Coveram Tablet 4 mg+5 mg

৳ 21.00

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Indications

Perindopril is an angiotensin converting enzyme inhibitor and amlodipine is a dihydropyridine calcium channel blocker, indicated for the treatment of hypertension to lower blood pressure:

  • In patients not adequately controlled with monotherapy.
  • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions

Therapeutic Class

Combined antihypertensive preparations

Pharmacology

Perindopril: Perindopril, a pro-drug, is hydrolyzed to perindoprilat, which inhibits ACE in humans and in animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of the inactive decapeptide, angiotensin I, to the vasoconstrictor substance angiotensin II. Angiotensin II is a potent peripheral vasoconstrictor, which stimulates aldosterone secretion by the adrenal cortex, and provides negative feedback on renin secretion. Inhibition of ACE results in decreased plasma angiotensin II, leading to decreased vasoconstriction, increased plasma renin activity and decreased aldosterone secretion. The latter results in diuresis and natriuresis and may be associated with an increase in serum potassium

Amlodipine: Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses.

Dosage & Administration

The recommended starting dose is 3.5/2.5 mg once daily. Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. The maximum recommended dose is 14/10 mg once daily

This combination may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. Consider use in patients unable to achieve adequate antihypertensive effect with amlodipine monotherapy because of dose-limiting peripheral edema caused by amlodipine

Administered as monotherapy, perindopril erbumine is an effective treatment for hypertension in once-daily doses ranging from 4 mg to 16 mg daily. Amlodipine is effective in once-daily doses of 5 mg and 10 mg. Adverse reactions related to perindopril are generally uncommon and independent of dose, while those related to amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter

Interaction

The pharmacokinetics of perindopril and amlodipine are not altered when the drugs are co-administered. No drug interaction studies have been conducted with Perindopril & Amlodipine, although studies have been conducted with
perindopril and amlodipine.

Contraindications

This tablets are contraindicated in patients with hereditary or idiopathic angioedema, with or without previous ACE inhibitor treatment, and in patients who are hypersensitive to perindopril, to any other ACE inhibitor, or to amlodipine. Do not co-administer aliskiren with ACE inhibitors, including this combination, in patients with diabetes.

Side Effects

The most common side effects are-

  • swelling of the feet, ankles, and hands
  • cough
  • headache
  • dizziness

Pregnancy & Lactation

Pregnancy Category D. 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. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue this combination as soon as possible

Nursing Mothers: It is not known whether perindopril or amlodipine is excreted in human milk, but radioactivity was detected in the milk of lactating rats following administration of perindopril. Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue this combination

Precautions

Anaphylactoid reactions, including angioedema (head, neck, or intestinal)

Myocardial infarction: Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Perindopril & Amlodipine, particularly in patients with severe obstructive coronary artery disease

Assess for hypotension and hyperkalemia

Monitor renal function during therapy

Use in Special Population

Dosage Adjustment in Renal Impairment: This is not recommended in patients with creatinine clearances <30 mL/min. For patients with creatinine clearance between 30 and 80 mL/min (mild or moderate renal impairment), do not exceed 7/5 mg

Monitoring in Elderly Patients (Over 65 Years of Age): Monitor blood pressure for up to two weeks following titrations at dosages above 7/5 mg in patients over 65 years of age

Pediatric Use: The safety and effectiveness of in pediatric patients have not been established.

Geriatric Use: The mean blood pressure effect of perindopril was somewhat smaller in patients over 60 years of age than in younger patients, although the difference was not significant. Plasma concentrations of both perindopril and perindoprilat in elderly patients (>65 years) are approximately twice those observed in younger patients. No adverse effects were clearly increased in older patients with the exception of dizziness and rash. Amlodipine is extensively metabolized in the liver. In the elderly, clearance of amlodipine is decreased with resulting increases in peak plasma levels, elimination half-life, and AUC.

Renal Impairment: Not recommended in patients with creatinine clearances <30 mL/min.

Storage Conditions

Store at 25°C. Protect from moisture. Dispense in tight container

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