Lamotrigine | Lameolep tablets 50 mg, 30 pcs.
Special Price
$28.13
Regular Price
$37.00
In stock
SKU
BID463837
Release form
Tablets are white or almost white, biconvex, engraved with L50 on one side.
Tablets are white or almost white, biconvex, engraved with L50 on one side.
Release form
Tablets are white or almost white, biconvex, engraved with L50 on one side.
Packing
10 pcs. - blisters (3) - packs of cardboard.
Pharmacological action
Antiepileptic drug. Stabilizes the voltage-dependent sodium channels of cell membranes. It blocks the release of neurotransmitters, mainly glutamine amino acid (which plays a key role in the development of epileptic seizures).
Pharmacokinetics
Absorption
After oral administration, it is rapidly and completely absorbed from the intestine and is not significantly affected by the first passage. Cmax is reached 2.5 hours after ingestion. Eating slows down the absorption process, but does not affect its effectiveness. Bioavailability is 98%. The pharmacokinetics of the drug after a single dose in a dose not exceeding 450 mg is linear. Concentration in an equilibrium state has a pronounced individual character.
Distribution of
Protein binding is 55%. It is unlikely that squeezing lamotrigine out of association with proteins can cause a toxic effect. Vd is 0.92-1.22 l / kg body weight. Excreted in breast milk. Concentration in breast milk is 40-60% of the plasma concentration. In some cases, the concentration of the drug in the blood serum of infants whose mothers took the drug during lactation reaches a therapeutic level.
Metabolism
Biotransformed in the liver under the influence of uridine diphosphate glucuronyl transferase. Among the metabolites, N-glucuronides predominate. Lamotrigine moderately and dose-dependently induces its own metabolism.
Excretion of
The average equilibrium clearance in healthy adults is 39 ± 14 ml / min. It is excreted together with urine in the form of a glucuronide conjugate, less than 10% - unchanged, about 2% (unchanged and metabolites) - with feces. The clearance and T1 / 2 are dose-independent. T1 / 2 of healthy volunteers is 24-35 hours.
Pharmacokinetics in special clinical cases
The clearance, calculated per kg of body weight, is higher in children than in adults and is highest up to 5- summer age. T1 / 2 in children is usually shorter than in adults.
T1 / 2 in children with simultaneous use with enzyme inducers is 7 hours, with sodium valproate - 45-60 hours.
Lamotrigine clearance in the elderly and younger patients is minimally different from each other.
Indications
Epilepsy
for adults and children over 12 years of age
as monotherapy or in combination with other antiepileptic drugs for the treatment of partial and generalized seizures (incl. tonic-clonic seizures and seizures in Lennox-Gastaut syndrome)
for children from 2 to 12 years of age
as part of combination therapy for the treatment of partial and generalized seizures (including tonic-clonic seizures and seizures in Lennox-Gastaut syndrome )
Bipolar disorder
for adults (18 years of age and older)
for the prevention and treatment of mainly episodes of depression.
Contraindications
children under 2 years of age
pregnancy
lactation (breastfeeding)
hypersensitivity to lamotrigine or any component of the drug.
Caution is advised to administer the drug to patients with renal failure (due to the possible cumulation of glucuronide metabolite).
Use caution in prescribing the drug to children as the drug of choice for monotherapy of epilepsy.
Use in case of impaired liver function
For impaired liver function of moderate degree (class B on the Child-Pugh scale), the initial, increasing and maintenance doses should be reduced by approximately 50%, in severe cases (class C on the Child-Pugh scale) - by 75 % Increasing and maintenance doses should be adjusted according to the clinical effect.
Use in cases of impaired renal function
Caution should be exercised when administering the drug to patients with renal failure.
Use in children
With caution, prescribe the drug to children as the drug of choice for monotherapy of epilepsy. Contraindication: children under 2 years old.
Use in elderly patients
Correction of the dosage regimen in elderly patients (over 65 years) is not required (since the pharmacokinetics in this age group are not different from those in adults).
Use during pregnancy and lactation
Lameolep is contraindicated in pregnancy, unless the expected therapeutic benefit to the mother outweighs the potential risk to the fetus. Due to the inhibitory effect of lamotrigine on dihydrofolate reductase, the development of fetal malformations during the use of the drug during pregnancy is likely, however, currently available data are insufficient to determine the degree of safety.
Data on the use of the drug during breastfeeding is limited. In some cases, the concentration of the drug in the blood serum of infants whose mothers took the drug during lactation, reaches a therapeutic level. When using the drug during lactation, the benefits of breastfeeding and the likelihood of side effects in the child should be carefully weighed.
Special instructions
There is no evidence to support the clinically significant inducing and inhibitory effects of lamotrigine on oxidative enzymes in the liver. The ability of the drug to induce its own metabolism is small and probably does not have clinical significance.
Lameolef should not be prescribed concurrently with other drugs containing lamotrigine.
If Lameolep provides good control of epilepsy attacks, you can stop taking other antiepileptic drugs.
An objective criterion for the effectiveness of treatment is the ability to reduce the frequency of peaks on the EEG by 78-98%.
In the first 8 weeks of treatment, skin reactions may develop. Skin rashes are usually mild and disappear spontaneously. Perhaps the development of severe forms requiring hospitalization and discontinuation of lamotrigine therapy (for example, Stevens-Johnson syndrome and toxic epidermal necrolysis). The use of the drug in high initial doses and the acceleration of the recommended rate of increase in the dose of lamotrigine, as well as the simultaneous administration of valproic acid preparations contribute to the appearance of a skin rash. To reduce the likelihood of developing such dermatological reactions, the indicated doses and the rate of their increase should be strictly observed.
Children are more prone to developing severe skin reactions (incidence, children requiring hospitalization is 1 / 300–1 / 100).
The early symptoms of an allergic rash are easily confused with an infectious rash, so if a fever and rash occur in the first 8 weeks of treatment, a drug reaction should be suggested.
It is important to remember that early manifestations of hypersensitivity reactions (eg, fever, lymphadenopathy) can occur without a rash. If a rash appears (regardless of the patient's age), a thorough examination of the patient should be immediately carried out and therapy with lamotrigine should be discontinued if the development of dermatological symptoms cannot be explained by another reason.
