This combination is indicated for the management of hypertension, either as monotherapy or in combination with other antihypertensive agents to achieve better blood pressure control. It may also be used as an initial treatment option in patients who are likely to require multiple medications to reach their target blood pressure levels. The decision to initiate combination therapy should be individualized, considering factors such as baseline blood pressure, desired treatment goals, and the likelihood of achieving adequate control compared to single-drug therapy. Blood pressure targets may vary depending on the patient’s overall cardiovascular risk profile.

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the entry of calcium ions into vascular smooth muscle and cardiac muscle cells, with a greater effect on vascular smooth muscle. It acts as a peripheral arterial vasodilator, reducing vascular resistance and lowering blood pressure.

Angiotensin II, produced from angiotensin I via the action of angiotensin-converting enzyme (ACE), is a potent vasoconstrictor and a key component in the development of hypertension. It also stimulates the release of aldosterone from the adrenal cortex.

Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) that selectively inhibits the binding of angiotensin II to AT1 receptors found in vascular smooth muscle and adrenal glands. By blocking this pathway, it reduces vasoconstriction and aldosterone secretion. Olmesartan acts as a reversible and competitive inhibitor of the AT1 receptor and does not inhibit ACE or affect bradykinin metabolism.

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.

This combination should not be used together with aliskiren in patients with diabetes.

Common side effects include peripheral edema, headache, flushing, and dizziness. In rare cases, it may cause gastrointestinal conditions such as sprue-like enteropathy.

Pregnancy Category D. This combination should not be used during the second and third trimesters as it may cause fetal death. If pregnancy is detected, the medication should be discontinued immediately. It is not known whether olmesartan or amlodipine is excreted into human breast milk. Due to the potential risk to the infant, a decision should be made to either discontinue breastfeeding or stop the medication.

This combination should be used with caution in the following conditions:

• Risk of hypotension in patients with low blood volume or sodium depletion
• Vasodilation effects may worsen in patients with severe aortic stenosis
• Increased frequency, duration, or severity of angina or risk of acute myocardial infarction in patients with severe obstructive coronary artery disease

Pediatric Use: Safety and effectiveness in children have not been established.

Geriatric Use: No significant differences in safety or effectiveness have been observed between elderly and younger patients.

Renal Impairment: No specific studies are available in patients with renal impairment.

Hepatic Impairment: Initial therapy is not recommended in patients with hepatic dysfunction.

There is no available data regarding overdose in humans.

Combined antihypertensive preparations

Store below 30°C. Protect from light and keep out of reach of children.