Neubatel hard capsules 300mg Davipharm treat local epilepsy (10 blisters x 10 tablets)
Dosage form Box of 10 blisters x 10 tablets
Specifications Gabapentin
Ingredient
| Composition information | Content |
| Gabapentin | 300mg |
Uses
Indications
Neubatel drug indications for treatment in the following cases:
Pharmacokology
ATC code: N03AX12.
Pharmacological group: anti -epileptic drugs, neurological treatment.
gabapentin is an anti -epileptic and pain relief due to neurological, unknown mechanism. On experimental animals, the drug has anti -stretching effects after electric shock and also inhibits convulsions caused by pentylenetetrazol. The effect in the above experiment is similar to Valproic acids other than Phenytoin and Carbamazepin, the chemical structure of Gabapentin is similar to neurotransmitters, Gama-Aminobutyric Acid (GABA), but Gabapentin has no affinity for Gabaa or Gabab receptors and does not change GABA.
gabapentin is not associated with other nerve transmission receptors of the brain and does not interact with the sodium channel. Gabapentin-mounted locations with high-level affinity throughout the brain, these positions correspond to the presence of calcium channels depending on the typical voltage with Alpha-2-Delta-1 supplementary units. This channel is in the Synap Money and can regulate the release of stimulating neurotransmitters that promote convulsions and pain.
pharmacokinetic pharmacokinetics
absorption
gabapentin absorbed through the gastrointestinal tract under saturated mechanism (when the dose increases, bioavailability decreases). The drug reaches the peak concentration in plasma after taking 2-3 hours and reaches a stable concentration after 1-2 days. The effective serum concentration of the drug has not been determined. However, in a study, the number of convulsions only decreased in people with gabapentin serum levels per mg/ liter (11.7 micromol/ liter). Gabapentin's plasma concentrations are generally within 2 mg/ liter (2 micrograms/ ml) to 20 mg/ liter (20 micrograms/ ml).
Birth is about 60% when used at a dose of 900 mg/ 24 hours and does not correspond to the dose, even when the dose increases, bioavailability decreases (bioavailability about 27% when used at a dose of 4.8 g/ 24 hours). Food, including a diet rich in fat, does not have a significant clinically affected on the pharmacokinetics of Gabapentin.
distribution
Gabapentin is distributed throughout the body, entering breast milk, linking with very low plasma proteins (3%). VA is 58 ± 6 liters in adults. In patients with epilepsy, gabapentine concentration in cerebrospinal fluid is about 20% of the bottom plasma concentration in the corresponding stable state.
transformation
There is no evidence of gabapentin metabolic in humans. Gabapentin does not touch the oxidase enzyme function in the liver is responsible for drug metabolism.
Elimination
gabapentin is excreted mainly through the renal in a constant form. Gabapentin's waste sale time does not depend on the dose and in about 5 to 7 hours in people with normal renal function.
Special subjects
In the elderly, and in patients with impaired renal function, gabapentine clearance in plasma decreases. Gabapentin excretion rate does not change, plasma clearance and kidney clearance are proportional to creatinine clearance.
Gabapentin may be excluded from plasma by hemolysis. Need to adjust the dose for patients with kidney damage or blood decomposition.
Children
Children under 1 year of age have a great change in drugs.
linear
Gabapentin's bioavailability decreases when increasing the dose indicates that the non -linear of pharmacokinetics parameters related to bioavailability (F) such as AE %, Cl/ F, VA/ F. Essential pharmacokinetics (pharmacokinetic parameters are not related to F such as Cl, and Belief) are best described by linear pharmacokinetic. Gabapentin concentration in a stable state can be predicted from single dose information.
Before taking Neubatel hard capsules 300mg Davipharm treat local epilepsy (10 blisters x 10 tablets)
How to use
Oral hard capsules, at the time of taking the drug, regardless of the meal, should swallow whole tablet with water.
Gabapentin is often considered ineffective in awareness of epilepsy.
Dosage
Starting dose of treatment for all indications and recommendations for adults and teenagers over the age of 12.
Advice to stop gabapentin slowly for at least a week for all indications.
anti -epileptic
Epilepsy treatment usually has to last. The treatment dose decided by the doctor based on tolerance and effectiveness on each individual.
Adults and children over 12 years: Support treatment or local epilepsy treatment with or without a total seizure.
It is possible to start the starting dose of 300 mg/ time x 3 times a day, or adjust the dose as recommended. After that, the dose may increase by 300 mg (divided 3 times) every 2-3 days increased every time, based on the response of the patient, until the dose of effective treatment, usually 900 - 3600 mg/day, divided 3 times; The maximum dose of 4800 mg/ day. Increasing gabapentin dose slower may be suitable for some patients. The time reached 1800 mg/ day is the minimum of 1 week, 2400 mg/ day is 2 weeks and 3600 mg/ day is 3 weeks.
