Forbidden while breastfeeding

Has restrictions for children

Has restrictions for seniors

Has limitations for liver problems

Has limitations for kidney problems

Tebantin capsules have anticonvulsant, neuroprotective, analgesic and sedative effects. The instructions for use of the drug indicate that the drug is intended to suppress partial seizures in adult patients and children over 12 years of age. Includes active ingredient gabapentin, which is an analogue of the inhibitory neurotransmitter of the central nervous system - γ-aminobutyric acid.

General information about the drug

Tebantin belongs to the group of glucocorticosteroids, INN -. It is popular and effective neurotropic agent, which is used in the treatment of epilepsy and seizure activity of other etiology.

Forms of production and prices for the drug, average in Russia

The product is available in a dosage dosage form- a hard gelatinous shell, 100, 300 and 400 mg each. Capsule color - from white to light yellow, contains a white crystalline encapsulate.

Average prices for Tebantin are shown in the table.

Composition

The capsule of the drug contains 100, 300 or 400 mg of the active substance - gabapentin. The auxiliary ingredients are:

• salts of magnesium and stearic acid - a filler, has a calming effect;
• talc - a filler that absorbs and disinfects;
• starch - thickener, serves to prevent allergic reactions;
• lactose monohydrate - normalizes the intestinal microflora.

The capsule shell consists of various food additives and gelatin.

Pharmacodynamics and pharmacokinetics

The active substance of the drug is similar to γ-aminobutyric acid, an important inhibitory neurotransmitter. It is equated to lipophilic substances, is well absorbed by the digestive tract, does not affect the capture and decomposition of gamma-aminobutyric acid (GABA).

Studies show that gabapentin reacts with the larger α-subunit of voltage-gated ion channels, inhibiting the calcium ions that trigger neuropathic pain. Additional effects are an increase in the production of GABA, inhibition of the release of monoamine neuromodulators. Unlike other antiepileptic drugs, the active ingredient does not bind to ion channels.

Gabapentin action

Clinical studies on animals have shown an increase in the metabolism of GABA in certain areas connective tissue brain. The component easily penetrates into the nervous tissue of the brain, blocking the appearance of seizures.

Gabapentin is rapidly absorbed, the maximum concentration in the liquid part of the blood is reached in less than 3 hours. Further administration of the drug accelerates the maximum concentration. The absolute bioavailability of the encapsulate reaches 60%. Eaten fatty foods do not have a large effect on pharmacokinetics, but some cases can provoke an increase in maximum concentration.

Reception of funds from 0.3 to 4.8 g increases the maximum and total concentration. Acceptance of a dose within 0.6 g, as well as large doses, did not significantly increase saturation. A one-time medication taken in young and middle-aged children showed a similar concentration with adult patients. Repeated doses of the drug normalized the satiety, which was maintained throughout the entire therapeutic course.

The active ingredient is practically not involved in metabolism. The anticonvulsant almost does not bind to plasma proteins, the distribution reaches 57.7 liters. Cerebrospinal fluid saturation reaches 20% of localization in the liquid part of the blood. It seeps through the blood-brain barrier, passes into breast milk.

The biological half-life is up to 7 hours, independent of the dose. It is excreted by the kidneys, artificially removed from the plasma by extrarenal blood purification. The rate of cleansing in elderly patients with kidney dysfunction decreases and is more than two days. Patients undergoing a blood purification procedure are advised to adjust the dose.

Indications and contraindications

Prescribed to the sick, suffering paroxysmal disorders... The following is what else is used this drug:

Clinical studies have not determined the effectiveness and safety of the drug for patients under the age of 18 years. The main contraindication to taking a remedy is the patient's individual intolerance to the components of the drug. Additional restrictions are:

1. Pathology of the pancreas of an inflammatory nature in an acute degree.
2. Monotherapy for children 3-12 years old.
3. Children under 3 years of age.
4. Lactation.
5. Lactose deficiency or intolerance, glucose-galactose malabsorption caused by impaired absorption of monosaccharides in the gastrointestinal tract.

It is used with caution by patients with impaired renal hemodynamics.

Risk hereditary pathology in children who received anticonvulsant drugs through breast milk or during the mother's pregnancy, it increases several times. The anomaly develops in the form of a "cleft" lip, pathologies of cardio-vascular system... The simultaneous use of several antiepileptic drugs negatively affects the health of the fetus, therefore, pregnant women are advised to resort to monotherapy.