The appearance of a rash can be accompanied by various systemic manifestations of hypersensitivity (high body temperature, lymphadenopathy, facial swelling, reactions from the liver and hematopoietic system). The severity of hypersensitivity reactions can be different, sometimes it is possible to develop disseminated intravascular coagulopathy and multiple organ failure. It should be borne in mind that early signs of hypersensitivity (for example, high body temperature, lymphadenopathy) are not always accompanied by a skin rash.
Impaired liver function is usually part of hypersensitivity syndrome, but is not always accompanied by other symptoms.
Long-term treatment with lamotrigine may alter folic acid metabolism, as lamotrigine is a weak dihydrofolate reductase inhibitor. At the same time, a long, 12-month treatment with lamotrigine does not significantly affect the level of hemoglobin, the average volume of red blood cells, the concentration of folic acid in plasma and red blood cells, and after 5 years of treatment, the concentration of folic acid.
In case of lactose intolerance, it should be borne in mind that the composition of tablets containing 25 mg of lamotrigine includes 16.35 mg of lactose monohydrate containing 50 mg - 32.5 mg, 100 mg - 65 mg.
Despite the fact that when taking oral contraceptives, lamotrigine does not affect the concentration of ethinyl estradiol and levonorgestrel, irregular menstruation during lamotrigine therapy in patients taking oral contraceptives requires close attention of the attending physician.
When treating patients with renal failure undergoing hemodialysis, it should be borne in mind that on average 20% of lamotrigine is excreted from the body during 4-hour hemodialysis.
Abrupt cessation of lamotrigine treatment provokes epileptic seizures, up to status epilepticus. Therefore, with the exception of special cases (for example, the appearance of a skin rash) requiring immediate discontinuation of therapy, drug withdrawal is carried out gradually with a smooth, 2-week, dose reduction.
Severe convulsions and epileptic status can lead to the development of rhabdomyolysis, multiple organ failure, and disseminated intravascular coagulopathy, sometimes fatal. Similar cases have occurred in connection with the use of lamotrigine.
For bipolar disorders, suicidal tendency is characteristic, therefore, when prescribing the drug to patients with a suicidal tendency, careful monitoring of patients is required.
Influence on the ability to drive vehicles and operate machinery
During treatment, it is forbidden to drive a car and engage in activities that require an increased concentration of attention and speed of psychomotor reactions.
Composition
1 tab.: lamotrigine - 50 mg.
Excipients:
silicon dioxide colloidal anhydrous,
magnesium stearate,
povidone,
sodium carboxymethyl starch,
lactose monohydrate,
microcrystalline cellulose.
Dosage and administration of
Epilepsy
In adults and children over 12 years of age for monotherapy, the initial dose of Lameolep is 25 mg 1 time / day for the first 2 weeks in the next 2 weeks - 50 mg 1 time / day. In the future, every 1-2 weeks, a dose increase of 50-100 mg is possible until the optimal therapeutic effect is achieved. The maintenance dose to maintain the optimal therapeutic effect is usually 100-200 mg / day in 1-2 doses. In isolated cases, to achieve a therapeutic effect, a drug at a dose of 500 mg / day is required.
As part of combination therapy when combined with valproic acid preparations in combination with or without other antiepileptic drugs, the initial dose of Lamolep for the first 2 weeks is 25 mg every other day thereafter - 25 mg daily 1 time / day for the next 2 weeks . In the future, every 1-2 weeks, a dose increase of 25-50 mg is possible until the optimal therapeutic effect is achieved. The maintenance dose is usually 100-200 mg / day in 1-2 doses.
When using Lameolep as part of combination therapy with drugs that induce glucuronidation of lamotrigine (phenytoin, carbamazepine, phenobarbital, primidone), with or without other antiepileptic drugs (but not taking valproic acid preparations), the initial dose is 50 mg 1 during the first 2 weeks 1 once / day, then for the next 2 weeks - 100 mg / day in 2 divided doses. In the future, every 1-2 weeks, a dose increase of 100 mg is possible until the optimal therapeutic effect is achieved. The maintenance dose is usually 200-400 mg / day in 1-2 doses. In isolated cases, a dose of 700 mg / day may be required.
When used in combination with an antiepileptic drug, whose pharmacokinetic interaction with lamotrigine has not been established, the dose of Lameolep should be increased gradually (and to a lesser extent) according to the scheme described for combination therapy with sodium valproate.
Table 1. Recommended dosing regimen in the treatment of epilepsy in adults and children over 12 years of age.
Treatment option Week 1-2 Week 3-4 Maintenance dose
Monotherapy 25 mg 1 time / day 50 mg
1 time / day 100-200 mg 1 or 2 times / day to achieve a therapeutic effect, the dose can be increased by 50- 100 mg every 1-2 weeks
Combination therapy with Lameolep and valproic acid preparations, regardless of other concomitant therapy 12. 5 mg (or 25 mg every other day) 25 mg
1 time / day 100-200 mg (in 1 or 2 doses) to achieve a therapeutic effect, the dose can be increased by 25-50 mg every 1-2 weeks
Combination therapy without valproic acid preparations (with phenytoin, carbamazepine, phenobarbital, primidone or other lamotrigine glucuronidation inducers) 50 mg 1 time / day 100 mg (in 2 doses) 200-400 mg (in 2 doses) to increase the therapeutic effect, the dose is increased by 100 mg every 1-2 weeks
In combination therapy with antiepileptic drugs, pharmaco whose kinetic interaction with lamotrigine is currently unknown, the regimen should be used, recommended for prescribing lamotrigine in combination with valproic acid preparations
In children aged 2 to 12 years, as a part of combination therapy with valproic acid preparations in combination with or without other antiepileptic drugs, the initial daily dose of Lameolez during the first 2 weeks is 0.15 mg / kg body weight 1 time / day, over the next 2 weeks - 0.3 mg / kg 1 time / day. Then, every 1-2 weeks, the dose should be increased by 0.3 mg / kg until the optimal therapeutic effect is achieved. The maintenance dose averages 1-5 mg / kg / day in 1-2 doses. The maximum daily dose is 200 mg.
As part of combination therapy with other antiepileptic drugs or other drugs that induce glucuronidation of lamotrigine (phenytoin, carbamazepine, phenobarbital and primidone), in combination with or without other probes (with the exception of valproic acid preparations), the initial dose of Lamolep during the first 2 weeks is 0.6 mg / kg / day in 2 doses, then in the next 2 weeks - 1.2 mg / kg / day in 2 reception. Then, every 1-2 weeks, the dose should be increased by a maximum of 1.2 mg / kg / day, until the optimal therapeutic effect is achieved. The maintenance dose averages 5-15 mg / kg / day in 2 divided doses. The maximum daily dose is 400 mg.
