Generic

Amlodipine Besilate + Olmesartan Medoxomil

Indications

Calnor is indicated for the treatment of hypertension, alone or with other antihypertensive agents. Calnor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Pharmacology

Amlodipine is a dihydropyridine calcium channel blocker that prevents calcium ions from crossing the blood-brain barrier and entering vascular smooth muscle and cardiac muscle. Compared to cardiac muscle cells, amlodipine has a stronger effect on vascular smooth muscle cells. Amlodipine is a peripheral artery vasodilator that reduces peripheral vascular resistance and blood pressure by acting directly on vascular smooth muscle.

Angiotensin II is a powerful vasoconstrictor, the principal vasoactive hormone of the Renin-angiotensin system, and an essential component in the pathogenesis of hypertension. It is generated from angiotensin I in a mechanism catalyzed by angiotensin-converting enzyme (ACE). It also causes the adrenal cortex to secrete more aldosterone.

By specifically blocking angiotensin II’s binding to the AT1 receptor located in numerous tissues, Olmesartan Medoxomil reduces the vasoconstrictor and aldosterone-secreting effects of angiotensin II (e.g. vascular smooth muscle, adrenal gland). Olmesartan Medoxomil is a reversible, competitive AT1 receptor inhibitor, according to in vitro binding tests.

Dosage and administration

General considerations

Maximum antihypertensive effects are attained within 2 weeks. Abecab® may be taken with or without food. Calnor may be administered with other antihypertensive agents. Dosage may be increased after 2 weeks. The maximum recommended dose of Abecab® is 2 tablets (10/40 mg) once daily.

Initial therapy

The usual starting dose of Abecab® is one tablet (5/20 mg) once daily. Depending on the blood pressure response, the dose may be titrated at intervals of 1-2 weeks to two tablets of Calnor (10/40 mg) once daily.

Replacement therapy

Calnor may be substituted for its individually titrated components. When substituting for individual components, the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.

Add-on Therapy

Calnor may be used to provide additional blood pressure lowering for patients not adequately controlled with Amlodipine (or another dihydropyridine calcium channel blocker) alone or with Olmesartan Medoxomil (or another Angiotensin receptor blocker) alone.

Elderly patients

No dosage adjustment is necessary in elderly patients ≥ 65 years age.

Patients with hepatic impairment Initial therapy with Calnor is not recommended in patient’s ≥75 years and in patients with hepatic impairment.

Interaction

In vitro data indicate that Amlodipine has no effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin. No significant drug interactions were reported when Olmesartan was co-administered with digoxin or warfarin.

Contraindications

Combination of Amlodipine and Olmesartan is contraindicated in patients who are hypersensitive to any component of this product or to any of its ingredients.

Side Effects

The overall incidence of side effects on therapy with Amlodipine and Olmesartan combination was similar to that seen with corresponding doses of the individual components and to placebo. The common side effects include edema, hypotension, orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, and nocturia.

Pregnancy and Lactation

Olmesartan medoxomil: Pregnancy Categories C (first trimester) and D (second and third trimesters). Amlodipine: There are no adequate and well-controlled studies in pregnant women. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When pregnancy is detected, discontinue this Amlodipine and Olmesartan combination as soon as possible. It is not known whether the Amlodipine or Olmesartan Medoxomil is excreted in human milk.

Precautions & Warnings

Caution should be exercised in patients with volume or salt depletion, severe aortic stenosis,severe obstructive coronary artery disease, congestive heart failure, impaired renal function, and hepatic impairment. No initial dosage adjustment is recommended for patients with moderate to marked renal impairment (Creatinine clearance).

Therapeutic Class

Combined antihypertensive preparations

Storage Conditions

Do not store at temperatures above 30°C. Keep out of the reach of youngsters and away from light.

Pharmaceutical Name

Opsonin Pharma Ltd.