Bisoprolol fumarate
Visa No.: 893110084324
Product: Biscapro 2,5
API: Bisoprolol fumarate
Product Category: Cardiovascular & Metabolism
Version approved leaflet: 406/QĐ-QLD_19/09/2017_159
INDICATIONS
Hypertension.
Angina pectoris.
Stable chronic heart failure associated with reduced systolic function, in combination with angiotensin-converting enzyme (ACE) inhibitors, diuretics, and cardiac glycosides.
DOSAGE AND ADMINISTRATION
Administration: Bisoprolol fumarate is administered orally. It should be taken in the morning on an empty stomach or with breakfast, swallowed whole.
Dosage: The dosage of bisoprolol fumarate must be inpidualized according to the patient and adjusted based on therapeutic response. Dose titration should be gradual, generally at intervals of at least 2 weeks.
For the treatment of hypertension and angina pectoris in adults, the usual initial dose is 2.5–5 mg once daily. As the β1-adrenergic blocking selectivity of bisoprolol fumarate is not absolute and decreases with increasing doses, the drug should be used with caution in patients with bronchospastic disease, and treatment should be initiated at a dose of 2.5 mg once daily. This reduced starting dose may also be appropriate for other patients. If the 5 mg dose does not provide adequate therapeutic effect, the dose may be increased to 10 mg and, if necessary in very severe cases, gradually increased to the maximum tolerated dose of 20 mg once daily. However, some authors recommend a usual dosage range of 2.5–10 mg/day for the treatment of hypertension. In patients with hypertension who do not respond adequately to bisoprolol at doses of 2.5–20 mg/day, or who develop severe hypokalemia after treatment with hydrochlorothiazide 50 mg/day, combination therapy should be considered. The recommended initial daily dose of the combination is bisoprolol 2.5 mg with hydrochlorothiazide 6.25 mg. If necessary, the dose of the fixed combination may be increased, but should not exceed 20 mg of bisoprolol & 12.5 mg of hydrochlorothiazide per day.
Treatment of stable chronic heart failure
Before initiating bisoprolol therapy, patients with chronic heart failure must be clinically stable, with no acute exacerbations within the preceding 6 weeks, and should have been stabilized on standard therapy (angiotensin-converting enzyme inhibitors, diuretics, and/or cardiac glycosides), achieving a “dry” heart failure state (resolution of edema, absence of pleural or pericardial effusion, no pulmonary congestion, and reduction in liver size). Bisoprolol should then be added to the treatment regimen according to the principle of starting at a low dose and gradually titrating upward. Treatment must be supervised by a cardiology specialist. Therapy of stable chronic heart failure with bisoprolol should begin with a dose-titration phase, during which the dose is increased stepwise as follows:
• Step 1: 1.25 mg once daily (taken in the morning) for 2 weeks. If tolerated, proceed to step 2.
• Step 2: 2.5 mg once daily for the following 2 weeks. If tolerated, proceed to step 3.
• Step 3: 5 mg once daily for the following 4 weeks. If tolerated, proceed to step 4.
• Step 4: 7.5 mg once daily for the following 4 weeks. If tolerated, proceed to step 5.
• Step 5: 10 mg once daily as maintenance therapy.
After initiation of the first dose of 1.25 mg, patients should be monitored for 4 hours, with particular attention to blood pressure, heart rate, conduction disturbances, and signs of worsening heart failure. The maximum recommended dose is 10 mg once daily.
Dose adjustment should not be based on clinical response but on the patient’s tolerance in order to achieve the target dose. In some patients, adverse reactions may occur, making it impossible to reach the maximum recommended dose. If necessary, the dose should be gradually reduced. In cases where treatment must be discontinued and subsequently restarted, careful re-titration is required. During the titration period, if heart failure worsens or the drug is not tolerated, the dose should be reduced, or treatment should be discontinued immediately if necessary (e.g. severe hypotension, worsening heart failure with acute pulmonary edema, cardiogenic shock, bradycardia, or atrioventricular block).
Treatment of stable chronic heart failure with bisoprolol is long-term and must not be stopped abruptly, as this may lead to worsening heart failure. If discontinuation is required, the dose should be tapered gradually, reducing the dose by half each week
Renal or hepatic impairment: The pharmacokinetics of bisoprolol may be altered in patients with renal impairment (creatinine clearance < 40 ml/min) or hepatic impairment; therefore, the recommended initial dose is 2.5 mg/day, and dose titration in these patients must be carried out with extreme caution. In patients with creatinine clearance < 20 ml/min who have angina pectoris or hypertension associated with severe hepatic impairment, the dose should not exceed 10 mg once daily.
Elderly: No dose adjustment is required.
Children: Data are not available. Use in children is not recommended.
CONTRAINDICATIONS
- Hypersensitivity to the active substance or to other beta-blockers.
- Uncontrolled heart failure, cardiogenic shock, second- or third-degree atrioventricular block, sick sinus syndrome, sinoatrial block, bradycardia below 50 beats per minute, hypotension, bronchial asthma, advanced peripheral circulatory disorders, and metabolic acidosis.
In patients with pheochromocytoma, bisoprolol fumarate should only be used after prior administration of an alpha-blocking agent.
- Children.
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed.
Keep out of children reach
