- Approval Id
- 206bc6e607a6afd6
- Drug Name
- BISODAC 5 FILM-COATED TABLETS 5MG
- Product Name
- BISODAC 5 FILM-COATED TABLETS 5MG
- Approval Number
- SIN16299P
- Approval Date
- 2021-08-16
- Registrant
- APOTHECA MARKETING PTE LTD
- Licence Holder
- APOTHECA MARKETING PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **Posology and method of administration**
Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocker, diuretics, and when appropriate cardiac glycosides. Patients should be stable (without acute failure) when bisoprolol treatment is initiated.
It is recommended that the treating physician should be experienced in the management of chronic heart failure.
Transient worsening of heart failure, hypotension, or bradycardia may occur during the titration period and thereafter.
Posology:
_Titration phase_
The treatment of stable chronic heart failure with bisoprolol requires a titration phase.
The treatment with bisoprolol is to be started with a gradual uptitration according to the following steps:
- 1.25 mg once daily for 1 week, if well tolerated increase to
- 2.5 mg once daily for a further week, if well tolerated increase to
- 3.75 mg once daily for a further week, if well tolerated increase to
- 5 mg once daily for the 4 following weeks, if well tolerated increase to
- 7.5 mg once daily for the 4 following weeks, if well tolerated increase to
- 10 mg once daily for the maintenance therapy.
The maximum recommended dose is 10 mg once daily.
Close monitoring of vital signs (heart rate, blood pressure) and symptoms of worsening heart failure is recommended during the titration phase. Symptoms may already occur within the first day after initiating the therapy.
_Treatment modification_
If the maximum recommended dose is not well tolerated, gradual dose reduction may be considered.
In case of transient worsening of heart failure, hypotension, or bradycardia reconsideration of the dosage of the concomitant medication is recommended. It may also be necessary to temporarily lower the dose of bisoprolol or to consider discontinuation.
The reintroduction and/or uptitration of bisoprolol should always be considered when the patient becomes stable again.
If discontinuation is considered, gradual dose decrease is recommended, since abrupt withdrawal may lead to acute deterioration of the patients condition.
Treatment of stable chronic heart failure with bisoprolol is generally a long-term treatment.
_Renal or hepatic impairment_
There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with impaired hepatic or renal function. Uptitration of the dose in these populations should therefore be made with additional caution.
_Elderly_
No dosage adjustment is required.
_Paediatric population_
There is no paediatric experience with bisoprolol, therefore its use cannot be recommended in paediatric patients.
Method of administration:
Bisoprolol tablets should be taken in the morning and can be taken with or without food. They should be swallowed with liquid and should not be chewed.
- Route Of Administration
- ORAL
- Indication Info
- **Therapeutic indications**
Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.
- Contraindications
- **Contraindications**
Bisoprolol is contraindicated in chronic heart failure patients with:
- Acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy
- Cardiogenic shock
- Second or third degree AV block (without a pacemaker)
- Sick sinus syndrome
- Sinoatrial block
- Symptomatic bradycardia
- Symptomatic hypotension
- Severe bronchial asthma or severe chronic obstructive pulmonary disease
- Severe forms of peripheral arterial occlusive disease or severe forms of Raynaud's syndrome
- Untreated phaeochromocytoma
- Metabolic acidosis
- Hypersensitivity to bisoprolol or to any of the excipients
- Atc Code
- C07AB07
- Atc Item Name
- bisoprolol
- Pharma Manufacturer Name
- APOTHECA MARKETING PTE LTD
- Company Detail Path
- /organization/apotheca-marketing-pte-ltd
