Tebantin

Tebantin - a drug that exhibits antiepileptic, analgesic (with neuropathy) activity, and also has anxiolytic and neuroprotective effects.

The active ingredient is gabapentin, a lipophilic substance whose structure is similar to the structure of the gamma-aminobutyric acid (GABA) neutrotransmitter. At the same time, the mechanism of action of gabapentin differs from some other interacting with GABA receptors drugs: it does not exhibit GABA-ergic properties and does not affect the capture and metabolism of GABA.

The drug is rapidly absorbed, and the maximum concentration in the plasma is observed after 3 hours. After repeated administration to achieve maximum concentration, it is necessary for 1 hour less than for a single dose. Absolute bioavailability of gabapentin in capsules is approximately 60%. When the dose of the drug is increased, the bioavailability of this substance decreases.

Clinical and pharmacological group

Anticonvulsant drug.

Terms of sale from pharmacies

Can buyby prescription.

Price

How much is Tebantin in pharmacies? The average price is at the level of800 rubles.

Composition and form of release

Medicinal form of Tebantin - capsules: hard gelatinous, Coni-Snap, contents - crystalline powder of white or almost white color (10 pcs. Each). in blisters, in a cardboard bundle of 5 or 10 blisters).

The active substance of the drug is gabapentin. Its content in capsules:

• Size # 3, with a white body and a pinkish-brown lid - 100 mg;
• Size No. 1, with a light yellow body and a pinkish-brown lid - 300 mg;
• Size No. 0, with a yellowish-orange body and a pinkish-brown lid - 400 mg.

Auxiliary components: pregelatinized starch, talc, lactose monohydrate, magnesium stearate.

The composition of the capsule shell: titanium dioxide (E171), gelatin, iron oxide pigments yellow (E172) and iron oxide red (E172).

pharmachologic effect

The exact mechanism of action of Tebantin is unknown.

Gabapentin is structurally related to GABA (γ-aminobutyric acid), but the mechanism of its action differs from other compounds interacting with synapses of GABA, including barbiturates, valproate, benzodiazepines, GABA capture inhibitors, GABA prodrugs, GABA agonists. In in vitro studies, a new peptide binding site in rat brain tissues has been described, which may be related to the analgesic, anticonvulsant effect of gabapentin.

In studies on animals, gabapentin easily penetrated the brain, prevented convulsions from chemical convulsants, maximum electric shock.

Pharmacokinetics

Eating does not affect the absorption of Gabapentin. Biological availability is within 60%. When taking a single dose, the peak concentration in the plasma is observed after 180 min and is reduced to 120 minutes with repeated admission. The therapeutic concentration is achieved on the second day of use and is maintained throughout the course of therapy. T1 / 2 - 5.2-6.1 hours. 63.6% of the received dose is excreted by the kidneys. A small portion of Gabapentin undergoes transformation in the liver, without altering the activity of its enzymes.

It penetrates through the BBB and is found in the milk of a nursing mother. 20% of the plasma concentration is determined in the synovial fluid. Displays in the procedure of hemodialysis. In elderly patients and patients with impaired renal function, the half-life of gabapentin increases. When the liver function is impaired, the excretion of the drug decreases in proportion to the decrease in QC (creatinine clearance).

Indications for use

Indications for the use of tablets of the drug Tebantine suggest their use in the treatment of patients with epilepsy and neuropathy. In epilepsy, adults and patients aged after 12 years, the drug is prescribed, either in monotherapy or in combination with other drugs means for the treatment of partial epileptic seizures, including seizures accompanied by secondary generalization.

Also, children of children (from 3 to 12 years old) are prescribed Tebantine as an auxiliary medicinal funds in the treatment of partial seizures, including seizures accompanied by secondary generalization. The effect of gabapentin on children under 3 years old, as well as on patients under 12 years of age as monotherapy, has not been studied.

The drug can be administered to patients with neuropathy and neuropathic pain syndrome.