When used in combination with an antiepileptic drug whose pharmacokinetic interaction with lamotrigine has not been established, the dose of Lamolep should be increased gradually (and to a lesser extent) according to the scheme described for combination therapy with sodium valproate.
table 2. Recommended dosing regimen in the treatment of children with epilepsy from 2 to 12 years old (total daily dose in mg / kg body weight).
Prescribing regimen Week 1-2 Week 3-4 Maintenance dose
Combination therapy with valproic acid preparations, regardless of other concomitant therapy 0.15 mg / kg 1 time / day 0.3 mg / kg 1 time / day * Dose increase by 0.3 mg / kg every 1-2 weeks until reaching a maintenance dose of 1-5 mg / kg / day (in 1-2 doses) to a maximum dose of 200 mg / day
Combination therapy without valproic acid preparations with phenytoin, carbamazepine, phenobarbital, primidone or other glucuronidation inducers lamotrigine 0.6 mg / kg (in 2 doses) 1.2 mg / kg (in 2 p iema) Increasing the dose to 1. 2 mg / kg every 1-2 weeks until a maintenance dose of 5-15 mg / kg / day (in 1-2 doses) is reached up to a maximum dose of 400 mg / day
In patients taking antiepileptic drugs whose pharmacokinetic interaction with lamotrigine is currently time is unknown, the regimen recommended for the appointment of lamotrigine in combination with valproic acid
preparations should be used * dose increase is carried out with whole tablets.
Bipolar Disorders
In the treatment of bipolar disorders, Lameolep is prescribed to prevent episodes of depression. Moreover, during short-term therapy, the maintenance dose of lamotrigine should be increased gradually, over a period of 6 weeks, until the patient's condition stabilizes. Then, with the appropriate clinical picture of the disease, the administration of a psychotropic or other antiepileptic drug can be stopped.
Adjuvant therapy may be required to prevent episodes of mania. the effectiveness of lamotrigine in mania and manic states is ambiguous.
Table 3. Recommended selection of a maintenance daily dose for adults (over 18 years old) for bipolar disorders.
Dosing regimen Weeks 1-2 Weeks 3-4 Week 5 Maintenance stabilizing dose (week 6)
Combination therapy with valproic acid preparations) 12.5 mg (25 mg every other day) 25 mg 1 time / day 50 mg / day (in 1- 2 doses) 100 mg / day (in 1-2 doses), maximum daily dose 200 mg
Combination therapy with lamotrigine glucuronidation inducers (without taking valproic acid preparations) 50 mg 1 time / day 100 mg / day (in 2 doses) 200 mg / day (in 2 doses) 300 mg at 6 weeks of therapy, if necessary, increase the dose to 400 mg at the 7th week of therapy (in 2 doses)
Combination therapy with drugs that do not interact with lamotrigine 25 mg 1 time / day 50 mg / day (1-2 doses) 100 mg / day (1 -2 doses) 200 mg (100 mg to 400 mg) in 1 or 2 doses of
In patients taking antiepileptic drugs, a pharmacokinet cal interaction with lamotrigine has not been studied, it is necessary to use mode recommended for the purpose of lamotrigine in combination with drugs
valproic acid in combination therapy with other antiepileptic drugs, inhibiting hepatic enzymes (for example, with valproic acid preparations), during the first 2 weeks the initial dose of Lameolep is 25 mg every other day, then during the next 2 weeks - 25 mg 1 time / day. At week 5, the dose should be increased to 50 mg / day in 1-2 doses. To achieve the optimal therapeutic effect, a dose of 100 mg / day in 1-2 doses is required. The maintenance daily dose is 1-5 mg / kg of body weight in 1-2 doses. The maximum daily dose is 200 mg.
As part of combination therapy with antiepileptic drugs that induce liver enzymes (e.g. carbamazepine, phenobarbital), in patients not receiving valproic acid, the initial dose is 50 mg 1 time / day for the next 2 weeks, then for the next 2 weeks - 100 mg / day in 2 divided doses, at week 5, the dose is increased to 200 mg / day in 2 divided doses. At week 6, the dose can be increased to 300 mg / day. At week 7, the daily dose can reach 400 mg in 2 divided doses.
With monotherapy or as part of combination therapy with drugs whose pharmacokinetic interaction with lamotrigine is unknown or possible, the initial dose of Lameolep is 25 mg 1 time / day for the first 2 weeks, then 50 mg / day in 1-2 for the next 2 weeks admission, at 5 weeks, the dose is increased to 100 mg / day in 1-2 doses. To achieve the optimal therapeutic effect, a dose of 200 mg / day in 1-2 doses is required. The maximum daily dose is 400 mg / day in 2 divided doses.
After reaching the daily maintenance stabilizing dose, other psychotropic drugs may be withdrawn.
table 4. Supportive stabilizing total daily dose for the treatment of bipolar disorders after withdrawal of concomitant psychotropic or antiepileptic drugs.
Supplementary therapy Week 1 Week 2 Week 3 onwards (max. dose 400 mg / day)
After withdrawal of lamotrigine glucuronidation inhibitors (for example, valproic acid preparations), the dose is increased by 2 times, no more than 100 mg / week, t .e. at 1 week, the dose should be 200 mg / day. Keep the dose at 200 mg / day in 2 doses of
. After withdrawal of lamotrigine glucuronidation inducers (for example, carbamazepine), depending on the initial dose. 400 mg 300 mg 200 mg
300 mg 225 mg 150 mg
200 mg 150 mg 100 mg
After withdrawal of other psychotropic or antiepileptic drugs in patients not taking inducers or inhibitors of glucuronidation of lamotrigine (for example, lithium preparations, bupropion) An adjusted dose of 200 mg / day should be prescribed (recommended dose in the range from 100 mg to 400 mg).
After discontinuation of an antiepileptic drug that does not interact with lamotrigine, it is recommended to increase the dose of Lameolep according to the scheme recommended when taking lamotrigine with valproic acid preparations
After canceling additional therapy with lamotrigine glucuronidation inhibitors (for example, valproic acid preparations), the initial stabilizing dose increases remains at this level after the abolition of valproic acid preparations.
After withdrawal of additional therapy with lamotrigine glucuronidation inducers (e.g. carbamazepine) the dose of lamotrigine is gradually reduced over 3 weeks.
