CELIPROLOL HYDROCHLORIDE Film-coated tablet Ref.[7778] Active ingredients: Celiprolol

Adults

The initial dose is 200 mg orally, taken once daily with a glass of water. Celiprolol should be taken on rising, one hour before meals, or 2 hours after meals. If response is inadequate, the dose may be increased to 400 mg once daily, after 2 to 4 weeks of treatment with 200 mg once daily. It may take several weeks of treatment for the anti-hypertensive effect of celiprolol to be fully established. There is no limit for the duration of treatment. This depends on the nature and severity of the disease. Treatment with celiprolol should not be discontinued abruptly, but should be discontinued gradually (i.e. over a period of 7-10 days), as discontinuing treatment abruptly may lead to an acute worsening of the patient’s condition.

In hypertensive patients, additional treatment with other anti-hypertensive agents according to clinical guidelines is possible, in particular with diuretics. When a combination is initiated an increased monitoring of the blood pressure is recommended

Elderly

The pharmacokinetics of celiprolol is not significantly different in the elderly people however a close monitoring of elderly patients should be exercised, as renal and hepatic functions may be decreased in this population

Dosage in renal impairment: The dosage of celiprolol should be reduced by half in patients with creatinine clearance values of 15-40 ml/minute, heart rate should be monitored and treatment should be reconsidered in case of bradycardia (less than 50-55 beats per minute at rest).

Celiprolol is not recommended for patients with creatinine clearance less than 15 ml/minute. Careful surveillance of such patients is recommended until steady state blood levels are achieved. A reduction in dosage may be necessary in patients with severe renal impairment, please see section 4.4.

Dosage in hepatic impairment: Patients with hepatic impairment should also be carefully monitored after commencing therapy and a reduced dosage should be considered.

Children

Not recommended.

No data are available regarding overdose in humans.

The most common symptoms to be expected following overdosage with a beta-adrenoceptor blocking drug are bradycardia, hypotension, bronchospasm and acute cardiac insufficiency.

General treatment should be symptomatic and supportive and be conducted under close supervision, with the use of gastric lavage, activated charcoal and a laxative to prevent absorption of any drug still present in the gastro-intestinal tract.

Haemodialysis or haemoperfusion may be considered.

Bradycardia or extensive vagal reactions should be treated with intravenous atropine, 1-2mg. Cardiac pacing should be considered in refractory bradycardia and heart block. Hypotension should be treated with plasma or plasma substitutes and, if necessary, intravenous catecholamines including dopamine and dobutamine.

Glucagon is the treatment of choice for severe hypotension, heart failure or cardiogenic shock. A bolus of 2-10mg IV in adults (50-150 micrograms/kg in a child) should be followed by an infusion of 1-5mg/hour (50 micrograms/kg/hour), titrated to clinical response. Note vials normally contain 1mg = 1 unit and other treatments may be more convenient to use. Some patients do not respond to glucagon and if vomiting occurs without any improvement in blood pressure, further glucagon is unlikely to be of benefit. Adverse effects of glucagon administration include vomiting, hyperglycaemia, hypokalaemia and hypocalcaemia.

If glucagon is not available or if there is severe bradycardia and hypotension, which is not improved by glucagon, use isoprenaline starting at an infusion rate of 5-10 micrograms/minute (0.02 micrograms/kg/min in children increasing to a maximum of 0.5 micrograms/kg/min) and increased as necessary depending on clinical response. Large doses (up to 800 micrograms/min) have been reported to be necessary on some occassions. Isoprenaline may be ineffective at improving blood pressure despite increasing heart rate.

In severe hypotension additional inotropic support may be necessary with a beta agonist such as dobutamine 2.5-40 micrograms/kg/min (adults and children). Other inotropes such as dopamine, adrenaline (epinephrine) or noradrenaline (norepinephrine) may occassionally be of benefit or consider the use of an intra-aortic balloon pump to sustain an adequate cardiac output. Management of cases of severe hypotension and cardiogenic shock should be discussed with your local poisons service in the UK NPIS 0844 892 0111.

In the case of cardiac decompensation in the neonate of mother treated with beta-blockers, the following should be administered:

• Glucagons, 0.3 mg/kg
• Hospitalization in an intensive care unit,
• Isoprenaline: treatment is generally needed at a high dosage, therefore patients monitoring in a specialized care unit is recommended.

3 years.

Store in the original container.

Blister strips comprising of white opaque PVC film with a backing of aluminium foil coated with heat seal lacquer.

Pack of 10, 20, 28, 30, 50, 56 and 100 tablets.

No special requirements.