Neurebtol Capsule 100 mg (Gabapentin)

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients aged 13 years and older To achieve a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, the initial dose may be one 300 mg capsule of this drug 3 times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin, and the total daily dose must not exceed 2,400 mg of gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day of gabapentin.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, the initial dose may be one 300 mg capsule of this drug 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day of gabapentin within one week, and the total daily dose must not exceed 3,600 mg of gabapentin. The total daily dose of this drug should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplantation, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dose adjustment may be necessary due to age-related decline in renal function (see table). 5. Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is required based on the following table. 1) Dosage in patients with renal impairment: Renal function: creatinine clearance (mL/min) Total daily dosea (mg/day) ≥80 900∼2,400 50∼79 600∼1,800 30∼49 300∼900 15∼29 150b∼600 <15 150b∼300 a: The total daily dose should be divided into 3 doses. b: The dose should be administered as 3 × 100 mg every 2 days. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dosage in patients receiving hemodialysis Initial dose: Gabapentin 300∼400 mg is recommended. Maintenance dose: Administer gabapentin 200∼300 mg after 4 hours of hemodialysis, and do not administer this drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) Swallow this drug whole with plenty of fluids. It may be administered with or without food. When administered 3 times daily, care should be taken not to allow more than 12 hours between doses to prevent recurrence of seizures. 2) If a dose of this drug is missed (when more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be taken to make up for the missed dose. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug must be discontinued or it is to be administered concomitantly with another antiepileptic drug, changes should be made gradually over at least 1 week. 5) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 6) To reduce the main adverse effects, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be administered at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years to 12 years - Day 1: Administer gabapentin 10 mg/kg of body weight - Day 2: Administer gabapentin 20 mg/kg of body weight - From Day 3: Administer gabapentin 30 mg/kg of body weight If necessary, the dose may be increased up to a maximum of 40 mg/kg of body weight per day. The total daily dose should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors, so you should consult a doctor immediately if you experience any unusual changes in mood or behavior while taking it. Abruptly stopping the medication can worsen seizures or lead to a prolonged seizure state, so it must be tapered off gradually according to a doctor's instructions. Some animal studies have reported a risk of cancer, but the risk in humans is not yet clear. Rare instances of sudden and unexpected death have been reported, so consult medical personnel immediately if any abnormal symptoms occur during treatment. If you experience severe pancreatitis symptoms such as hemorrhagic pancreatitis, stop taking the medication immediately and visit a hospital. Children aged 3 to 12 years may experience neuropsychiatric side effects such as emotional instability, aggression, decreased concentration, and hyperactivity when taking this medication, so careful observation is advised. Coadministration of this medication with central nervous system depressants, including narcotics, can lead to respiratory distress, severe drowsiness, and coma, so caution is required when combining these medications. If any allergic reactions, pancreatitis, severe skin rashes, or anaphylaxis symptoms occur, stop taking the medication immediately and seek emergency treatment. Women who are pregnant or planning to become pregnant must consult a doctor before taking this medication, and breastfeeding mothers should also consult a doctor before taking it. Dizziness or drowsiness may occur while taking the medication, so it is advisable to avoid driving or operating dangerous machinery. Patients with impaired renal function may require dosage adjustments, and elderly patients are also at an increased risk of side effects, so caution is needed. This medication may cause drug dependence and abuse potential; therefore, those with a history of substance abuse should be particularly careful. Discontinuation of the medication may lead to withdrawal symptoms, so it should be gradually reduced according to a doctor's instructions. There may be interactions when taken with other drugs, so be sure to inform the doctor of all medications currently being taken.

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, cognitive disturbances, hyperactivity, abdominal pain, back pain, fatigue, fever, headache, viral infections, vasodilation, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disturbances, insomnia, hyperreactive responses, nystagmus, drowsiness, cognitive disturbances, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, bloating, anorexia, gingivitis, arthralgia, dizziness, hyperactivity, increased reflex activity, decreased reflex activity, sensory disturbances, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, coagulopathy, loss of warning signs, laryngeal neuritis, sleepwalking, croup-like symptoms, hoarseness, injuries due to accidents, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory impairment, tremor, vertigo, dyspnea, rash, suicidal thoughts, suicidal behavior, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea-acanthocytosis, movement disorders, dystonia, metabolic myoclonus, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

Store this medication in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

An opaque white capsule containing a white or off-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle