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CEZEMIN is a brand name for Carbamazepine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Epilepsy - generalised tonic-clonic and partial seizures. Carbamazepine Noumed Prolonged-release Tablet is indicated in newly diagnosed patients with epilepsy and in those patients who are uncontrolled or unable to tolerate their current anti-convulsant therapy. Note: Carbamazepine is not usually effective in absences…
Verbatim from this product's MHRA label. Tap a section to expand.
Cezemin Prolonged Release is given orally, generally in the same total daily dose as conventional carbamazepine dosage forms but usually in two divided doses. In a few patients when changing from other oral dosage forms of carbamazepine to Cezemin Prolonged Release the total daily dose may need to be increased, particularly when it is used in polytherapy.
When starting treatment with Cezemin Prolonged Release in monotherapy, 100-200mg once or twice daily is recommended. This may be followed by a slow increase in dosage until the best response is obtained, often 800- 1200mg daily. In some instances, 1600mg or even 2000mg daily may be necessary.
Cezemin Prolonged Release (either the whole or half divisible tablet as prescribed), should not be chewed but should be swallowed with a little liquid, before, during or between meals. The divisible tablet presentation enables flexibility of dosing to be achieved.
Before deciding to initiate treatment, patients of Han Chinese and Thai origin should whenever possible be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated Stevens- Johnson syndrome(See information on genetic testings and cutaneous reactions in section
). g. fever or sore throat. Carbamazepine should also be discontinued if any evidence of significant bone marrow depression appears. Liver function tests should also be performed before commencing treatment and periodically thereafter, particularly in patients with a history of liver disease and in elderly patients.
The drug should be withdrawn immediately in cases of aggravated liver dysfunction or acute liver disease. Some liver function tests in patients receiving carbamazepine may be found to be abnormal, particularly gamma glutamyl transferase.
This is probably due to hepatic enzyme induction. Enzyme induction may also produce modest elevations in alkaline phosphatase. These enhancements of hepatic metabolising capacity are not an indication for the withdrawal of carbamazepine.
Severe hepatic reactions to carbamazepine occur very rarely. The development of signs and symptoms of liver dysfunction or active liver disease should be urgently evaluated and treatment with carbamazepine suspended pending the outcome of the evaluation.
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for carbamazepine. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Serious dermatological reactions, including toxic epidermal necrolysis (TEN: also known as Lyell’s syndrome) and Stevens Johnson syndrome (SJS) have been reported very rarely with carbamazepine.
4 Epilepsy: The dose of carbamazepine should be adjusted to the needs of the individual patient to achieve adequate control of seizures. Determination of plasma levels may help in establishing the optimum dosage. In the treatment of epilepsy, the dose of carbamazepine usually requires total plasma- carbamazepine concentrations of about 4 to 12 micrograms/mL (17 to 50 micromoles/litre) (see warnings and precautions).
Adults:
It is advised that with all formulations of carbamazepine, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient.
Elderly population (65 years or above):
Due to the potential for drug interactions, the dosage of carbamazepine should be selected with caution in elderly patients.
Children and adolescents:
It is advised that with all formulations of carbamazepine, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient. Usual dosage 10-20mg/kg bodyweight daily taken in several divided doses.
Age Upto 5 years:
Cezemin Prolonged-release Tablets are not recommended 5-10 years: 400-600 mg daily 10-15 years: 600-1000 mg >15 years of age: 800 to 1200 mg daily (same as adult dose) Maximum recommended dose Up to 6 years of age: 35 mg/kg/day 6-15 years of age: 1000 mg/day >15 years of age: 1200 mg/day.
Wherever possible, Cezemin Prolonged Release should be prescribed as the sole antiepileptic agent but if used in polytherapy the same incremental dosage pattern is advised. When carbamazepine is added to existing antiepileptic therapy, this should be done gradually while maintaining or, if necessary, adapting the dosage of the other antiepileptic(s) (see
g. tricyclic antidepressants) or any other component of the formulation. g. acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda). The use of carbamazepine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs) (see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients with serious dermatological reactions may require hospitalization, as these conditions may be life-threatening and may be fatal. Most of the SJS/TEN cases appear in the first few months of treatment with carbamazepine. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly Caucasian populations.
g. SJS, Lyell's syndrome/TEN) appear, carbamazepine should be withdrawn at once and alternative therapy should be considered. Cutaneous reactions Serious and sometimes fatal cutaneous reactions including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) have been reported during treatment with carbamazepine.
These reactions are estimated to occur in 1-6 per 10 000 new users in countries with mainly Caucasian populations, but the risk in some Asian countries is estimated to be about 10 times higher. 2). HLA-B*1502 allele - in Han Chinese, Thai and other Asian populations HLA-B*1502 in individuals of Han Chinese and Thai origin has been shown to be strongly associated with the risk of developing Stevens- Johnson syndrome (SJS) when treated with carbamazepine.
The prevalence of HLA-B*1502 carrier is about 10% in Han Chinese and Thai populations. 2). If these individuals test positive, carbamazepine should not be started unless there is no other therapeutic option. Tested patients who are found to be negative for HLA-B*1502 have a low risk of SJS, although the reactions may still very rarely occur.
There are some data that suggest an increased risk of serious carbamazepine-associated TEN/SJS in other Asian populations. g. above 15% in the Philippines and Malaysia), testing genetically at risk populations for the presence of HLA-B*1502 may be considered.
g. European descent, African, Hispanic populations sampled, and in Japanese and Koreans (< 1%). 8) in people of European descent and the Japanese. The frequency of the HLA-A*3101 allele varies widely between ethnic populations. HLA-A*3101 allele has a prevalence of 2 to 5% in European populations and about 10% in Japanese population.
8%. There are insufficient data supporting a recommendation for HLA-A*3101 screening before starting carbamazepine treatment. If patients of European descent or Japanese origin are known to be positive for HLAA* 3101 allele, the use of carbamazepine may be considered if the benefits are thought to exceed risks.
g. isolated macular or maculopapular exanthema, can also occur and are mostly transient and not hazardous. They usually disappear within a few days or weeks, either during the continued course of treatment or following a decrease in dosage.
However, since it may be difficult to differentiate the early signs of more serious skin reactions from mild transient reactions, the patient […]