Source: Health Sciences Authority (SG) Revision Year: 2023 Publisher: France: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France Singapore: Servier Singapore Pte Ltd, 67 Ubi Avenue 1, #06-09 StarHub Green, Singapore 408942
Cosyrel 5 mg/5 mg and Cosyrel 10 mg/5 mg: Cosyrel 5 mg/5 mg and Cosyrel 10 mg/5 mg are indicated as substitution therapy for treatment of hypertension and/or stable coronary artery disease (in patients with a history of myocardial infarction and/or revascularisation) and/or stable chronic heart failure with reduced systolic left ventricular function in adult patients adequately controlled with bisoprolol and perindopril given concurrently at the same dose level.
Cosyrel 5 mg/10 mg and Cosyrel 10 mg/10 mg: Cosyrel 5 mg/10 mg and Cosyrel 10 mg/10 mg are indicated as substitution therapy for treatment of hypertension and/or stable coronary artery disease (in patients with a history of myocardial infarction and/or revascularisation) in adult patients adequately controlled with bisoprolol and perindopril given concurrently at the same dose level.
The usual posology is one tablet once daily.
Patients should be stabilized with bisoprolol and perindopril at the same dose level for at least 4 weeks. The fixed dose combination is not suitable for initial therapy.
For patients stabilized with bisoprolol 2.5 mg and perindopril 2.5 mg: one half 5 mg/5 mg tablet once daily.
If a change of posology is required, titration should be done with the individual components.
In patients with renal impairment, the recommended dose of Cosyrel 5 mg/5 mg should be based on creatinine clearance as outlined in table 1 below:
Table 1. Dosage adjustment in renal impairment:
| Creatinine clearance (mL/min) | Recommended daily dose |
|---|---|
| ClCR ≥ 60 | One tablet of Cosyrel 5 mg/5 mg |
| 30 < ClCR < 60 | One half tablet of Cosyrel 5 mg/5 mg |
| ClCR < 30 | Not suitable. Individual dose titration with the monocomponents is recommended |
No dosage adjustment is necessary in patients with hepatic impairment.
It should be administered according to the renal function.
The safety and efficacy of Cosyrel in children and adolescents have not been established. No data are available. Therefore, use in children and adolescents is not recommended.
Cosyrel tablet should be taken as a single dose once daily in the morning before a meal.
There is no information on overdose with Cosyrel in humans.
In general the most common signs expected with overdosage of a beta-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycaemia. To date a few cases of overdose (maximum: 2000 mg) with bisoprolol have been reported in patients suffering from hypertension and/or coronary heart disease showing bradycardia and/or hypotension; all patients recovered. There is a wide interindividual variation in sensitivity to one single high dose of bisoprolol and patients with heart failure are probably very sensitive.
If overdose occurs, bisoprolol treatment should be stopped and supportive and symptomatic treatment should be provided. Limited data suggest that bisoprolol is hardly dialysable. Based on the expected pharmacologic actions and recommendations for other beta-blockers, the following general measures should be considered when clinically warranted.
Bradycardia: Administer intravenous atropine. If the response is inadequate, isoprenaline or another agent with positive chronotropic properties may be given cautiously. Under some circumstances, transvenous pacemaker insertion may be necessary.
Hypotension: Intravenous fluids and vasopressors should be administered. Intravenous glucagon may be useful.
AV block (second or third degree): Patients should be carefully monitored and treated with isoprenaline infusion or transvenous cardiac pacemaker insertion.
Acute worsening of heart failure: Administer i.v. diuretics, inotropic agents, vasodilating agents.
Bronchospasm: Administer bronchodilator therapy such as isoprenaline, beta2-sympathomimetic drugs and/or aminophylline.
Hypoglycaemia: Administer i.v. glucose.
Limited data are available for overdosage in humans. Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.
The recommended treatment of overdosage is intravenous infusion of sodium chloride 9 mg/ml (0.9%) solution. If hypotension occurs, the patient should be placed in the shock position. If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered. Perindopril may be removed from the general circulation by haemodialysis (see section 4.4). Pacemaker therapy is indicated for therapy-resistant bradycardia. Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.
Polypropylene tablet container of 10 film-coated tablets: 24 months.
Polypropylene tablet container of 30 film-coated tablets: 30 months.
Tablet container of 10 film-coated tablets: Once opened, Cosyrel should be used within 20 days.
Tablet container of 30 film-coated tablets: Once opened, Cosyrel should be used within 60 days.
Store below 30°C.
Tablet container of 10 or 30 film-coated tablets: white polypropylene tablet container equipped with a lowdensity polyethylene flow reducer and a white opaque stopper containing a desiccant gel.
Box of 1 tablet container of 10 or 30 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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