Betafix 5

Indications of Betafix 5 Tablet

Betafix® (Bisoprolol) is indicated in the management of hypertension and in the treatment of angina and heart failure. It may be used alone or in combination with other antihypertensive agents.

 

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.

 

Contraindications

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.

 

Therapeutic Class

Anti adrenergic agent (Beta blockers), Beta-adrenoceptor blocking drugs, Beta-blockers

 

Storage Conditions

Store at temperature not exceeding 30 0 C in a dry place. Protect from light and moisture.

 

Pharmaceutical Name of Betafix 5 Tablet

Healthcare Pharmaceuticals Ltd

 

Generic of Betafix 5 Tablet

Bisoprolol Hemifumarate