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CARBAGEN is a brand name for Carbamazepine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Epilepsy Adults either as monotherapy • or in combination with another antiepileptic treatment treatment of generalised epilepsy: generalised tonic-clonic seizures treatment of partial seizures with or without secondary generalisation Children • either as monotherapy • or in combination with another antiepileptic…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dosage must be adjusted to the individual patient based on clinical response and administered in 2 or 3 doses during the day. Doses should be based on seizure control and the development of clinical intolerance. Plasma levels are indicative whether a patient is within or outside the therapeutic range in order to explain a lack of seizure control or development of intolerance.
This may be particularly useful, if combination therapy is used. 1). A maximum daily dose of 1,600 to 2,000 mg may be required in adults. When patients are transferred from an immediate-release carbamazepine product, the same total daily dose will generally be suitable.
In a few patients, it may be necessary to increase the total daily dose, particularly when it is used with other antiepileptics. In patients with severe cardio-vascular disease, liver disease or renal damage and in older people a reduced dose may be sufficient.
Furthermore the dose required by some patients may differ substantially from the recommendation for initial and maintenance dose below, due to increased metabolism caused by auto-induction of hepatic enzymes or drug interactions during combination therapy.
4).
Dosage recommendations:
Epilepsy Treatment is started with a low dose set individually according to the type and severity of symptoms. The dose is then slowly increased in intervals of 2 to 5 days to achieve the optimal maintenance dose in about 2 weeks to suit the patient.
Adults 10 to 15 mg/kg/day on average, in 2 or 3 doses. Paediatric population For children aged 4 years or less, the initial dose is 20–60 mg/day, increasing the dose by 20– 60 mg every second day. For children aged over 4 years, the initial dose may be 100 mg/day, increasing the dose by 100 mg on a weekly basis.
Maintenance dose: 10 to 20 mg/kg/day on average, divided into several doses throughout the day.
Maximum recommended dose:
The maximum recommended dose is 35 mg/kg/day for a child aged under 6 years, 1 000 mg/day for a child aged between 6 and 15 years and 1 200 mg/day for those aged over 16 years. It is recommended that a carbamazepine monotherapy treatment is used whenever possible.
The following undesirable effects appear dependent on the dose in particular at the start of therapy, too high initial dose or in older patients. These symptoms may abate spontaneously within a few days or if the dose is transiently reduced: dizziness, headache, ataxia, drowsiness, fatigue, diplopia, disorders of accommodation, confusion, agitation, nausea, vomiting and allergic skin reactions.
The dose-related adverse reactions usually abate within a few days, either spontaneously or after a transient dosage reduction. 9), as well as hypersensitivity reactions, require therapy cessation. The occurrence of CNS adverse reactions may be a manifestation of relative overdosage or significant fluctuation in plasma levels.
In such cases it is advisable to monitor the plasma levels and divide the daily dosage into smaller fractional doses. Adverse reactions compiled from clinical trials are listed by MedDRA system organ class. Within each system organ class, adverse reactions are ranked by frequency, from most to least common.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Side effects listed according to organ system with the frequency estimate very common (≥1/10), common (≥1/100 to 1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 to 1/1,000), very rare (≤1/10,000) and not known (cannot be estimated from the available data): Infections and infestations Not known: Reactivation of an infection with human herpes virus 6 Blood and lymphatic system disorders Very common: Leucopenia Common: eosinophilia, thrombocytopenia Rare: Lymphadenopathy, leucocytosis Very rare: Agranulocytosis, bone marrow failure, aplastic anaemia, pure red cell aplasia, anaemia, megaloblastic anaemia, reticulocytosis, haemolytic anaemia, enlarged spleen, pancytopenia According to literature sources the most frequent disorder is benign leucopenia, 10% of the cases being of a transient nature, 2% persistent.
If reactions such as fever, sore throat, other infections, rash, ulcers in the mouth, easy bruising, petechial or purpuric haemorrhage, nausea, yellowing of the skin, and liver enlargement appears, the patient should be advised to consult his physician immediately, and immediate monitoring of complete blood count (see Precautions for use).
Suicidal ideation and behaviour 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 antiepileptic 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. Women of childbearing potential Carbamazepine may cause foetal harm when administered to a pregnant woman.
6). Carbamazepine should not be used in women of childbearing potential unless the benefit is judged to outweigh the risks following careful consideration of alternative suitable treatment options. Women of childbearing potential should be fully informed of the potential risk to the foetus if they take carbamazepine during pregnancy.
Before the initiation of treatment with carbamazepine in a woman of childbearing potential, pregnancy testing should be considered. Women of childbearing potential should use effective contraception during treatment and for two weeks after stopping treatment.
6). 6). Women of childbearing potential should be counselled to contact her doctor immediately if she becomes pregnant or thinks she may be pregnant and is taking carbamazepine. Serious 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.
Carbamazepine may not be taken with: - known bone marrow depression. - atrio ventricular conduction abnormalities. 1. g. acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda). 5). - herbal preparations containing St.
