TRILEPTAL SUSP 60MG/ML 100ML

Active ingredient and dosage form

Trileptal oral suspension:
1 ml contains oxcarbazepine 60 mg;
Excipients: propyl parahydroxybenzoate; sodium saccharinate; sorbic acid; macrogol stearate 400; methyl parahydroxybenzoate; vitamin C; dispersible cellulose (MCC and carmellose sodium); yellow plum-lemon aroma 39К020 (aroma 39К020 is a solution containing 36% ethanol and 16% propylene glycol); distilled propylene glycol; sorbitol 70% liquid; purified water;
in dark glass vials of 100 or 250 ml (complete with an adapter, a syringe dosing plastic volume of 1 or 10 ml);

film-coated tablets:
1 tab. contains oxcarbazepine 150, 300 and 600 mg;
Excipients: anhydrous colloidal silicon dioxide; crospovidone; hypromellose (hydroxypropylmethylcellulose / HP-M cellulose 603); Magnesium stearate; MCC (Avicel PH 102);
The composition of the shell of tablets, film-coated, 150 mg: titanium dioxide; talc; hypromellose (hydroxypropylmethylcellulose / HP-M cellulose 603); ferric oxide black (E172); iron oxide red (E172); iron oxide yellow (E172); macrogol 4000;
The composition of the shell of tablets, film-coated, 300 mg: titanium dioxide; talc; hypromellose (hydroxypropylmethylcellulose / HP-M cellulose 603); iron oxide yellow (E172); macrogol 8000 (polyethylene glycol 8000);
The composition of the shell of tablets, film coated, 600 mg: titanium dioxide; talc; hypromellose (hydroxypropylmethylcellulose / HP-M cellulose 603); ferric oxide black (E172); iron oxide red (E172); macrogol 4000;
Packed in 10, 20, 30 and 50 pcs.

Mechanism of action

Trileptal has antiepileptic effect.

Indications and usage

The drug Trileptal is a first-line drug for monotherapy or combination therapy:
simple, complex partial epileptic seizures with or without secondary generalization in adults and children ages 1 month and older;
generalized tonic-clonic epileptic seizures in adults and children aged 2 years and older.
The drug Trileptal can be used to replace other antiepileptic drugs in cases where the use of the latter does not achieve a satisfactory therapeutic response to treatment.

Contraindications

Common to both dosage forms: Hypersensitivity to oxcarbazepine or any other components of the drug.
For film-pills (optional):children's age up to 3 years.
For oral suspension (optional):children up to 1 month
The use of the drug in children under the age of 1 month has not been studied in controlled clinical trials.
Carefully:
severe abnormal liver function (use of the drug has not been studied);
known hypersensitivity to Carbamazepine, because in this group of patients, hypersensitivity reactions to oxcarbazepine may develop in approximately 25–30% of cases. In patients with no history of indications of hypersensitivity to carbamazepine, it is also possible to develop hypersensitivity reactions to the drug, including multiorgan disorders.
When using the drug Trileptal in clinical practice in some cases (post-marketing messages), the development of immediate type hypersensitivity (type I), including rash, pruritus, urticaria, angioedema, and Anaphylactic reactions was noted. Angioedema and anaphylactic reactions with lesions of the larynx, vocal folds (region of the glottis), lips, eyelids developed both with the first and with repeated use of the drug Trileptal. In the case of the development of immediate hypersensitivity drug Trileptal should immediately cancel the appointment of alternative therapy.

Pregnancy and Breastfeeding

Experience with the use of the drug Trileptal during pregnancy is limited. Available reports suggest a possible connection with the use of the drug during pregnancy with the development of birth defects (for example, wolf mouth).
In experimental studies with the use of the drug Trileptal in toxic doses, there was an increase in embryonic mortality, slowing down and impaired development and growth of the fetus.If the patient is planning to become pregnant or became pregnant during the use of the drug, as well as when there is a question about the appointment of the drug Trileptal during pregnancy, it is necessary to carefully compare the expected benefits of therapy and the possible risk to the fetus, especially in the first trimester of pregnancy.

