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CELIPROLOL HYDROCHLORIDE is a brand name for Celiprolol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Celiprolol is indicated for the treatment of hypertension.
Verbatim from this product's MHRA label. Tap a section to expand.
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 200mg 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. 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
Beta-adrenoceptor blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia (in particular, tachycardia). Occasional side effects, which are usually mild and transient have occurred. These include headache, hot flushes, asthenia, dizziness, fatigue, somnolence and insomnia (sleep disturbances).
Additional side effects associated with beta-2 agonist activity, tremor and palpitations, have been reported. These effects usually do not require withdrawal of therapy. Bronchospasm, skin rashes and/or visual disturbances have been reported in association with the use of beta blockers.
Celiprolol should be discontinued if these effects occur. The following undesirable effects have been observed during treatment with celiprolol and other beta-blockers with the following frequencies.
The frequencies of adverse events are ranked according to the following:
Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), Not known (cannot be estimated from available data).
Metabolism and nutrition disorders Not known:
Hypoglycaemia, Hyperglycaemia Latent diabetes mellitus may come to light, and apparent diabetes mellitus may worsen. Beta-blockers may mask the symptoms of hypoglycaemia or thyrotoxicosis (in particular tachycardia and tremor). Psychiatric disorders Common: depression has been reported.
Uncommon: insomnia Very rare: psychoses Not known: hallucinations, nightmare, libido decrease Nervous system disorders Common: headache and dizziness, somnolence, nightmares and insomnia (sleep disturbances), tremor and sensation of coldness in the extremities have been reported, paraesthesia, asthenia.
Very rare: confusion Not known: syncope Eye disorders Not known: impaired vision, visual disturbances have been reported including xerophthalamias; dry eyes (to be considered if the patient uses contact lenses). Ear and labyrinth disorders Rare: tinnitus Cardiac disorders Common: significant decrease in blood pressure including when standing up from a lying position (orthostatic hypotension), have been reported.
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. 1. Celiprolol is also contraindicated in patients with: - Second or third degree heart block; - Severe bradycardia (< 45-50 beats per minute); - Sick sinus syndrome (including Sinoartrial block); - Untreated phaeochromocytoma (celiprolol may only be administered once the alpha receptors have been blocked); - Metabolic acidosis; - Hypotension (systolic blood pressure less than 100 mmHg); - Severe peripheral arterial circulatory disturbances - Uncontrolled heart failure; - Cardiogenic shock; - Severe renal impairment with creatinine clearance less than 15ml per minute; and - Acute episode of asthma, Severe bronchial asthma and severe chronic obstructive pulmonary disease.
- Late stages of peripheral arterial occlusive disease and Raynaud's syndrome Celiprolol should not be prescribed for patients being treatment with theophylline. 4 Special warnings and precautions for use Although cardiac selective beta blockers may have less effect on lung function than non-selective beta blockers, as with all beta blockers, these should be avoided in patients with chronic obstructive airways disease, and in patients with a history of bronchospasm or bronchiol asthma, unless there are compelling clinical reasons for their use.
Where such reasons exist, celiprolol may be used but with the utmost caution under specialist supervision.
The label will carry the following warning:
If you have a history of asthma or wheezing, please ask your doctor before taking this medicine The pharmacokinetics are not significantly different in the elderly, however these patients should be regularly monitored and due regard made for decreased renal and liver function in this age group.
1. Celiprolol is also contraindicated in patients with: - Second or third degree heart block; - Severe bradycardia (< 45-50 beats per minute); - Sick sinus syndrome (including Sinoartrial block); - Untreated phaeochromocytoma (celiprolol may only be administered once the alpha receptors have been blocked); - Metabolic acidosis; - Hypotension (systolic blood pressure less than 100 mmHg); - Severe peripheral arterial circulatory disturbances - Uncontrolled heart failure; - Cardiogenic shock; - Severe renal impairment with creatinine clearance less than 15ml per minute; and - Acute episode of asthma, Severe bronchial asthma and severe chronic obstructive pulmonary disease.
- Late stages of peripheral arterial occlusive disease and Raynaud's syndrome Celiprolol should not be prescribed for patients being treatment with theophylline.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Uncommon: palpitations Rare: slowed AV-conduction, increased cardiac insufficiency with peripheral oedema and/or exertional dyspnoea. Heart failure, cold and cyanotic extremities. In susceptible patients: precipitation of existing A-V block.
Not known: bradycardia, cardiac failure Vascular disorders Common:
Hot flush, In susceptible patients: exacerbation of intermittent claudication Raynaud’s disease or syndrome have been reported.
Uncommon:
Cold extremities, hypotension Respiratory,thoracic and mediastinal system disorders Uncommon: Dyspnoea Rare: hypersensitivity pneumonitis, asthmatic dyspnoea especially in patients with bronchial asthma or a history of asthmatic complaints.
Not known:
Interstitial pneumonitis, bronchospasm Gastrointestinal disorders Common: nausea, vomiting, abdominal pain and abdominal discomfort can occur, dry mouth Rare: constipation. Not known: diarrhoea. g. itching, flush, rash, pruritus, urticaria, purpura).
Very rare:
Beta blockers can cause psoriasis in isolated cases, worsen the symptoms of this disease or lead to the formation of psoriasiform exanthemes. Musculoskeletal and connective tissue disorders Common: muscle cramps Uncommon: arthralgia Rare: muscle weakness Not known: systemic lupus erythmatosus Reproductive system and breast disorders Common: erectile dysfunction Rare: male impotence, libido decrease General disorders and administration site conditions Common: fatigue.
Investigations Common:
An increase in antinuclear antibodies (ANA) has been seen, its clinical relevance is not clear. Antinuclear antibodies have been observed, exceptional and reversible lupus syndrome Not known: hepatic transaminases increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
Celiprolol may be used in patients with mild to moderate degrees of reduced renal function as celiprolol is cleared by both renal and non-renal excretory pathways. A reduction in dosage by half may be appropriate in patients with creatinine clearances in the range of 15 to 40ml per minute.
However, careful surveillance of such patients is recommended until steady state blood levels are achieved which typically would be within one week. Celiprolol is not recommended for patients with creatinine clearance less than 15 ml per minute.
Patients with hepatic impairment should also be carefully monitored after commencing therapy and a reduced dosage should be considered. The initial treatment of severe malignant hypertension should be so designed as to avoid reduction in diastolic blood pressure with impairment of autoregulatory mechanisms.
In patients with coronary insufficiency, treatment should not be discontinued abruptly. Sudden withdrawal of beta-adrenoceptor blocking agents in patients with ischemic heart disease may result in the appearance of anginal attacks of increased frequency or severity or deterioration in cardiac state.
Although no adverse effects due to abrupt cessation of celiprolol have been studied in clinical trials, therapy should be gradually reduced over 1-2 weeks, at the same time, if necessary, initiating replacement therapy to prevent exacerbation of angina pectoris.
Celiprolol therapy must be reported to the anaesthetist prior to general anaesthesia. If it is decided to withdraw the medicinal product before surgery, 48 hours should be allowed to elapse between the last dose and anaesthesia. Continuation of beta blockade reduces the risk of arrhythmias during induction and intubation, although reflex tachycardia may be attenuated and the risk of hypotension may be increased (see “Interactions”).
In the event of continuation of celiprolol treatment, special care should be exercised when using anaesthetic agents such as ether, cyclopropane or trichloroethylene (sees section