Women of fertile age who require antiepileptic therapy should visit their doctor for advice. If pregnancy occurs during the period of taking medications, an abrupt termination of treatment is unacceptable, as this threatens the occurrence of seizures and deterioration of the health of the mother and fetus.

There is no adequate data on the use of an anticonvulsant by pregnant women. But this does not prove the absence of reproductive toxicity. Tebantin is recommended to be used during pregnancy only with obvious potential benefits that exceed the possible negative consequences for the bearing fetus.

Obvious negative impact on infant also not identified, but studies have proven that the active ingredient passes into breast milk. Therefore, breastfeeding while using anticonvulsants remedies must be agreed with your doctor.

Instructions for use

The dosage form is well absorbed by the gastric mucosa, therefore Tebantin is taken orally, and regardless of the time of the meal.

The dosage of the medicine is selected individually for each patient. The daily dose is prescribed for older patients and children from 12 years old - from 0.9 to 1.2 g. Palliative therapy is carried out according to the following scheme:

The highest daily dose should not exceed 2.4 g. An alternative treatment regimen is to use the drug three times a day, starting at 0.9 g, and gradually increasing by 300 mg daily.

A child's dose from 5 to 12 years old is based on the calculation of 30 mg per kilogram of the child's weight. Moreover, on the first day, it is recommended to take no more than 10 mg, the second - 20, the third - 30 mg per kilogram of weight. The daily intake should be adjusted by the pediatrician as it reaches therapeutic effect... For children 3-4 years old, no more than 50 mg / kg is prescribed daily.

Treatment of neurological pathologies begins with the intake of 300 mg of the medication, increasing daily to 0.6, and then to 0.9 g. In the absence of the expected effect, the dosage should be increased to 1.8 g, dividing it into equal parts.

With severe pain, the daily dose starts from 0.9 g - three capsules of 300 mg three times a day. Further, the volume increases to 1,800 mg, but does not exceed 3,600 mg.

For patients with low body weight who have undergone a transplant internal organs, serious condition health, the daily dosage increases by no more than 100 mg of the drug. For elderly patients with renal dysfunction, the dose is regulated by a doctor.

With the following indicators of the rate of cleansing of blood serum from creatinine, the following therapy regimen should be applied:

• more than 80 ml / min - the daily rate should not exceed 2.4 g of the substance;
• 50-80 ml / min - no more than 1.8 g;
• 30-49 0.9 g;
• 15-29 - 0.6 g;
• less than 15 ml / min - 0.3 g of Tebantine.

Some cases of the disease do not provide for the maximum dose, it is shown taking 100 mg of the medication three times a day every other day.

Patients on plasmapheresis or hemodialysis are prescribed a saturating dose of 0.3-0.4 g, followed by 0.2 g of medication every 4 hours of the procedure. During the absence of extrarenal blood cleansing sessions, Tebantin is not prescribed.

The duration of antiepileptic therapy is determined by the attending physician. Cancellation of the drug or the transition to another anticonvulsant should be carried out gradually. The opposite significantly increases the risk of recurrence of spontaneous seizures with loss of consciousness.

Tebantin is recommended to be taken only after consulting a doctor. Particular attention to taking the medication should be given to pregnant women, breastfeeding mothers and children under 12 years of age. Failure to comply with the rules of admission can cause physiological changes in the fetus or child.

Possible side effects and overdose

In the treatment of epileptic crises, neuropathic pain in the form of monotherapy or palliative therapy, the following negative reactions are noted:

Side effects can be expressed by an increase in body weight, spasms blood vessels, pathological hair loss, increased glucose levels in patients with diabetes mellitus. Palliative care in children under 12 years of age can cause increased hostility and inadequate physical activity.

An overdose of the drug is expressed by the development of drowsiness, attacks of dizziness, speech impairment, and frequent bowel movements. Acute intoxication was not observed even with excessive overdose. There is no drug that stops or weakening the effect of gabapentin on the body. A pronounced overdose will require plasmapheresis or intestinal dialysis.

Interaction with other medicinal products and special instructions

The combined use of ethanol and Tebantin is accompanied by the risk of developing a negative effect of gabapentin on the central or peripheral nervous system... The use of the drug with other anticonvulsants increases the activity of liver enzymes, which leads to a change in low-density cholesterol levels.

