Abecab^®

Abecab is a combination of Amlodipine Besilate & Olmesartan Medoxoml. Amlcxiipine Besilate is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel and Olmesartan is an angiotensin II receptor blocker. Ammpine inhibits the transmembrane influx of calcium ions into vascular smooth musde and cardiac musde and Olmesartan Medoxomil uocks the vasownstrictor effects of angiotensin II.

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Abecab is indicated for the treatment of done or with Other antihypertensive agents, to lower blood pressure. Abecab may also used as initial therapy in patients who are likely to need antihypertensive agents to achieve their 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 after 1 to 2 weeks Of therapy to a maximum of one 10/40 tablet daly as to control pressure.

Elderly: Initial therapy with Abecab is not in paients >=75 years old.

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

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

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

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

Hypotension should be anticipated in volume or salt patients with treatment initiation. Treatment should be started under dose supervision. Increased angina or myocardial infarction may 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 Sprue-like enteropathy has been Monitor serum ebctrolytes periodially.

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

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

Drug interaction with medication: Amlodipine may increase the systemic exposure of simvastatin, cydosporine or tacrolimus when Co-administration of ambdipine 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 risk of renal impairment and loss of effect. Dual blockade of the renin-angiotensin system (RAS) with angiotensin blockers, ACE inhibitors or aliskiren is with 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 pressure, renal function and electrolytes in patients on this drug and other agents that affect the RAS. Concurrent administration of bile acid agent hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Increases in serum lithium concentrations and lithium toxicity have been during administration with this

Drug interaction with food and others: Not applicable.

There is no information on overdose with this 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 initiated.

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

Abecab 5/20 tablet: Each coated tablet Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Olmesartan Medoxomil USP 20 mg.
Abecab 5/40 tablet: Each tablet Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Olmesartan Medoxomil USP 40 mg.
Abecab 10/20 tablet: Each tablet Arnlodipine Besilate BP equivalent to Amlodipine 10 mg and Olmesartan Medoxomil USP 20 mg.
Abecab 10/40 tablet: Each tablet Arnlodipine Besilate BP equivalent to Amlodipine 10 mg and Olmesartan Medoxomil USP 40 mg.