5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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When treatment is changed from another drug to carbamazepine the dose of the other antiepileptic drug should be reduced slowly. Antiepileptic therapy must be administered daily as a long-term treatment, sometimes indefinitely. The prescription of carbamazepine must be monitored regularly.
4). Carbamazepine therapy is discontinued by slow dose reduction. Carbamazepine prolonged-release tablets can be broken in half to treat children/adults with divided doses where necessary. * Carbamazepine prolonged-release tablets are not generally suitable for children under the age of 5 years.
A conventional tablet or syrup presentation of carbamazepine may be given. In general, a dose reduction or withdrawal of antiepileptic medication may be considered, when patients are seizure-free for at least two or three years. Instead of age dependant dose adjustment, children may outgrow the dose per kg body weight.
Pain Prevention of paroxysmal pain of trigeminal neuralgia The recommended initial daily dose is 200 to 400 mg/day carbamazepine, in 2 doses. The lower initial dose may be sufficient for older or sensitive patients. The dose is increased until the patient is free of pain, in trigeminal and glossopharyngeal neuralgia, generally with a dose of 600 to 800 mg/day taken in 1 to 2 doses with a maximum dose of 1,600 mg.
The dose may be gradually reduced if the patient is pain-free thereafter, and may possibly be stopped after a few weeks of treatment, if there is no recurrence of pain. e. 400 to 800 mg/day on average. Prophylaxis of manic-depressive psychosis An initial dose of 100 to 400 mg daily in divided doses, increased gradually until symptoms are controlled, or a maximum of 800 mg, in exceptional cases maximum 1,600 mg, in divided doses is reached.
The recommended maintenance dose is 400 to 600 mg daily, given in divided doses. Prophylaxis of manic-depressive psychosis is a long-term treatment. 8 mval/L), if in exceptional cases carbamazepine is used in combination with lithium for the prophylaxis of manic depressive psychosis, which cannot be controlled with lithium treatment alone.
Neuroleptic treatment must not be done concurrently and must have been discontinued at least 8 weeks beforehand. 7). Special populations Elderly (65 years and above) Due to possible interactions and differences in the pharmacokinetic properties of various antiepileptics, the dosage of carbamazepine should be chosen with caution in elderly patients.
In elderly patients, an initial dose of 100 mg twice daily is recommended. This initial dose may be increased slowly each day until there is pain relief (usually 200 mg 3–4 times a day). The dose should then be gradually reduced to the lowest possible maintenance dose.
Renal failure/hepatic failure No data are available on the pharmacokinetics of […]
Immune system disorders Uncommon:
Delayed multi-organ hypersensitivity disorder (DRESS) with fever, skin rashes, vasculitis, swollen lymph nodes, pseudolymphoma, painful joints (arthralgia), leucopenia, eosinophilia, hypogammaglobulinaemia, enlargement of liver and spleen or altered liver function tests and vanishing bile duct syndrome occurring in various combinations.
Other organs such as lung, kidney, pancreas, colon and cardiac muscle may also be affected. The existence of rare cases of cross sensitivity to carbamazepine, phenytoin, phenobarbital and oxcarbazepine calls for caution when substituting carbamazepine with any of these medicinal products.
Rare:
Hepatitis, which may be severe Very rare: Generalised acute allergic reactions, anaphylactic reactions, angioedema Not known: Drug rash with eosinophilia and systemic symptoms (DRESS) Endocrine disorders Common: Weight gain, oedema, hyponatraemia related to syndrome of inappropriate antidiuretic hormone secretion.
Very rare: galactorrhoea, gynaecomastia.
Metabolism and nutrition disorders Common:
Fluid retention Rare: Folic acid deficiency, reduced appetite Not known: Hyperammonaemia Psychiatric disorders Uncommon: Confusion and agitation in older patients, depressive disorders, aggressive behaviour, thinking difficulties, hallucinations (visual or auditory), activation of latent psychosis Rare: Restlessness, mania Very rare: Phobias Nervous system disorders Very common: Dizziness, somnolence, sedation, ataxia (atactic and cerebral disturbances) Common: Headache Uncommon: Lack of drive, abnormal involuntary movements like asterixis, tremor, dystonia, dyskinetic disorders like orofacial dyskinesia or tics or nystagmus.
g. g. 4), alterations in skin pigmentation, acne, hirsutism, photosensitivity, erythema exudativum, multiforme and nodosum, purpura, acute generalised exanthematous pustulosis (AGEP) Not known: Lichenoid keratosis, onychomadesis There is increasing evidence regarding the […]
These reactions are estimated to occur in 1 to 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). The allele frequencies indicated here represent the percentage of chromosomes carrying the allele of interest in the specified population.
e. the "carrier frequency") is almost twice as high as the allele frequency. Thus, the percentage of patients potentially at risk is almost double the allele frequency. 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 the severe cutaneous reactions known as Stevens-Johnson syndrome (SJS) or TEN when treated with carbamazepine.
The prevalence of HLA-B*1502 carrier is between 2% and 12% of Han Chinese and 8% of 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 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, and up to 2% and 6% in Korea and India, respectively), 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 HLA- A*3101 allele, the use of […]