Medicines to neutralize of hydrochloric acid in the stomach reduce the effect of gabapentin. It is recommended to alternate the antiepileptic drug with antacids at intervals of at least two hours. Combination therapy with anticonvulsants significantly reduces the hormonal effect of contraceptive oral contraception.

The antagonist of H2-histamine receptors Cimetidine slows down the excretion of Tebantin metabolites in the urine. Tebantin is ineffective in the treatment of absence seizures caused by abnormal or intense brain activity.

Patients with diabetes mellitus need to control the glucose content, change the dose of synthetic antidiabetic agents. The first manifestation of pancreatic disease will require discontinuation of gabapentin use. The patient should undergo a thorough clinical examination.

In case of manifestation increased sleepiness or fatigue, impaired coordination of movements, dizziness, a sharp increase in body weight, you should immediately stop treatment and consult a doctor.

If there is an increase in hostility or inadequate physical activity in children, it is necessary to stop using Tebantin and consult a pediatrician.

Analogs

The most effective analogues of Tebantin are the following anticonvulsants:

The use of drugs similar in action to Tebantin should be agreed with the attending physician.

Result: positive feedback

12 +

Strong and efficient

Benefits: helps

Disadvantages: price

The medicine is very powerful. After a head injury, I started having epileptic seizures. I will not say that they are so frequent, but they still fully interfere with life. To stop these seizures themselves, the doctor prescribed Tebantin. She took the medicine according to a special scheme, starting with one capsule. After the drug, I constantly wanted to sleep, so I drank the capsule only before bedtime. With the intake of Tebantin, the frequency of attacks gradually became less, then everything went away altogether. The medicine is certainly not one of the cheap ones, but it definitely costs its money. The main thing is to observe the dosage selected by the doctor.

Result: negative feedback

Did not like

Benefits: No

Disadvantages: Weak effect, many heavy side effects, dear, it's inconvenient to take

A very problematic drug, starting from the admission schedule (you need to drink it 3 times a day, it's hard not to forget) and ending with the selection of the dose. Saw low, so the effect was extremely weak, the attacks continued to torment. I began to drink high, so a huge number of side effects immediately crawled out. I endured Tebantin extremely hard, felt wild weakness, dizziness, my head constantly ached, my stomach ached, my joints ached, my muscles were stiff. Appetite disappeared, nausea pursued even at night. My head refused to work, I confused and forgot everything, and became very irritable. Sleep also went wrong, cramps began to happen at night, and when I began to feel a constant lack of air, and terrible pains arose in the liver area (this happened only after 3 weeks of treatment!), I decided to look for other options. And the effect, meanwhile, was not at all impressed, even with a high dose, the attacks did not completely stop, so I see no reason to endure such torment.

Result: positive feedback

It is necessary for me

Benefits: Relieves pain and cramps

Disadvantages: Contraindicated in young children and pregnant women

After the stroke, he suffered from pain and convulsions, the doctors prescribed Tebantin. The capsules are very expensive, the treatment cost a pretty penny, although it was effective, and this is the main thing in such a situation. Saw according to the scheme, then increasing, then decreasing the dosage. As a result, let go, gradually came to relative rate... Now I drink when my legs twist at night and my toes go numb, especially in rainy weather. Always helps quickly. But it is necessary to strictly monitor the reaction of the body, as side effects are possible. The medicine is not cheap, but in a package of 50 or 100 capsules. I bought where for 100, so it turns out more profitable. The capsules are two-color, it is difficult to confuse with others, after all, I also take other medicines, so for me this is a plus. Another plus - the medicine soothes a little, without causing drowsiness.

Result: negative feedback

Benefits: No

Disadvantages: Doesn't help, drowsiness, weakness

It does not help at all, the pain does not decrease. A bunch of side effects. The doctor prescribed 3 times a day. It is impossible to go to work. Like a drunk, I don't understand anything, and most importantly, the sore hurts. (Pinched nerve in the cervical spine).

Result: neutral feedback

Dangerous pain reliever

Benefits: helps

Disadvantages: many serious side effects

I had frequent migraine attacks, how strong that I had to go to the hospital with this problem. There, among other things, Tebantin was discharged, but I did not like him at all. That is ... he helped, the pain attacks began to decrease over time, and then disappeared altogether, but this remedy is too dangerous. It has a long list of side effects, and I've experienced some of them the hard way. There were dizziness (up to fainting), "fog in the head", inhibition of reactions. She asked to cancel the drug without completing the course completely. Now there are enough other painkillers, there is no need to torment yourself like this.

