Indications

Betafix tablets are indicated for the treatment of:

• Hypertension (high blood pressure)
• Angina
• Moderate to severe heart failure Betafix is not intended for the emergency treatment of hypertensive crises.

Pharmacology

Bisoprolol Fumarate is a highly selective β1​-blocker. It works by selectively blocking β1​ adrenergic receptors in the heart and vascular smooth muscle, which decreases heart rate and cardiac output, leading to a reduction in arterial blood pressure. Unlike some other beta-blockers, Bisoprolol does not have an adverse effect on cholesterol fractions, including the cardioprotective HDL-cholesterol, during long-term therapy. The drug's pharmacokinetic properties, including high absorption and a half-life of 10-12 hours, make it suitable for a once-daily dose.

Dosage & Administration

• Adults: For mild to moderate hypertension, the dosage should be individualized. The usual starting dose is 5 mg once daily. If the response is insufficient, the dose can be increased to 10 mg and, if necessary, to 20 mg once daily. Doses should be titrated at intervals of at least 2 weeks. Doses above 20 mg daily provide minimal additional benefit.
• Children: The safety and effectiveness of Betafix in children have not been established.
• Patients with Renal or Hepatic Impairment: The initial daily dose should be 5 mg. Dose titration should be done with caution due to the possibility of drug accumulation.
• Geriatrics: Dose adjustment is usually not necessary unless there is significant renal or hepatic dysfunction.

Interaction

• Other β-blocking Agents: Betafix should not be used in combination with other β-blockers.
• Catecholamine-Depleting Drugs: Patients taking these drugs (e.g., reserpine) should be closely monitored as Betafix can cause an excessive reduction in sympathetic activity.
• Centrally Active Antihypertensive Agents (e.g., clonidine): Beta-blockers may worsen the rebound hypertension that can occur after discontinuing clonidine.
• Calcium Channel Blockers: Co-administration with certain calcium channel blockers (e.g., verapamil, diltiazem) can lead to severe hypotension, bradycardia, and cardiac failure, particularly in patients with heart function or conduction issues.

Contraindications

Betafix is contraindicated in patients with cardiogenic shock, overt heart failure, second or third-degree A-V block, right ventricular failure secondary to pulmonary hypertension, and sinus bradycardia.

Side Effects

Common side effects include fatigue, dizziness, headache, gastrointestinal disturbances (nausea, vomiting, diarrhea, constipation, or abdominal pain), cold or numb hands and feet, muscle weakness or cramps, and a slower-than-normal heart rate. In patients with asthma or COPD, it may cause breathing difficulties due to bronchospasm.

Pregnancy & Lactation

This drug is in Pregnancy Category C. Animal studies showed fetotoxic effects, but there are no studies in pregnant women. Betafix should be used during pregnancy only if the potential benefits outweigh the potential risks to the fetus. Small amounts of bisoprolol have been found in the milk of lactating rats. It is not known if the drug is excreted in human milk, so mothers should stop nursing if use of Betafix is considered essential.

Precautions & Warnings

Caution should be used when adjusting the dose in patients with renal or hepatic impairment. Patients with a history of severe anaphylactic reactions may be more reactive to allergens while taking beta-blockers and may not respond to the usual doses of epinephrine used to treat allergic reactions.

Therapeutic Class

Betafix is an anti-adrenergic agent, specifically a beta-adrenoceptor blocking drug, or beta-blocker.

Storage Conditions

Keep in a dry place, away from light and heat. Keep out of the reach of children.