Coversyl

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.

perindopril

(per-in-do-pril) ,

Aceon

(trade name),

Coversyl

(trade name)

Classification

Therapeutic: antihypertensives
Pharmacologic: ace inhibitors
Pregnancy Category: D

Indications

Alone or with other agents in the management of hypertension.Reduction of risk of death from cardiovascular causes or non-fatal myocardial infarction in patients with stable coronary artery disease.

Action

Angiotensin-converting enzyme (ACE) inhibitors block the conversion of angiotensin I to the vasoconstrictor angiotensin II. ACE inhibitors also prevent the degradation of bradykinin and other vasodilatory prostaglandins. ACE inhibitors also increase plasma renin levels and reduce aldosterone levels. Net result is systemic vasodilation.

Therapeutic effects

Lowering of BP in patients with hypertension.
Decreased risk of death from cardiovascular causes or myocardial infarction in patients with stable coronary artery disease.

Pharmacokinetics

Absorption: 25% bioavailability as perindoprilat following oral administration.
Distribution: Crosses the placenta; may enter breast milk.
Metabolism and Excretion: Converted by the liver to perindoprilat, the active metabolite; primarily excreted in urine.
Half-life: Perindoprilat: 3–10 hr (↑ in renal impairment).

Time/action profile (plasma concentrations)

ROUTEONSETPEAKDURATION
POwithin 1–2 hr3–7 hrup to 24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity; History of angioedema with previous use of ACE inhibitors; History of hereditary or idiopathic angioedema; Concurrent use with aliskiren in patients with diabetes or moderate-to-severe renal impairment (CCr <60 mL/min) Obstetric: Can cause injury or death of fetus – if pregnancy occurs, discontinue immediately. Lactation: Discontinue drug or use formula.
Use Cautiously in: Renal impairment, hypovolemia, hyponatremia, concurrent diuretic therapy (initial dosage ↓ recommended); genetic implication Black patients (monotherapy for hypertension less effective, may require additional therapy; higher risk of angioedema); Surgery/anesthesia (hypotension may be exaggerated); Women of childbearing potential; Pediatric: Safety not established Geriatric: Initial dosage ↓ recommended.
Exercise Extreme Caution in: Family history of angioedema.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache
  • weakness

Respiratory

  • cough (most frequent)

Cardiovascular

  • hypotension (most frequent)

Gastrointestinal

  • diarrhea
  • dyspepsia

Genitourinary

  • impaired renal function

Dermatologic

  • rashes

Fluid and Electrolyte

  • hyperkalemia

Musculoskeletal

  • back pain

Miscellaneous

  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

Excessive hypotension may occur with concurrent use of diuretics.Additive hypotension with other antihypertensives.↑ risk of hyperkalemia with concurrent use of potassium supplements,potassium-containing salt substitutes, and potassium-sparing diuretics.↑ risk of hyperkalemia, renal dysfunction, hypotension, and syncope with concurrent use of angiotensin II receptor antagonists or aliskiren ; avoid concurrent use with aliskiren in patients with diabetes or CCr <60 mL/minNSAIDs and selective COX-2 inhibitors may blunt the antihypertensive effect and ↑ the risk of renal dysfunction.May ↑ levels risk of toxicity of lithium.

Route/Dosage

Hypertension

Oral (Adults) 4 mg once daily, may be slowly ↑ up to 16 mg/day in 1–2 divided doses (should not exceed 8 mg/day in elderly patients) (initiate therapy at 2–4 mg/day (in 1–2 divided doses) in patients receiving diuretics).

Stable Coronary Artery Disease

Oral (Adults) 4 mg once daily for 2 wks, may be ↑, if tolerated, to 8 mg once daily. Elderly patients—2 mg once daily for 1 wk, may be ↑, if tolerated, to 4 mg once daily for 1 wk; then, ↑ as tolerated to 8 mg once daily.

Renal Impairment

Oral (Adults) CCr 30–60 ml/min—Initiate therapy at 2 mg once daily, may be slowly titrated up to 8 mg/day in 1–2 divided doses; CCr <30 ml/min—Not recommended.

Availability (generic available)

Tablets: 2 mg, 4 mg, 8 mg

Nursing implications

Nursing assessment

  • Monitor BP and pulse frequently during initial dose adjustment and periodically during therapy. Notify health care professional of significant changes.
  • Monitor frequency of prescription refills to determine compliance.
  • Assess patient for signs of angioedema (dyspnea, facial swelling).
  • Lab Test Considerations: Monitor renal function. May cause ↑ BUN and serum creatinine.
    • Monitor serum potassium periodically during therapy. May cause hyperkalemia.
    • Monitor CBC periodically during therapy in patients with collagen vascular disease and/or renal disease. May rarely cause ↓ hemoglobin and hematocrit as well as neutropenia and eosinophilia.
    • May cause ↑ AST, ALT, alkaline phosphatase, uric acid, and glucose.

Potential Nursing Diagnoses

Decreased cardiac output (Indications,  Side Effects)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)
Noncompliance (Patient/Family Teaching)

Implementation

  • Correct volume depletion, if possible, before initiation of therapy.

