perindopril erbumine

perindopril erbumine

Aceon, Apo-Perindopril (CA), Coversyl (UK)

Pharmacologic class: Angiotensin-converting enzyme (ACE) inhibitor

Therapeutic class: Antihypertensive

Pregnancy risk category D

FDA Box Warning

• Drugs that act directly on the renin-angiotensin system can cause injury to or death of a developing fetus. Discontinue drug as soon as possible when pregnancy is detected.

Action

Inhibits conversion of angiotensin I to angiotensin II (a potent vasoconstrictor). This effect leads to decreased plasma angiotensin II, reduced vasoconstriction, enhanced plasma renin activity, and decreased aldosterone activity.

Availability

Tablets: 2 mg, 4 mg, 8 mg

Indications and dosages

Essential hypertension

Adults: 4 mg P.O. daily; may titrate upward to 16 mg/day, given as a single dose or in two divided doses. (Start with 2 to 4 mg/day in patients receiving diuretics.)

Coronary artery disease

Adults: Initially, 4 mg P.O. daily for 2 weeks; then increase as tolerated to a maintenance dosage of 8 mg P.O. daily.

Dosage adjustment

• Renal impairment
• Elderly patients

Off-label uses

• Heart failure
• Diabetic nephropathy

Contraindications

• Hypersensitivity to drug or other ACE inhibitors
• Hereditary or idiopathic angioedema

Precautions

Use cautiously in:
• hepatic failure, renal impairment, renal artery stenosis, hyperkalemia, cough
• black patients
• pregnant or breastfeeding patients
• children (safety not established).

Administration

• Give without regard to food.

Know that drug (especially first dose) may cause angioedema. Keep epinephrine and antihistamines at hand in case of airway obstruction.
• For elderly patient, titrate dosage upward very slowly.
• Know that drug may be given alone or with other drugs.

Adverse reactions

CNS: dizziness, fatigue, headache, insomnia, sleep disorder, weakness, asthenia, drowsiness, vertigo, depression, paresthesia

CV: hypotension, angina pectoris, palpitations, chest pain, abnormal ECG, tachycardia

EENT: ear infection, sinusitis, rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, abdominal pain, flatulence

GU: proteinuria, urinary tract infection, erectile or other male sexual dysfunction, decreased libido, menstrual disorder

Metabolic: hyperkalemia

Musculoskeletal: back, arm, leg, neck, or joint pain; hypertonia; myalgia; arthritis

Respiratory: cough, upper respiratory infection

Skin: rash, angioedema

Other: fever, viral infection, edema

Interactions

Drug-drug.

Antihypertensives, general anesthetics, nitrates, phenothiazines: additive hypotension

Diuretics: excessive hypotension Gold (sodium aurothiomalate): increased risk of rare nitritoid reactions (including facial flushing, nausea, vomiting, and hypotension)

Lithium: increased lithium toxicity Nonsteroidal anti-inflammatory drugs: may result in deterioration of renal function, including acute renal failure and attenuated ACE inhibitor antihypertensive effect

Potassium-sparing diuretics, potassium supplements: increased risk of hyperkalemia

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, creatinine, potassium, triglycerides: increased levels Hematocrit, hemoglobin: decreased values

Drug-food.Salt substitutes containing potassium: hyperkalemia

Drug-herbs.Capsaicin: cough

Drug-behaviors.Acute alcohol ingestion: additive hypotension

Patient monitoring

• Assess blood pressure. Be aware that dosage increases or concomitant diuretic use may cause severe hypotension.

Watch for angioedema, especially after first dose.
• Stay alert for signs and symptoms of infection, particularly EENT and respiratory infections.
• Monitor potassium level. Watch for signs and symptoms of hyperkalemia.
• Monitor liver and kidney function tests before and during therapy.

In black patients, watch closely for angioedema and monitor drug efficacy. Monotherapy may be less effective in these patients.

Patient teaching

• Tell patient to take at same time each day, with or without food.

Instruct patient to stop using drug and contact prescriber immediately if hoarseness or difficulty swallowing or breathing occurs.
• Tell patient to avoid excessive perspiration or decreased fluid intake, which may cause symptomatic blood pressure drop. Inform him that vomiting or diarrhea also may lower blood pressure.
• Tell patient to report signs and symptoms of infection.
• Advise patient not to use potassium-containing salt substitutes.

Caution female patient of child-bearing age to contact prescriber immediately if she suspects pregnancy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.

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References in periodicals archive ?
Tenders invited for Tab perindopril erbumine 4 mg & amlodipine besilate 5 mg
Summary: The present study was carried out to prepare different combinations of Perindopril Erbumine with different polymers like Hydroxy propyl methyl cellulose Hydroxy propyl methyl cellulose K4M Hydroxy propyl methyl cellulose K15M Xanthan gum and Ethyl cellulose thereby to determine any possible interactions between Perindopril erbumine and polymers.
Keywords: Perindopril erbumine Fourier Transform Infrared (FTIR) Spectroscopy Hydroxy propyl methyl cellulose Xanthan gum Ethyl cellulose.
Perindopril erbumine (PE) is the tert- butylamine salt of perindopril the ethyl ester of a non-sulfhydryl an angiotensin converting enzyme (ACE) inhibitor that is used in the treatment of mild to moderate hypertension.
According to IMS, annual total sales of Perindopril Erbumine tablets, two mg, four mg and eight mg, at Average Wholesale Price were around USD3.
Last year Roxane Labs received Food and Drug Administration approvals for 18 medications and launched the following new products: levetiracetam tablets and oral solution (for epilepsy seizures), methadone diskets and oral concentrate (for opioid addiction), mycophenolate mofetil tablets and capsules (for organ anti-rejection), risperidone oral solution (for schizophrenia), galantamine oral solution (for dementia), morphine sulfate oral solution (for acute or chronic pain), buprenorphine sublingual tablets (for opioid dependence) and perindopril erbumine tablets (for coronary artery/hypertension).
According to IMS, annual total sales of Perindopril Erbumine Tablets, 2 mg, 4 mg and 8 mg, at Average Wholesale Price (AWP) were approximately USD3.
Lupin has received the tentative approval for its abbreviated new drug applications for memantine hydrochloride tablets in 5-mg and 10-mg strengths, and been given the nod from the FDA to market perindopril erbumine tablets in strengths of 2 mg, 4 mg and 8 mg.
Perindopril erbumine is used in treatment of stage I or II hypertension, congestive heart failure and left ventricular dysfunction after myocardial infarction.
Tenders are invited for Each Tab Cap Contains Perindopril Perindopril Erbumine 4 Mg Plus Amlodipine 5 Mg Tab In Strip/Blister Pack Only.