Lamictal 25mg 30 tablets — Made in Poland — Free Delivery

Product description

Lamictal ™ tablets are used for the indications below.

Epilepsy:

• adults and children over the age of 13:
• adjunctive therapy or monotherapy for partial and generalized seizures of epilepsy, including tonic-clonic seizures;
• seizures associated with Lennox-Gastaut syndrome ("Lamictal ™" is prescribed as an additional therapy, but in Lennox-Gastaut syndrome, it can be prescribed as an initial antiepileptic preparation (PEP));
• children aged 2 to 12 years:
• adjunctive therapy for partial and generalized seizures of epilepsy, including tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome;
• monotherapy for typical absences.

Bipolar Disorder (Adults - 18+): Prevention of depressive conditions in patients with bipolar I disorder who are predominantly depressed (Lamictal ™ is not indicated for the emergency treatment of manic or depressive episodes).

Compound

The active ingredient is lamotrigine (one tablet contains lamotrigine 25 mg).

Excipients: lactose monohydrate, microcrystalline cellulose, povidone K30, sodium starch glycolate (type A), iron oxide yellow (E172), magnesium stearate.

Contraindications

"Lamictal ™" is contraindicated in patients with known hypersensitivity to lamotrigine or to any other component of the preparation.

Mode of application

Lamictal ™ tablets should be swallowed whole without chewing or breaking.

If the estimated dose of lamotrigine (for example, for the treatment of children with epilepsy or patients with impaired liver function) is not a multiple of the whole tablets, the dose that is applied should correspond to the nearest smaller number of whole tablets.

Restarting treatment

Physicians should assess the need to increase the dose to a maintenance dose when resuming Lamictal ™ for patients who, for whatever reason, have stopped taking Lamictal ™, since the risk of developing a serious rash is associated with high initial doses and exceeding the recommended dose escalation regimen. lamotrigine. The longer the period of time after taking the previous dose, the more attention should be paid to increasing the dose to a maintenance dose. If the interval from the moment of cessation of lamotrigine intake exceeds five half-lives, the dose of the preparation "Lamictal ™" should be increased to the maintenance one according to the existing scheme. It is not recommended to resume taking Lamictal ™ for patients who have stopped taking because of a rash associated with previous Lamictal ™ therapy, unless the potential benefit of treatment clearly outweighs the risk.

Epilepsy

Recommendations for dose escalation and maintenance doses for adults and children 13 years of age and older, as well as for children 2 to 12 years of age, are given below. Because of the risk of developing a rash, do not exceed the initial dose and the rate of its further increase.

When concomitant AEDs are withdrawn or other AEDs / preparations are added to treatment regimens containing lamotrigine, the effect they may have on the pharmacokinetics of lamotrigine should be considered.

Recommended treatment regimens for epilepsy for adults and children over 13 years of age:

monotherapy:

• 1st + 2nd weeks - 25 mg / day (one dose);
• 3rd + 4th weeks - 50 mg / day (one dose);
• the usual maintenance dose is 100-200 mg / day (one or two doses) (to achieve a maintenance dose, it should be increased by a maximum of 50-100 mg every one or two weeks until an optimal response is achieved; some patients required a dose of 500 mg / day to achieve the desired answer);

adjunctive therapy with valproate (an inhibitor of lamotrigine glucuronidation) (this treatment regimen involves the use of valproate, despite the use of other concomitant preparations):

• 1st + 2nd weeks - 12.5 mg / day (take 25 mg every other day);
• 3rd + 4th weeks - 25 mg / day (one dose);
• the usual maintenance dose is 100-200 mg / day (one or two doses) (to achieve a maintenance dose, it should be increased by a maximum of 25-50 mg every one or two weeks until an optimal response is achieved);

additional therapy without the use of valproate and with the use of lamotrigine glucuronidation inducers (this treatment regimen does not provide for the use of valproate, but provides for the use of: phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir / ritonavir):

• 1st + 2nd weeks - 50 mg / day (one dose);
• 3rd + 4th weeks - 100 mg / day (two doses);
• the usual maintenance dose is 200-400 mg / day (two doses) (to achieve a maintenance dose, it should be increased by a maximum of 100 mg every one or two weeks until an optimal response is achieved; some patients required a dose of 700 mg / day to achieve the desired response);

additional therapy without the use of valproate and lamotrigine glucuronidation inducers (this treatment regimen involves the use of preparations that do not show a significant inhibitory or inductive effect on hepatic enzymes):

• 1st + 2nd weeks - 25 mg / day (one dose);
• 3rd + 4th weeks - 50 mg / day (one dose);
• the usual maintenance dose is 100-200 mg / day (one or two doses) (to achieve a maintenance dose, it should be increased by a maximum of 50-100 mg every one or two weeks until an optimal response is achieved).