1 capsule of Tebantin contains an active substance - gabapentin 100 mg 300 mg and 400 mg.

Additional components relative to the mass of the active substance:

• 1.33 mg - 3.99 mg - 5.32 mg - magnesium stearate;
• 3.99 mg - 11.97 mg - 15.96 mg - talcum powder;
• 5.54 mg - 16.62 mg - 22.16 mg - pregelatinized starch;
• 22.14 mg - 66.42 mg - 88.56 mg - lactose monohydrate.

Sheath:

• dyes (iron oxide yellow and red);
• gelatin;
• titanium dioxide.

Release form

Tebantin is available in the form of capsules of 100 mg, 300 mg and 400 mg. The package contains 50 or 100 capsules.

pharmachologic effect

Anticonvulsant, analgesic.

Pharmacodynamics and pharmacokinetics

Tebantin is a drug that exhibits antiepileptic, analgesic (with neuropathies ) activity, as well as having anxiolytic and neuroprotective effects.

Gabapentin is the active substance of the drug and belongs to the structural analogs of GABA ( gamma-aminobutyric acid ). Gabapentin molecules are lipophilic due to which they easily penetrate the blood-brain barrier. It has not yet been possible to fully determine the mechanism of action of the drug, but it is known that Gabapentin alters the work of calcium channels and is involved in the release neurotransmitters. In conducted (in vitro) studies, the drug Tebantin affects glutamate synthetase and GABA synthetase , changing their activity, and also increases GABA synthesis in the structure of the brain.

Food intake does not affect the absorption of Gabapentin. Bioavailability within 60%. When taking a single dose, the peak plasma concentration is observed after 180 minutes and is reduced to 120 minutes when taken again. The therapeutic concentration is achieved on the second day of use and is maintained throughout the entire course of therapy. T1 / 2 - 5.2-6.1 hours. 63.6% of the dose taken is excreted by the kidneys. A small part of Gabapentin undergoes transformation in the liver, without changing its activity enzymes Penetrates through BBB and is found in the milk of a nursing mother. twenty% plasma concentration defined in synovial fluid. Displayed during the procedure . In the elderly and patients with disabilities kidney function , the half-life of Gabapentin is increased. In case of violation liver function excretion of the drug decreases in proportion to the decrease CC (creatinine clearance).

Indications for Tebantin's use

Indications for the use of tablets of the drug Tebantin suggest their use in the therapy of patients and . At epilepsy, for adults and patients over the age of 12 years, the drug is prescribed, as in monotherapy, and in combination with other means for treatment partial epileptic seizures secondary generalization.

Also, pediatric patients (from 3 to 12 years old) are prescribed Tebantin as an adjunct drug in the treatment partial seizures , including seizures accompanied by secondary generalization. The effect of Gabapentin on children under 3 years of age, as well as on patients under 12 years of age as monotherapy, has not been studied. The drug Tebantin can be prescribed to patients with neuropathy and neuropathic pain syndrome.

Contraindications

• the patient's age up to 3 years;
• lactation;
• hypersensitivity to the components of Tebantine.

Side effects

CNS (central nervous system):

• blurred vision ( , diplopia );
• violation of thinking processes;
• emotional lability;
• feeling anxious;
• irritability and increased nervous irritability ;
• violation of consciousness;
• tics;
• decreased sensitivity;
• hypo- or areflexia;
• hostility and hyperkinesis (in patients under 12 years of age).

The cardiovascular system:

• change in blood pressure (in any direction);
• vasodilation.

Gastrointestinal tract (gastrointestinal tract):

• nausea ;
• flatulence;
• vomit ;
• hemorrhagic pancreatitis;
• anorexia;
• or ;
• increased appetite;
• gingivitis;
• feeling of dryness in the mouth;
• discoloration of the enamel of the teeth or damage to them.

Circulatory system:

• leukopenia.

Musculoskeletal system:

• myalgia;
• excessive bone fragility;
• arthralgia.

Respiratory system:

• cough;

Sense organs:

• tinnitus.

Allergic manifestations:

• erythema multiforme;
• Stevens-Johnson syndrome;

Skin:

• acne rash.