Contraindications

Teabantin is strictly contraindicated in the following cases:

• Children under 3 years;
• Children age from 3 to 12 years with gabapentin alone;
• Acute pancreatitis;
• Malabsorption of glucose / galactose, lactase deficiency, lactose intolerance;
• Lactation period;
• Hypersensitivity to the components of the drug.

There is no data on the safety of the intake of Tebantin during pregnancy, so it can be prescribed only if the expected benefit exceeds potential risks.

Under special supervision during the treatment should be patients with renal insufficiency.

Intended use for pregnancy and lactation

In the first trimester of pregnancy, the use of Tebantin is not recommended, since during this period, all organs and fetal systems, and data on the safety of the drug for pregnant women and the unborn child are not provided.

In the second and third trimesters of pregnancy, the use of Tebantin is justified only if the benefit for the expectant mother is greater than the potential risks to the child. The drug is used in a minimally effective dosage and under the strict supervision of a physician.

It is not known whether active active substance of the drug can be excreted in breast milk and how it is reflected on the body of the baby, so the drug is not recommended for treatment of nursing mothers. If necessary, lactation should be discontinued.

Dosage and route of administration

As indicated in the instructions for use, Tebantin capsules are taken orally, regardless of food intake, not chewed, swallowed whole and washed down with a sufficient amount of liquid.

With partial cramps to provide antiepileptic effect to adults and children over 12 years of age, Tebantin is prescribed at a dose of 900-1200 mg per day. Recommended treatment regimens:

• scheme A: the first day - 300 mg (100 mg three times a day or 300 mg once), the second day - 600 mg (200 mg three times a day or 300 mg twice a day), the third day - 900 mg (300 mg three times a day), the fourth day - 1200 mg (400 mg three times a day);
• scheme B: the first day - 900 mg (300 mg three times a day), in the following days you can increase the daily dose to 1200 mg (400 mg three times a day).

The maximum daily dose of Tebantin is , 00 mg (800 mg three times a day).

As an additional therapy for partial seizures, children 3-12 years of age with a body weight of more than 17 kg are prescribed 25-35 mg / kg of body weight per day, divided into three doses. Recommended initial doses:

• children aged 3 to 12 years with a body weight of 17-25 kg: the first day - 200 mg per day once, the second day - 200 mg twice a day, the third day - 200 mg three times a day;
• children aged 3 to 12 years with a body weight of more than 26 kg: the first day - 300 mg per day once, the second day - 300 mg twice a day, the third day - 300 mg three times a day.

Starting from the fourth day of therapy, the daily dose of gabapentin can be increased to 35 mg / kg per day in three divided doses. According to clinical studies, the dose of the drug in 40-50 mg / kg per day was well tolerated.

Recommended maintenance daily doses for children aged 3 to 12 years, with body weight:

• 17-25 kg - 600 mg each;
• 26-36 kg - 900 mg each;
• 37-50 kg - for 1200 mg;
• 51-72 kg - for 1800 mg.

For neuropathic pains for adults over 18 years of age, the dose of Tebantyn is determined by titration, taking into account the effectiveness of the therapy and the tolerability of the drug. The maximum daily dose is 3600 mg per day in three divided doses.

Recommended treatment regimens:

• Scheme A: the first day - 300 mg (100 mg three times a day or 300 mg once), the second day - 600 mg 200 mg three times a day or 300 mg twice a day), the third day - 900 mg (300 mg three times a day);
• scheme B (with intense pain): the first day - 900 mg (300 mg three times a day), in the next 7 days you can increase the daily dose to 1800 mg per day.

Patients with low body weight, weakened individuals and patients who underwent organ transplantation, the dose is increased gradually, by no more than 100 mg per day.

With renal failure (if creatinine clearance is less than 80 ml / min), elderly people with reduced creatinine clearance and patients on hemodialysis dose Tebantine is selected individually, given the degree of impaired renal function.

