Betafix Plus 2.5 mg + 6.25mg Tablet: Each tablet contains Bisoprolol Fumarate + Hydrochlorothiazide 2.5 mg + 6.25mg.
Betafix Plus 5 mg + 6.25 mg Tablet: Each tablet contains Bisoprolol Fumarate + Hydrochlorothiazide 5 mg + 6.25 mg.
Description:
Bisoprolol blocks the action of the sympathetic nervous system on the heart by blocking the heart’s beta-1 adrenergic receptors. Bisoprolol reduces the heart rate & force of contraction of the heart whereas Hydrochlorothiazide affects renal tubular mechanisms of electrolyte reabsorption and increase excretion of sodium & chloride in approximately equivalent amounts, thus lowers blood pressure.
PHARMACOLOGY:
Bisoprolol and Amlodipine combination increases the antihypertensive and anti-anginal efficacy through the complementary mechanisms of action of the two active compounds: the vasoselective effect of Amlodipine (which decreases peripheral resistance) and the cardioselective beta-blocker Bisoprolol (which decreases cardiac output).
The combination of Bisoprolol and Amlodipine is indicated for the treatment of hypertension as substitution therapy in patients adequately controlled with the individual products given concurrently at the same dose levels as in the combination but as separate tablets.
The recommended daily dose is one tablet, taken with or without food. The dose may be increased if the desired therapeutic effect is not achieved.
Centrally Acting Antihypertensive Drugs: Concomitant use with Bisoprolol may lead to a reduction in heart rate and cardiac output, as well as vasodilation.
CYP3A4 Inhibitors: Strong or moderate CYP3A4 inhibitors can increase plasma Amlodipine concentrations to a clinically relevant extent.
Anesthetic Agents: The combination with Bisoprolol may reduce reflex tachycardia and increase the risk of hypotension.
Cardiac Glycosides (Digitalis): Concurrent use may reduce heart rate or prolong atrioventricular conduction time.
The Bisoprolol & Amlodipine combination is contraindicated in patients with acute heart failure, high-grade aortic stenosis, cardiogenic shock, second or third-degree AV block, sick sinus syndrome, slowed heart rate, symptomatic bradycardia, symptomatic hypotension, severe bronchial asthma, and hypersensitivity to Bisoprolol, Amlodipine, or any of the excipients.
Common side effects include headache, drowsiness, dizziness, and bradycardia.
Overdose:
The most common signs expected with an overdose of Bisoprolol & Amlodipine are bradycardia, hypotension, bronchospasm, peripheral vasodilation, and reflex tachycardia.
USE IN PREGNANCY & LACTATION:
Pregnancy: The Bisoprolol & Amlodipine combination is not recommended during pregnancy unless clearly necessary.
Nursing Mothers: It is unknown whether Bisoprolol or Amlodipine is excreted in human milk; therefore, caution is advised.
USE IN CHILDREN & GERIATRIC PATIENTS:
Children: The safety and effectiveness of this combination in pediatric patients have not been established.
Geriatric Patients: No dosage adjustment is required; however, caution is advised when increasing the dose.
Centrally Acting Antihypertensive Drugs (e.g., Clonidine, Methyldopa, Moxonidine, Rilmenidine): Concomitant use of these drugs with Bisoprolol may lead to a reduction in heart rate and cardiac output as well as vasodilation.
CYP3A4 Inhibitors: Concomitant use of Amlodipine with strong or moderate CYP3A4 inhibitors (e.g., protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil, or diltiazem) may significantly increase plasma concentrations of Amlodipine.
Anesthetic Agents: When combined with Bisoprolol, reflex tachycardia may be attenuated, and the risk of hypotension may increase.
Cardiac Glycosides (Digitalis): Concomitant use with Bisoprolol may lead to a reduction in heart rate or an increase in atrioventricular conduction time.
Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.
Medicine: Keep out of reach of children.