Genitourinary system:

Laboratory indicators:

• violation of blood glucose;
• increased activity of transaminases.

• swelling of the face;
• increase in body weight;
• abdominal pain;
• peripheral edema;
• backache;
• asthenia;
• heat;
• purpura;
• symptoms inherent .

Tebantin, application instruction (Way and dosage)

Tebantin is indicated for oral administration. The tablets are swallowed whole, regardless of the meal. Dosage gabapentin and the duration of the course of therapy is determined exclusively by the attending physician, depending on the pathology and course of the disease. For suffering patients epilepsy the dose of the drug is selected individually.

For adults and adolescents over 12 years of age, an average maintenance daily dose of 900-1200 mg is recommended. The maintenance dose is determined over several days of treatment using the scheme described below: 1st day of therapy - the daily dose is 300 mg of the active substance Gabapentin (1 capsule of Tebantin 300 mg). 2nd day of therapy - the daily dose is 600 mg (1 capsule of 300 mg or 2 capsules of 100 mg in three divided doses). 3rd day of therapy - the daily dose is 900 mg (1 capsule 300 mg in three divided doses). From the 4th day of therapy, Gabapentin is prescribed in a daily dose of 900 mg (can be increased to 1200 mg).

There is an alternative scheme for the selection of an individual dose of Tebantin, which recommends taking the first daily dose of 900 mg (300 mg three times a day). After, the initial dose is titrated, increasing it daily by 300-400 mg, and stop when the required therapeutic effect... The individual dose thus derived is divided into three doses per day. The maximum dose of Tebantin per day is 2400 mg in terms of active substance... There are no data on the safety and effectiveness of doses exceeding the maximum dose.

Patients aged 5 to 12 years suffering from epilepsy it is recommended to start therapy with the first daily dose of 10 mg / kg body weight, doubling it (20 mg / kg) on ​​the second day of treatment. On the third day, the dose is increased to 25-35 mg / kg and remains at this level with possible adjustment by the attending physician in accordance with the achieved effect. At epilepsy in children aged 3 - 4 years, the recommended daily dose gabapentin equals 40 mg / kg body weight. The therapeutic dose is determined gradually over 3 days, from taking the first daily dose of 10 mg / kg to the required dose, increasing the initial dose by no more than twice in 1 day. The maximum daily dose for patients of this age should not exceed 50 mg / kg of body weight.

Adult patients for therapy neuralgia , as a rule, it is recommended to carry out a course of treatment in daily doses of 900-1800 mg. According to indications and if the drug is well tolerated, the Tebantin dose can be increased to 3600 mg. Therapy begins with a dose of 300 mg per day, gradually increasing the dose of the drug each subsequent day by 300 mg, until a daily dose of 900 mg is reached (3rd day). If the daily dose of 900 mg is ineffective, it can be doubled (up to 1800 mg) for 7 days. Dose gabapentin , which exceeds 300 mg per day, is divided into several doses (mainly three doses). An alternative therapy regimen consists in prescribing a daily dose of the drug, which is 900 mg divided into three doses (3 capsules of 300 mg each).

At inefficiency and in the absence of contraindications, gradually (within 7 days) increase the dose to 1800 mg. This treatment regimen is usually used for acute pain. Instructions for the use of Tebantine 300 mg at neuralgia, indicates the maximum daily dose of the drug, which is 3600 mg. It must be borne in mind that in case of severe general condition patient, low weight, as well as after organ transplant , the daily dose of the drug can be increased by no more than 100 mg per day. You may need to adjust the dose of the drug Tebantin, elderly patients. With kidney pathologies, the daily dose gabapentin , like the duration of the course of treatment, is determined exclusively by the attending physician and depends on the indicators CC (creatinine clearance in ml / min).

• CC 80 and above - no more than 3600 mg;
• CC 50-79 - no more than 1800 mg;
• CC 30-49 - no more than 900 mg;
• KK 15-29 - no more than 600 mg;
• CC less than 15 - no more than 300 mg.

Taking the daily dose of the drug is divided into three times. If there is no need to use the maximum dose, Tebantin is prescribed 100 mg three times a day and taken every other day (300 mg per day with a break of 24 hours). In case of appointment gabapentin patients with CC less than 15 undergoing the procedure hemodialysis and those who have not previously taken this drug, a saturating dose of the drug (300-400 mg) is recommended.