After the withdrawal of concomitant psychotropic or antiepileptic drugs that do not have significant pharmacokinetic interaction with lamotrigine (for example, lithium preparations, bupropion), lamotrigine continues to be used at a dose selected during the increase regimen.
There is no clinical experience with the correction of daily doses of lamotrigine in patients with bipolar disorders after the addition of other drugs. However, based on studies on drug interactions, the following recommendations can be made.
Table 5. Correction of daily doses of lamotrigine in patients with bipolar disorder after other drugs are added to therapy.
Complementary therapy Initial dose of Lameolep (mg / day) Week 1 Week 2 Week 3 and on
After withdrawal of lamotrigine glucuronidation inhibitors (e.g. valproic acid preparations) depending on the initial dose of Lameolep 200 mg 100 mg Save dose 100 mg / day
300 mg 150 mg Save dose 150 mg / day
400 mg 200 mg Save dose 200 mg / day
Addition of lamotrigine glucuronidation inducers (e.g. carbamazepine) in patients not receiving valproic acid preparations, depending on the initial dose of Lameolep 200 mg 200 mg 300 mg 40 0 mg
150 mg 150 mg 225 mg 300 mg
100 mg 100 mg 150 mg 200 mg
Addition of other psychotropic or antiepileptic drugs with unknown pharmacokinetic interaction with lamotrigine (e.g. lithium preparations, bupropion) Dose, dosage range achieved from the increase regimen (200 mg / day) from 100 mg to 400 mg
For patients taking antiepileptic drugs whose pharmacokinetic interaction with lamotrigine is not currently known, the dosage regimen used when taking lamotrigine with valproic acid preparations is recommended
Abolition of Lamolep for bipolar disorders does not require a gradual dose reduction.
Safety and efficacy of lamotrigine in bipolar disorder in children and adolescents under 18 years of age have not been evaluated, therefore, there are no recommendations on the dosage regimen.
Tablets should be taken orally without chewing and drinking a little water.
If the calculated dose of lamotrigine cannot be divided into a whole number of tablets of a lower dosage, then the patient should be given a dose that corresponds to the closest value of the whole tablet at a lower dosage.
Correction of the dosing regimen in elderly patients (over 65 years) is not required (because the pharmacokinetics in this age group does not differ from that in adults).
In cases of moderate liver dysfunction (class B on the Child-Pugh scale), the initial, increasing and maintenance doses should be reduced by approximately 50%, and in severe cases (class C on the Child-Pugh scale) - by 75%. Increasing and maintenance doses should be adjusted according to the clinical effect.
Caution should be exercised when administering the drug to patients with renal failure. In the terminal stage of renal failure, the initial dose of lamotrigine depends on the dosage regimen of another antiepileptic drug. For patients with a significant reduction in renal function, a maintenance dose reduction may be recommended.
Side effects
Adverse reactions are presented for each indication separately, using the following conditional classification of the frequency of adverse reactions: very often (> 1/10), often (> 1 / 100.1 / 1000, <1/100), rarely (> 1/10 000,
In patients with
Co epilepsy sides of the hematopoietic system: very rarely - neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis
Allergic reactions: very often - in the first 8 weeks of treatment, a skin rash (maculopapular) that disappears after withdrawal of lamotrigine rarely - Stevens-Johnson, very rarely - hypersensitivity syndrome (including symptoms such as fever, lymphadenopathy, swelling of the face, disorders of the blood and liver function, DIC, multi-organ disorders), toxic epidermal necrolysis (Lyell's syndrome, in some cases, recovery with scarring).
From the side of the central nervous system: very often - headache often - irritability, drowsiness, insomnia, dizziness, tremor, nystagmus, ataxia, anxiety sometimes - aggressiveness very rarely - increased irritability, hallucinations, confusion, imbalance, worsening of Parkinson's disease, extrapyramidal disorders, choreoathetosis, increased frequency of convulsive seizures.
From the side of the organ of vision: very often - diplopia, blurred vision rarely - conjunctivitis.
From the digestive system: often - nausea, vomiting very rarely - increased levels of liver enzymes, impaired liver function, liver failure.
Other: often - increased fatigue very rarely - lupus-like syndrome.
In patients with bipolar disorder
In addition to the symptoms listed above, the following phenomena are also possible.
From the musculoskeletal system: often - arthralgia, myalgia, back pain.
Drug interaction
With simultaneous use, valproic acid preparations competitively block liver enzymes and interfere with lamotrigine metabolism, almost double its average T1 / 2, extending it to 70 hours.
Antiepileptic drugs-inducers of liver enzymes (such as phenazenbenzo carbenazen and primidone), as well as paracetamol stimulate the metabolism of lamotrigine and reduce its T1 / 2 by 2 times, up to 14 hours (phenytoin, carbamazepine). In patients taking carbamazepine, the introduction of lamotrigine can cause unwanted effects from the central nervous system, including dizziness, ataxia, diplopia, decreased visual acuity and nausea. Reducing the dose of carbamazepine usually leads to the disappearance of these phenomena.
With simultaneous use, lamotrigine does not affect the concentration of other antiepileptic drugs in plasma, as well as the concentration of ethinyl estradiol and levonorgestrel (which are part of the simultaneously used oral contraceptives).
With the simultaneous use of lamotrigine does not reduce the clearance of drugs in the metabolism of which CYP2D6 is involved.
With the simultaneous use of clozapine, phenelzine, risperidone, sertaline and trazodone, apparently do not affect the clearance of lamotrigine.
There is no data on the effect of lamotrigine on the pharmacokinetics of other antiepileptic drugs and on the drug interaction between it and drugs metabolized with the participation of isoenzymes of the cytochrome P450 system.
Perhaps combined with sedatives, antiepileptic and anxiolytic agents.
Overdose
Symptoms: nystagmus, ataxia, headache, vomiting, drowsiness, impaired consciousness up to coma.
Treatment: hospitalization in hospital and appropriate supportive and symptomatic therapy if necessary, gastric lavage and activated charcoal.
Storage conditions
The product should be stored in the original container in a place out of reach of children at 30 РC
Shelf life
2 years
Where Active ingredient
Lamotrigine
Pharmacy terms
Prescription
dosage form
tablets
Possible product names
LAMOLEP 0.05 N30 TABLE
Lameolep 50mg Tab. X30
Lamolep 50mg Tab. X30 (R)! Until 03.10g. /
Lamolep 50mg Tab. X30 (R)! Until 05.10g. /
Lameolep 50mg Tab. X30 (R) /! Until 09.09. /
Tablets are white or almost white, biconvex, engraved with L50 on one side.