Adverse reactions

The following adverse reactions were most frequently reported: drowsiness, headache, dizziness, diplopia, nausea, vomiting, fatigue (more than 10% of patients).
In clinical studies, it was shown that undesirable effects are usually mild or moderately pronounced, are transient in nature and are observed mainly at the beginning of therapy.
The data below summarizes the information on adverse events registered during clinical trials, as well as data on the safety profile of the drug, obtained during its use in clinical practice.
Criteria for assessing the frequency of occurrence of adverse events: very often (≥1 / 10); often (≥1 / 100, <1/10); sometimes (≥1 / 1000, <1/100); rarely (≥1 / 10,000, <1/1000); very rarely (<1/10000), including individual messages.
Hemic and lymphatic: sometimes leukopenia; very rarely, suppression of bone marrow blood formation, agranulocytosis, aplastic anemia, neutropenia, pancytopenia, thrombocytopenia.
Immune system:very rarely - hypersensitivity, accompanied by fever and rash (including multiorgan disorders).With the development of hypersensitivity reactions, damage to the circulatory and lymphatic systems (eosinophilia, thrombocytopenia, lymphadenopathy, splenomegaly), muscles and joints (myalgia, swelling in the joints, arthralgia), nervous system (encephalopathy), kidneys (proteinuria, interstitial nephritis, renal failure ), lungs (dyspnea, pulmonary edema, bronchospasm, interstitial inflammation), abnormal liver function indicators, angioedema, anaphylactic reactions.
Metabolic disorders and eating disorders:often - hyponatremia; very rarely - hyponatremia, leading to the development of such manifestations and symptoms as convulsive seizures, confusion, decreased consciousness, encephalopathy, visual disturbances (including blurred vision), nausea, vomiting, folic acid deficiency; very rarely - hypothyroidism.
From the side of the central nervous system:very often - drowsiness, headache, dizziness; often - ataxia, tremor, nystagmus, impaired attention, amnesia, confusion, depression, apathy, agitation, emotional lability.
Special senses:very often - diplopia; often - visual impairment, blurred vision, vertigo.
Cardiovascular: very rarely - arrhythmias, AV blockade, arterial hypertension.
From the digestive tract: very often - nausea, vomiting; often - diarrhea, constipation, abdominal pain; very rarely, pancreatitis and / or increased lipase and / or amylase levels.
Liver and biliary tract: very rarely - hepatitis.
Dermatologic: often - rash, alopecia, acne; sometimes - urticaria; very rarely - angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme.
From the connective tissue: very rarely - systemic lupus erythematosus.
Other: very often - feeling tired; often - asthenia.

Dosage and administration

Inside, regardless of the meal (during, after a meal or in between meals).
The drug Trileptal can be used both as a 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 the drug Trileptal at the beginning of taking the drug Trileptal, you should gradually reduce the dose of the drug being replaced. When using the drug Trileptal as part of combination therapy, it may be necessary to reduce the dose of concomitant antiepileptic drugs and / or a slower increase in the dose of the drug Trileptal.
The recommendations below apply to patients with normal renal function. For this category of patients there is no need to control the concentration of the active substance in the plasma in order to optimize therapy with the drug Trileptal.
There are risks on the tablets, they can be broken into 2 parts to facilitate swallowing.
When using the drug Trileptal in children under 3 years old who cannot swallow tablets, and also in cases where it is impossible to measure the required dose when using the drug in the form of tablets, prescribe the drug Trileptal in the form of a suspension for oral administration.
Adults and Elderly Patients
Monotherapy: initial dose - 600 mg / day (8-10 mg / kg body weight per 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. The dose is increased by no more than 600 mg / day with an interval of about 1 week, until a desired therapeutic response is achieved. In stationary conditions, there is experience of rapidly increasing the dose to 2400 mg / day for 48 hours.
Combination therapy: the initial dose is 600 mg / day (8-10 mg / kg of body weight per 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. The dose is increased by no more than 600 mg / day with an interval of about 1 week, until a desired therapeutic response is achieved.
The use of the drug Trileptal in a daily dose above 2400 mg. There is limited experience with the use of the drug in a daily dose of up to 4200 mg.
A special correction of the dosage regimen for elderly patients is not required, since the therapeutic dose of the drug is determined individually.

In the dark place at a temperature of no higher than 25 ° C.

3 years.