Neugafen Capsule 300mg (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 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medicine may be administered 3 times daily as the starting dose (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 medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medicine may be administered 3 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, and the total daily dose must not exceed 3,600 mg of gabapentin. When administering this medicine, the total daily dose should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dosage adjustment may be necessary due to age-related decline in renal function (see table). 5. Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients receiving hemodialysis: Dosage adjustment is required based on the following table. 1) Dose 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. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to the creatinine clearance. 2) Dose 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, and 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 plenty of fluid and may be administered with or without food. When administered 3 times daily, 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 (if 12 hours or more have elapsed since the last dose), whether to administer an additional dose to make up for it should be determined by the physician. 3) When coadministered 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 bioavailability of this medicine. 4) The duration of administration of 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 this medicine is to be discontinued or used in combination with another antiepileptic drug, the change 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 taken at bedtime.

Child dose

1) 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 onward: Administer gabapentin 30 mg/kg of body weight The dose may be increased, if necessary, to a maximum of 40 mg/kg of body weight per day. The total daily dose of this drug should be administered in 3 divided doses.

This medication may cause mental health changes, such as suicidal thoughts or behaviors, and depression, during use. Patients and caregivers should immediately report any of these symptoms to medical personnel. Additionally, sudden discontinuation of this medication may lead to more frequent seizures or progress to continuous status epilepticus, so it must be gradually reduced under a doctor's direction. Serious side effects such as pancreatitis may occur; thus, if symptoms like upper abdominal pain, nausea, or repeated vomiting occur, immediately stop taking the medication and visit a hospital. In pediatric patients, neurological and psychiatric adverse effects may manifest as emotional instability, aggressive behavior, decreased concentration, or hyperactivity, requiring caution. When taken with other central nervous system depressants or narcotics, severe drowsiness, respiratory depression, or coma may occur; use the minimal dose for the shortest duration necessary. Those with hypersensitivity to this medication, acute pancreatitis, certain types of seizures, or lactose intolerance should not take it. Patients with decreased kidney function, elderly patients, patients with a history of mental illness, women who are pregnant or planning to become pregnant, and lactating women should exercise extra caution when using this medication. Dizziness or drowsiness may occur during use; therefore, it is advisable to avoid driving or operating hazardous machinery. Side effects such as weight gain, visual disturbances, and skin rashes may occur, necessitating regular observation and consultation. This medication may affect the fetus during pregnancy, so women of childbearing age must consult with a doctor and use effective contraception. Lactating women should either stop breastfeeding or consult their physician when taking this medication. Sudden discontinuation of this medication may result in withdrawal symptoms such as anxiety, insomnia, tremors, or headaches, so it should be tapered off gradually under the doctor's instructions. Finally, this medication should be stored out of the reach of children and kept in its original container to prevent misuse or quality degradation.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal mood and behavior changes
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought disorder
• hyperkinesis
• weakness

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius.

Appearance

A hard capsule of upper and lower yellowish color containing white or grayish powder

Package unit

30 capsules/bottle, 100 capsules/bottle