Katena capsules 300mg, No. 50

• Treatment of neuropathic pain in adults over the age of 18;

• monotherapy of partial seizures with and without secondary generalization in adults and children over 12 years of age;

• as an additional agent in the treatment of partial seizures with and without secondary generalization in adults and children aged 3 years and older.

The drug KatenaЃ is prescribed by mouth, regardless of the meal. If it is necessary to reduce the dose, discontinue the drug or replace it with an alternative remedy, this should be done gradually over at least one week.

Neuropathic pain in adults.

The initial dose is 900 mg per day in three divided doses; if necessary, depending on the effect, the dose is gradually increased to a maximum of 3600 mg / day. Treatment can be started immediately with a dose of 900 mg / day (300 mg 3 times a day), or during the first 3 days, the dose can be gradually increased to 900 mg per day according to the following scheme:
1st day: 300 mg 1 time per day
2nd day: 300 mg 2 times a day
3rd day: 300 mg 3 times a day

Partial seizures

Adults and children over the age of 12 : The effective dose is 900 to 3600 mg per day. Therapy can be started with a dose of 300 mg 3 times a day on the first day, or gradually increased to 900 mg according to the scheme described above (see section 'Neuropathic pain in adults'). Subsequently, the dose can be increased to a maximum of 3600 mg / day in three divided doses in equal doses. The maximum interval between doses when taking the drug three times should not exceed 12 hours in order to avoid the resumption of seizures. The drug was well tolerated at doses up to 4800 mg / day.

Children aged 3-12 years : The initial dose of the drug varies from 10 to 15 mg / kg / day, which is prescribed in equal doses 3 times a day and increased to an effective dose within about 3 days. The effective dose of gabapentin in children aged 5 years and older is 25-35 mg / kg / day in equal doses in 3 divided doses. The effective dose of gabapentin in children aged 3 to 5 years is 40 mg / kg / day in equal doses in three divided doses. The drug was well tolerated at doses up to 50 mg / kg / day with prolonged use. The maximum interval between taking doses of the drug should not exceed 12 hours in order to avoid the resumption of seizures.
It is not necessary to monitor the plasma concentration of gabapentin. KatenaЃ can be used in combination with other anticonvulsants without taking into account changes in plasma concentration or serum concentrations of other anticonvulsants.

Recommendations for patients on hemodialysis For
patients on hemodialysis who have not previously taken gabapentin, it is recommended to prescribe the drug in a saturating dose of 300-400 mg, and then use it at 200-300 mg every 4 hours of hemodialysis.

Capsules 300 mg: active substance: gabapentin - 300 mg;
excipients: lactose monohydrate, corn starch, talc;
capsule shell: titanium dioxide (E 171), iron dye yellow oxide (E 172), gelatin.

Hypersensitivity to gabapentin or auxiliary components of the drug.

Children under 3 years old.

Carefully

Renal failure (see 'Dosage and Administration').

Trade name of the drug:

KatenaЃ

International non-proprietary name:

Gabapentin

Dosage form:

capsules

Composition
One capsule contains:

Capsules 100 mg: active substance: gabapentin - 100 mg;
excipients: lactose monohydrate, corn starch, talc;
capsule shell: titanium dioxide (E 171), gelatin.
Capsules 300 mg: active substance: gabapentin - 300 mg;
excipients: lactose monohydrate, corn starch, talc;
capsule shell: titanium dioxide (E 171), iron dye yellow oxide (E 172), gelatin.
Capsules 400 mg: active substance: gabapentin - 400 mg;
excipients : lactose monohydrate, corn starch, talc;
capsule shell: titanium dioxide (E 171), iron dye yellow oxide (E 172), iron dye red oxide (E172), gelatin.

Description

Capsules 100 mg: white crystalline powder in a white capsule shell, size 3.

Capsules 300 mg: white crystalline powder in a yellow capsule shell, size 1.

Capsules 400 mg: white crystalline powder in orange capsule shell, size 0.

Pharmacotherapeutic group:

antiepileptic drug.

ATX code

[NO3AX12].

Pharmacological properties

Pharmacodynamics

Gabapentin is structurally similar to the neurotransmitter gamma-aminobutyric acid (GABA), but its mechanism of action differs from that of some other drugs that interact with GABA receptors, including valproate, barbiturates, benzodiazepines, GABA transaminase inhibitors, GABA uptake inhibitors and agonists prodrugs of GABA: it does not have GABAergic properties and does not affect the uptake and metabolism of GABA. Preliminary studies have shown that gabapentin binds to the ?2-?-subunit of voltage-dependent calcium channels and suppresses the flow of calcium ions, which plays an important role in the onset of neuropathic pain. Other mechanisms involved in the action of gabapentin in neuropathic pain are: a decrease in glutamate-dependent neuronal death, an increase in GABA synthesis,suppression of the release of neurotransmitters of the monoamine group. Gabapentin, at clinically relevant concentrations, does not bind to receptors for other common drugs or neurotransmitters, including the GABAA, GABAB, benzodiazepine, glutamate, glycine, or N-methyl-D-aspartate receptors. Unlike phenytoin and carbamazepine, gabapentin does not interact with sodium channels.