Packing
10 pcs. - blisters (3) - packs of cardboard.
Pharmacological action
Antiepileptic drug. Stabilizes the voltage-dependent sodium channels of cell membranes. It blocks the release of neurotransmitters, mainly glutamine amino acid (which plays a key role in the development of epileptic seizures).
Pharmacokinetics
Absorption
After oral administration, it is rapidly and completely absorbed from the intestine and is not significantly affected by the first passage. Cmax is reached 2.5 hours after ingestion. Eating slows down the absorption process, but does not affect its effectiveness. Bioavailability is 98%. The pharmacokinetics of the drug after a single dose in a dose not exceeding 450 mg is linear. Concentration in an equilibrium state has a pronounced individual character.
Distribution of
Protein binding is 55%. It is unlikely that squeezing lamotrigine out of association with proteins can cause a toxic effect. Vd is 0.92-1.22 l / kg body weight. Excreted in breast milk. Concentration in breast milk is 40-60% of the plasma concentration. In some cases, the concentration of the drug in the blood serum of infants whose mothers took the drug during lactation reaches a therapeutic level.
Metabolism
Biotransformed in the liver under the influence of uridine diphosphate glucuronyl transferase. Among the metabolites, N-glucuronides predominate. Lamotrigine moderately and dose-dependently induces its own metabolism.
Excretion of
The average equilibrium clearance in healthy adults is 39 ± 14 ml / min. It is excreted together with urine in the form of a glucuronide conjugate, less than 10% - unchanged, about 2% (unchanged and metabolites) - with feces. The clearance and T1 / 2 are dose-independent. T1 / 2 of healthy volunteers is 24-35 hours.
Pharmacokinetics in special clinical cases
The clearance, calculated per kg of body weight, is higher in children than in adults and is highest up to 5- summer age. T1 / 2 in children is usually shorter than in adults.
T1 / 2 in children with simultaneous use with enzyme inducers is 7 hours, with sodium valproate - 45-60 hours.
Lamotrigine clearance in the elderly and younger patients is minimally different from each other.
Indications
Epilepsy
for adults and children over 12 years of age
as monotherapy or in combination with other antiepileptic drugs for the treatment of partial and generalized seizures (incl. tonic-clonic seizures and seizures in Lennox-Gastaut syndrome)
for children from 2 to 12 years of age
as part of combination therapy for the treatment of partial and generalized seizures (including tonic-clonic seizures and seizures in Lennox-Gastaut syndrome )
Bipolar disorder
for adults (18 years of age and older)
for the prevention and treatment of mainly episodes of depression.
Contraindications
children under 2 years of age
pregnancy
lactation (breastfeeding)
hypersensitivity to lamotrigine or any component of the drug.
Caution is advised to administer the drug to patients with renal failure (due to the possible cumulation of glucuronide metabolite).
Use caution in prescribing the drug to children as the drug of choice for monotherapy of epilepsy.
Use in case of impaired liver function
For impaired liver function of moderate degree (class B on the Child-Pugh scale), the initial, increasing and maintenance doses should be reduced by approximately 50%, in severe cases (class C on the Child-Pugh scale) - by 75 % Increasing and maintenance doses should be adjusted according to the clinical effect.
Use in cases of impaired renal function
Caution should be exercised when administering the drug to patients with renal failure.
Use in children
With caution, prescribe the drug to children as the drug of choice for monotherapy of epilepsy. Contraindication: children under 2 years old.
Use in elderly patients
Correction of the dosage regimen in elderly patients (over 65 years) is not required (since the pharmacokinetics in this age group are not different from those in adults).
Use during pregnancy and lactation
Lameolep is contraindicated in pregnancy, unless the expected therapeutic benefit to the mother outweighs the potential risk to the fetus. Due to the inhibitory effect of lamotrigine on dihydrofolate reductase, the development of fetal malformations during the use of the drug during pregnancy is likely, however, currently available data are insufficient to determine the degree of safety.
Data on the use of the drug during breastfeeding is limited. In some cases, the concentration of the drug in the blood serum of infants whose mothers took the drug during lactation, reaches a therapeutic level. When using the drug during lactation, the benefits of breastfeeding and the likelihood of side effects in the child should be carefully weighed.
Special instructions
There is no evidence to support the clinically significant inducing and inhibitory effects of lamotrigine on oxidative enzymes in the liver. The ability of the drug to induce its own metabolism is small and probably does not have clinical significance.
Lameolef should not be prescribed concurrently with other drugs containing lamotrigine.
If Lameolep provides good control of epilepsy attacks, you can stop taking other antiepileptic drugs.
An objective criterion for the effectiveness of treatment is the ability to reduce the frequency of peaks on the EEG by 78-98%.
In the first 8 weeks of treatment, skin reactions may develop. Skin rashes are usually mild and disappear spontaneously. Perhaps the development of severe forms requiring hospitalization and discontinuation of lamotrigine therapy (for example, Stevens-Johnson syndrome and toxic epidermal necrolysis). The use of the drug in high initial doses and the acceleration of the recommended rate of increase in the dose of lamotrigine, as well as the simultaneous administration of valproic acid preparations contribute to the appearance of a skin rash. To reduce the likelihood of developing such dermatological reactions, the indicated doses and the rate of their increase should be strictly observed.
Children are more prone to developing severe skin reactions (incidence, children requiring hospitalization is 1 / 300–1 / 100).
The early symptoms of an allergic rash are easily confused with an infectious rash, so if a fever and rash occur in the first 8 weeks of treatment, a drug reaction should be suggested.
It is important to remember that early manifestations of hypersensitivity reactions (eg, fever, lymphadenopathy) can occur without a rash. If a rash appears (regardless of the patient's age), a thorough examination of the patient should be immediately carried out and therapy with lamotrigine should be discontinued if the development of dermatological symptoms cannot be explained by another reason.
The appearance of a rash can be accompanied by various systemic manifestations of hypersensitivity (high body temperature, lymphadenopathy, facial swelling, reactions from the liver and hematopoietic system). The severity of hypersensitivity reactions can be different, sometimes it is possible to develop disseminated intravascular coagulopathy and multiple organ failure. It should be borne in mind that early signs of hypersensitivity (for example, high body temperature, lymphadenopathy) are not always accompanied by a skin rash.