After each session hemodialysis , amounting to 4 hours, take 200-300 mg of the drug. On days free from hemodialysis Tebantin is not accepted. Cancellation of the drug Tebantin, as well as the transfer of the patient to another drug with antiepileptic activity , is carried out gradually, due to the risk of occurrence epileptic seizures.

Overdose

In case of an overdose, Tebantin was observed dizziness, development of drowsiness, dysarthria, double vision and diarrhea. Acute cases intoxication , which could threaten the patient's life, has not been identified, even with a tenfold dose exceeded.

Specific antidote no. Supportive symptomatic therapy is indicated. If necessary, appoint hemodialysis.

Interaction

When taking Tebantin with other antiepileptic drugs ( , Phenytoin, Phenobarbital, ) their concentration in the blood does not change. When administered with oral contraceptives Gabapentin does not affect their effectiveness, however, when using combination therapy with other antiepileptic drugs that reduce the effect of oral contraceptives , it is possible to reduce their effect.

Renal Elimination of Gabapentin Decreased When Taken Cimetidine. Antacid medicines, preparations containing magnesium or aluminum (acid-neutralizing) can affect the bioavailability of Gabapentin, reducing it by 24%. In this regard, it is recommended to take Tebantin no earlier than 2 hours after application. antacids.

Side effects of Tebantin from the central nervous system can intensify drinks containing alcohol, as well as drugs that act on the central nervous system. It is possible to obtain a false positive result in laboratory tests, using a litmus test, when analyzing the total protein in the urine. This analysis should be confirmed using alternative research methods.

Terms of sale

On prescription.

Storage conditions

At a temperature not exceeding 25 ° C.

Shelf life

special instructions

Constant monitoring of blood glucose levels in patients suffering from . It may be necessary to adjust the dose of antidiabetic drugs.

Patient intolerance lactose it should be borne in mind that the capsules of the drug Tebantin contained lactose.

When the first symptoms are detected acute pancreatitis (nausea, persistent abdominal pain, repeated vomiting) therapy should be discontinued. The patient must be assigned a thorough examination (laboratory and clinical tests) to confirm or deny the diagnosis of acute pancreatitis.

When the appearance Gdizziness, drowsiness, increased fatigue, ataxia, weight gain, nausea or vomiting in adult patients, and hyperkinesia, hostility and sleepiness in children, it is necessary to discontinue therapy and consult with the attending physician.

For children

The efficacy and safety of the use of Gabapentin in children under 3 years of age as an additional treatment for epilepsy, as well as in children under 12 years of age in monotherapy, has not been established. There is also no information about the effect of the drug on patients under 18 years of age during treatment neuropathy.

Newborn

The effect of Gabapentin on neonates has not been established.

With alcohol

Alcohol intake can increase the side effects of the central nervous system.

During pregnancy and lactation

Use with extreme caution during pregnancy. It is recommended to refuse breastfeeding during treatment with Tebantin or to choose another drug.

Tebantin– medicinal product, which has antiepileptic, analgesic (in neuropathy models), neuroprotective and anxiolytic effects.

Pharmacological properties

Tebantin contains the active component gabapentin - a structural analogue of gamma-aminobutyric acid. Due to the lipophilicity of the molecule, gabapentin penetrates well through the blood-brain barrier. The exact mechanism of action of gabapentin is unknown, the active component of the drug Tebantin modulates the action of calcium channels, as well as the release of transmitters. Tebantin alters the activity of GABA synthetase and glutamate synetase in vitro, and also leads to an increase in the synthesis of gamma-aminobutyric acid in the brain. Absorption of gabapentin does not depend on food intake, peak plasma concentrations are reached within 3 hours after a single dose of Tebantin. After repeated doses, the time to reach peak plasma concentrations is reduced to 2 hours. The saturation stage is reached on the second day of therapy and is maintained throughout the entire course of admission. The half-life of gabapentin reaches 5.2-6.1 hours, about 63.6% of the dose taken is excreted in the urine. The bioavailability of gabapentin does not depend on the dose and with repeated doses is about 60%. Some part of gabapentin is metabolized in the liver, the drug does not change the activity of liver enzymes. Tebantin crosses the blood-brain barrier; in the synovial fluid, the concentration of gabapentin is about 20% of the plasma concentration. In elderly patients, as well as in those with impaired renal function, there is an increase in the half-life of gabapentin, while in patients with impaired liver function, the excretion of gabapentin decreases in proportion to the decrease in creatinine clearance. Gabapentin is excreted during hemodialysis.

