Lisinopril (Lisinopril)

Trade Name : LISINOPRIL

NuCare Pharmaceuticals, Inc.

TABLET

Strength 10 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 NuCare Pharmaceuticals, Inc.. It is available in strength of 10 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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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.

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
  • 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 n n n n n )n n n n n 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 n n n n n ) n n n n n n n n n
  • Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for:
  • n Treatment of hypertension in adults and pediatric patients 6 years of age and older (n n n n n n n n n )nttttttt n n n n n n n n n
  • Adjunct therapy for heart failure (n n n n n n n n n )n n n n n n n n n
  • Treatment of Acute Myocardial Infarction (n n n n n n n n n )n n n n n n n n n
  • No data
  • n 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 n n n n n n
  • Pediatric patients with glomerular filtration rate > 30 mL/min/1.73mn n n n n n n 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 n n n n n ) n n n n n n n n n
  • Heart Failure: Initiate with 5 mg once daily. Increase dose as tolerated to 40 mg daily n n n n n n 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 n n n n n n
  • Renal Impairment: For patients with creatinine clearance u2265 10 mL/min and u2264 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 n n n n n n n n n n
  • Lisinopril tablets, USP 2.5 mg are white to off white, round, biconvex uncoated tablets with debossing u20182.5u2019 on one side and u2018LIu2019 on the other side.
  • Lisinopril tablets, USP 5 mg are white to off white, round, biconvex uncoated tablets with debossing u20185u2019 on one side and u2018LIu2019 on the other side with break line.
  • Lisinopril tablets, USP 10 mg are white to off white, round, biconvex uncoated tablets with debossing u201810u2019 on one side and u2018LIu2019 on the other side.
  • Lisinopril tablets, USP 20 mg are white to off white, round, biconvex uncoated tablets with debossing u201820u2019 on one side and u2018LIu2019 on the other side.
  • Lisinopril tablets, USP 30 mg are white to off white, round, biconvex uncoated tablets with debossing u201830u2019 on one side and u2018LIu2019 on the other side.
  • Lisinopril tablets, USP 40 mg are white to off white, round, biconvex uncoated tablets with debossing u201840u2019 on one side and u2018LIu2019 on the other side.
  • Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg n n n n n n 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 n n n n n ]n nn n nn n nn
  • Angioedema or a history of hereditary or idiopathic angioedema n n n n n n n n n n
  • Hypersensitivity n n n n n n n n n n
  • Co-administration of aliskiren with lisinopril in patients with diabetes ( n n n n n n n n n , n n n n n n n n n )n n n n n n n n n
  • No data
  • Angioedema: Discontinue lisinopril, provide appropriate therapy and monitor until resolved n n n n n n n n n n
  • Renal impairment: Monitor renal function periodicallyn n n n n n n n n n n
  • Hypotension: Patients with other heart or renal diseases have increased risk, monitor blood pressure after initiationn n n n n n n n n n n
  • Hyperkalemia: Monitor serum potassium periodically n n n n n n n n n n n
  • Cholestatic jaundice and hepatic failure: Monitor for jaundice or signs of liver failure n n n n n n n n n n n
  • Common adverse reactions (events 2% greater than placebo) by use:n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or n n n n n n n n n .n n n n n n n n n
  • Hypertension: headache, dizziness and cough n n n n n n n n n n
  • Heart Failure: hypotension and chest pain n n n n n n n n n n
  • Acute Myocardial Infarction: hypotension ( n n n n n n n n n )n n n n n n n n n
  • No data
  • Diuretics: Excessive drop in blood pressure n n n n n n n n n n
  • NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy n n n n n n n n n n
  • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia ( n n n n n n n n n )n n n n n n n n n
  • Lithium: Symptoms of lithium toxicity n n n n n n n n n n
  • Gold: Nitritoid reactions have been reported n n n n n n n n n n
  • No data
  • Lactation: Advise not to breastfeed. (n n n n n n ) n n n n n n
  • Race: Less antihypertensive effect in blacks than non blacks n n n n n n 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 n n n n n ].n nn n nn 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 n n n n n n n -(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is Cn n n n n n n n n Hn n n n n n n n n Nn n n n n n n n n On n n n n n n n n n 2Hn n n n n n n n n O and its structural formula is:n nn n nn n nn
  • 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 2.5 mg, 5 mg, 10 mg, 20 mg, 30u00a0mg and 40 mg tablets for oral administration. Inactive Ingredients: corn starch, colloidal anhydrous silica, dibasic calcium phosphate, magnesium stearate, mannitol and pregelatinised starch.
  • 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 timesn n n n n n n n n 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.n nn n nn n nn
  • 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 in vitro alkaline elution rat hepatocyte assay. In addition, lisinopril did not produce increases in chromosomal aberrations in an in vitro test in Chinese hamster ovary cells or in an in vivo 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/mn n n n n n n n n , respectively.n nn n nn 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 n n n 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 n nn n nn
  • No data
  • Lisinopril tablets, USP 10 mg: white to off white, round, biconvex uncoated tablets with debossing u201810u2019 on one side and u2018LIu2019 on the other side are supplied as follows:n n nBottles of 30 Tablets (NDC 66267-577-30)n n nBottles of 60 Tablets (NDC 66267-577-60)n n nBottles of 90 Tablets (NDC 66267-577-90)n
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F) [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 n n n n n n . n nn n nn
  • 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 n n n n n n .n nn 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 n n n n n ]. n nn n nn 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.
  • Manufactured For:
  • Manufactured By:
  • 10 0038 1 667527
  • Issued May 2016
  • No data

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