Olmetor AM 5 mg+40 mg (Tablet)

Indications

• Treatment of hypertension alone or with other antihypertensive agents
• Initial therapy for patients needing multiple antihypertensive agents
• Customized therapy based on baseline blood pressure and patient's risk

Pharmacology

• Amlodipine as a dihydropyridine calcium channel blocker
• Amlodipine's effect on vascular and cardiac muscle cells
• Amlodipine as a peripheral arterial vasodilator
• Olmesartan Medoxomil's blocking of vasoconstrictor and aldosterone-secreting effects of angiotensin II
• Inhibition of angiotensin-converting enzyme (ACE) by Olmesartan Medoxomil

Dosage & Administration

• Individual titration of components for patients on Amlodipine and Olmesartan Medoxomil
• Possibility of increased dosage of Amlodipine, Olmesartan Medoxomil, or both
• Recommended starting dose of Amlodipine for elderly patients
• Initiation with 5/20 mg once daily and titration to a maximum of 10/40 mg once daily
• Not recommended initial therapy with 5/20 mg combination in patients >75 years old

Interaction

• Possible attenuation of antihypertensive effect by NSAIDs including selective COX-2 inhibitors
• Need for close monitoring of blood pressure, renal function, and electrolytes in patients on combination therapy

Contraindications

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

Side Effects

• Common side effects such as peripheral edema, headache, flushing, and dizziness
• Potential to cause sprue-like enteropathy

Pregnancy & Lactation

• Pregnancy Category D, not recommended in 2nd and 3rd trimester
• Need for discontinuation of the combination when pregnancy is detected
• Unknown excretion of Olmesartan and Amlodipine in human milk

Precautions & Warnings

• Caution required in volume- or salt-depleted patients
• Risks of vasodilation in patients with severe aortic stenosis
• Possibility of increased angina or acute Ml in patients with severe obstructive coronary artery disease

Use in Special Populations

• Lack of established safety and effectiveness in pediatric patients
• No overall differences observed in safety or effectiveness for subjects 65 years of age or older
• No studies in patients with renal impairment
• Not recommended for hepatically impaired patients

Overdose Effects

• No information on overdosage in humans

Therapeutic Class

• Combined antihypertensive preparations

Storage Conditions

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

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