Trade Name: lisinopril

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals, Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 40 mg/1

Storage and handling

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

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • WARNING: FETAL TOXICITY
  • See full prescribing information for complete boxed warning.
  • When pregnancy is detected, discontinue lisinopril as soon as possible. n n n n
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. n n n n
  • Lisinopril tablets are an angiotensin converting enzyme (ACE) inhibitor indicated for:
  • Treatment of hypertension in adults and pediatric patients 6 years of age and older n n n n
  • Adjunct therapy for heart failure n n n n
  • Treatment of Acute Myocardial Infarction n n n n
  • No data
  • 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 n n n n
  • Pediatric patients with glomerular filtration rate greater than 30 mL/min/1.73mn n n : Initial dose in patients 6 years of age and older is 0.07 mg per kg (up to 5 mg total) once daily n n n n
  • Heart Failure: Initiate with 5 mg once daily. Increase dose as tolerated to 40 mg daily n n n n
  • Acute Myocardial Infarction (MI): Give 5 mg within 24 hours of MI. Followed by 5 mg after 24 hours, then 10 mg once daily n n n n
  • Renal Impairment: For patients with creatinine clearance greater than or equal to 10 mL/min and less than or equal to 30 mL/min, halve usual initial dose. For patients with creatinine clearance less than 10 mL/min or on hemodialysis, the recommended initial dose is 2.5 mg n n n n
  • 2.5 mg are white, round, biconvex, uncoated tablets debossed u201cn n n 25u201d on one side and plain on the other side.n nn
  • 5 mg are pink, oval, biconvex, uncoated tablets debossed u201cn n n 54u201d on one side and bisected on the other side.n nn
  • 10 mg are pink, round, biconvex, uncoated tablets debossed u201cn n n 101u201d on one side and plain on the other side.n nn
  • 20 mg are peach, round, biconvex, uncoated tablets debossed u201cn n n 102u201d on one side and plain on the other side.n nn
  • 30 mg are red, round, biconvex, uncoated tablets debossed u201cn n n 103u201d on one side and plain on the other side.n nn
  • 40 mg are yellow, round, biconvex, uncoated tablets debossed u201cn n n 104u201d on one side and plain on the other side.n nn
  • Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg n n n n
  • Lisinopril is contraindicated in patients with:
  • Do not co-administer aliskiren with lisinopril in patients with diabetes [see n n n ]n nn
  • Angioedema or a history of hereditary or idiopathic angioedema n n n n
  • Hypersensitivity n n n n
  • Co-administration of aliskiren with lisinopril in patients with diabetes n n n n
  • No data
  • Angioedema: Discontinue lisinopril, provide appropriate therapy and monitor until resolved n n n n
  • Renal impairment: Monitor renal function periodically n n n n
  • Hypotension: Patients with other heart or renal diseases have increased risk, monitor blood pressure after initiation n n n n
  • Hyperkalemia: Monitor serum potassium periodically n n n n
  • Cholestatic jaundice and hepatic failure: Monitor for jaundice or signs of liver failure n n n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or
  • www.fda.gov/medwatch.
  • Common adverse reactions (events 2% greater than placebo) by use.n
  • Hypertension: headache, dizziness and cough n n n n
  • Heart Failure: hypotension and chest pain n n n n
  • Acute Myocardial Infarction: hypotension n n n n
  • No data
  • Diuretics: Excessive drop in blood pressure n n n n
  • NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy n n n n
  • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia n n n n
  • Lithium: Symptoms of lithium toxicity n n n n
  • Gold: Nitritoid reactions have been reported n n n n
  • No data
  • Lactation: Advise not to breastfeed n n n n
  • Race: Less antihypertensive effect in Blacks than non-Blacks n n n n
  • 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 n n n ].n nn
  • Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[n n n -(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is Cn n n Hn n n Nn n n On n n u2022 2Hn n n O and its structural formula is:n nn
  • Lisinopril, USP 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, for oral administration, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets.
  • Inactive Ingredients:
  • 2.5 mg tablets u2013 dibasic calcium phosphate, magnesium stearate, mannitol, corn starch.
  • 5 mg, 10 mg and 30 mg tablets u2013 dibasic calcium phosphate, magnesium stearate, mannitol, corn starch, red iron oxide.
  • 20 mg tablets u2013 dibasic calcium phosphate, magnesium stearate, mannitol, corn starch, red iron oxide, yellow iron oxide.
  • 40 mg tablets u2013 dibasic calcium phosphate, magnesium stearate, mannitol, corn starch, 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 n n n alkaline elution rat hepatocyte assay. In addition, lisinopril did not produce increases in chromosomal aberrations in an n n n test in Chinese hamster ovary cells or in an n n n study in mouse bone marrow.n nn
  • 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/mn n n , respectively.n nn
  • 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 n n n 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.n nn
  • *Calculations assume a human weight of 50 kg and human body surface area of 1.62mn n n n
  • No data
  • Lisinopril Tablets, USP, for oral administration, are available as
  • Arrayn- 40 mg
  • Yellow, round, biconvex, uncoated tablets debossed u201c n 104u201d on one side and plain on the other side and supplied as:n
  • NDC 66267-583-30 bottles of 30
  • NDC 66267-583-60 bottles of 60
  • NDC 66267-583-90 bottles of 90
  • Storage
  • Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.
  • 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.
  • Pregnancy
  • Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to notify their healthcare provider with a known or suspected pregnancy [seen n n n n andn n n n ]n n n n
  • Angioedema
  • Angioedema, including laryngeal edema may occur at any time during treatment with angiotensin converting enzyme inhibitors, including lisinopril. 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.
  • Lactation
  • Advise women not to breastfeed during treatment with lisinopril [see n n n ].n nn
  • 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 hypoglycaemia closely, especially during the first month of combined use [see n n n ].n nn
  • Leukopenia/Neutropenia
  • Tell patients to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of leukopenia/neutropenia.
  • Sandoz Inc.
  • Princeton, NJ 08540
  • 46158592
  • Rev. May 2016
  • MF0025REV05/16
  • No data

Ask for Quote

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of lisinopril (lisinopril) which is also known as lisinopril and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 40 mg/1.

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.

Browse Our Services And Processes

Name Patient Supply

Name Patient Supply

Validated Cold Chain Shipment

Validated Cold Chain Shipment

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

Our Process - The Gnh Way

Our Process - The Gnh Way

Other Pharmaceutical Products

BENZALKONIUM CHLORIDE - 1 (nickelodeon bright bubble gum scented hand sanitizer)

BENZALKONIUM CHLORIDE - 1 (nickelodeon bright bubble gum scented hand sanitizer)

Liposomal Amphotericin - B for Injection IP (AmBisome)

Liposomal Amphotericin - B for Injection IP (AmBisome)

Edatate Calcium Disodium Injection USP 200mg/ml (Cal-Rsodate)

Edatate Calcium Disodium Injection USP 200mg/ml (Cal-Rsodate)

Melphalan Injection IP 50mg (Alkacel)

Melphalan Injection IP 50mg (Alkacel)

Monobenzone Cream USP 20% (Albaquin)

Monobenzone Cream USP 20% (Albaquin)

Beclomethasone Dipropionate and Levosalbutamol Inhaler (Aerocort)

Beclomethasone Dipropionate and Levosalbutamol Inhaler (Aerocort)

Are you an existing customer or a vendor of GNH India? Log in here to