TRILEPTAL film-coated tablets 600 mg No. 50


Trileptal®

Trileptal® can be used both as monotherapy and in combination with other antiepileptic drugs. In both cases, the course of treatment begins with a clinically effective dose, the frequency of administration is 2 times a day. The dose may be increased depending on the response to therapy. When replacing another antiepileptic drug with Trileptal, at the beginning of taking Trileptal, the dose of the drug being replaced should be gradually reduced. When using Trileptal as adjunctive therapy as part of polytherapy, a dose reduction of concomitant antiepileptic drugs and/or a slower increase in the dose of Trileptal may be required.

Trileptal can be taken regardless of meals (during, after meals or between meals).

The recommendations below apply to patients with normal renal function. For this category of patients, there is no need to monitor plasma concentrations of the active substance in order to optimize Trileptal therapy.

The tablets are marked and can be broken into two pieces to make them easier to swallow.

When used in children under 3 years of age

who cannot swallow tablets, as well as in cases where it is impossible to measure the required dose when using the drug in tablet form, Trileptal® is prescribed in the form of an oral suspension.

Adults and elderly patients

Monotherapy:

The initial dose is 600 mg/day (8-10 mg/kg body weight/day), divided into 2 doses. A good therapeutic response was observed in the dose range of 600-2400 mg/day. If necessary, a gradual increase in dose is possible. The dose is increased by no more than 600 mg/day at intervals of approximately 1 week until the desired therapeutic response is achieved. In hospital settings, there is experience with rapidly increasing the dose to 2400 mg/day over 48 hours.

Combination therapy:

The initial dose is 600 mg/day (8-10 mg/kg body weight/day), divided into 2 doses. A good therapeutic response was observed in the dose range of 600-2400 mg/day. If necessary, a gradual increase in dose is possible. The dose is increased by no more than 600 mg/day at intervals of approximately 1 week until the desired therapeutic response is achieved.

Use of the drug Trileptal® in a daily dose above 2400 mg. There is limited experience with the use of the drug in daily doses of up to 4200 mg.

No special adjustment of the dosage regimen is required for elderly patients, since the therapeutic dose of the drug is set individually.

Special dosage adjustments for elderly patients

is not required, since the therapeutic dose of the drug is determined individually.

Children

In monotherapy and when using the drug as part of combination therapy:

The recommended initial dose is 8-10 mg/kg body weight/day, divided into 2 doses.

If necessary, a gradual increase in dose is possible to achieve the desired therapeutic effect. At intervals of approximately 1 week, the dose is increased by a maximum of 10 mg/kg/day, to a maximum daily dose of 60 mg/kg.

When using the drug Trileptal® as monotherapy and as part of combination therapy, when adjusted for body weight, the apparent clearance in children decreases significantly with increasing age. Children aged 1 month to 4 years

a dose of the drug 2 times higher than the dose for adults may be required when adjusted for body weight;
Children aged 4 to 12 years
may require a dose 50% higher than the adult dose when adjusted for body weight.

In children aged 1 month to 4 years, the effect of antiepileptic drugs - inducers of liver enzymes on their apparent clearance is more pronounced than in children of older age groups (when adjusted for body weight). When using the drug Trileptal® in children aged 1 month to 4 years in combination with antiepileptic drugs - inducers of liver enzymes, a dose of oxcarbazepine may be required 60% higher (when adjusted for body weight) than with monotherapy with the drug Trileptal® or when using it in combination with antiepileptic drugs that do not induce enzymes. For children of older age groups, when conducting combination therapy with Trileptal® with liver enzyme inducers, a slight increase in the dose of the drug may be required compared to monotherapy.

In children under 3 years of age

the drug should be used in the form of an oral suspension due to the difficulties of using solid dosage forms in this age group.

No dosage adjustment is required in patients with mild to moderate liver dysfunction

.

For patients with impaired renal function (creatinine clearance less than 30 ml/min)

The recommended starting dose is 300 mg/day and should be increased slowly until the desired therapeutic response is achieved.

Instructions for use of oral suspension

Trileptal dose conversion table from mg to ml.

Dose in milligrams (mg)Dose in milliliters (ml)
10 mg0.2 ml
20 mg0.3 ml
30
mg
0.5
ml
40 mg0.7 ml
50 mg0.8 ml
60
mg
1.0
ml
70 mg1.2 ml
80 mg1.3 ml
90 mg1.5
ml
100 mg1.7 ml
200 mg3.3 ml
300
mg
5.0
ml
400 mg6.7 ml
500 mg8.3 ml
600
mg
10.0
ml
700 mg11.7 ml
800 mg13.3 ml
900
mg
15.0
ml
1000 mg16.7 ml

Before taking the oral suspension, the bottle should be shaken thoroughly and the required amount of suspension should be immediately measured. The required dose (ml) is drawn from the bottle using the supplied syringe. When using a 10 ml syringe (supplied with a 250 ml bottle - for adults and older children), the amount of suspension should be rounded to 0.5 ml. When using a 1 ml syringe (supplied with a 100 ml bottle - for young children), the amount of suspension should be rounded to 0.1 ml. After each use, close the bottle tightly and wipe the syringe with a clean, dry cloth. The suspension can be taken directly from the syringe or diluted with a small amount of water before use. Store an open bottle for no more than 7 weeks.

