Betabis-A 2.5/5 mg Tablet, 1 strip

Betabis-A 2.5/5 mg Tablet, 1 strip

COMPOSITION

BetabisTM-A 2.5/5: Each film-coated tablet contains Bisoprolol Fumarate USP 2.5 mg & Amlodipine Besilate BP equivalent to Amlodipine 5 mg.

PHARMACOLOGY

BetabisTM-A is a fixed-dose combination of Bisoprolol and Amlodipine. Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscles. It has greater affinity towards vascular smooth muscles than on cardiac muscles. Amlodipine is a peripheral vasodilator that acts directly on vascular smooth muscles to cause a reduction in peripheral vascular resistance and thus reduces blood pressure. Bisoprolol is a cardioselective beta (β1) blocker without intrinsic sympathomimetic activity in its therapeutic dosage range. This combination allows increasing the antihypertensive and anti-anginal efficacy by complementary mechanism of actions of the two active compounds..

INDICATION

BetabisTM-A (Bisoprolol & Amlodipine combination) is indicated for the treatment of hypertension and angina pectoris. It is also indicated for the treatment of hypertension as substitution therapy in patients adequately controlled or not controlled with the individual products given concurrently at the same doses level as in the combination, but as separate tablets. It is also indicated for those patients with angina pectoris and hypertension as co-existing diseases.

DOSAGE & ADMINISTRATION

Route of Administration: BetabisTM-A needs to be taken orally. The usual starting dose of BetabisTM-A is one tablet daily with or without food. If the desired therapeutic effect cannot be achieved, the dose may be increased. The dose however should be individualized.

OR AS DIRECTED BY THE PHYSICIAN.

CONTRAINDICATION

This combination is usually well-tolerated. But it is contraindicated for patients with cardiogenic shock, high grade aortic stenosis, sinoatrial block, symptomatic bradycardia and symptomatic hypotension.

WARNINGS AND PRECAUTIONS

Bronchospasm: The combination should be used with caution in patients with airway obstruction.

For Renal Impairment: No dose adjustment is required for patients with mild to moderate renal impairment. In case of severe renal impairment (creatinine clearance <20 mL/min), the daily dose must not exceed 10 mg. For Hepatic Impairment: In case of severe hepatic impairment, the daily dose must not exceed 10 mg.

SIDE EFFECTS

Common side effects: Headache, drowsiness, dizziness, somnolence, palpitations, flushing, feeling of coldness or numbness, nausea, vomiting, diarrhea, constipation, abdominal pain, edema and fatigue. Rare side effects: Bradycardia, dyspnea, syncope, insomnia, mood changes, depression, sleep disorder , tremor, hypotension, drymouth, alopecia, chest pain, dyspepsia, allergic reactions, night mare, hallucination, confusion etc.

USE IN PREGNANCY AND LACTATION

In Pregnancy: There are no adequate and well-controlled studies in pregnant women. This combination should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In Lactation: This combination should be stopped during breast feeding.

USE IN CHILDREN & GERIATRIC PATIENTS

In Children: Safety and effectiveness in paediatric patients have not been established. In Geriatric Patilents: No dosage adjustment is required. But caution is advised when the dose is increased.

DRUG INTERACTION

With Medicines:

CYP3A4 Inhibitors: Concomitant use of Amlodipine with strong or moderate CYP3A4 Inhibitors (e. g. Protease Inhibitors, Verapamil or Diltiazem) can be expected to increase the plasma concentrations of Amlodipine.

Insulin & Oral Antidiabetic Drugs: In combination of Bisoprolol with these drugs, intensification of blood sugar lowering effect may occur.

Centrally Acting Antihypertensive Drugs : Concomitant use of these drugs (e.g. Clonidine, Methyldopa, Moxonidine, Rilmenidine) with Bisoprolol may lead to reduction

of heart rate and cardiac output, as well as to vasodilation. Anesthetic Agents: In combination with Bisoprolol, the reflex tachycardia may be attenuated and the risk of hypotension may be increased. Cardiac glycosides: Concomitant use of these drugs (e.g. Digitalis) with Bisoprolol may lead to a reduction of heart rate or an increase of atrio-ventricular conduction time. With foods & others: No food interaction with this combination.

OVERDOSE

The most common signs expected with overdose of Bisoprolol & Amlodipine combination are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency, hypoglycemia, peripheral vasodilation and possibly reflex tachycardia.

STORAGE

Store below 300  C and in dry place, protected from light. Keep all medicines out of reach of children.

PACKING

BetabisTM-A 2.5/5 : Each box contains 3X10 tablets in Alu-Alu blister strips