Saturday, November 17, 2018

Tebantin

Description overdue on 08/12/2014

  • Latin name: Tebantin
  • ATC code: N03AX12
  • Active substance: Gabapentin (Gabapentin)
  • Manufacturer: JSC "Gedeon Richter". 1103, Budapest, Hungary.
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  • Composition
  • Product form
  • Pharmacological action
  • Pharmacodynamics and pharmacokinetics
  • Indications Tebantin
  • Contraindications
  • Side effects
  • Tebantin, instructions for use (method and dosage)
  • Overdose
  • Cooperation
  • Terms of sale
  • Storage conditions
  • Shelf life
  • Cautions
  • Analogs
  • Synonyms
  • Babies
  • Newborns
  • With alcohol
  • During pregnancy (and lactation)
  • Reviews
  • Price, where to buy

 Tebantin

Composition

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

Additional components of the weight of the active substance:

  • 1, 33 mg - 3 mg of 99 - 5, 32 mg - magnesium stearate ;
  • 3, 99 mg - 11 mg 97 - 15, 96 mg - talc;
  • 5, 54 mg - 16 mg 62 - 22, 16 mg - pregelatinized starch;
  • 22, 14 mg - 66 mg 42 - 88, 56 mg - lactose monohydrate.

Sheath:

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

Product form

Tebantin produced in the form of capsules, 100 mg, 300 mg and 400 mg. The package includes 50 or 100 capsules.

Pharmacological action

Anticonvulsant, analgesic.

Pharmacodynamics and pharmacokinetics

Tebantin - drug exhibiting anti-epileptic, sedative (at Neuropathy ) Activity, as well as having anxiolytic and neuroprotective effects.

Gabapentin   It is an active drug substance and refers to a structural GABA analogs ( gamma aminobutyric acid, ). Gabapentin lipophilic molecules differ so easily penetrate the blood-brain barrier. Completely determine the mechanism of action of the drug is still not possible, but it is known that alters the operation of gabapentin and calcium channels involved in the release of neurotransmitters.   The conducted (in vitro) studies, the drug affects the Tebantin glutamate synthetase and GABA synthetase Altering their activity, and increases the the synthesis of GABA   in brain structure.


Food intake does not affect absorption of gabapentin. Bioavailability within 60%. When receiving a single dose of the peak plasma concentration is observed after 180 mine and is reduced to 120 minutes at readmission. Therapeutic concentration is reached on the second day of application and maintained throughout the course of therapy. T1 / 2 - 5, 2-6, 1 hour. 63, 6% received dose is excreted by the kidneys. A small part of gabapentin undergoes transformation in the liver without affecting its activity enzymes   Absorbed through BBB   and is found in the milk of nursing mothers. 20% plasma concentrations   determined synovial fluid.   Displayed when the procedure hemodialysis.   In the elderly and in patients suffering from disorders renal function Elimination half-life of gabapentin increases. In case of violation liver function excretion of the drug is reduced in proportion to the decrease   CC (creatinine clearance).

Indications Tebantin

Indications tablets drug Tebantin suggest their use in the treatment of patients epilepsy and neuropathy.   With epilepsy, adults and patients over the age of 12 years, the drug is prescribed as in monotherapy .   and in combination with other agents for the treatment of partial seizures Including seizures, accompanied secondary generalization.

Also pediatric patients (3 to 12 years) Tebantin administered as adjuvant in the treatment of partial seizures Including seizures, accompanied secondary generalization.   The action of gabapentin for children up to 3 years, as well as in patients up to 12 years as monotherapy has not been studied. Tebantin drug can be administered to patients with neuropathy   and neuropathic pain syndrome.

Contraindications

  • the patient's age up to 3 years;
  • acute pancreatitis;
  • lactation;
  • hypersensitivity   Tebantin to the constituents.

Side effects

CNS (central nervous system) :

  • drowsiness ;
  • dizziness ;
  • nystagmus;
  • ataxia;
  • blurred vision ( amblyopia, diplopia );
  • tremor;
  • headache;
  • dysarthria;
  • disturbance of thinking;
  • amnesia;
  • depression;
  • emotional lability;
  • anxiety;
  • irritability, and increased nervous irritability ;
  • impaired consciousness;
  • Tiki;
  • decrease sensitivity;
  • hypo- or areflexia;
  • hostility and hyperkinesis   (patients under 12 years).

Cardiovascular system :

  • changes in blood pressure   (in either direction);
  • vasodilation.

