese hamster lung cells. Lisinopril did not produce single strand DNA breaks in an alkaline elution rat hepatocyte assay. In addition, lisinopril did not produce increases in chromosomal aberrations in an test in Chinese hamster ovary cells or in an study in mouse bone marrow.
  • There were no adverse effects on reproductive performance in male and female rats treated with up to 300 mg/kg/day of lisinopril (33 times the MRHDD when compared on a body surface area basis).
  • Studies in rats indicate that lisinopril crosses the blood brain barrier poorly. Multiple doses of lisinopril in rats do not result in accumulation in any tissues. Milk of lactating rats contains radioactivity following administration of C lisinopril. By whole body autoradiography, radioactivity was found in the placenta following administration of labeled drug to pregnant rats, but none was found in the fetuses.
  • No data
  • PRINIVIL is supplied as oval-shaped, compressed tablets scored on one side.
  • Storage
  • Store at controlled room temperature, 15-30u00b0C (59-86u00b0F), and protect from moisture.
  • Dispense in a tight container, if product package is subdivided.
  • NOTE: This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
  • Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • The trademarks depicted herein are owned by their respective companies.
  • Copyright u00a9 1988-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk0521-t-1911r016
  • NDC 0006-0019-54
  • Priniviln (Lisinopril) Tablets
  • 5 mg
  • Each tablet contains 5 mg lisinopril.
  • USUAL DOSAGE: See Package Insert.
  • Rx only
  • 90 Tablets
  • NDC 0006-0106-54
  • Priniviln (Lisinopril) Tablets
  • 10 mg
  • Each tablet contains 10 mg lisinopril.
  • USUAL DOSAGE: See Package Insert.
  • Rx only
  • 90 Tablets
  • NDC 0006-0207-54
  • Priniviln (Lisinopril) Tablets
  • 20 mg
  • Each tablet contains 20 mg lisinopril.
  • USUAL DOSAGE: See Package Insert.
  • Rx only
  • 90 Tablets

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