Patients taking preparationswith unknown effect on the pharmacokinetics of lamotrigine should use the treatment regimen recommended for the simultaneous use of lamotrigine and valproate.

Recommended treatment regimen for epilepsy for children aged 2 to 12 years:

monotherapy for typical absences:

• 1st + 2nd weeks - 0.3 mg / kg / day (one or two doses per day);
• 3rd + 4th weeks - 0.6 mg / kg / day (one or two doses per day);
• the usual maintenance dose is 1-15 mg / g / day (one or two doses per day) (to achieve a maintenance dose, it should be increased by a maximum of 0.6 mg / kg / day every one or two weeks until an optimal response is achieved, maximum maintenance dose - 200 mg / day);

adjunctive therapy with valproate (an inhibitor of lamotrigine glucuronidation) (this treatment regimen involves the use of valproate, despite the use of other concomitant preparations):

• 1st + 2nd weeks - 0.15 mg / kg / day (one dose per day);
• 3rd + 4th weeks - 0.3 mg / kg / day (one dose per day);
• the usual maintenance dose is 1-5 mg / kg / day (one or two doses per day) (to achieve a maintenance dose, it should be increased by a maximum of 0.3 mg / kg / day every one or two weeks until an optimal response is achieved, maximum maintenance dose - 200 mg / day);

additional therapy without the use of valproate and with the use of lamotrigine glucuronidation inducers (this treatment regimen does not include the use of valproate, but involves the use of phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir / ritonavir):

• 1st + 2nd weeks - 0.6 mg / kg / day (two doses);
• 3rd + 4th weeks - 1.2 mg / kg / day (two doses);
• the usual maintenance dose is 5-15 mg / kg / day (one or two doses) (to achieve a maintenance dose, it should be increased by a maximum of 1.2 mg / kg / day every one or two weeks until an optimal response is achieved, the maximum maintenance dose is 400 mg / day);

additional therapy without the use of valproate and lamotrigine glucuronidation inducers (this treatment regimen involves the use of preparations that do not have a significant inhibitory or inductive effect on hepatic enzymes):

• 1st + 2nd weeks - 0.3 mg / kg / day (one or two doses);
• 3rd + 4th weeks - 0.6 mg / kg / day (one or two doses);
• the usual maintenance dose is 1-10 mg / kg / day (one or two doses) (to achieve a maintenance dose, it should be increased by a maximum of 0.6 mg / kg / day every one or two weeks until an optimal response is achieved, the maximum maintenance dose is 200 mg / day).

Patients taking preparations with unknown effects on the pharmacokinetics of lamotrigine should be treated with a treatment regimen that is recommended for the concomitant use of lamotrigine and valproate.

To ensure the maintenance of the therapeutic dose, it is necessary to control the child's body weight and change the dose in the event of a change in body weight. It is likely that patients between the ages of two and six years require a maintenance dose approaching the upper end of the recommended range.

If epileptic control is achieved with the help of additional therapy, the use of concomitant AEDs can be canceled and monotherapy with Lamictal ™ can be continued.

Children under 2 years old. There are limited data on the efficacy and safety of lamotrigine for the adjunctive therapy of partial seizures in children aged 1 month to 2 years. There are no data on the use of lamotrigine in children under 1 month of age. Therefore, "Lamictal ™" is not recommended for use in children under the age of 2 years.

Bipolar disorder

The recommended dose increases for adults over 18 years of age are shown below. The transition regimen includes increasing the dose of lamotrigine to a maintenance stabilization dose for six weeks, after which other psychotropic and / or antiepileptic preparations can be canceled if clinically appropriate. Because of the risk of rash, the starting dose and the rate of further dose escalation should not be exceeded.

The recommended dose escalation regimen until the maintenance stabilization daily dose is reached in the treatment of bipolar disorders in adults (over 18 years of age):

monotherapy with lamotrigine or additional therapy without the use of valproate and inducers of lamotrigine glucuronidation (this treatment regimen involves the use of preparations that do not show a significant inhibitory or inductive effect on hepatic enzymes):

• 1st + 2nd weeks - 25 mg / day (one dose);
• 3rd + 4th weeks - 50 mg / day (one or two doses);
• 5th week - 100 mg / day (one or two doses);
• target stabilization dose (6th week) - 200 mg / day - the usual target dose for obtaining an optimal response (one or two doses) (in clinical studies, doses in the range of 100-400 mg / day were used);

adjunctive therapy with valproate (an inhibitor of lamotrigine glucuronidation) (this treatment regimen involves the use of valproate, despite the use of other concomitant preparations):