Impaired liver function is usually part of hypersensitivity syndrome, but is not always accompanied by other symptoms.
Long-term treatment with lamotrigine may alter folic acid metabolism, as lamotrigine is a weak dihydrofolate reductase inhibitor. At the same time, a long, 12-month treatment with lamotrigine does not significantly affect the level of hemoglobin, the average volume of red blood cells, the concentration of folic acid in plasma and red blood cells, and after 5 years of treatment, the concentration of folic acid.
In case of lactose intolerance, it should be borne in mind that the composition of tablets containing 25 mg of lamotrigine includes 16.35 mg of lactose monohydrate containing 50 mg - 32.5 mg, 100 mg - 65 mg.
Despite the fact that when taking oral contraceptives, lamotrigine does not affect the concentration of ethinyl estradiol and levonorgestrel, irregular menstruation during lamotrigine therapy in patients taking oral contraceptives requires close attention of the attending physician.
When treating patients with renal failure undergoing hemodialysis, it should be borne in mind that on average 20% of lamotrigine is excreted from the body during 4-hour hemodialysis.
Abrupt cessation of lamotrigine treatment provokes epileptic seizures, up to status epilepticus. Therefore, with the exception of special cases (for example, the appearance of a skin rash) requiring immediate discontinuation of therapy, drug withdrawal is carried out gradually with a smooth, 2-week, dose reduction.
Severe convulsions and epileptic status can lead to the development of rhabdomyolysis, multiple organ failure, and disseminated intravascular coagulopathy, sometimes fatal. Similar cases have occurred in connection with the use of lamotrigine.
For bipolar disorders, suicidal tendency is characteristic, therefore, when prescribing the drug to patients with a suicidal tendency, careful monitoring of patients is required.
Influence on the ability to drive vehicles and operate machinery
During treatment, it is forbidden to drive a car and engage in activities that require an increased concentration of attention and speed of psychomotor reactions.
Composition
1 tab.: lamotrigine - 50 mg.
Excipients:
silicon dioxide colloidal anhydrous,
magnesium stearate,
povidone,
sodium carboxymethyl starch,
lactose monohydrate,
microcrystalline cellulose.
Dosage and administration of
Epilepsy
In adults and children over 12 years of age for monotherapy, the initial dose of Lameolep is 25 mg 1 time / day for the first 2 weeks in the next 2 weeks - 50 mg 1 time / day. In the future, every 1-2 weeks, a dose increase of 50-100 mg is possible until the optimal therapeutic effect is achieved. The maintenance dose to maintain the optimal therapeutic effect is usually 100-200 mg / day in 1-2 doses. In isolated cases, to achieve a therapeutic effect, a drug at a dose of 500 mg / day is required.
As part of combination therapy when combined with valproic acid preparations in combination with or without other antiepileptic drugs, the initial dose of Lamolep for the first 2 weeks is 25 mg every other day thereafter - 25 mg daily 1 time / day for the next 2 weeks . In the future, every 1-2 weeks, a dose increase of 25-50 mg is possible until the optimal therapeutic effect is achieved. The maintenance dose is usually 100-200 mg / day in 1-2 doses.
When using Lameolep as part of combination therapy with drugs that induce glucuronidation of lamotrigine (phenytoin, carbamazepine, phenobarbital, primidone), with or without other antiepileptic drugs (but not taking valproic acid preparations), the initial dose is 50 mg 1 during the first 2 weeks 1 once / day, then for the next 2 weeks - 100 mg / day in 2 divided doses. In the future, every 1-2 weeks, a dose increase of 100 mg is possible until the optimal therapeutic effect is achieved. The maintenance dose is usually 200-400 mg / day in 1-2 doses. In isolated cases, a dose of 700 mg / day may be required.
When used in combination with an antiepileptic drug, whose pharmacokinetic interaction with lamotrigine has not been established, the dose of Lameolep should be increased gradually (and to a lesser extent) according to the scheme described for combination therapy with sodium valproate.
Table 1. Recommended dosing regimen in the treatment of epilepsy in adults and children over 12 years of age.
Treatment option Week 1-2 Week 3-4 Maintenance dose
Monotherapy 25 mg 1 time / day 50 mg
1 time / day 100-200 mg 1 or 2 times / day to achieve a therapeutic effect, the dose can be increased by 50- 100 mg every 1-2 weeks
Combination therapy with Lameolep and valproic acid preparations, regardless of other concomitant therapy 12. 5 mg (or 25 mg every other day) 25 mg
1 time / day 100-200 mg (in 1 or 2 doses) to achieve a therapeutic effect, the dose can be increased by 25-50 mg every 1-2 weeks
Combination therapy without valproic acid preparations (with phenytoin, carbamazepine, phenobarbital, primidone or other lamotrigine glucuronidation inducers) 50 mg 1 time / day 100 mg (in 2 doses) 200-400 mg (in 2 doses) to increase the therapeutic effect, the dose is increased by 100 mg every 1-2 weeks
In combination therapy with antiepileptic drugs, pharmaco whose kinetic interaction with lamotrigine is currently unknown, the regimen should be used, recommended for prescribing lamotrigine in combination with valproic acid preparations
In children aged 2 to 12 years, as a part of combination therapy with valproic acid preparations in combination with or without other antiepileptic drugs, the initial daily dose of Lameolez during the first 2 weeks is 0.15 mg / kg body weight 1 time / day, over the next 2 weeks - 0.3 mg / kg 1 time / day. Then, every 1-2 weeks, the dose should be increased by 0.3 mg / kg until the optimal therapeutic effect is achieved. The maintenance dose averages 1-5 mg / kg / day in 1-2 doses. The maximum daily dose is 200 mg.
As part of combination therapy with other antiepileptic drugs or other drugs that induce glucuronidation of lamotrigine (phenytoin, carbamazepine, phenobarbital and primidone), in combination with or without other probes (with the exception of valproic acid preparations), the initial dose of Lamolep during the first 2 weeks is 0.6 mg / kg / day in 2 doses, then in the next 2 weeks - 1.2 mg / kg / day in 2 reception. Then, every 1-2 weeks, the dose should be increased by a maximum of 1.2 mg / kg / day, until the optimal therapeutic effect is achieved. The maintenance dose averages 5-15 mg / kg / day in 2 divided doses. The maximum daily dose is 400 mg.
