Lisinopril (Lisinopril)

Trade Name : Lisinopril

Hikma Pharmaceuticals USA Inc.

TABLET

Strength 5 mg/1

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

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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 (Lisinopril) which is also known as Lisinopril and Manufactured by Hikma Pharmaceuticals USA Inc.. It is available in strength of 5 mg/1 per ml. Read more

Lisinopril (Lisinopril) 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

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No data

WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.

When pregnancy is detected, discontinue Lisinopril Tabletsu00a0as soon as possible. ()
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ()

Lisinopril Tablets, USPu00a0 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: 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: 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. For patients with creatinine clearance < 10 mL/min or on hemodialysis, the recommended initial dose is 2.5 mg ()

Lisinopril Tablets, USP 5 mg: Pink, Mottled, Capsule Shape Tablet, Bisected Tablet; Debossed u201cWW 66u201d
Lisinopril Tablets, USP 10 mg: Pink, Mottled, Round Tablet; Debossed u201cWWu201d on one side and u201c267u201d on the other side.
Lisinopril Tablets, USP 20 mg: Red, Mottled, Round Tablet; Debossed u201cWW 268u201d
Lisinopril Tablets, USP 40 mg: Golden Yellow, Mottled, Round Tablet; Debossed u201cWW 270u201d
Tablets: 5 mg, 10 mg, 20 mg, 40 mgu00a0()

Lisinopril tablets areu00a0contraindicated in patients with:
Do not co-administer aliskiren with lisinopril tabletsu00a0in patients with diabetes n

Angioedema or a history of hereditary or idiopathic angioedema ()
Hypersensitivity ()
Co-administration of aliskiren with lisinopril in patients with diabetes (, )

No data

Angioedema: Discontinue lisinopril tablets, 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 ()

Common adverse reactions (events 2% greater than placebo) by use:
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-233-2001, 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 and hyperkalemia ()
Lithium: Symptoms of lithium toxicity ()
Gold: Nitritoid reactions have been reported ()

No data

Pregnancy: Discontinue drug 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/1.73m ()
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 n

Lisinopril is an oral long-acting angiotensin converting enzyme (ACE)u00a0inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is CHNOu20222HO and its structural formula is:
Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol.
Lisinopril Tablets, USP are supplied as 5 mg, 10 mg, 20 mg, and 40 mg tablets for oral administration.
Inactive ingredients are as follows:
5 mg, 10 mg, and 20 mg: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Mannitol, Red Iron Oxide, and Sodium Starch Glycolate.
40 mg: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Mannitol, Sodium Starch Glycolate, and Yellow 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 (about 56 or 9 times* the maximum recommended daily human dose, based on body weight and body surface area, respectively). There was no evidence of carcinogenicity when lisinopril was administered for 92 weeks to (male and female) mice at doses up to 135 mg per kg per day (about 84 times* the maximum recommended daily human dose). This dose was 6.8 times the maximum human dose based on body surface area in mice.
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 u00a0alkaline elution rat hepatocyte assay. In addition, lisinopril did not produce increases in chromosomal aberrations in an u00a0test 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 per kg per day of lisinopril. This dose is 188 times and 30 times the maximum human dose when based on mg/kg and mg/m, respectively.
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.
*Calculations assume a human weight of 50 kg and human body surface area of 1.62 mn

No data

Lisinopril Tablets, USP 5 mg: Pink, Mottled, Capsule Shape Tablet, Bisected Tablet; Debossed u201cWW 66u201dBottles of 100 tabletsBottles of 1000 tablets
Lisinopril Tablets, USP 10 mg: Pink, Mottled, Round Tablet; Debossed u201cWWu201d on one side and u201c267u201d on the other side.Bottles of 100 tabletsBottles of 1000 tablets
Lisinopril Tablets, USP 20 mg: Red, Mottled, Round Tablet; Debossed u201cWW 268u201dBottles of 100 tabletsBottles of 1000 tablets
Lisinopril Tablets, USP 40 mg: Golden Yellow, Mottled, Round Tablet; Debossed u201cWW 270u201dBottles of 100 tabletsBottles of 1000 tablets
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

NOTE:u00a0u00a0u00a0u00a0u00a0 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.
Pregnancy: Tell female patients of childbearing age about the consequences of exposure to lisinopril tabletsu00a0during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible.
Angioedema: Angioedema, including laryngeal edema may occur at any time during treatment with angiotensin converting enzyme inhibitors, including lisinopril tablets. Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.
Symptomatic Hypotension: Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patient to discontinue the drug until they have consulted with the prescribing physician.
Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients accordingly.
Hyperkalemia: Tell patients not to use salt substitutes containing potassium without consulting their physician.
Hypoglycemia: Tell diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor to monitor for hypoglycemia closely, especially during the first month of combined use .
Leukopenia/Neutropenia: Tell patients to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of leukopenia/neutropenia.
Manufactured by:n Eatontown, NJ 07724
Revised January 2015

Lisinopril Tablets, USPu00a05 mg0143-1266

Lisinopril Tablets, USPu00a010 mg0143-1267

Lisinopril Tablets, USPu00a020 mg0143-1268

Lisinopril Tablets, USPu00a040 mg0143-1270

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Lisinopril (Lisinopril)

Trade Name : Lisinopril

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Lisinopril (Lisinopril)

Trade Name : Lisinopril

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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QUICK LINKS

CONTACT US

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