Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aurobindo Pharma Limited
918917642
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Perindopril Erbumine
Product Details
Perindopril Erbumine
Product Details
Perindopril Erbumine
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
Dosage Forms & Strengths Section
Highlight:
Tablets: 2 mg, 4 mg and 8 mg (3)
3 DOSAGE FORMS AND STRENGTHS
2 mg tablet is white to off-white colored round biconvex, uncoated tablets, with debossing “D” on one side and “5” & “7” on either side of the breakline on another side.
4 mg tablet is white to off-white colored capsule shaped uncoated tablets, with debossing “D” on one side and “5” & “8” on either side of the breakline on another side.
8 mg tablet is white to off-white colored round biconvex uncoated tablets, with debossing “D” on one side and “5” & “9” on either side of breakline on another side.
Contraindications Section
Highlight: * Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema. (4, 5.1)
- Do not co-administer aliskiren with perindopril erbumine tablets in patients with diabetes (4, 7.8)
- Do not take a neprilysin inhibitor with perindopril erbumine tablets (4).
- Do not administer perindopril erbumine tablets within 36 hours of switching to or from sacubitril/valsartan (4).
4 CONTRAINDICATIONS
Perindopril erbumine tablets are contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor. Perindopril erbumine tablets are also contraindicated in patients with hereditary or idiopathic angioedema.
Do not co-administer aliskiren with perindopril erbumine tablets in patients with diabetes. [see Drug Interactions (7.8)]
Perindopril erbumine tablets are contraindicated in combination with neprilysin inhibitor (e.g., sacubitril). Do not administer perindopril erbumine tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.1)].
Boxed Warning Section
WARNING: FETAL TOXICITY
Overdosage Section
10 OVERDOSAGE
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 (e.g., 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.
Information For Patients Section
17 PATIENT COUNSELING INFORMATION
Female patients of childbearing age should be told about the consequences of exposure to perindopril erbumine 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 (e.g., sore throat, fever) which could be a sign of neutropenia.
Distributed by:
Aurobindo Pharma USA, Inc.
****279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
****Hyderabad-500 032, India
Revised: 03/2024
How Supplied Section
16 HOW SUPPLIED/STORAGE AND HANDLING
**Perindopril ErbumineTablets USP,**2 mg are white to off-white colored round biconvex, uncoated tablets, with debossing “D” on one side and “5” & “7” on either side of the breakline on another side.
Bottles of 100 NDC 65862-286-01
** Perindopril ErbumineTablets USP,**4 mg are white to off-white colored capsule shaped uncoated tablets, with debossing “D” on one side and “5” & “8” on either side of the breakline on another side.
Bottles of 100 NDC 65862-287-01
** Perindopril ErbumineTablets USP,**** 8 mg** are white to off-white colored round biconvex uncoated tablets, with debossing “D” on one side and “5” & “9” on either side of breakline on another side.
Bottles of 100 NDC 65862-288-01
** Store at**20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
** Keep out of the reach of children.**
For further information, please call Aurobindo Pharma USA, Inc. at 1-866-850-2876.