Indications for use

Tebantin is used to treat patients with epilepsy.

In particular, Tebantin is prescribed for adults and children over 12 years old as monotherapy or in complex treatment partial epileptic seizures, including seizures, which are accompanied by secondary generalization.

For children from 3 to 12 years old, Tebantin is prescribed as an additional agent in the treatment of partial seizures, including seizures, which are accompanied by secondary generalization. There are no data on the use of gabapentin in children under 3 years of age, as well as in children under 12 years of age, as monotherapy.

Tebantin can be prescribed to patients suffering from neuropathy, as well as neuropathic pain.

Mode of application

Tebantin is taken orally. The capsules can be taken with or without food. The dose of gabapentin is determined by the doctor depending on the nature of the disease.

In epilepsy, the dose is selected individually, for adults and adolescents over 12 years of age, the average maintenance daily dose is 900-1200 mg of gabapentin. The maintenance dose is selected over several days according to the proposed scheme:

On the first day of therapy, take 300 mg of gabapentin (1 capsule Tebantin 300) per day.

On the second day of therapy, 600 mg of gabapentin are taken (1 capsule Tebantin 300 twice a day or 2 capsules Tebantin 100 three times a day).

On the third day of therapy, 900 mg of gabapentin are taken (1 capsule of Tebantin 300 three times a day).

Starting from the fourth day of therapy, they take 900 mg of gabapentin per day or increase the dose to 1200 mg of gabapentin per day (1 capsule of Tebantin 400 three times a day).

An alternative dose selection scheme is to take 900 mg of gabapentin per day (1 Tebantin 300 capsule three times a day), after which the dose is titrated, increasing daily by 300-400 mg until the desired effect is achieved. The received daily dose is divided into 3 doses.

Children from 5 to 12 years old with epilepsy are recommended to prescribe gabapentin at a dose of 25-35 mg / kg of body weight per day. At the same time, on the first day, it is recommended to take gabapentin at a dose of 10 mg / kg body weight, on the second day of therapy - 20 mg / kg body weight per day, on the third day 25-35 mg / kg body weight per day. The daily dose can be adjusted by the attending physician depending on the effect achieved.

Children 3-4 years old with epilepsy are recommended to prescribe gabapentin at a dose of 40 mg / kg of body weight per day. The dose is selected gradually over 3 days, starting from 10 mg / kg of gabapentin weight per day and increasing by no more than 10 mg / kg of weight in 1 day.

For the treatment of neuralgia in adult patients, gabapentin between 900 and 1800 mg is generally recommended.

With good tolerance of the drug Tebantin, the dose can be increased according to indications to 3600 mg of gabapentin.

The therapy should be started gradually: on the first day, 300 mg of gabapentin are taken, on the second day of therapy, the dose is increased to 600 mg of gabapentin per day, on the third - to 900 mg of gabapentin per day. If the intake of 900 mg of gabapentin per day does not give the expected effect, the dose is gradually increased (per week, the dose can be increased to 1800 mg of gabapentin per day). The daily dose of gabapentin in excess of 300 mg is divided into several doses.

An alternative dose selection scheme is the appointment of 900 mg of gabapentin per day (1 capsule Tebantin 300 three times a day), after which, if necessary, the dose is gradually increased to 1800 mg during the week. This scheme is used mainly for severe pain syndrome.

It should be noted that in patients with a general serious condition, low body weight, as well as in patients who have undergone organ transplantation, the dose should be increased by no more than 100 mg of gabapentin per day.

Elderly patients may need a dose adjustment of Tebantin.

In case of impaired renal function, the dose of gabapentin is adjusted depending on the creatinine clearance parameters.

With creatinine clearance values ​​above 80 ml / min, the daily dose should not exceed 2400 mg of gabapentin.

With creatinine clearance rates of 50-79 ml / min, the daily dose should not exceed 1800 mg of gabapentin.

With creatinine clearance rates of 30-49 ml / min, the daily dose should not exceed 900 mg of gabapentin.

With creatinine clearance rates of 15-29 ml / min, the daily dose should not exceed 600 mg of gabapentin.