Side effects

On the background of the use of the drug in patients can develop side effects, which are clinically manifested as follows:

1. Cardiac disorders: palpitations.
2. From the side of the organ of vision: diplopia, amblyopia.
3. From the side of the organ of hearing, balance: dizziness, ringing in the ears.
4. From the side of the vascular system: arterial hypertension, vasodilation.
5. Respiratory, thoracic, mediastinal disorders: rhinitis, dyspnea, pharyngitis, bronchitis, cough.
6. From the hepatobiliary system: hepatitis, jaundice.
7. Infections / invasions: pneumonia, viral infection, respiratory infections, otitis media, urinary tract infections.
8. From the blood, lymphatic system: thrombocytopenia, leukopenia.
9. From the immune system: lymphadenopathy, eosinophilia, allergic reactions.
10. Metabolic disorders: increased appetite, anorexia.
11. From the musculoskeletal system: myalgia, arthralgia, muscle twitching, back pain.
12. From the urinary system: acute renal failure, incontinence.
13. From the side of the reproductive system, the mammary glands: hypertrophy of the mammary glands, impotence, gynecomastia.
14. Common disorders: fever, fatigue, peripheral edema, gait disturbance, generalized edema, asthenia, malaise, pain, flu-like syndrome, withdrawal reactions (anxiety, sweating, nausea, insomnia, pain), chest pain, weight gain.
15. Deviations from the norm in laboratory studies: a decrease in the level of leukocytes, fluctuations in blood glucose levels in patients with diabetes mellitus, an increase in plasma concentrations of hepatic enzymes.
16. From the nervous system: dizziness, drowsiness, ataxia, hyperkinesia, convulsions, dysarthria, tremor, amnesia, insomnia, paresthesia, headache, hypesthesia, nystagmus, impaired coordination, increase, decrease / absence of reflexes, impaired movement (hypokinesia, dyskinesia, choreoathetosis, dystonia).
17. On the part of the gastrointestinal tract: nausea, vomiting, changes in the teeth, diarrhea, gingivitis, abdominal pain, constipation, indigestion, dry mouth / pharynx, pancreatitis, flatulence.
18. From the skin, subcutaneous tissue: purpura, face swelling, rash, acne, itching, Stevens-Johnson syndrome, erythema multiforme, angioedema, alopecia.
19. Mental disorders: confusion, hostility, emotional lability, anxiety, depression, increased excitability, hallucinations, pathological thinking.
20. Injuries: fracture, accidental injury, scratches.

The development of the described adverse reactions to the drug requires immediate consultation with the doctor and the decision to discontinue therapy or correct the prescribed dose.

Overdose

Even after taking 49 g of Tebantin daily, symptoms of life-threatening acute poisoning were not observed.

In case of an overdose, there is a speech disorder, double vision, dizziness, diarrhea, drowsiness and lethargy. Symptomatic treatment is recommended. When treating patients with severe renal failure, hemodialysis is possible.

special instructions

Before you start using the drug, read the special instructions:

1. The drug is ineffective for the treatment of absent epileptic seizures.
2. The safety and efficacy of therapy for neuropathic pain in patients under the age of 18 years have not been established.
3. The safety and efficacy of gabapentin in children under 3 years of age as an additional therapy for epilepsy and in children under 12 years of age have not been established as monotherapy.
4. In the process of selecting the optimal therapeutic dose, there is no need to measure the concentration of the drug in the plasma.
5. When gabapentin is used, it is necessary to monitor the blood glucose level in patients with diabetes mellitus; sometimes there is a need to change the dose of hypoglycemic drug.
6. When lactose intolerance should be taken into account that 1 caps. (100 mg) contains 22.14 mg of lactose, 1 caps. (300 mg) - 66.42 mg lactose, and 1 caps. (400 mg) - 88.56 mg of lactose.
7. Reduce the dose, cancel the drug or substitute for another alternative means should be gradually over a minimum of 1 week. A sharp cessation of therapy can provoke an epileptic status.
8. When the first signs of acute pancreatitis (prolonged pain in the abdominal cavity, nausea, repeated vomiting) should stop treatment with gabapentin. A thorough examination of the patient (clinical and laboratory tests) should be carried out for the purpose of early diagnosis of acute pancreatitis.
9. In the case of adult drowsiness, ataxia, dizziness, increased fatigue, nausea and / or vomiting, weight gain, and in children drowsiness, hyperkinesia and hostility, you should stop taking the drug and consult with your doctor.

