Abecab^®

Abecab ® is a combination of Amlodipine Besilate & Olmesartan Medoxomil. Amlodipine Besilate is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) and Olmesartan Medoxomil is an angiotensin II receptor blocker. Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle and Olmesartan Medoxomil blocks the vasoconstrictor effects of angiotensin II

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Abecab ® is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Abecab may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals

Route of administration: Abecab® tablet is taken in oral route. The usual starting dose of Abecab ® is 5/20 mg once daily. The dose can
be increased after 1 to 2 weeks of therapy to a maximum dose of one 10/40 mg tablet once daily as needed to control blood pressure.

Elderly: Initial therapy with Abecab ® is not recommended in patients ≥75 years old.

Hepatic impairment: Initial therapy with Abecab ® is not recommended in patients with severe hepatic impairment

Pregnancy: It can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue it as soon as possible.
Consider alternative antihypertensive therapy during pregnancy.

Lactation: Amlodipine is present in human milk. Because of the potential for adverse effects on the nursing infant, breastfeeding is not
recommended during treatment with this combination.

Use in children and adolescents
The safety and effectiveness of this combination in pediatric patients have not been established

Hypotension should be anticipated in volume or salt depleted patients with treatment initiation. Treatment should be started under close supervision.
Increased angina or myocardial infarction may occur upon dose initiation or increase. Since amlodipine is extensively metabolized by the liver,
titrate slowly when administering to patients with severe hepatic impairment. Changes in renal function may occur. Sprue-like enteropathy
has been reported. Monitor serum electrolytes periodically. 

Most common side effects are edema, hypotension, orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, nocturia, dizziness and flushing.

This combination is contraindicated in patients with known hypersensitivity to amlodipine, olmesartan or any other components of this product. Co-administration of aliskiren with this combination in patients with diabetes is also contraindicated

Drug interaction with medication: Amlodipine may increase the systemic exposure of simvastatin, cyclosporine or tacrolimus when co-administered. Co-administration of amlodipine with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Co-administration of olmesartan medoxomil with nonsteroidal anti-inflammatory drugs (NSAIDs) may lead to increased risk of renal impairment and loss of antihypertensive effect. Dual blockade of the renin angiotensin system (RAS) with angiotensin receptor blockers, ACE inhibitors or aliskiren is associated with increased risks of hypotension, hyperkalemia and changes in renal function (including acute renal failure) compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on this drug and other agents that affect the RAS. Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration with this combination.

Drug interaction with food and others: Not applicable.

There is no information on overdose with this combination in humans. If massive overdose occurs, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. If symptomatic hypotension occurs, supportive treatment should be initiated

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Store in a cool and dry place. Protect from light.