Perindopril

Perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. (1.1) Perindopril erbumine tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. (1.2) 1.1 Hypertension Perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. Perindopril erbumine tablets may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. …

• Hypertension The recommended initial dose is 4 mg once a day
• The dosage may be titrated upward until blood pressure, when measured just before the next dose, is controlled or to a maximum of 16 mg per day
• Stable Coronary Artery Disease Perindopril erbumine tablets should be given at an initial dose of 4 mg once daily for 2 weeks, and then increased, as tolerated, to a maintenance dose of 8 mg once daily
• Hypertension Use in Uncomplicated Hypertensive Patients: In patients with essential hypertension, the recommended initial dose is 4 mg once a day
• The dose may be titrated, as needed to a maximum of 16 mg per day
• The usual maintenance dose range is 4 mg to 8 mg administered as a single daily dose or in two divided doses
• Use in Elderly Patients: The recommended initial daily dosage of perindopril erbumine tablets for the elderly is 4 mg daily, given in one or two divided doses
• Experience with perindopril erbumine tablets is limited in the elderly at doses exceeding 8 mg
• Dosages above 8 mg should be administered with careful blood pressure monitoring and dose titration [see Use in Specific Populations ]
• Use with Diuretics: In patients who are currently being treated with a diuretic, symptomatic hypotension can occur following the initial dose of perindopril erbumine tablets
• Consider reducing the dose of diuretic prior to starting perindopril erbumine tablets [see Drug Interactions ] . …

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. …

• Neonates With a History of in utero Exposure to Perindopril Erbumine: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion
• Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function
• Perindopril, which crosses the placenta, can theoretically be removed from the neonatal circulation by these means, but limited experience has not shown that such removal is central to the treatment of these
• Infants. …

The mean blood pressure effect of perindopril was somewhat smaller in patients over 60 than in younger patients, although the difference was not significant. Plasma concentrations of both perindopril and perindoprilat were increased in elderly patients compared to concentrations in younger patients. No adverse effects were clearly increased in older patients with the exception of dizziness and possibly rash. …

• 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

• 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 ] Perindopril erbumine tablets are contraindicated in combination with neprilysin inhibitor (e.g., sacubitril). …

Diuretics: Excessive drop in blood pressure. (7.1) Potassium-Sparing Diuretics/Potassium Supplements: Hyperkalemia. (7.2) Lithium: Increase serum lithium levels, symptoms of lithium toxicity. (7.3) Injectable Gold: Nitritoid reactions (facial flushing, nausea, vomiting, and hypotension). (7.4) NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect. (7.7) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. ( 7.8 ) Neprilysin Inhibitor: risk of angioedema ( 7 ). …

Watch for anaphylactoid reactions, including angioedema. (5.1) Monitor renal function during therapy. (5.5) Assess for hypotension and hyperkalemia. (5.2 , 5.6) 5.1 Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including perindopril erbumine) may be subject to a variety of adverse events, some of them serious. Black patients receiving ACE inhibitors have a higher incidence of angioedema compared to nonblacks. …

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. Hypertension: Most common adverse events (incidence greater than or equal to 5%) are cough, dizziness and back pain. (6.1) Stable Coronary Artery Disease: Most common adverse events leading to discontinuation were cough, drug intolerance, and hypotension. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Pregnancy Category D [see Boxed Warning and Warnings and Precautions (5.4) ] . Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. …

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. …

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