Pharmacology of Betafix 5 Tablet
Absorption: Rapid and almost complete.
Distribution: Widely; highest concentrations in heart, liver, lungs, and saliva.
Metabolism: Extensively hepatic; significant first-pass effect (-20%).
Excretion: Urine (50% as unchanged drug, remainder as inactive metabolites); feces (<2%).
Dosage & Administration of Betafix 5 Tablet
Hypertension: The dose of Bisoprolol must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose. If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily.
Angina: Usually 10 mg once daily (5 mg may be adequate in some patients) max 20 mg daily.
Heart Failure: Initially 1.25 mg once daily (in the morning) for 1 week then, if well tolerated, increased to 2.5 mg once daily for 1 week, then 3.75 mg once daily for 1 week, then 5 mg once daily for 4 weeks, then- 7.5 mg once daily for 4 weeks, then 10 mg once daily maximum 10 mg daily.
Interactions of Betafix 5 Tablet
Bisoprolol should not be combined with other ß-blocking agents.
Bisoprolol is contraindicated in patients with cardiogenic shock, overt cardiac failure, second- or third-degree AV block, and marked sinus bradycardia.
Side Effects of Betafix 5 Tablet
Fatigue, dizziness, headache, disturbances of the gut such as nausea, vomiting, diarrhoea, constipation or abdominal pain, cold or numb extremities, e.g., hands and feet, muscle weakness or cramps, slower than normal heart beat (bradycardia), worsening of heart failure, sleep disturbance, depression, breathing difficulties due to a narrowing of the airways (bronchospasm) in people with asthma or COPD.
Pregnancy & Lactation
Pregnancy: Bisoprolol should not be used during pregnancy unless clearly necessary. If treatment with Bisoprolol is considered necessary, the uteroplacental blood flow and the foetal growth should be monitored. In case of harmful effects on pregnancy or the foetus, alternative treatment should be considered. The newborn infant must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days.
Precautions & Warnings
Impaired renal or hepatic function: Use caution in adjusting the dose of Bisoprolol in patients with renal or hepatic impairment. Risk of anaphylactic reaction: While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
Anti-adrenergic agent (Beta blockers), Beta-adrenoceptor blocking drugs, Beta-blockers
Store at temperature not exceeding 30 0 C in a dry place. Protect from light and moisture.