GI (gastrointestinal tract) :

  • nausea ;
  • bloating;
  • vomiting ;
  • hemorrhagic pancreatitis;
  • anorexia;
  • diarrhea   or   constipation;
  • increased appetite;
  • gingivitis;
  • sensation of dryness in the oral cavity;
  • discoloration of tooth enamel or defeat.

Circulatory system :

  • leukopenia.

Locomotor apparatus :

  • myalgia;
  • excessive bone fragility;
  • arthralgia.

Respiratory system :

  • sore throat;
  • cough;
  • shortness of breath;
  • rhinitis.

Senses :

  • ringing in the ears.

Allergic symptoms :

  • exudative erythema multiforme;
  • Stevens-Johnson syndrome;
  • fever.

Skin :

  • itching;
  • rash of acne.

Genito-urinary system :

  • impotence;
  • incontinence.

Laboratory findings:

  • violation of blood glucose;
  • increase in transaminases.

Others:

  • swelling of the face;
  • weight gain;
  • abdominal pain;
  • peripheral edema;
  • back pain;
  • asthenia;
  • fever;
  • Purpura;
  • Symptoms characteristic Influenza.

Tebantin, instructions for use (method and dosage)

Tebantin indicated for oral administration. Tablets are swallowed whole, regardless of the meal. Dosage gabapentin   and the duration of therapy is determined solely by the attending physician, depending on the pathology of the disease. For patients suffering from epilepsy   the dose is adjusted individually.

Adult patients and adolescents over 12 years of supporting the recommended average daily dose of 900-1200 mg component. The maintenance dose is determined over several days of treatment using the below-described scheme: 1st day of therapy - daily dose is 300 mg of active ingredient gabapentin (1 Tebantin capsule formulation 300 mg). 2 nd day of therapy - a daily dose of 600 mg (1 capsule of 300 mg or 2 capsules of 100 mg in three divided doses). 3rd day therapy - a daily dose of 900 mg (1 capsule 300 mg in three steps). On the 4th day of therapy administered in a daily dose of 900 mg (may be increased to 1200 mg) of gabapentin.

There is an alternative scheme Tebantin individual dose, which is recommended to take the first daily dose of 900 mg (300 mg three times a day). After that, the initial dose was titrated daily increasing its 300-400 mg, and stop when you reach the desired therapeutic effect. The deduced thus individual dose is divided into three doses per day. Tebantin maximum dose per day - 2400 mg in terms of active ingredient. Data on the safety and efficacy of doses in excess of the maximum dose, no.

Patients aged from 5 th to 12 years, suffering epilepsy recommend starting treatment with the first daily dose of 10 mg / kg body weight, increasing its half (20 mg / kg) on ​​the second day of treatment. On the third day the dose is increased to 25-35 mg / kg and remained at this level with a possible adjustment of the attending physician, respectively, to achieve the effect. With epilepsy   in children 3 - 4 years, the recommended daily dose gabapentin is 40 mg / kg body weight. Determine therapeutic dose gradually over 3 days from administration of the first daily dose of 10 mg / kg and the dose desired by increasing the initial no more than twice for 1 day. The maximum daily dose for patient of age should not exceed 50 mg / kg body weight.

Adult patients for therapy neuralgia Usually recommend a course of treatment at daily doses of 900-1800 mg. According to the testimony, and good tolerability of the drug dose can be increased to Tebantin 3600 mg. Therapy is started with a dose of 300 mg per day, gradually increasing the dose each successive day in the 300 mg to achieve a daily dose of 900 mg (Day 3). When failure daily dose of 900 mg can be doubled (up to 1800 mg) for 7 days. Dose gabapentin That exceeds 300 mg per day, divided into one to several doses (mainly in three steps). An alternative scheme of therapy is intended daily dose of 900 mg three divided doses (3 capsules of 300 mg).

With ineffectiveness   and there are no contraindications gradually (within 7 days) increase the dose up to 1800 mg. This treatment regimen is usually used in acute pain expressed. Instructions for use Tebantin 300 mg for neuralgia,   indicates the maximum daily dose, is 3600 mg. Please note that in severe general condition of the patient, low weight, and after Organ Transplantation Daily dose of the drug can be increased by not more than 100 mg per day. You may need a dose adjustment of the drug Tebantin, elderly patients. When kidney disease daily dose gabapentin As well as the duration of treatment, is determined solely by the attending physician and depends on the performance CC (creatinine clearance in mL / min).

