Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
Anticonvulsants. The mechanism of action is associated with the influence on the potential-dependent sodium channels of the presynaptic membrane. This leads to a decrease in the release into the synaptic cleft of mediators, primarily glutamate, an excitatory amino acid that plays an important role in the formation of epileptic discharges in the brain.
PHARMACOKINETICS
After ingestion lamotrigine quickly and completely absorbed from the digestive tract. C max in plasma is reached after about 2.5 hours. Binding to plasma proteins is 55%. It is subject to intensive metabolism with the formation of the main metabolite of N-glucuronide.
T 1/2 in adults is an average of 29 hours. It is excreted by the kidneys mainly in the form of a metabolite; about 8% of the active substance is excreted unchanged.
T 1/2 in children is less than in adults.
INDICATIONS
Partial and generalized tonic-clonic convulsive seizures (more often in cases of resistance to treatment with other anticonvulsants).
DOSING MODE
When administered orally for adults and children over 12 years of age, the initial single dose is 25-50 mg, maintaining doses - 100-200 mg / day. In rare cases, doses of 500-700 mg / day may be required.
For children aged 2 to 12 years, the initial dose is 0.2-2 mg / kg / day, maintaining - 1-15 mg / kg / day.
The maximum daily dose for children aged 2 to 12 years, depending on the treatment regimen used, is 200-400 mg.
The frequency of admission, intervals between doses when the dose increases, depends on the treatment regimen used, the patient's response to ongoing treatment.
SIDE EFFECT
From the side of the central nervous system: headache, dizziness, drowsiness, sleep disorders, fatigue, aggressiveness, confusion.
On the part of the digestive system: nausea, liver function disorders.
On the part of the hematopoiesis system: leukopenia, thrombocytopenia.
Allergic reactions: skin rash (usually maculopapular), angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, lymphadenopathy.
CONTRAINDICATIONS
Severe violations of the liver, increased sensitivity to lamotrigine.
PREGNANCY AND LACTATION
Clinical data on the safety of lamotrigine during pregnancy and lactation are not sufficient.
When deciding whether to use in pregnancy, the expected benefit of therapy for the mother and the potential risk to the fetus should be compared.
Preliminary data show that lamotrigine penetrates into breast milk in a concentration of 40-45% of the plasma concentration. A small number of infants whose mothers received lamotrigine did not experience side effects.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use with caution in patients with renal insufficiency.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe violations of liver function.
APPLICATION FOR CHILDREN
Do not use lamotrigine in children under 2 years of age.
APPLICATION IN ELDERLY PATIENTS
Do not use lamotrigine in elderly patients.
SPECIAL INSTRUCTIONS
Use with caution in patients with renal insufficiency.
Do not use lamotrigine in elderly patients.
If severe allergic skin reactions develop, lamotrigine should be discontinued.
With a sudden withdrawal of lamotrigine, the manifestation of epilepsy is possible, so it is necessary to gradually stop treatment, reducing the dose for 2 weeks.
With simultaneous application with carbamazepine, dizziness, diplopia, ataxia, visual impairment, nausea are possible. These phenomena, as a rule, take place with a decrease in the dose of carbamazepine.
Do not use lamotrigine in children under 2 years of age.
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, the speed of psychomotor reactions slows down. This should be taken into account by persons involved in potentially hazardous activities requiring increased attention and rapid psychomotor reactions.
DRUG INTERACTION
With simultaneous use with anticonvulsants - inducers of metabolism in the liver (including with phenytoin, carbamazepine, phenobarbital, primidon), metabolism of lamotrigine is accelerated. With the simultaneous use of lamotrigine and carbamazepine or phenytoin, a decrease in T 1/2 of lamotrigine occurs. There are reports of dizziness, ataxia, diplopia, blurred vision and nausea in patients taking carbamazepine after lamotrigine treatment.
Due to the inhibition of microsomal enzymes of the liver under the influence of sodium valproate, simultaneous use slows the metabolism of lamotrigine, increases T1/2 lamotrigine.