Oral suspension and film-coated tablets are interchangeable in equivalent doses.

Compound

1 tablet of oxcarbazepine 150 mg, 300 mg or 600 mg.
Silicon dioxide, crospovidone, hypromellose, magnesium stearate, MCC - as excipients.

1 ml of oxcarbazepine 60 mg. Sodium saccharinate, sorbic acid, propyl parahydroxybenzoate, macrogol stearate, sorbitol , methyl parahydroxybenzoate, ascorbic acid, propylene glycol, cellulose, plum-lemon flavor, purified water - as excipients.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

The mechanism of antiepileptic action is associated with the blockade of sodium channels, which respond to changes in membrane potential. This entails the stabilization of overexcited neurons, a decrease in the conduction of impulses in synapses and the suppression of serial discharges. In the antiepileptic effect of the drug, an increase in K+ conductivity and modulation of calcium channels, which are activated by high neuronal membrane potential, are also important. There are no interactions of the active substance with brain neurotransmitters.

Effective against epileptic seizures in monotherapy and combination therapy in adults and children. In addition, Trileptal has a normothimic effect - it eliminates circular mental disorders (mood fluctuations) and prevents the development of depression.

Pharmacokinetics

When taken orally it is well absorbed. Food intake does not affect the degree of absorption. Metabolized to form the active metabolite MHP (monohydroxy derivative). 40% of MGP is bound to blood proteins. After taking a suspension at a dose of 600 mg, Cmax MGP is achieved after 6 hours, and when taking the same dose in tablet form - after 4.5 hours. In the form of metabolites, 95% is excreted by the kidneys, 4% with feces.

Side effects of Trileptal

Side effects that occur very often (more than 10%): dizziness , drowsiness, diplopia , headache, nausea, vomiting .

Commonly encountered (up to 10%): asthenia , fatigue, amnesia , apathy , impaired concentration , depression , emotional instability, nystagmus , blurred vision, tremor , , abdominal pain , diarrhea , hyponatremia , acne , alopecia , rash .

Rarely observed: leukopenia , increased transaminase activity , urticaria , angioedema .

Interaction

It should be borne in mind that the active substance is an inhibitor of cytochrome CYP2C19, therefore the administration of large doses of this drug and Phenobarbital , Phenytoin leads to interaction.

The concentration of Phenytoin increases by 40% when Trileptal is co-administered above 1200 mg/day, and therefore the dose of Phenytoin can be reduced. The drug increases the concentration of Phenobarbital, at the same time Phenobarbital reduces its concentration by 30-31%.

Felbamate and Clobazam do not affect the concentration of this drug.

Valproic acid reduces concentration by 18%.

Prescription along with hormonal contraceptives leads to a decrease in the effectiveness of contraceptives.

Strengthens the sedative effect of ethanol .

Cimetidine , Erythromycin , Warfarin , Dextropropoxyphene do not affect MGP parameters.

Verapamil reduces the concentration of active metabolites by 20%.

Reviews about Trileptal

Reviews of Trileptal on forums indicate the effectiveness of this drug both in focal epileptic seizures and in generalized tonic-clonic ones . Many patients have successfully replaced Carbamazepine , Gabapentin , Phenytoin or Valproate with Trileptal alone on the recommendation of a physician.

Its effectiveness was no lower, and tolerability was much better, which made it possible to take this drug for a long time without complications. Thus, it is noted that within 12 months. treatment with this drug alone, a complete disappearance of seizures was observed in patients with a generalized form of epilepsy . All those who have taken the drug note that it, compared to Finlepsin and Carbamazepine , has fewer side effects.

“I finally switched from Finlepsin to Trileptal, after taking it the headache does not hurt, and the night attacks have passed. Among the side effects, I can complain about drowsiness.”

“Very good drug. I switched to Trileptal 300 and everything changed - minimal drowsiness, appetite as usual. Only positive reviews."

“I take 1800 mg (3 times 600), transferred a year ago. Compared to Finlepsin, I feel very cheerful, I walked around like a somnambulist on Finlepsin.”

“My daughter has been taking Trileptal for six years, she has no seizures, before that she took Finlepsin and had seizures at night.”

The most common adverse reactions are drowsiness, increased appetite, tearfulness, dizziness and double vision 40 minutes after taking the tablet.

Trileptal price, where to buy

You can buy it in many pharmacies in Moscow. The price of Trileptal depends on the dose. Tablets of 150 mg No. 50 can be purchased for 402–515 rubles, and tablets of 600 mg No. 50 for 1444–1638 rubles.

  • Online pharmacies in RussiaRussia

ZdravCity

  • Trileptal tablets p.p.o.
    150 mg 50 pcs Novartis Pharma S.р.A RUR 323 order
  • Trileptal tablets p.p.o. 600 mg 50 pcs Novartis Pharma S.р.A

    968 RUR order

  • Trileptal Susp. internal 60mg/ml 100ml n1Novartis Pharma/Delpharm Young

    290 rub. order

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