Information about FINLEPSIN UNI
The composition:
Each tablet contains: Carbamazepine 200 mg.
Mechanism of Action:
Carbamazepine has demonstrated anticonvulsant properties. It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation. Carbamazepine greatly reduces or abolishes pain induced by stimulation of the infraorbital nerve in cats and rats. It depresses thalamic potential and bulbar and polysynaptic reflexes, including the linguomandibular reflex in cats.
Pharmacokinetics:
Carbamazepine in blood is 76% bound to plasma proteins. Plasma levels of Carbamazepine are variable and may range from 0.5 to 25 mcg/mL.
Indications:
Epilepsy: Carbamazepine is indicated for use as an anticonvulsant drug. In patients with the following seizure types:
1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types.
2. Generalized tonic-clonic seizures (grand mal).
3. Mixed seizure patterns, which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by Carbamazepine.
Trigeminal Neuralgia: Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia.
This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
Bipolar disorder: Carbamazepine is used to treat or prevent the manic episodes associated with bipolar disorder.
Pregnancy, Category D:
Carbamazepine can cause fetal harm when administered to a pregnant woman.
Epidemiological data suggest that there may be an association between the use of carbamazepine during pregnancy and congenital malformations, including spina bifida.
Antiepileptic drugs should not be discontinued abruptly in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.
Nursing Mothers:
Carbamazepine and its epoxide metabolite are transferred to breast milk.
Because of the potential for serious adverse reactions in nursing infants from carbamazepine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Dosage and administration:
1. Epilepsy:
Adults and children over 12 years of age:
• Initial: 200 mg b.i.d. for tablets. Increase at weekly intervals by adding up to 200 mg/day using q.i.d. regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances.
• Maintenance: Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.
Children 6 to 12 years of age:
• Initial: 100 mg b.i.d. for tablets. Increase at weekly intervals by adding up to 100 mg/day using a t.i.d. or q.i.d. regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily.
• Maintenance: Adjust dosage to the minimum effective level, usually 400 to 800 mg daily.
Children under 6 years of age:
• Initial: 10 to 20 mg/kg/day b.i.d. or t.i.d. as tablets. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d.
• Maintenance: optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made.
Combination Therapy: Carbamazepine may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased.
2. Trigeminal Neuralgia:
• Initial: On the first day, either 100 mg b.i.d. for tablets. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets, only as needed to achieve freedom from pain. Do not exceed 1200 mg daily.
• Maintenance: Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.
Storage conditions:
Store at a temperature not exceeding 30° C, protect from moisture.
How supplied:
Carton pack of 50 tablets.