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CURATIL 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. Curatil 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 (petit mal) and myoclonic seizures.…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology Dosage Treatment with Carbamazepine is gradually started, with a low initial dose, depending on the type and severity of the clinical picture, on an individual basis, after which the dose is slowly increased to the most effective maintenance dose.
The daily dose is usually administered in 1 to 2 single doses. The general daily dosage range is between 400 and 1,200 mg of carbamazepine. A total daily dose of 1,600 mg of carbamazepine should generally not be exceeded because higher doses increase the number of side effects.
The therapeutic dose should be determined, especially in combination therapy, by determining plasma levels and depending on efficacy. Experience has shown that the therapeutic carbamazepine level is between 4 and 12 micrograms/ml. g.
due to accelerated metabolism through enzyme induction or due to drug interactions in the event of combined medication). Carbamazepine should preferably be used alone (monotherapy) to treat epilepsy. Treatment should be supervised by a specialist doctor experienced in the treatment of epilepsy.
When switching to treatment with carbamazepine, the dose of the antiepileptic to be discontinued should be reduced gradually. The following general dosing regimen is recommended for the treatment of epileptic seizure disorders: Initial daily dose in mg (or number of prolonged- release tablets) Maintenance dose daily in mg (or number of prolonged-release tablets) Adults: 200 mg in the evening (1 prolonged-release tablet) 200 to 600 mg in the morning (1 to 3 prolonged- release tablets) 400 to 600 mg in the evening (2 to 3 prolonged-release tablets) Children:* 6 to 10 years old 200 mg in the evening (1 prolonged-release tablet) 200 mg in the morning (1 prolonged-release tablet) 200 to 400 mg in the evening (1 to 2 prolonged- release tablets) 11 to 15 years 200 mg in the evening (1 prolonged-release tablet) 200 to 400 mg in the morning (1 to 2 prolonged- release tablets) 400 to 600 mg in the evening (2 to 3 prolonged-release tablets) > 15 years According to the adult dose * Note: For children under 6 years of age, non-delayed dosage forms (suspension or tablets) are available for initial and maintenance dosing.
The administration of prolonged- release tablets cannot be recommended due to insufficient knowledge. Maximum recommended dose: 6 to 15 years of age: 1,000 mg/day >15 years of age: 1,200 mg/day Children under 6 years of age Carbamazepine is unsuitable for children under the age of 6 because of the high active ingredient content and lack of experience with retard tablets.
). It has been observed that the HLA-A*3101 allele is associated with the occurrence of hypersensitivity syndrome, including maculopapular rash. Patients who have demonstrated hypersensitivity reactions to carbamazepine should be informed that approximately 25-30% of these patients may experience hypersensitivity reactions to oxcarbazepine.
, phenytoin, primidone, phenobarbital). If signs or symptoms of a hypersensitivity reaction occur, carbamazepine should be discontinued immediately. Seizures Since carbamazepine can cause absences or intensify existing ones, carbamazepine should not be used in patients who suffer from absences or mixed forms of epilepsy that include them.
In these constellations, carbamazepine could lead to seizure exacerbation. If seizures exacerbate, carbamazepine should be discontinued. Liver function Liver values must be checked before and during treatment with carbamazepine; assessment is recommended before starting treatment, then at weekly intervals during the first month of treatment, then at monthly intervals thereafter.
This is especially true for patients with a history of liver disease or for elderly patients. After 6 months of treatment, checks 2 to 4 times a year are sometimes sufficient. Patients must be instructed to seek medical attention immediately if symptoms of hepatitis such as fatigue, loss of appetite, nausea, yellowing of the skin, enlargement of the liver occur.
If hepatic dysfunction worsens or florid liver disease occurs, carbamazepine should be discontinued immediately. Kidney function It is recommended that urinary status and urea nitrogen be measured before and regularly during treatment with carbamazepine.
Hyponatremia Hyponatremia is known to occur with the use of carbamazepine. g. diuretics, medicinal products associated with inappropriate ADH secretion), the serum sodium concentration should be determined prior to treatment. Thereafter, serum sodium levels should be measured initially after approximately two weeks and then at monthly intervals for the first three months of treatment or as clinically necessary.
