Bizoran 5/20

Generic

Amlodipine Besilate + Olmesartan Medoxomil

Indications

It is suitable for treating hypertension alone or together with other antihypertensive drugs to lower blood pressure. The combination drug is suitable for the initial treatment of patients who may require multiple antihypertensive drugs to achieve blood pressure goals. The decision to use combination therapy as the initial treatment should be individualized and formulated based on factors such as baseline blood pressure, target goals, and the increased likelihood of combination therapy to achieve goals compared to monotherapy. Personal blood pressure goals may vary depending on the patient's risk.

Pharmacology

Amlodipine is a dihydropyridine calcium channel blocker, which can inhibit calcium ions from transmembrane into vascular smooth muscle and myocardium. The effect of amlodipine on vascular smooth muscle cells is greater than that on cardiomyocytes. Amlodipine is a peripheral arterial vasodilator that directly acts on vascular smooth muscle, resulting in a decrease in peripheral vascular resistance and blood pressure. 
Angiotensin II is formed by angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE). It is an effective vasoconstrictor and the main vasoactive hormone of the renin-angiotensin system. It is also a high blood pressure An important part of pathophysiology. It also stimulates the adrenal cortex to secrete aldosterone. 
Olmesartan medoxomil blocks the vasoconstriction and aldosterone secretion of angiotensin II by selectively blocking the binding of angiotensin II to AT1 receptors found in many tissues (such as vascular smooth muscle, adrenal glands). In vitro binding studies have shown that Olmesartan Medoxomil is a reversible competitive inhibitor of AT1 receptor. Olmesartan medoxomil does not inhibit ACE (kinase II, an enzyme that converts angiotensin I into angiotensin II and breaks down bradykinin).

Dosage & Administration

Substitute individually titrated components for patients on Bizoran. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.

Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.

Interaction

The antihypertensive effects of angiotensin II receptor antagonists (including olmesartan medoxomil) can be attenuated with non-steroidal anti-inflammatory drugs (including selective COX2 inhibitors). Patients on combination therapy and other medications that affect RAS should be closely monitored for blood pressure, kidney function, and electrolytes.

Contraindications

Diabetes patients cannot be combined with Aliskiren.

Side-Effects

The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause intestinal problems called Spruelike bowel disease.

Pregnancy & Lactation

Pregnancy category D. The combination of amlodipine and olmesartan medoxomil should not be used in the second and third trimesters as it can cause fetal death. When pregnancy is detected, this combination should be stopped as soon as possible. It is not clear whether olmesartan and amlodipine are excreted in human milk. Due to possible adverse effects in breastfeeding babies, the decision should be based on the importance of the drug to the mother whether to stop breastfeeding or to stop taking the drug.

Precautions & Warnings

The combination of amlodipine and olmesartan medoxomil should be used with caution because of the risk of volume hypotension or salt depletion. Vasodilation in patients with severe aortic stenosis. Increased frequency, duration, or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.

Therapeutic Class

Combined  antihypertensive  preparations

Storage Conditions

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

Pharmaceutical Name

Beximco Pharmaceuticals Ltd.

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