Neurofen 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 medicine once daily, or one 100 mg capsule of this medicine three times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine three times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medicine may be administered three times daily as the starting dose (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin; 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 medicine once daily, or one 100 mg capsule of this medicine three times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine three times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medicine may be administered three times daily as the starting dose (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day of gabapentin within one week; the total daily dose must not exceed 3,600 mg of gabapentin. The total daily dose of this medicine 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. Older adults: 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 for 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: Administer 3 × 100 mg every 2 days. For patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dosage for patients receiving hemodialysis Initial dose: 300∼400 mg of gabapentin is recommended. Maintenance dose: Administer 200∼300 mg of gabapentin after 4 hours of hemodialysis; do not administer this medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine should be swallowed whole with sufficient fluid and may be taken with or without food. When administered 3 times daily, care should be taken to ensure that the interval between doses does not exceed 12 hours, to prevent recurrence of seizures. 2) If a dose of this medicine is missed (more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be administered to make up for the missed dose. 3) When used concomitantly with antacids containing magnesium or aluminum, this medicine should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. 4) The duration of treatment with this medicine should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (increased 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 medicine must be discontinued or it is to be used 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 longer 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 Day 1 should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years — Day 1: Administer gabapentin 10 mg/kg body weight Adjunctive therapy in children aged 3 to 12 years — Day 2: Administer gabapentin 20 mg/kg body weight Adjunctive therapy in children aged 3 to 12 years — From Day 3: Administer gabapentin 30 mg/kg body weight Adjunctive therapy in children aged 3 to 12 years — The dose may be increased, as needed, to a maximum of 40 mg/kg body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors, so if there are any changes in mood or behavior while taking it, you should consult a doctor immediately. Abruptly discontinuing this medication may cause seizures to occur more frequently or progress to severe epilepsy, so the dosage should be gradually reduced under a doctor's guidance. This drug can cause severe side effects such as pancreatitis; if persistent abdominal pain, nausea, or vomiting occurs during use, you must stop taking it immediately and go to the hospital. Neurological side effects such as dizziness, drowsiness, ataxia, and memory impairment may occur, so it is advisable to avoid driving or operating hazardous machinery during the initial period of dosing. Particularly in children and adolescents, behavioral changes such as emotional instability, aggression, and decreased concentration may be observed, so careful monitoring is necessary. This medication, when taken with other central nervous system depressants or opioids, may cause severe sedation or respiratory depression; hence, you must follow your doctor's instructions when combining them. Patients with poor kidney function need dosage adjustments, and elderly patients should also take it with caution. Women who are pregnant or planning to become pregnant must consult a doctor before taking this medication, and if breastfeeding, the decision to continue use should be made carefully. If any symptoms such as skin rash, fever, or lymph node swelling occur while taking this medication, you must stop taking it immediately and seek medical attention. When discontinuing this drug, withdrawal symptoms (anxiety, insomnia, trembling, etc.) may appear, so it should be tapered gradually according to a doctor's instructions. This medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation in quality.

• suicidal ideation
• suicidal behavior
• depression
• emotional instability
• hostility
• abnormal thinking
• hyperactivity
• weakness
• apathy
• facial swelling

This medication must be stored tightly sealed in a container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

White or off-white powder in a white opaque hard capsule

Package unit

30 capsules/bottle, 200 capsules/bottle