Duoblock 5/20

Generic

Amlodipine Besilate + Olmesartan Medoxomil

Indications

To lower blood pressure, it's used to treat hypertension alone or in combination with other antihypertensive drugs. This combination medicine is recommended as the first treatment for patients who are likely to require numerous antihypertensive medications to meet their blood pressure objectives. Considerations such as baseline blood pressure, the desired goal, and the incremental likelihood of meeting the goal with a combination versus monotherapy should all be considered when deciding whether to employ a combination as initial therapy. Depending on the patient's risk, blood pressure objectives may differ.

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. Olmesartan Medoxomil has no effect on ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).

Dosage and Administration

Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. 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

NSAIDs such as selective COX-2 inhibitors may reduce the antihypertensive impact of angiotensin II receptor antagonists like Olmesartan Medoxomil. In patients receiving combination treatment or other medications that influence the RAS, blood pressure, renal function, and electrolytes should be continuously monitored.

Contraindications

Cannot be co-administered with Aliskiren in patients with diabetes.

Side Effects

The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.

Pregnancy & Lactation

D is the pregnancy category. The combination of amlodipine and olmesartan medoxomil should not be used in the second or third trimester since it can cause fetal mortality. This combination should be stopped as soon as possible if pregnancy is detected. Olmesartan and Amlodipine are not known to be excreted in human milk. Because of the risk of harm to the nursing infant, a decision should be taken on whether to stop breastfeeding or stop taking the medicine, taking into account the drug's importance to the mother.

Precautions & Warnings

• Because of the potential of hypotension in volume- or salt-depleted individuals, the combination of Amlodipine and Olmesartan Medoxomil should be used with caution.
• Patients with severe aortic stenosis benefit from vasodilation.
• Angina or acute Ml with a higher frequency, length, or severity in patients with significant 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

Aristopharma Ltd.

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