Pharmacokinetics

Absorption The
bioavailability of gabapentin is not dose proportional; so, with an increase in the dose, it decreases. After oral administration, the maximum concentration (Cmax) of gabapentin in plasma is reached after 2-3 hours. The absolute bioavailability of gabapentin in capsules is about 60%. Foods, including those with a high fat content, have no effect on pharmacokinetics. The clearance of gabapentin from plasma is best described using a linear model.
Distribution
Pharmacokinetics does not change with repeated use; equilibrium plasma concentrations can be predicted from the results of a single dose of the drug. Gabapentin practically does not bind to plasma proteins (<3%) and has a volume of distribution of 57.7 liters.
Metabolism
No signs of metabolism were found in humans. The drug does not induce mixed liver oxidative enzymes involved in drug metabolism.
Withdrawal
The half-life (T?) From plasma does not depend on the dose and averages 5-7 hours. It is excreted exclusively by the kidneys in an unchanged form.

Pharmacokinetics in special clinical cases
Clearance of gabapentin from plasma is reduced in the elderly and patients with impaired renal function. Elimination rate constant, plasma clearance and renal clearance are directly proportional to creatinine clearance. Gabapentin is removed from plasma by hemodialysis. In patients with impaired renal function and in patients receiving hemodialysis treatment, dose adjustment is recommended (see Dosage and Administration).
It was found that the plasma concentrations of gabapentin in children aged 4 to 12 years are generally similar to those in adults.

Indications for use

• Treatment of neuropathic pain in adults (18 years and older). Efficacy and safety in patients under the age of 18 have not been established.

• Monotherapy of partial seizures in epilepsy with and without secondary generalization in adults and children over the age of 12 years. The efficacy and safety of monotherapy in children under 12 years of age have not been established.

• As an additional agent in the treatment of partial seizures in epilepsy with and without secondary generalization in adults and children aged 3 years and older. The safety and effectiveness of adjunctive therapy with gabapentin in children less than 3 years of age has not been established.

Contraindications

Hypersensitivity to gabapentin or auxiliary components of the drug.

Children under 3 years old.

Carefully

Renal failure (see 'Dosage and Administration').

Pregnancy and lactation

Pregnancy

There are no data on the safety and efficacy of the drug during pregnancy, therefore, the use of gabapentin during pregnancy is possible only if the intended benefit to the mother justifies the possible risk to the fetus.

Lactation

Gabapentin is excreted in breast milk, so breastfeeding should be avoided during treatment.

Method of administration and dosage

The drug KatenaЃ is prescribed by mouth, regardless of the meal. If it is necessary to reduce the dose, discontinue the drug or replace it with an alternative remedy, this should be done gradually over at least one week.

Neuropathic pain in adults.

The initial dose is 900 mg per day in three divided doses; if necessary, depending on the effect, the dose is gradually increased to a maximum of 3600 mg / day. Treatment can be started immediately with a dose of 900 mg / day (300 mg 3 times a day), or during the first 3 days, the dose can be gradually increased to 900 mg per day according to the following scheme:
1st day: 300 mg 1 time per day
2nd day: 300 mg 2 times a day
3rd day: 300 mg 3 times a day

Partial seizures

Adults and children over the age of 12 : The effective dose is 900 to 3600 mg per day. Therapy can be started with a dose of 300 mg 3 times a day on the first day, or gradually increased to 900 mg according to the scheme described above (see section 'Neuropathic pain in adults'). Subsequently, the dose can be increased to a maximum of 3600 mg / day in three divided doses in equal doses. The maximum interval between doses when taking the drug three times should not exceed 12 hours in order to avoid the resumption of seizures. The drug was well tolerated at doses up to 4800 mg / day.

Children aged 3-12 years : The initial dose of the drug varies from 10 to 15 mg / kg / day, which is prescribed in equal doses 3 times a day and increased to an effective dose within about 3 days. The effective dose of gabapentin in children aged 5 years and older is 25-35 mg / kg / day in equal doses in 3 divided doses. The effective dose of gabapentin in children aged 3 to 5 years is 40 mg / kg / day in equal doses in three divided doses. The drug was well tolerated at doses up to 50 mg / kg / day with prolonged use. The maximum interval between taking doses of the drug should not exceed 12 hours in order to avoid the resumption of seizures.
It is not necessary to monitor the plasma concentration of gabapentin. KatenaЃ can be used in combination with other anticonvulsants without taking into account changes in plasma concentration or serum concentrations of other anticonvulsants.

