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Perindopril Erbumine (Perindopril Erbumine)

Trade Name : Perindopril Erbumine

West-Ward Pharmaceuticals Corp.

TABLET

Strength 2 mg/1

PERINDOPRIL ERBUMINE 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 Perindopril Erbumine (Perindopril Erbumine) which is also known as Perindopril Erbumine and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 2 mg/1 per ml. Read more

Perindopril Erbumine (Perindopril Erbumine) 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
  • WARNING: FETAL TOXICITY
  • See full prescribing information for complete boxed warning.
  • When pregnancy is detected, discontinue perindopril erbumine as soon as possible. ()
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ()
  • No data
  • Hypertension
  • Stable Coronary Artery Disease
  • Perindopril Erbumine Tablets USP
  • 2 mg tablets: white to off-white, round, biconvex tablets, debossed with product identification u201c54u201d over u201c551u201d on one side and scored on the other side.
  • 4 mg tablets: white to off-white, round, biconvex tablets, debossed with product identification u201c54u201d over u201c327u201d on one side and scored on the other side.
  • 8 mg tablets: white to off-white, round, biconvex tablets, debossed with product identification u201c54u201d over u201c715u201d on one side and scored on the other side.
  • Tablets: 2 mg, 4 mg and 8 mg ()
  • Perindopril erbumine is contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor. Perindopril erbumine is also contraindicated in patients with hereditary or idiopathic angioedema.
  • Do not co-administer aliskiren with perindopril erbumine in patients with diabetes [].
  • Perindopril erbumine is contraindicated in combination with neprilysin inhibitor (e.g., sacubitril). Do not administer perindopril erbumine within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [].
  • 4n- 5.1
  • 4n- 7.8
  • No data
  • 5.2n- 5.6
  • Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or .
  • Hypertension:
  • Stable Coronary Artery Disease:
  • No data
  • No data
  • In animals, doses of perindopril up to 2,500 mg/kg in mice, 3,000 mg/kg in rats and 1,600 mg/kg in dogs were non-lethal. Past experiences were scant but suggested that overdosage with other ACE inhibitors was also fairly well tolerated by humans. The most likely manifestation is hypotension, and treatment should be symptomatic and supportive. Therapy with the ACE inhibitor should be discontinued, and the patient should be observed. Dehydration, electrolyte imbalance and hypotension should be treated by established procedures.
  • Among the reported cases of perindopril overdosage, patients who were known to have ingested a dose of 80 mg to 120 mg required assisted ventilation and circulatory support. One additional patient developed hypothermia, circulatory arrest and died following ingestion of up to 180 mg of perindopril. The intervention for perindopril overdose may require vigorous support.
  • Laboratory determinations of serum levels of perindopril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of perindopril overdose.
  • No data are available to suggest physiological maneuvers (, maneuvers to change the pH of the urine) that might accelerate elimination of perindopril and its metabolites. Perindopril can be removed by hemodialysis, with clearance of 52 mL/min for perindopril and 67 mL/min for perindoprilat.
  • Angiotensin II could presumably serve as a specific antagonist-antidote in the settling of perindopril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of perindopril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat perindopril overdose by infusion of normal saline solution.
  • Perindopril Erbumine Tablets USP contain the tert-butylamine salt of perindopril, the ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Perindopril erbumine USP is chemically described as (2S,3aS,7aS)-1-[(S)-N-[(S)-1-Carboxybutyl]alanyl]hexahydro-2-indolinecarboxylic acid, 1-ethyl ester, compound with tert-butylamine (1:1). Its molecular formula is CHNOCHN. Its structural formula is:
  • Perindopril erbumine is a white to almost white powder with a molecular weight of 368.47 (free acid) or 441.61 (salt form). It is freely soluble in water (60% w/w), alcohol and chloroform.
  • Perindopril is the free acid form of perindopril erbumine, is a pro-drug and metabolized by hydrolysis of the ester group to form perindoprilat, the biologically active metabolite.
  • Perindopril Erbumine Tablets USP are available for oral administration containing either 2 mg, 4 mg or 8 mg strengths of perindopril erbumine. Each tablet contains the following inactive ingredients: lactose (anhydrous), magnesium stearate, microcrystalline cellulose and silicon dioxide.
  • No data
  • Carcinogenesis
  • No evidence of carcinogenic effect was observed in studies in rats and mice when perindopril was administered at dosages up to 20 times (mg/kg) or 2 to 4 times (mg/m) the maximum proposed clinical doses (16 mg/day) for 104 weeks.
  • Mutagenesis
  • No genotoxic potential was detected for perindopril, perindoprilat and other metabolites in various and investigations, including the Ames test, the D4 test, cultured human lymphocytes, TK u00b1 mouse lymphoma assay, mouse and rat micronucleus tests and Chinese hamster bone marrow assay.
  • Impairment of Fertility
  • There was no meaningful effect on reproductive performance or fertility in the rat given up to 30 times (mg/kg) or 6 times (mg/m) the proposed maximum clinical dosage of perindopril during the period of spermatogenesis in males or oogenesis and gestation in females.
  • No data
  • Perindopril Erbumine Tablets USP
  • 2 mg tablets are supplied as a white to off-white, round, biconvex tablet, debossed with product identification u201c54u201d over u201c551u201d on one side and scored on the other side.
  • NDC 0054-0110-25: Bottle of 100 Tablets
  • 4 mg tablets are supplied as a white to off-white, round, biconvex tablet, debossed with product identification u201c54u201d over u201c327u201d on one side and scored on the other side.
  • NDC 0054-0111-25: Bottle of 100 Tablets
  • 8 mg tablets are supplied as a white to off-white, round, biconvex tablet, debossed with product identification u201c54u201d over u201c715u201d on one side and scored on the other side.
  • NDC 0054-0112-25: Bottle of 100 Tabletsn
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, child-resistant container as defined in the USP/NF.u00a0
  • Female patients of childbearing age should be told about the consequences of exposure to perindopril during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
  • Tell patients to report promptly any indication of infection (, sore throat, fever) which could be a sign of neutropenia.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10005475/08
  • Revised March 2019
  • Perindopril Erbumine Tablets USP, 2 mg
  • 0054-0110-25, Rx only
  • Perindopril Erbumine Tablets USP, 4 mg
  • 0054-0111-25, Rx only
  • Perindopril Erbumine Tablets USP, 8 mg
  • 0054-0112-25, Rx only

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