When used in combination with an antiepileptic drug whose pharmacokinetic interaction with lamotrigine has not been established, the dose of Lamolep should be increased gradually (and to a lesser extent) according to the scheme described for combination therapy with sodium valproate.
table 2. Recommended dosing regimen in the treatment of children with epilepsy from 2 to 12 years old (total daily dose in mg / kg body weight).
Prescribing regimen Week 1-2 Week 3-4 Maintenance dose
Combination therapy with valproic acid preparations, regardless of other concomitant therapy 0.15 mg / kg 1 time / day 0.3 mg / kg 1 time / day * Dose increase by 0.3 mg / kg every 1-2 weeks until reaching a maintenance dose of 1-5 mg / kg / day (in 1-2 doses) to a maximum dose of 200 mg / day
Combination therapy without valproic acid preparations with phenytoin, carbamazepine, phenobarbital, primidone or other glucuronidation inducers lamotrigine 0.6 mg / kg (in 2 doses) 1.2 mg / kg (in 2 p iema) Increasing the dose to 1. 2 mg / kg every 1-2 weeks until a maintenance dose of 5-15 mg / kg / day (in 1-2 doses) is reached up to a maximum dose of 400 mg / day
In patients taking antiepileptic drugs whose pharmacokinetic interaction with lamotrigine is currently time is unknown, the regimen recommended for the appointment of lamotrigine in combination with valproic acid
preparations should be used * dose increase is carried out with whole tablets.
Bipolar Disorders
In the treatment of bipolar disorders, Lameolep is prescribed to prevent episodes of depression. Moreover, during short-term therapy, the maintenance dose of lamotrigine should be increased gradually, over a period of 6 weeks, until the patient's condition stabilizes. Then, with the appropriate clinical picture of the disease, the administration of a psychotropic or other antiepileptic drug can be stopped.
Adjuvant therapy may be required to prevent episodes of mania. the effectiveness of lamotrigine in mania and manic states is ambiguous.
Table 3. Recommended selection of a maintenance daily dose for adults (over 18 years old) for bipolar disorders.
Dosing regimen Weeks 1-2 Weeks 3-4 Week 5 Maintenance stabilizing dose (week 6)
Combination therapy with valproic acid preparations) 12.5 mg (25 mg every other day) 25 mg 1 time / day 50 mg / day (in 1- 2 doses) 100 mg / day (in 1-2 doses), maximum daily dose 200 mg
Combination therapy with lamotrigine glucuronidation inducers (without taking valproic acid preparations) 50 mg 1 time / day 100 mg / day (in 2 doses) 200 mg / day (in 2 doses) 300 mg at 6 weeks of therapy, if necessary, increase the dose to 400 mg at the 7th week of therapy (in 2 doses)
Combination therapy with drugs that do not interact with lamotrigine 25 mg 1 time / day 50 mg / day (1-2 doses) 100 mg / day (1 -2 doses) 200 mg (100 mg to 400 mg) in 1 or 2 doses of
In patients taking antiepileptic drugs, a pharmacokinet cal interaction with lamotrigine has not been studied, it is necessary to use mode recommended for the purpose of lamotrigine in combination with drugs
valproic acid in combination therapy with other antiepileptic drugs, inhibiting hepatic enzymes (for example, with valproic acid preparations), during the first 2 weeks the initial dose of Lameolep is 25 mg every other day, then during the next 2 weeks - 25 mg 1 time / day. At week 5, the dose should be increased to 50 mg / day in 1-2 doses. To achieve the optimal therapeutic effect, a dose of 100 mg / day in 1-2 doses is required. The maintenance daily dose is 1-5 mg / kg of body weight in 1-2 doses. The maximum daily dose is 200 mg.
As part of combination therapy with antiepileptic drugs that induce liver enzymes (e.g. carbamazepine, phenobarbital), in patients not receiving valproic acid, the initial dose is 50 mg 1 time / day for the next 2 weeks, then for the next 2 weeks - 100 mg / day in 2 divided doses, at week 5, the dose is increased to 200 mg / day in 2 divided doses. At week 6, the dose can be increased to 300 mg / day. At week 7, the daily dose can reach 400 mg in 2 divided doses.
With monotherapy or as part of combination therapy with drugs whose pharmacokinetic interaction with lamotrigine is unknown or possible, the initial dose of Lameolep is 25 mg 1 time / day for the first 2 weeks, then 50 mg / day in 1-2 for the next 2 weeks admission, at 5 weeks, the dose is increased to 100 mg / day in 1-2 doses. To achieve the optimal therapeutic effect, a dose of 200 mg / day in 1-2 doses is required. The maximum daily dose is 400 mg / day in 2 divided doses.
After reaching the daily maintenance stabilizing dose, other psychotropic drugs may be withdrawn.
table 4. Supportive stabilizing total daily dose for the treatment of bipolar disorders after withdrawal of concomitant psychotropic or antiepileptic drugs.
Supplementary therapy Week 1 Week 2 Week 3 onwards (max. dose 400 mg / day)
After withdrawal of lamotrigine glucuronidation inhibitors (for example, valproic acid preparations), the dose is increased by 2 times, no more than 100 mg / week, t .e. at 1 week, the dose should be 200 mg / day. Keep the dose at 200 mg / day in 2 doses of
. After withdrawal of lamotrigine glucuronidation inducers (for example, carbamazepine), depending on the initial dose. 400 mg 300 mg 200 mg
300 mg 225 mg 150 mg
200 mg 150 mg 100 mg
After withdrawal of other psychotropic or antiepileptic drugs in patients not taking inducers or inhibitors of glucuronidation of lamotrigine (for example, lithium preparations, bupropion) An adjusted dose of 200 mg / day should be prescribed (recommended dose in the range from 100 mg to 400 mg).
After discontinuation of an antiepileptic drug that does not interact with lamotrigine, it is recommended to increase the dose of Lameolep according to the scheme recommended when taking lamotrigine with valproic acid preparations
After canceling additional therapy with lamotrigine glucuronidation inhibitors (for example, valproic acid preparations), the initial stabilizing dose increases remains at this level after the abolition of valproic acid preparations.
After withdrawal of additional therapy with lamotrigine glucuronidation inducers (e.g. carbamazepine) the dose of lamotrigine is gradually reduced over 3 weeks.
After the withdrawal of concomitant psychotropic or antiepileptic drugs that do not have significant pharmacokinetic interaction with lamotrigine (for example, lithium preparations, bupropion), lamotrigine continues to be used at a dose selected during the increase regimen.