Recommendations for patients on hemodialysis For
patients on hemodialysis who have not previously taken gabapentin, it is recommended to prescribe the drug in a saturating dose of 300-400 mg, and then use it at 200-300 mg every 4 hours of hemodialysis.

Side effect

From the side of the cardiovascular system : symptoms of vasodilation, hypertension.
From the digestive system : dyspepsia, flatulence, nausea, vomiting, abdominal pain, constipation, diarrhea, dry mouth or throat, anorexia, gingivitis, dental diseases, increased appetite, increased activity of 'liver' transaminases.
From the musculoskeletal system : myalgia, arthralgia, back pain, increased fragility of bones.
From the nervous system: drowsiness, dizziness, ataxia, amnesia, confusion, lack of coordination, increased fatigue, impaired thinking, tremor, hypesthesia, depression, dysarthria, insomnia, nervousness, nystagmus, increased, weakening or absence of reflexes, asthenia, anxiety, hostility, hyperkinesia, emotional lability.
From the respiratory system : pharyngitis, rhinitis, shortness of breath, cough, pneumonia, bronchitis, respiratory infections.
From the genitourinary system : urinary tract infections, impotence.
From the senses : visual impairment, amblyopia, diplopia.
On the part of the hematopoietic organs : leukopenia, purpura (most often it is described as bruising caused by physical injury).
Allergic reactions: skin rash, itching, acne.
Others : fever, viral infection, weight gain, pain of various localization, peripheral edema, facial edema, headache.

Post-registration experience of application

Cases of sudden unexplained death have been reported, the relationship of which with gabapentin treatment has not been established. Other adverse events: acute renal failure, allergic reactions, including urticaria, alopecia, angioedema, generalized edema; fluctuations in the concentration of glucose in the blood in patients with diabetes mellitus, chest pain, an increase in the volume of the mammary glands, gynecomastia, increased liver function indicators, exudative erythema multiforme (including Stevens-Johnson syndrome), hallucinations, movement disorders such as choreoathetosis, dyskinesia and dystonia, palpitations, pancreatitis, tinnitus, thrombocytopenia, urinary incontinence, myoclonus.

Overdose

Symptoms : dizziness, double vision, speech impairment, drowsiness, lethargy and diarrhea.
Treatment : gastric lavage, intake of activated charcoal, symptomatic therapy. Hemodialysis may be indicated in patients with severe renal impairment.

Interaction with other medicinal products

With the simultaneous use of gabapentin and morphine, when morphine was taken 2 hours before taking gabapentin, there was an increase in the mean area under the concentration-time pharmacokinetic curve (AUC) of gabapentin by 44% compared with gabapentin monotherapy, which was associated with an increase in pain threshold ( cold pressor test). The clinical significance of this change has not been established, while the pharmacokinetic characteristics of morphine did not change. The side effects of morphine when taken together with gabapentin did not differ from those when morphine was taken together with placebo.
Interactions between gabapentin and phenobarbital, phenytoin, valproic acid and carbamazepine have not been observed. The steady state pharmacokinetics of gabapentin are similar in healthy individuals and in patients receiving other anticonvulsants.
The simultaneous use of gabapentin with oral contraceptives containing norethisterone and / or ethinyl estradiol was not accompanied by changes in the pharmacokinetics of both components.
The simultaneous use of gabapentin with antacids containing aluminum and magnesium is accompanied by a decrease in the bioavailability of gabapentin by about 20%.
It is recommended to take gabapentin approximately 2 hours after taking the antacid.
Probenecid does not affect the renal excretion of gabapentin.
A slight decrease in renal excretion of gabapentin while
taking cimetidine probably has no clinical significance.

special instructions

With joint therapy with morphine, an increase in the concentration of gabapentin may occur in patients. At the same time, it is necessary to ensure careful monitoring of patients for the development of such a sign of depression of the central nervous system (CNS), such as drowsiness. In this case, the dose of gabapentin or morphine should be adequately reduced (see 'Interaction with other medicinal products').
Laboratory Tests
With gabapentin and other anticonvulsants, false positive results have been reported in urine protein determination with Ames N-Multistix SGЃ test strips. For the determination of protein in urine, it is recommended to use a more specific precipitation method with sulfosalicylic acid.

Influence on the ability to drive vehicles and mechanisms

According to the results of clinical studies, it is believed that the effect of betahistine on the ability to drive a car and other mechanisms is absent or insignificant, since no effects potentially affecting this ability have been found.

Release form

Capsules 100 mg, 300 mg, 400 mg.
Capsules 100 mg : 10 capsules in PVC / Al blister. Two blisters are placed together with instructions for use in a cardboard box.
Capsules 300 mg and 400 mg : 10 capsules in PVC / Al blister. Five blisters are placed together with instructions for use in a cardboard box.

Storage conditions

At a temperature not exceeding 25 ? C.
Keep out of the reach of children!

Shelf life

3 years.
Do not use after the expiration date.

Vacation conditions

On prescription.