During the period of treatment, patients should refrain from driving vehicles and practicing potentially dangerous Activities that require increased concentration and speed of psychomotor reactions.

Interaction with other drugs

When using the drug, it is necessary to take into account the interaction with other drugs:

1. Means that neutralize the acidity of the stomach, containing magnesium or aluminum, reduce the bioavailability of gabapentin by 24%. Capsules Tebantyn should be taken 2 hours after taking antacids.
2. With the combination of cimetidine with gabapentin, the excretion of the latter by the kidneys slightly decreases, which probably has no clinical significance.
3. Other drugs that affect the central nervous system, as well as ethanol, can increase the side effects of gabapentin on the CNS (eg, drowsiness, ataxia).
4. Probenecid does not affect renal excretion of gabapentin.
5. Interactions between gabapentin and phenytoin, carbamazepine, valproic acid, and phenobarbital have not been observed. The pharmacokinetics of gabapentin in the equilibrium state is the same in healthy people and patients receiving other antiepileptic drugs.
   Gabapentin does not affect the pharmacokinetics and efficacy of oral contraceptives containing norethisterone and / or ethinylestradiol. However, the reduction / cessation of the contraceptive effect of these drugs is possible when combining the drug Tebantin with other antiepileptic drugs that reduce the effectiveness of oral contraceptives.
6. When gabapentin was added to other anticonvulsants, false positive results were recorded in determining the total protein in the urine using semi-quantitative tests. If positive results are obtained with such tests, it is recommended to use a more specific method of precipitation with sulfosalicylic acid or biuret breakdown.
7. With the joint administration of gabapentin and morphine, when morphine in the form of capsules with controlled release of 60 mg was taken 2 hours prior to gabapentin, there was observed an increase in AUC of gabapentin by 44%, compared with gabapentin alone, which was accompanied by an increase in the pain threshold (cold pressor test). The clinical significance of these changes is not established. When gabapentin was administered 2 hours after morphine administration, there was no change in the pharmacokinetic parameters of morphine. The side effects of morphine when combined with gabapentin did not differ from those observed when taking morphine with placebo.

Reviews

We offer you to familiarize yourself with the opinions of people who used Tebantyn:

1. Marfa. I was helped only by tebantin. Entered the hospital in the pose of the letter "G". The month was treated - injections, physio procedures, massage, radon baths. By the time of discharge, I straightened up, but my left leg was pulling and loosening, and I limped. When I was discharged to me, tebantin was prescribed according to the scheme - gradual increase and decrease. Leg let go. At stresses again pulls a leg and gives in a back. Try not to take everything to heart. Take care of yourself.
2. Tatyana. Accepted this drug to the appointment of a neurologist, since the diagnosis of trigeminal neuralgia did not help even carbamazepine in large doses. Capsules immediately helped. The course was held for 3 months in May 2015, and this disease did not bother me yet (although it is a chronic disease). The medicine is expensive - 50 capsules costs 2300, why on the site it is written from 684 rubles. - I do not know. Tablets are sold only on the prescription of a doctor, but not all pharmacies are.
3. Irina. Of the side effects manifested a lot. It all began 10-12 hours after application with acute stitching pain in the spine and legs, excited state and heat. Sorrow and unbearable pain lasted more than a day. All ended with a fever (temperature for 39). An eerie condition. "Chased" a very, very plentiful drink. Remove a persistent pain syndrome with lumboschialgia did not help.

Analogues

Structural analogs for the active substance:

• Gabagamma;
• Gabapentin;
• Gapentec;
• Caten;
• Convalis;
• Neuronthin;
• Egipentin;
• Eplorontin.

Before buying an analogue, consult your doctor.

Shelf life and storage conditions

Keep out of the reach of children at room temperature.

Shelf life - 5 years.

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