Lamitor pills 50 mg 50 pcs
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Active ingredients
Lamotrigine
Release form
Pills
Composition
Tablets 1 tab. lamotrigine * 25 mg.
Pharmacological effect
Anticonvulsant (antiepileptic) drug. The blocker voltage-dependent sodium channels. Causes a block of pulsed discharges in the culture of neurons and inhibits the excessive release of glutamate (amino acids that play a key role in generating epileptic seizures) along with the inhibition of glutamate-induced effector pulses.
Pharmacokinetics
Absorption: After oral administration, lamotrigine is rapidly and completely absorbed from the gastrointestinal tract. Cmax in plasma is observed 2.5 ± 1.5 h after oral administration. The time to reach Cmax is somewhat longer in the case of taking the drug after a meal, but the degree of absorption remains unchanged. Pharmacokinetics is linear up to a dose of 450 mg - the maximum single dose that has been studied. There are significant individual differences in the Cmax values of the drug, but individual concentrations differ very little. Distribution: Plasma protein binding is approximately 55%. Metabolism: Metabolized in the liver to form predominantly glucuronides. Withdrawal: T1 / 2 in healthy adults is 24-35 hours. The average clearance values in healthy people are 39 ± 14 ml / min. Lamotrigine is excreted in the urine as glucuronides. Less than 10% is excreted unchanged in the urine. Only 2% of metabolic products are excreted in the feces. Pharmacokinetics in special clinical situations: T1 / 2 lamotrigine largely depends on concomitant drug therapy. T1 / 2 lamotrigine is reduced to 14 hours when it is combined with drugs that induce the activity of cytochrome P450 isoenzymes, such as carbamazepine and phenytoin, and increases on average to about 70 hours when combined with sodium valproate. T1 / 2 lamotrigine in children is usually shorter than in adults. T1 / 2 in children is approximately 7 hours when taken with drugs that induce the activity of isoenzymes, such as carbamazepine, phenytoin, phenobarbital and primidone. T1 / 2 increases to 45-55 hours when combined with sodium valproate. A study of the pharmacokinetics of lamotrigine in single doses in patients with kidney disease suggests that the pharmacokinetic parameters change slightly, but the concentration of the main metabolite as glucuronide increases almost 8 times due to a decrease in renal clearance.
Indications
Lamitor is recommended as monotherapy and adjuvant therapy for adults and children over 12 years old: - simple partial seizures - complex partial seizures - secondary generalized tonic-clonic seizures - primary generalized tonic-clonic seizures - typical abscesses - atypical abscesses - myoclonic seizures - seizures resistant to other antiepileptic drugs of any type. Lamitor is also used as an adjuvant therapy for children aged 2 to 12 years.
Contraindications
- severe liver dysfunction - hypersensitivity to lamotrigine and other components of the drug.
Use during pregnancy and lactation
The drug should not be prescribed during pregnancy and lactation, except in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus and child.
Dosage and administration
The initial dose of Lamitor for adults and children over 12 years old, not taking sodium valproate, but taking other antiepileptic drugs that induce isoenzymes is 50 mg 1 time / day for the first 2 weeks and 100 mg / day (2 doses) for the next 2 weeks. Then the dose should be increased to 200-400 mg / day (in 2 doses). The initial dose of Lamitor for patients taking sodium valproate in combination with other antiepileptic drugs that induce isoenzymes is 25 mg every other day for the first 2 weeks and then 25 mg 1 time / day for the next 2 weeks. Then the dose should be increased to achieve the optimal therapeutic effect. Maintenance dose - 100-200 mg (in 1 or 2 doses). The initial dose of Lamitor for children from 2 to 12 years old, not taking sodium valproate, but taking other antiepileptic drugs that induce isoenzymes is 2 mg / kg / day (in 2 doses) for the first 2 weeks and 5 mg / kg / day ( in 2 doses) over the next 2 weeks. Maintenance dose - 5-15 mg / kg / day (in 2 doses). The initial dose of Lamitor for children taking sodium valproate in combination with other antiepileptic drugs that induce isoenzymes is 0.2 mg / kg 1 time / day for the first 2 weeks, then 0.5 mg / kg 1 time / day for the next 2 weeks.Then the dose should be increased to achieve the optimal therapeutic effect. Maintenance dose - 1-5 mg / kg (in 1 or 2 doses).
