CELECTOL Film-coated tablet Ref.[27919] Active ingredients: Celiprolol

Posology

Adults

The initial dose is 200 mg orally taken once daily with a glass of water. Celectol should preferably be taken first thing in the morning, 30 minutes before food or 2 hours after a meal. If response is inadequate, the dose may be increased to 400 mg once daily according to the therapeutic response.

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

Elderly

Dosage as for adults. However close monitoring of elderly patients should be exercised, as renal and hepatic functions may be decreased in this population.

Paediatric population

Not recommended.

Renal impairment

Dosage may require adjustment (see section 4.4). For patients with a creatinine clearance 15-40 ml per minute, heart rate should be monitored and treatment must be reconsidered in case of bradycardia (less than 50-55 beats per minute at rest) (see section 4.3). Celiprolol is not recommended in patients with a creatinine clearance less than 15 ml per minute (see section 4.3).

Method of administration

Oral administration.

No data are available regarding celiprolol overdose in humans.

The most common symptoms to be expected following overdose with a beta-blocker 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 gastrointestinal tract. Haemodialysis or haemoperfusion may be considered.

Bradycardia or extensive vagal reactions should be treated with intravenous atropine, 1-2 mg. 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 2-10 mg IV in adults (50-150 micrograms/kg in a child) should be followed by an infusion of 1-5 mg/hour (50 micrograms/kg/hour), titrated to clinical response. Note vials normally contain 1 mg = 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 occasions. 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 occasionally 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.

36 months.

Store below 25°C.

Not all pack sizes may be marketed.

No special instructions.