There is no clinical experience with the correction of daily doses of lamotrigine in patients with bipolar disorders after the addition of other drugs. However, based on studies on drug interactions, the following recommendations can be made.
Table 5. Correction of daily doses of lamotrigine in patients with bipolar disorder after other drugs are added to therapy.
Complementary therapy Initial dose of Lameolep (mg / day) Week 1 Week 2 Week 3 and on
After withdrawal of lamotrigine glucuronidation inhibitors (e.g. valproic acid preparations) depending on the initial dose of Lameolep 200 mg 100 mg Save dose 100 mg / day
300 mg 150 mg Save dose 150 mg / day
400 mg 200 mg Save dose 200 mg / day
Addition of lamotrigine glucuronidation inducers (e.g. carbamazepine) in patients not receiving valproic acid preparations, depending on the initial dose of Lameolep 200 mg 200 mg 300 mg 40 0 mg
150 mg 150 mg 225 mg 300 mg
100 mg 100 mg 150 mg 200 mg
Addition of other psychotropic or antiepileptic drugs with unknown pharmacokinetic interaction with lamotrigine (e.g. lithium preparations, bupropion) Dose, dosage range achieved from the increase regimen (200 mg / day) from 100 mg to 400 mg
For patients taking antiepileptic drugs whose pharmacokinetic interaction with lamotrigine is not currently known, the dosage regimen used when taking lamotrigine with valproic acid preparations is recommended
Abolition of Lamolep for bipolar disorders does not require a gradual dose reduction.
Safety and efficacy of lamotrigine in bipolar disorder in children and adolescents under 18 years of age have not been evaluated, therefore, there are no recommendations on the dosage regimen.
Tablets should be taken orally without chewing and drinking a little water.
If the calculated dose of lamotrigine cannot be divided into a whole number of tablets of a lower dosage, then the patient should be given a dose that corresponds to the closest value of the whole tablet at a lower dosage.
Correction of the dosing regimen in elderly patients (over 65 years) is not required (because the pharmacokinetics in this age group does not differ from that in adults).
In cases of moderate liver dysfunction (class B on the Child-Pugh scale), the initial, increasing and maintenance doses should be reduced by approximately 50%, and in severe cases (class C on the Child-Pugh scale) - by 75%. Increasing and maintenance doses should be adjusted according to the clinical effect.
Caution should be exercised when administering the drug to patients with renal failure. In the terminal stage of renal failure, the initial dose of lamotrigine depends on the dosage regimen of another antiepileptic drug. For patients with a significant reduction in renal function, a maintenance dose reduction may be recommended.
Side effects
Adverse reactions are presented for each indication separately, using the following conditional classification of the frequency of adverse reactions: very often (> 1/10), often (> 1 / 100.1 / 1000, <1/100), rarely (> 1/10 000,
In patients with
Co epilepsy sides of the hematopoietic system: very rarely - neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis
Allergic reactions: very often - in the first 8 weeks of treatment, a skin rash (maculopapular) that disappears after withdrawal of lamotrigine rarely - Stevens-Johnson, very rarely - hypersensitivity syndrome (including symptoms such as fever, lymphadenopathy, swelling of the face, disorders of the blood and liver function, DIC, multi-organ disorders), toxic epidermal necrolysis (Lyell's syndrome, in some cases, recovery with scarring).
From the side of the central nervous system: very often - headache often - irritability, drowsiness, insomnia, dizziness, tremor, nystagmus, ataxia, anxiety sometimes - aggressiveness very rarely - increased irritability, hallucinations, confusion, imbalance, worsening of Parkinson's disease, extrapyramidal disorders, choreoathetosis, increased frequency of convulsive seizures.
From the side of the organ of vision: very often - diplopia, blurred vision rarely - conjunctivitis.
From the digestive system: often - nausea, vomiting very rarely - increased levels of liver enzymes, impaired liver function, liver failure.
Other: often - increased fatigue very rarely - lupus-like syndrome.
In patients with bipolar disorder
In addition to the symptoms listed above, the following phenomena are also possible.
From the musculoskeletal system: often - arthralgia, myalgia, back pain.
Drug interaction
With simultaneous use, valproic acid preparations competitively block liver enzymes and interfere with lamotrigine metabolism, almost double its average T1 / 2, extending it to 70 hours.
Antiepileptic drugs-inducers of liver enzymes (such as phenazenbenzo carbenazen and primidone), as well as paracetamol stimulate the metabolism of lamotrigine and reduce its T1 / 2 by 2 times, up to 14 hours (phenytoin, carbamazepine). In patients taking carbamazepine, the introduction of lamotrigine can cause unwanted effects from the central nervous system, including dizziness, ataxia, diplopia, decreased visual acuity and nausea. Reducing the dose of carbamazepine usually leads to the disappearance of these phenomena.
With simultaneous use, lamotrigine does not affect the concentration of other antiepileptic drugs in plasma, as well as the concentration of ethinyl estradiol and levonorgestrel (which are part of the simultaneously used oral contraceptives).
With the simultaneous use of lamotrigine does not reduce the clearance of drugs in the metabolism of which CYP2D6 is involved.
With the simultaneous use of clozapine, phenelzine, risperidone, sertaline and trazodone, apparently do not affect the clearance of lamotrigine.
There is no data on the effect of lamotrigine on the pharmacokinetics of other antiepileptic drugs and on the drug interaction between it and drugs metabolized with the participation of isoenzymes of the cytochrome P450 system.
Perhaps combined with sedatives, antiepileptic and anxiolytic agents.
Overdose
Symptoms: nystagmus, ataxia, headache, vomiting, drowsiness, impaired consciousness up to coma.
Treatment: hospitalization in hospital and appropriate supportive and symptomatic therapy if necessary, gastric lavage and activated charcoal.
Storage conditions
The product should be stored in the original container in a place out of reach of children at 30 РC
Shelf life
2 years
Where Active ingredient
Lamotrigine
Pharmacy terms
Prescription
dosage form
tablets
Possible product names
LAMOLEP 0.05 N30 TABLE
Lameolep 50mg Tab. X30
Lamolep 50mg Tab. X30 (R)! Until 03.10g. /
Lamolep 50mg Tab. X30 (R)! Until 05.10g. /
Lameolep 50mg Tab. X30 (R) /! Until 09.09. /
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