Should divide the total daily daily dose for 3 times to take the drug and the maximum distance should not exceed 12 hours.
Children: Treatment of supporting local epilepsy or not accompanied by whole seizures.
Children 2 - Under 6 years old: The indications are not suitable for the form of preparation
Children 6 - 12 years old:
Dosage: The indications are not suitable for the form of preparation.
Maintenance dose is 900 mg/ day for children weighing from 26 - 36 kg and 1200 mg/ day for children weighing 37 - 50 kg, total dose/ day is divided into 3 times. Maximum dose: 70 mg/ kg/ day, divided 3 times.
Note:
Some children do not tolerate the daily increase, prolonging the increased time (up to weeks) may be more appropriate.
There is no evaluation of the use of gabapentin for children under 12 years old with kidney failure.
No need to monitor plasma gabapentin levels to optimize treatment. Moreover, Gabapentin can be used in combination with other anti -epileptic drugs without worrying about changing the plasma concentration of Gabapentin or the serum concentration of other anti -epileptic drugs.
neurological treatment
Adults:
It is possible to start the starting dose of 300 mg/ time x 3 times a day, or adjust the dose as recommended. Then the dose can increase by 300 mg (divided 3 times) every 2-3 days increased every time, based on the response of the patient, until the dose is effective, the maximum dose is 3600mg/day. Increasing gabapentin dose slower may be suitable for some patients. The time reached 1800mg/day is the minimum of 1 week, 2400 mg/day is 2 weeks and 3600 mg/day is 3 weeks.
In the treatment of peripheral neuropathy such as diabetes and neurological pain after shingles, effectiveness and safety have not been tested in clinical trials with longer treatment period for more than 5 months. If you need to take medicine for more than 5 months to treat peripheral neuropathy, it is advisable to assess the clinical condition of the patient and determine the need for coordination treatment.
Note for indications
In patients with poor health, such as low weight, after organ transplantation ..., should increase the dose slower, by using lower dose or increasing dose time.
Elderly patients
Elderly patients may need to adjust the dose due to the age of renal function.
Sleep, peripheral edema and weaker in the elderly.
Patients with renal failure
For patients with impaired kidney function and hemolysis must reduce the dose; The appropriate dose needs to be adjusted according to the CLCR, recommended as follows:
Gabapentin maintenance dose is based on the recommended dose in the table above. Additional recommendations to maintain a dose of 200 - 300 mg after every 4 hours of hemolysis.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose?
Symptoms of overdose include dizziness, double -looking, stuttering, drowsiness, loss of consciousness, coma and mild diarrhea. All patients recover completely during supportive treatment. Reducing the absorption at a higher dose of gabapentin may limit the absorption of active ingredients at an overdose and, thus reducing toxicity when overdose.
Overdose of Gabapentin, especially when combined with other central nervous system inhibitors that can cause coma.
Although Gabapentin can be removed by hemolysis, previous experiences show that it is not necessary to perform. However, in patients with severe renal failure, blood decline can be indicated.
Gabapentin's death dose has not been determined in mice for high doses of 8000 mg/ kg. Signs of acute poisoning in animals include loss of air conditioning, shortness of breath, eyelid prolapse, or stimulation.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
When using Neubatel often has unwanted effects (ADR) such as:
is very common, ADR ≥ 1/10
rarely, 1/1,000 ≤ ADR
Respiratory infections, otitis media, convulsions and bronchitis are only reported in clinical research in children. In addition, in children's clinical research, constant acts and hyperactivity are reported with common frequency.
The drug can cause other unwanted effects, recommend patients to notify unwanted effects when using the drug.
Instructions for handling ADR
Loss of movement combination is usually related to the dose. If the dose is reduced without helping, it is necessary to stop the drug.
If there is a suspected Stevens Johnson syndrome, the drug must be stopped.
Do not stop the drug suddenly because it can increase the frequency of seizures. Before stopping the drug or switching to other anti -epileptic drugs, it is necessary to reduce the dose slowly within at least 7 days.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Neubatel drugs contraindicated in the following cases:
Precautions when using drugs
Use cautiously for people with a history of mental disorders, impaired kidney function and hemolysis, train operators or machinery.
suicide or suicide thought
Be careful for all patients who are being treated or begun treatment with any anti -convulsions for any indications, the patient must be closely monitored because they may appear depression or severe depression, suicidal thoughts or any abnormal changes in aerodynamic, not to change the treatment regimen without consulting the physician. Advise patients and caregivers to find advice from medical staff if there are signs or symptoms of suicide or behavior.
acute pancreatitis
If the ring appears acute pancreatitis when taking gabapentin, it is recommended to stop the drug.
convulsions
Although there is no evidence of recovery corresponding to Gabapentin, stopping using sudden anti -epileptic drugs in epilepsy patients can cause epilepsy.