Side effects
Side effects observed in the appointment of Lamitor as a monotherapy. From the side of the central nervous system: dizziness, headache, drowsiness, sleep disturbance, fatigue. On the part of the digestive system: nausea. Allergic reactions: maculo-papular skin rash (2%), most often observed in the first 4 weeks after the start of treatment and disappears after discontinuation of the drug. In some cases, Stevens-Johnson syndrome, angioedema, toxic epidermal necrolysis. Side effects that occur when prescribing Lamitor as an additional therapy to standard antiepileptic drugs From the central nervous system: dizziness, headache, drowsiness, imbalance, fatigue, irritability, aggressiveness, tremor, confusion. On the part of the organ of vision: diplopia, impaired visual acuity. From the hematopoietic system: neutropenia, leukopenia. On the part of the digestive system: nausea, vomiting, dyspeptic phenomena.
Overdose
Symptoms: nystagmus, ataxia, dizziness, drowsiness, headache, nausea, loss of consciousness, coma. Treatment: gastric lavage, taking activated charcoal. If necessary, conduct symptomatic therapy.
Interaction with other drugs
With simultaneous use with antiepileptic drugs that induce liver isoenzymes (phenytoin, carbamazepine, phenobarbital, primidone), Lamitor metabolism increases, which may require an increase in its dose. Sodium valproate, competing with lamotrigine for liver metabolizing isoenzymes, inhibits its metabolism. There is no evidence that Lamitor is able to induce or inhibit liver isoenzymes that metabolize other drugs. Lamitor can induce its own metabolism, but this effect is very slight and does not cause serious clinical manifestations. Although some patients show changes in the concentration of other antiepileptic drugs in plasma, controlled studies have not confirmed the effects of Lamitor on the levels of simultaneously taken antiepileptic drugs in plasma. Data from in vitro studies indicate that Lamitor does not compete with other antiepileptic drugs for plasma protein binding sites.
special instructions
Information on the use of Lamitor in elderly patients is limited. Therefore, with caution should appoint a drug in this category of patients. If you exceed the dose of Lamitor may develop skin rash (in this situation, the drug should be discontinued). In some cases, the appointment of the drug may develop severe skin rash (including Stevens-Johnson syndrome). Such reactions often develop in children. Lamitor should be canceled at the first sign of a rash. The risk of such complications increases when Lamitor is prescribed simultaneously with sodium valproate and if the dose of Lamitor used exceeds the recommended initial and maximum daily dose. With the development of skin rash, the use of the drug should be stopped immediately. The use of Lamitor may develop such symptoms of hypersensitivity (in some cases up to the development of a fatal outcome), such as fever, malaise, cold symptoms, drowsiness, lymphadenopathy, swelling of the face, and in very rare cases, liver dysfunction, blood disorders (leukopenia and thrombocytopenia) . In most patients, these symptoms disappear after the abolition of Lamitor. When a rash, chill, cold symptoms, drowsiness, deterioration of seizure control (especially during the first month) occur during the use of the drug, liver function tests, kidney function indicators, and blood clotting should be monitored. With the abrupt cancellation of Lamitor possible increased seizures. The dose of Lamitor should be reduced gradually over a period of 2 weeks. In patients with impaired renal function in the terminal stage of the disease, an accumulation of the metabolite in the form of a glucuronide should be expected. Therefore, if necessary, the appointment of such patients should be careful. Impact on the ability to drive vehicles and control mechanisms The question of the ability to drive vehicles and work with moving machinery during the reception of Lamitor is solved individually, taking into account the clinical situation.