Patient/Family Teaching

  • Emphasize the importance of continuing to take medication as directed at the same time each day, even if feeling well. Take missed doses as soon as remembered but not if almost time for next dose. Do not double doses. Warn patient not to discontinue ACE inhibitor therapy unless directed by health care professional.
    • Caution patient to avoid salt substitutes containing potassium or foods containing high levels of potassium or sodium unless directed by health care professional (see ).
    • Caution patient to change positions slowly to minimize orthostatic hypotension. Use of alcohol, standing for long periods, exercising, and hot weather may increase orthostatic hypotension.
    • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any Rx, OTC, or herbal products, especially cough, cold, or allergy remedies.
    • May cause dizziness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
    • Advise patient to inform health care professional of medication regimen prior to treatment or surgery.
    • Instruct patient to notify health care professional if rash; mouth sores; sore throat; fever; swelling of hands or feet; irregular heartbeat; chest pain; dry cough; hoarseness; swelling of face, eyes, lips, or tongue; or if difficulty swallowing or breathing occurs. Persistent dry cough may occur and may not subside until medication is discontinued. Consult health care professional if cough becomes bothersome. Also notify health care professional if nausea, vomiting, or diarrhea occurs and continues.
    • Advise women of childbearing age to use contraception and notify health care professional of pregnancy is planned or suspected, or if breastfeeding.
    • Emphasize the importance of follow-up examinations to evaluate effectiveness of medication.
  • Hypertension: Encourage patient to comply with additional interventions for hypertension (weight reduction, low-sodium diet, discontinuation of smoking, moderation of alcohol consumption, regular exercise, and stress management). Medication controls but does not cure hypertension.
    • Instruct patient and family on correct technique for monitoring BP. Advise them to check BP at least weekly and to report significant changes to health care professional.

Evaluation/Desired Outcomes

  • Decrease in BP without appearance of excessive side effects.
  • Reduction in risk of death from cardiovascular causes and myocardial infarction in patients with stable coronary artery disease.

Coversyl

A brand name for PERINDOPRIL.
References in periodicals archive ?
A similar effect was seen with Coversyl, where only 46% identified perindopril, but 96% correctly described it as an angiotensinconverting enzyme inhibitor or antihypertensive agent.
Assess how Servier will perform in the face of growing generic competition facing its number one product, Coversyl
As a result of this we are able to produce true innovations which address unmet patient need and we are very proud of the heritage of the Coversyl family (the active ingredient of which is perindopril).
Perindopril 8 Mg With Amlodipine 5 Mg , Coversyl Am 8/5 In Strip Packing
List of products purchased online Cardiovascular and respiratory: Lipitor (Pfizer), Plavix (sanofi-aventis), Seretide (GSK), Coversyl (Servier), Micardis (Boehringer-Ingelheim), Spiriva (Boehringer-Ingelheim) Mental health: Zyprexa (Lilly), Efexor (Wyeth), Risperdal (J&J) Alzheimer's disease: Aricept (Pfizer), Reminyl (Shire) Men's health: Cialis (Lilly), Levitra (Bayer-Schering), Viagra (Pfizer), Propecia (MSD) Other: Zoton (Wyeth), Reductil (Abbott), Mirapex (Boehringer-Ingelheim)
1) List of products purchased online Cardiovascular and respiratory: Lipitor (Pfizer), Plavix (sanofi- aventis), Seretide (GSK), Coversyl (Servier), Micardis (Boehringer- Ingelheim), Spiriva (Boehringer-Ingelheim) Mental Health: Zyprexa (Lilly), Efexor (Wyeth), Risperdal (J&J) Alzheimer's disease: Aricept (Pfizer), Reminyl (Shire) Men's health: Cialis (Lilly), Levitra (Bayer-Schering), Viagra (Pfizer), Propecia (MSD) Other: Zoton (Wyeth), Reductil (Abbott), Mirapex (Boehringer-Ingelheim
As regards products, despite a decline in sales of Durotep, an analgesic for persistent cancer pain due to the ending of a joint sales contract, strong sales were maintained by Allelock, an antiallergic agent, Depakene, an anti-epileptic agent, and Patanol, an antiallergic ophthalmic solution, while sales of Coversyl, an ACE inhibitor for treatment of hypertension, that commenced in April, 2008, also performed well and contributed to growth in sales.
Perindopril / indapamide combinations are registered under the following trade names: Preterax, BiPreterax, Preterax Forte, Biprel, Noliprel, Noliprel Forte, Prelectal, Prelectal forte, Predonium, Noliprel, Coversyl Plus, Coversyl Comp, Coversum Combi, Armix Comb, Prestarium Combi, and Prestarium Plus.
Learn how, Coversyl, the company's biggest growth driver over 2001 to 2007 will become its biggest growth resistor during the forecast period
For the investigators, given the evidence from ASCOT-BPLA and previous trials, it seems that the beneficial effect of the amlodipine/perindopril regimen is largely a composition of the protective effect of Coversyl, amlodipine playing a neutral role, whereas atenolol and thiazide have adverse effects.
The EMEA gave the green light to approve the new indication for Coversyl based on the results of EUROPA (The European Trial on Reduction of Cardiac Events with Perindopril in Stable Coronary Artery Disease), a landmark trial involving 12,218 patients with stable CAD and without heart failure which showed that Coversyl significantly cuts the risk of cardiovascular mortality and non-fatal MI by 20% compared to placebo (p=0.
As regards sales by product, sales of Durotep, an analgesic for persistent cancer pain declined, due to the ending of a joint sales contract, but strong sales were maintained by Allelock, an antiallergic agent, Patanol, an antiallergic ophthalmic solution and others, while sales of Coversyl, an ACE inhibitor for treatment of hypertension, that commenced in April, 2008, also performed well and contributed to growth in sales.