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CARBAMAZEPINE STRANDHAVEN 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. Note: Carbamazepine is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal evidence suggests that seizure exacerbation may occur in patients with atypical absences. The paroxysmal pain of trigeminal neuralgia. For the…
Verbatim from this product's MHRA label. Tap a section to expand.
Carbamazepine Suspension is given orally, usually in two or three divided doses. Carbamazepine Suspension (the suspension should be shaken before use) may be taken during, after or between meals. After taking this medicine, a full glass of water (approximately 240 ml) should be taken.
This medicinal product must not be administered via enteral feeding tubes. Administer only by the oral route. Since a given dose of Carbamazepine Suspension will produce higher peak levels than the same dose in tablet form, it is advisable to start with low doses of the liquid and to increase them slowly so as to avoid adverse effects on the central nervous system such as dizziness and lethargy.
When switching a patient from tablets to liquid the same overall dose may be used but in smaller, more frequent, doses. 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. Carbamazepine should be taken in a number of divided doses although initially 100-200 mg once to twice daily is recommended.
This may be followed by a slow increase until the best response is obtained, often 800-1200 mg daily. Adult patients who require doses exceeding 1200 mg up to 2000 mg/day of Carbamazepine, should be switched to alternative oral formulations of Carbamazepine, such as immediate release and prolonged release tablets.
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 (4 weeks of age or above) and adolescents:
). 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 anti-epileptic 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.
Warnings Agranulocytosis and aplastic anaemia have been associated with Carbamazepine; however, due to the very low incidence of these conditions, meaningful risk estimates for Carbamazepine are difficult to obtain. 0 persons per million per year for aplastic anaemia.
Decreased platelet or white blood cell counts occur occasionally to frequently in association with the use of Carbamazepine. Nonetheless, complete pre- treatment blood counts, including platelets and possibly reticulocytes and serum iron, should be obtained as a baseline, and periodically thereafter.
Patients and their relatives should be made aware of early toxic signs and symptoms indicative of a potential haematological problem, as well as symptoms of dermatological or hepatic reactions. If reactions such as fever, sore throat, rash, ulcers in the mouth, easy bruising, petechial or purpuric haemorrhage appear, the patient should be advised to consult the physician immediately.
8 Undesirable Effects). 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.
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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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 10-20 mg/kg bodyweight daily in several divided doses.
Age up to 1 year: 1-5 years: 5-10 years: 10-15 years: >15 years of age: 100 to 200 mg daily (5-10 ml liquid per day). 200 to 400 mg daily (10-20 ml liquid per day). 400 to 600 mg daily (20-30 ml liquid per day to be taken in divided doses).
600 to 1000 mg daily (30-50 ml liquid per day to be taken in several divided doses). 800 to 1200 mg daily (same as adult dose). Maximum recommended dose From ≥ 4 weeks up to 6 years of age: 35 mg/kg/day 6 to 15 years of age: 1000 mg/day >15 years of age: 1200 mg/day.
Caution is advised when administering to infants under 1 year of age due to the presence of propylene glycol (25 mg/ml). The maximum recommended daily dose (10 ml) results in an exposure of 250 mg/day, equivalent to 50 mg/kg/day in a 5 kg infant – the EMA safety threshold would be exceeded in infants of weights lower than 5 kg.
Consider alternative formulations or monitor closely if use is clinically justified. Wherever possible anti-epileptic agents should be prescribed as the sole drug anti-epileptic agent but if used in polytherapy, the same incremental dosage pattern is advised.
5 Interaction with other medicinal products and other forms of interaction).
Trigeminal neuralgia:
Slowly raise the initial dosage of 200-400 mg daily until freedom from pain is achieved (normally at 200 mg 3-4 times daily). In the majority of patients a dosage of 200 mg 3 or 4 times a day is sufficient to maintain a pain free state.
The dosage should be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200 mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs.
Elderly population (65 years of age or above):
Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of Carbamazepine should be selected with caution in elderly patients. Dosage in Trigeminal neuralgia In elderly patients, an initial dose of 100 mg twice daily is recommended.
The initial dosage of 100 mg twice daily should be slowly raised daily until freedom from pain is achieved (normally at 200 mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level.
Maximum recommended dose is 1200 mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs. For the prophylaxis of manic depressive psychosis in patients unresponsive to lithium therapy: Initial starting dose of 400 mg daily, in divided doses, increasing gradually until symptoms are controlled or a total of 1200 mg given in divided doses is reached.
The usual dosage range is 400-600 mg daily, given in divided doses. Adult patients who require doses exceeding 1200 mg up to 1600 mg/day of Carbamazepine, should be switched to alternative oral formulations of Carbamazepine, such as immediate release and prolonged release tablets.
Special populations Renal impairment / Hepatic impairment No data are available on the pharmacokinetics of carbamazepine in patients with impaired hepatic or renal function.
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 HLA-A*3101 allele, the use of carbamazepine may be considered if the benefits are thought to exceed risks.
, 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 […]
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic 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.
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%). HLA-A*3101 allele - European descent and Japanese populations There are some data that suggest HLA-A*3101 is associated with an increased risk of carbamazepine induced cutaneous adverse drug reactions including SJS, TEN, Drug rash with eosinophilia (DRESS), or less severe acute generalized exanthematous pustulosis […]