This product is a combination of two antihypertensive drugs: Amlodipine is a dihydropyridine calcium antagonist and Olmesartan Medoxomil is an angiotensin-II receptor blocker. The Amlodipine component inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle and the Olmesartan Medoxomil component blocks the vasoconstrictor effects of angiotensin-II.
Each film coated tablet contains Amlodipine Besylate equivalent to Amlodipine 5 mg and Olmesartan Medoxomil 20 mg
Initial Therapy: The usual starting dose of Duovas is 5/20 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of 10/40 mg once daily as needed to control blood pressure. Duovas may be taken with or without food. Duovas may be administered with other antihypertensive agents. Initial therapy with this combination product is not recommended in patient ≥ 75 years old or with hepatic impairment. Replacement Therapy: Duovas 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: Duovas may be used to provide additional blood pressure lowering for patients not adequately controlled with Amlodipine (or another dihydropyridine calcium channel antagonist) alone or with Olmesartan Medoxomil (or another angiotensin II receptor blocker) alone.
The reported adverse reactions were generally mild and seldom led to discontinuation of treatment. The most common side effects include edema, dizziness, flushing and palpitation. Other side effects may include vomiting, diarrhoea, rhabdomyolysis, alopecia, pruritus, urticaria etc.
Aliskiren is contraindicated with Duovas in patients with diabetes.
Pregnancy: When pregnancy is detected, discontinue this combination product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
The pharmacokinetics of Amlodipine and Olmesartan Medoxomil are not altered when the drugs are co-administered. No drug interaction studies have been conducted with Amlodipine and Olmesartan combination tablet and other drugs, although studies have been conducted with the individual Amlodipine and Olmesartan Medoxomil components and no significant drug interactions have been observed.
Over dosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. If massive overdose should occur, active cardiac and respiratory monitoring should be instituted.
Store in a cool and dry place, protect from light and moisture.
Keep out of the reach of children.
Each box contains 3 Alu-Alu blister packs of 14 film coated tablets.