As other anti -epileptic drugs, some patients may have increased convulsions or new convulsions when using gabapentin.
As other anti -epileptic drugs, the stopping of an anti -epileptic drug in patients taking more than one anti -epileptic drug, to single -time Gabapentin has a low success rate.
Gabapentin is not effective for the whole epilepsy of the whole primary as the absence of awareness and can worsen convulsions in some patients. Therefore, be careful when using Gabapentin for patients with mixed epilepsy including absent consciousness.
Gabapentin can cause dizziness and drowsiness to increase the likelihood of an accident (falling). There are also confused reports, loss of consciousness and mental impairment. Therefore, it is advisable to advise patients to be cautious until they get used to the possible effects of the drug.
Used with opioids
Should carefully monitor the central neurological inhibition signs in patients who need to treat simultaneously with gabapentin with opioid, such as drowsiness, sedation and respiratory failure. Patients using gabapentin and morphine may have increased gabapentin concentrations. The dose of gabapentin or opioid should be reduced appropriately.
Elderly (over 65 years old)
There is no system research on patients aged 65 and over with Gabapentin.
In a blind study in patients with nerve pain, drowsiness, peripheral edema and weakness occurred at a higher rate in patients aged 65 and older than younger patients. Except for the above finding, clinical research in this group of patients does not show the difference in unwanted effects compared to younger patients.
Children
The impact of long -term Gabapentin treatment (over 36 weeks) on learning, intelligence and development of children and young people has not been fully studied. Need to consider the benefits and risks of prolonged treatment.
Abuse and drug dependence
Ancient reports for abuse and drug dependence. It is advisable to carefully evaluate the patient's medical abuse and observing signs of gabapentin abuse that may have such as acts of finding drugs, increasing dose rapidly, tolerance.
rash caused by drugs with eosinophilia and systemic symptoms (dress)
Hypersensitivity reactions, whole body, life -threatening as Dress has been reported in patients using anti -epileptic drugs including gabapentin.
Should pay attention to early hypersensitivity such as fever or lymphadenopathy, even when the rash is unclear. If there are these symptoms, the patient should be assessed immediately. Stop treatment with gabapentin if there is no other cause for signs and symptoms.
Testing
The drug can positive for the results of the proteinuria quantitative test with a test strip. Therefore, it is recommended to confirm the positive results when tested by test strips by other methods such as biuret methods, turbidity measurement methods or color substances, or use of alternative methods from the beginning.
Anaphylaxis
Gabapentin may cause anaphylaxis. Signs and symptoms in cases are reported including shortness of breath, swelling of the lips, throat and tongue, and hypotension to be emergency. The patient should be instructed to stop the drug and go to the medical center as soon as the signs or symptoms are available.
Used for pregnant and lactating women
Pregnant women
There is no adequate information about the use of gabapentin in pregnant women.
Research on animals shows reproductive toxicity. The risk in people is still unclear. Gabapentin should not be used during pregnancy unless the maternal benefits are clear compared to the risk of the fetus.
There is no conclusion that Gabapentin is associated with the risk of birth defects when used during pregnancy, because of the presence of epilepsy and anti -epileptic drugs in reports.
breastfeeding women
gabapentin secretes breast milk. Because the impact of gabapentin on infants is unknown, should be cautious when using gabapentin in nursing women. Gabapentin should only be used for breastfeeding women when the benefits are clear compared to the risk.
fertility
There has been no impact of gabapentin on animal studies.
The effect of the drug on driving and operating machinery
gabapentin may cause slightly reducing driving and operating machinery on average. Gabapentin acts on the central nervous system and can cause drowsiness, dizziness or other related symptoms. Although only mild or medium, these unwanted effects can be dangerous for patients if driving or operating machines. This is especially true when starting treatment and after increasing the dose.
Drug interaction
There are reports of respiratory failure and/or sedation related to the combination of gabapentin and opioid, the average AUC of Gabapentin increases 44% when used with morphine. Consider when using this combination, especially in the elderly.
No observations of interactions between Gabapentin and Phenobarbital, Phenytoin, Valproic acid or carbamazepin.
Gabapentin's stable pharmacokinetics in healthy subjects similar to patients with epilepsy using anti -epileptic drugs. Shared Gabapentin and oral contraceptives containing norethindron and/or ethinyl estradiol does not affect the stable pharmacokinetics of both drugs.
Gabapentin shared and aluminum and magnesium antacids that reduce gabapentin use by 24%. Gabapentin should be used for at least 2 hours after taking antacids.
Probenecid does not change the excretion through the kidneys of gabapentin.
There is a slight decrease in clinically eliminated by gabapentin when used with cimetidine.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
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