8); - Patients who have previously discontinued treatment with carbamazepine; - Patients with myotonic dystrophy, since cardiac conduction disorders are common in this patient group. Haematological events Agranulocytosis and aplastic anaemia have been associated with carbamazepine; however, an assessment of the risk is difficult due to the very low frequency.
0 cases per million per year for aplastic anaemia. A temporary or permanent reduction in the number of blood platelets or the number of white blood cells is uncommon to common with carbamazepine. In the majority of cases this is transient and does not predict the onset of agranulocytosis or aplastic anaemia.
However, blood counts (including platelets and reticulocytes and serum iron) should be checked prior to treatment with carbamzepine, then at weekly intervals during the first month of treatment, and then at monthly intervals. After 6 months of treatment, checks 2 to 4 times a year are sometimes sufficient.
Patients should be alerted to early signs of potential haematologic problems and likewise to symptoms of dermatologic and hepatic reactions. If reactions such as fever, sore throat, allergic skin reactions such as rash with lymph node swelling and/or flu-like illness symptoms, ulcers in the mouth, haematoma tendency, petechial or purpuric haemorrhages occur during treatment with carbamazepine, the patient should immediately consult the physician and the blood count should be determined.
Discontinuation of carbamzepine may be required if certain blood count abnormalities (especially leukocytopenia and thrombocytopenia) occur; this is always the case if symptoms such as allergic symptoms, fever, sore throat or skin bleeding occur at the same time.
3% = 20,000/mm3; - Increase in serum iron over 150 micrograms%. Discontinuation of carbamazepine required for: - Petechial or purpuric bleeding; - Decrease in erythrocytes below 4 million/mm3; - Decrease in hematocrit below 32%; - Decrease in hemoglobin below 11 g%; - Decrease in leukocytes below 2,000/mm3 or granulocytes below 1,000/mm3 or thrombocytes below 80,000/mm3; - Symptomatic blood disorders.
g. g. acute intermittent porphyria, variegata porphyria, porphyria cutanea tarda); - Concomitant treatment with a monoamine oxidase inhibitor.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The following dosage recommendations apply:
Epilepsy: In general, in adults the initial dose of 1 to 2 prolonged-release tablets of carbamazepine (equivalent to 200 to 400 mg carbamazepine/day) is slowly increased to the maintenance dose of 4 to 6 prolonged-release tablets of carbamazepine (equivalent to 800 to 1,200 mg carbamazepine).
In general, the maintenance dose for children is an average of 10 to 20 mg carbamazepine/kg bodyweight/day. For recommended dosing schedule, see above.
Trigeminal neuralgia:
The daily dose is increased from an initial dose of 1 to 2 prolonged-release tablets of carbamazepine 200mg (corresponding to 200 to 400mg carbamazepine) to an average of 2 to 4 prolonged-release tablets of carbamazepine 200mg (corresponding to 400 to 800mg carbamazepine) – divided into 1 to 2 doses - until freedom from pain is achieved.
Subsequently, in some cases, it is possible to continue treatment with a lower maintenance dose of 1 prolonged-release tablet of carbamazepine 200mg (corresponding to 400mg carbamazepine) twice daily. The maximum recommended dose is 1,200mg/day.
Once pain relief has been achieved, an attempt should be made to gradually discontinue therapy until another pain episode occurs. Elderly and sensitive patients In elderly and sensitive patients, an initial dose of 1 prolonged-release tablet (equivalent to 200 mg carbamazepine) in the morning or evening is sufficient.
Prophylaxis of manic depressive psychoses in patients unresponsive to lithium therapy: The initial dose, which is usually also sufficient as a maintenance dose, is 1 to 2 prolonged-release tablets of carbamazepine 200mg (equivalent to 200 to 400mg carbamazepine) daily.
If necessary, the dose can be increased to 2 prolonged-release tablets of carbamazepine 200mg (equivalent to 800mg carbamazepine) twice a day. Elderly and patients with severe cardiovascular disease, liver and kidney disease A lower dosage is indicated in patients with severe cardiovascular disease, liver and kidney disease and in the elderly.