  • QC 80 and above - no more than 3,600 mg;
  • CC 50-79 - no more than 1,800 mg;
  • CC 30-49 - not more than 900 mg;
  • CC 15-29 - not more than 600 mg;
  • CC less than 15 - not more than 300 mg.

Receiving daily dose is divided into three times. If there is no need to use the maximum dose administered Tebantin 100 mg three times a day and take in a day (300 mg per day with an interval of 24 hours). In the case of appointment gabapentin patients with CC less than 15 undergoing the procedure Hemodialysis   and not previously treated with the drug, it is recommended loading dose of the drug (300-400 mg).

After each session Hemodialysis Equal to 4 hours, take 200-300 mg. In the days free Hemodialysis Tebantin not accept. Cancel the drug Tebantin as transfer the patient to another drug with antiepileptic activity It is carried out gradually due to the risk of epileptic seizures.

Overdose

In overdose Tebantin watched dizziness, drowsiness development, dysarthria, double vision, and diarrhea.   Cases of acute intoxication Which could endanger the patient's life is not detected, even when a tenfold dose exceeded.

Specific antidote   no. It shows the supported symptomatic therapy. If necessary, designate conduct hemodialysis.

Cooperation

When integrated with a reception Tebantin other antiepileptic drugs ( valproate, phenytoin, phenobarbital, carbamazepine ) Concentration in the blood does not change. In the appointment of oral contraceptives   Gabapentin does not affect their performance, but the application of combination therapy with other antiepileptic drugs, which reduce the effect of oral contraceptives May decrease their effect.

Renal elimination of gabapentin declines at reception Cimetidine.   Antacids medicaments, preparations containing magnesium or aluminum (acid-) can affect the bioavailability of gabapentin, reducing it to 24%. In this regard, we recommend taking Tebantin no earlier than 2 hours after application antacids.

Side effects Tebantin CNS may enhance beverages containing alcohol and drugs acting on the CNS. Possible to obtain false positive results in laboratory tests, using litmus paper, when analyzing total protein in the urine. It should confirm the details of such an analysis using alternative methods.

Terms of sale

Prescription.

Storage conditions

The temperature is not above 25 ° C.

Shelf life

5 years.

Cautions

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

When a patient intolerance lactose   keep in mind that the capsule formulation contain Tebantin lactose.

If any of the first symptoms acute pancreatitis   (nausea, recurring abdominal pain, repeated vomiting) therapy should be discontinued. The patient must assign a thorough examination (laboratory and clinical tests) that would confirm or refute the diagnosis - acute pancreatitis.

When g olovokruzheniya , Somnolence, fatigue, ataxia, weight gain, nausea or vomiting   in adults and hyperkinesia, hostility   and sleepiness   children need to discontinue therapy and consult a physician.

During the therapy, you should be careful when driving a car.

Analogs

Match code ATC 4th level:
  •  Tebantin  Keppra
  •  Tebantin  Pregabalin Richter

The most famous counterparts Tebantin are:

  • Vimpat;
  • Konvulsan;
  • Keppra;
  • Lamictal;
  • Lyrics;
  • Seyzar;
  • Lamotriks;
  • Pregabalin;
  • Epimaks   etc.

Synonyms

  • Gabapeptin;
  • Gabagamma;
  • Neurontin;
  • Konvalis;
  • Katena;
  • Egipentin   etc.

Babies

Not established efficacy and safety of gabapentin children under 3 years of age as an additional treatment of epilepsy, and children up to 12 years in monotherapy. There is also no information on the effect of the drug on patients under 18 years in the treatment of neuropathy.

Newborns

Effect of Gabapentin in the newborn is not established.

With alcohol

Drinking alcohol can enhance the side effects of the central nervous system.

During pregnancy and lactation

Used with caution during pregnancy. Recommend to give up breast-feeding during treatment Tebantin or choose another drug.

Reviews Tebantin

Reviews Tebantin forums as a preparation for treating seizures epilepsy, rather contradictory. Some estimate the drug exclusively on the positive side and say decrease the frequency and severity of attacks, while others do not experience any changes in their health status. Perhaps this is due to wrong assignment of courses of therapy and the selection of the individual therapeutic doses.

Reviews of patients neuropathic pain   Tebantin speak about its high efficiency, provided that all the recommendations of the attending physician. Among the side effects most commonly noted slight dizziness and drowsiness .

Price Tebantin where to buy

Price Tebantin pharmacies in Russia is approximately 300 mg №50 - 900 rubles; 300 mg №100 - 1700 rubles.

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