• 1st + 2nd weeks - 12.5 mg / day (25 mg every other day);
• 3rd + 4th weeks - 25 mg / day (one dose);
• 5th week - 50 mg / day (one or two doses);
• target stabilization dose (6th week) - 100 mg / day - the usual target dose to obtain an optimal response (one or two doses) (you can use a maximum dose of 200 mg / day, depending on the clinical response);

additional therapy without the use of valproate and with the use of lamotrigine glucuronidation inducers (this treatment regimen does not include the use of valproate, but involves the use of phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir / ritonavir):

• 1st + 2nd weeks - 50 mg / day (one dose);
• 3rd + 4th weeks - 100 mg / day (two doses);
• 5th week - 200 mg / day (two doses);
• target stabilization dose (week 6) - 300 mg / day at week 6, if necessary, the usual target dose of 400 mg / day is increased at week 7 to achieve an optimal response (two doses).

Patients taking medications with unknown effect on the pharmacokinetics of lamotrigine should use the dose escalation regimen recommended for concomitant use of lamotrigine with valproate.

Maintenance stabilization daily dose after discontinuation of concomitant medications for the treatment of bipolar disorders in adults (over 18 years of age). After reaching the required maintenance stabilization dose, other psychotropic preparations can be canceled according to special schemes.

Children (under 18). This preparationis not recommended for use in children with bipolar disorder (under 18 years of age) because randomized withdrawal trials have not shown significant efficacy and have shown an increase in suicidality rates.

Application features

Pregnant

A large amount of data on pregnant women who received lamotrigine monotherapy during the first trimester of pregnancy (more than 8700) do not indicate a significant increase in the risk of serious congenital malformations, including oral gaps. If therapy with the preparation "Lamictal ™" is considered necessary during pregnancy, it is recommended to use it in the lowest possible therapeutic dose.

Various concentrations of lamotrigine have been reported to pass into breast milk, with the result that the total concentration of lamotrigine in a newborn can reach approximately 50% of the concentration of lamotrigine recorded in the mother. Thus, in some breastfed infants, serum lamotrigine concentrations may reach levels at which pharmacological effects appear. The potential benefits of breastfeeding must be weighed against the risk of side effects in the infant. If a woman receiving lamotrigine treatment decides to breastfeed, the baby should be closely monitored and monitored for adverse events such as sedation, rash, and insufficient weight gain.

Animal studies have shown no effect of lamotrigine on fertility.

Drivers

Two studies involving volunteers found that the effects of lamotrigine on visual coordination, eye movement, body control, and subjective sedation were similar to those of placebo. When using lamotrigine in clinical trials, neurological adverse reactions, such as dizziness and diplopia, have been reported, so patients should first assess their own response to lamotrigine treatment before driving or operating other mechanisms. Since there is an individual reaction to antiepileptic preparations, the patient should consult a doctor about the peculiarities of driving in these cases.

Overdose

Symptoms and Signs

There are reports of cases of acute overdose (when taking doses that are 10-20 times higher than the maximum therapeutic dose), including deaths. Overdose symptoms were ataxia, nystagmus, impaired consciousness, major seizures, and coma. Also, in case of an overdose, it was reported about the expansion of the QRS complex (delayed intraventricular conduction). Expansion of the QRS complex to more than 100 msec may be associated with more severe toxicity.

Treatment

In case of overdose, the patient must be hospitalized for appropriate supportive therapy. It is necessary to apply therapy aimed at reducing absorption (activated carbon), if necessary. Additional treatment is prescribed according to clinical indications. There is no experience in the use of hemodialysis for the treatment of overdose. In six volunteers with renal insufficiency, 20% of lamotrigine was excreted during a 4-hour hemodialysis session.

Side effects

Psychiatric disorders: very often (≥ 1/10) - aggression, irritability.

From the nervous system: very often (≥ 1/10) - headache; often (≥ 1/100, <1/10) - drowsiness, dizziness, tremors, insomnia, anxiety.

From the gastrointestinal tract: often (≥ 1/100, <1/10) - nausea, vomiting, diarrhea, dry mouth.

On the part of the skin and subcutaneous tissue: very often (≥ 1/10) - skin rash.

On the part of skeletal muscles and connective tissue: often (≥ 1/100, <1/10) - arthralgia.

Storage conditions

Store at temperatures below 30 ° C, out of reach of children.

Shelf life is 3 years.