Method of administration The prolonged-release tablets should be swallowed whole and not chewed or crushed. g. 1 glass of water) during or after meals. In some cases, dividing the daily dose into 4 to 5 individual doses has proven to be particularly effective.
In these cases, immediate release formulations of carbamazepine are preferable to prolonged release formulations. The duration of use depends on the respective indication and the individual reaction of the patient. In any case, this medicine must not be discontinued by the patient on their own initiative.
The duration of use varies individually and is determined by the attending physician. Antiepileptic therapy is basically a long-term therapy. The adjustment duration of treatment and discontinuation of carbamazepine should be decided on a case-by-case basis by a specialist experienced in the treatment of epilepsy.
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The risk factors mentioned above occur particularly in elderly patients. If hyponatremia is detected, fluid restriction is an important countermeasure when clinically indicated. Hypothyroidism Carbamazepine may reduce serum concentrations of thyroid hormones through enzyme induction, necessitating an increase in the dose of thyroid hormone replacement therapy in patients with hypothyroidism.
Therefore, monitoring of thyroid function is recommended to adjust the dosage of thyroid hormone replacement therapy. Anticholinergic effects Carbamazepine has weak anticholinergic activity. 8 Undesirable effects). Psychiatric Reactions The possibility of activation of latent psychoses and, especially in elderly patients, the occurrence of states of confusion or agitation should always be taken into account.
Suicidal thoughts and suicidal behavior Suicidal ideation and behavior have been reported in patients treated with antiepileptic medicinal products for various indications. A meta-analysis of randomized placebo-controlled trials of antiepileptic drugs also showed a slightly increased risk for the occurrence of suicidal ideation and behavior.
The mechanism for triggering this side effect is not known and the available data do not exclude the possibility of an increased risk when taking carbamazepine. Therefore, patients should be monitored for signs of suicidal ideation and behavior and appropriate treatment should be considered.
Patients (and their caregivers) should be advised to seek medical help if signs of suicidal thoughts or behavior occur. 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 women 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.
Hormonal contraceptives Breakthrough bleeding has been reported in patients treated with carbamazepine and using hormonal contraceptives (the "pill") at the same time. The reliability of hormonal contraception with estrogen and/or progesterone derivatives can be negatively influenced or even eliminated due to the enzyme-inducing properties of carbamazepine.
Therefore, alternative, non-hormonal methods of contraception […]
Severe skin reactions Cases of life-threatening skin reactions (Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported in association with the use of carbamazepine. Patients should be informed of the signs and symptoms of these serious adverse reactions and monitored closely for the occurrence of skin reactions.
The risk for the occurrence of SJS or TEN is highest during the first few weeks of treatment. , a progressive rash, often with blistering or accompanying mucosal lesions), therapy with carbamazepine must be discontinued. e. early discontinuation improves the prognosis.
After the occurrence of SJS or TEN associated with the use of carbamazepine, the patient must never be treated with carbamazepine again. Serious and sometimes fatal cutaneous reactions including toxic epidermal necrolysis (TEN) and Stevens- Johnson Syndrome (SJS), are estimated to occur in 1 to 6 in 10,000 new users in predominantly Caucasian countries, but in some Asian countries the risk is estimated to be about 10 times higher.
2). g. 8). The frequency of the HLA-A*3101 allele shows strong variation between different population groups. The HLA-A*3101 allele has a prevalence of 2% to 5% in the European population and about 10% in the Japanese population. 8%. There are insufficient data to recommend testing for the presence of the HLA-A*3101 allele prior to initiating carbamazepine treatment.
If patients of European or Japanese origin are known to carry the HLA- A*3101 allele, the use of carbamazepine may be considered if the expected benefit outweighs the risk. Allele HLA-B*1502 in Han Chinese, Thai and other Asians Population groups It has been demonstrated that the presence of the HLA-B*1502 allele in individuals of Han Chinese or Thai descent is strongly associated with the risk of developing severe skin reactions, namely Stevens-Johnson Syndrome.
The prevalence of carriers of […]