Tebantin capsules 300mg, No. 100

partial seizures with or without secondary generalization in adults and children over 12 years of age as monotherapy or adjunctive therapy;

partial seizures with or without secondary generalization in children from 3 to 12 years of age as adjunctive therapy;

neuropathic pain in patients over 18 years of age (efficacy and safety in patients under the age of 18 have not been established).

Inside, regardless of food intake, without chewing, with a sufficient amount of liquid. When administered three times, it should be borne in mind that the time between two doses should not exceed 12 hours.

Partial seizures

Adults and children over 12 years of age: usually the antiepileptic effect is provided by a dose of 900 to 1200 mg / day. The desired therapeutic effect is achieved within a few days after titration.

Recommended dosage regimens:

A. 1st day - 300 mg / day (1 capsule 300 mg / day or 1 capsule 100 mg 3 times a day); 2nd day - 600 mg / day (1 capsule 300 mg 2 times a day or 2 capsules 100 mg 3 times a day); 3rd day - 900 mg / day (1 capsule 300 mg 3 times a day or 3 capsules 100 mg 3 times a day); from the 4th day - the daily dose can be increased to 1200 mg, divided into 3 doses per day (for example, 1 capsule 400 mg 3 times a day);

B. Alternative dosing regimen. The initial dose on the 1st day is 1 caps. 300 mg 3 times a day (corresponds to 900 mg of gabapentin), after which the dose can be increased to 1200 mg / day. Depending on the effect obtained, the dose can be increased by 300-400 mg / day, but not exceeding the total daily dose (when taken three times) of 2400 mg, which is associated with insufficient data on the efficacy and safety of higher doses.

The use of the drug as an adjunctive therapy in children 3Ц12 years old with a body weight of more than 17 kg: due to insufficient data on the efficacy and safety, the drug is not recommended for children under 3 years of age, as well as for children from 3 to 12 years old as monotherapy.

The recommended daily dose of the drug (divided into 3 doses) is 25Ц35 mg / kg / day. Table 2 lists the recommended daily doses of gabapentin per kg. An effective dose is achieved by titration according to the following scheme: 1st day - 10 mg / kg / day; 2nd day - 20 mg / kg / day; 3rd day - 30 mg / kg / day, according to the method shown in the table. Then, if necessary, the daily dose of gabapentin (divided into 3 doses) can be increased to 35 mg / kg / day. Long-term clinical studies have confirmed that doses of 40Ц50 mg / kg / day are well tolerated.

table 2

Initial doses of gabapentin in children 3Ц12 years of age weighing more than 17 kg

Table 3

Maintenance doses of gabapentin in children 3-12 years old with a body weight of more than 17 kg

Treatment of neuropathic pain in adults (over 18 years of age)

The optimal therapeutic dose for the treatment of neuropathic pain is titrated by the treating physician based on efficacy and tolerability. Depending on the individual response of the patient, the dose can reach 3600 mg / day.

Recommended dosage regimens:

A. 1st day - 300 mg / day (1 capsule 300 mg / day or 1 capsule 100 mg 3 times a day); 2nd day - 600 mg / day (1 capsule 300 mg 2 times a day or 2 capsules 100 mg 3 times a day); 3rd day - 900 mg / day (1 capsule 300 mg 3 times a day or 3 capsules 100 mg 3 times a day);

B. Alternative dosing regimen for intense pain. The initial dose on the 1st day is 1 caps. 300 mg 3 times a day (corresponds to 900 mg of gabapentin), after which the dose can be increased within 7 days to 1800 mg / day.

In some cases, in order to achieve the desired analgesic effect, the dose can be increased to a maximum of 3600 mg / day, distributing it into 3 doses (in clinical studies, during the 1st week, the dose was increased to 1800 mg, and for the 2nd and 3rd weeks - up to 2400 and 3600 mg, respectively).

Weakened patients, with low body weight or who have undergone organ transplantation, the dose can be increased strictly by 100 mg / day.

For elderly patients in accordance with the age-related decrease in creatinine clearance, as well as for patients with renal insufficiency (Cl creatinine <80 ml / min) or on hemodialysis, the therapeutic dose is selected individually according to the following scheme, presented in Table 4.

Table 4

Recommended doses of gabapentin for decreased renal function

* The daily dose should be divided into 3 doses.

** Reception of a dose 3 times, 100 mg every other day.

Dosing regimen for hemodialysis

Patients on hemodialysis and who have not previously taken gabapentin are recommended to prescribe a saturating dose of 300-400 mg, then 200-300 mg every 4 hours of hemodialysis. On days free from hemodialysis, gabapentin should not be taken.

hypersensitivity to any component of the drug;

acute pancreatitis;

lactase deficiency, lactose intolerance, glucose-galactose malabsorption (the dosage form of the drug contains lactose);

lactation period;

monotherapy in children aged 3 to 12 years;

children up to age 3 years.

With caution: renal failure.