If creatinine clearance is less than 15 ml / min, the daily dose should not exceed 300 mg of gabapentin. If the appointment maximum dose is not necessary, such patients are prescribed 100 mg of gabapentin three times a day every other day (300 mg of gabapentin a day every other day).

Patients who are on hemodialysis and have not previously taken gabapentin are prescribed 300-400 mg of gabapentin (saturating dose), after which another 200-300 mg of gabapentin should be taken every 4 hours of hemodialysis. On days when a hemodialysis session is not performed, gabapentin is not prescribed.

The duration of therapy is determined by the doctor. Cancellation of gabapentin or switching to another antiepileptic drug should be carried out gradually, otherwise the risk of developing epileptic seizures increases.

Side effects

When taking the drug Tebantin in patients, the development of such an undesirable effect due to gabapentin was noted:

On the nervous system: dizziness, drowsiness, lack of coordination, increased fatigue, decreased visual acuity, headache, nystagmus, tremor of the extremities, dysarthria, impaired memory and thinking, depression and emotional lability. In addition, it is possible the development of insomnia, fatigue, and paresthesias.

On the digestive tract: vomiting, decreased or increased appetite, nausea, change in body weight, abdominal pain, stool disorders, dyspeptic symptoms, dryness of the oral mucosa, flatulence.

Allergic reactions: allergic rhinitis, cough, epithelial lesions, itchy skin, urticaria, acne.

Other side effects: back pain, hyperthermia, vasodilation, deterioration of tooth enamel, leukopenia, edema. In addition, there may be an increased risk of bone fractures, the development of myalgia, decreased sensitivity and shortness of breath.

When taking Tebantin in the course of post-marketing studies, there were cases of impotence, aggression and hyperkinesia, as well as hemorrhagic pancreatitis and allergic reactions in the form of Stevens-Johnson syndrome and erythema multiforme.

Tebantin can lead to false positive results for protein in the urine (with some types of diagnostics).

If side effects develop, you should inform your doctor about them.

Contraindications

Tebantin is not indicated for patients with intolerance to gabapentin or capsule auxiliary components.

Tebantin capsules are not prescribed for patients with rare forms of lactose intolerance.

Tebantin is not used to treat patients with acute pancreatitis.

Gabapentin is not prescribed for generalized primary seizures (due to the ineffectiveness of the drug in such conditions).

Care should be taken to prescribe the drug Tebantin to patients with diabetes mellitus, impaired renal function and pancreatitis.

During the period of therapy with Tebantin, driving a car and driving unsafe equipment should be excluded (taking into account the risk of developing undesirable effects from the nervous system).

Pregnancy

There is no data on the use of gabapentin during pregnancy. The drug Tebantin for women during pregnancy can be prescribed only after a careful study of the balance of risks and benefits.

Tebantin is contraindicated during lactation, if gabapentin therapy cannot be avoided, the issue of stopping breastfeeding should be resolved.

Interaction with other medicinal products

Ethyl alcohol, when combined with Tebantin, increases the risk of developing an undesirable effect of gabapentin on the central nervous system.

There is an increase in the activity of hepatic enzymes with the combined use of gabapentin with other antiepileptic drugs.

Antacids containing aluminum and magnesium, when taken together, reduce the absorption of gabapentin. It is necessary to observe an interval of at least 2 hours between taking Tebantin and taking antacids.

Overdose

When intoxication with Tebantin, patients develop drowsiness, double vision, dizziness, dysarthria and diarrhea. Development acute intoxication, life-threatening, was not observed even when taking doses ten times higher than the maximum.

The specific antidote for gabapentin is not known. With the development of an overdose, supportive therapy is carried out, and symptomatic agents are prescribed.

In severe overdose, hemodialysis may be performed to reduce plasma levels of gabapentin.

Storage conditions

Tebantine should be kept away from children when temperature conditions 15 to 30 degrees Celsius.

The shelf life of Tebantin capsules is 2 years.

Release form

Tebantin capsules, 10 pieces packaged in blisters, in a cardboard box of 50 or 100 capsules.

Composition

• 1 capsule of Tebantin 100 contains:

Gabapentin 100 mg

• 1 capsule of Tebantin 300 contains:

Gabapentin - 300 mg;

Additional ingredients including lactose monohydrate.

• 1 capsule of Tebantin 400 contains:

Gabapentin 400 mg

Additional ingredients including lactose monohydrate.

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