Neuropentin Capsule (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 2 times 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, apart from the methods above, the starting 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 2 times 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, apart from the methods above, the starting 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. When taking this drug, the total daily dose 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: 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) 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: 3 × 100 mg should be administered every 2 days. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to the creatinine clearance. 2) Dosage in 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 drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) This drug 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 drug is missed (if 12 hours or more have elapsed since the most recent dose), whether to administer an additional dose to make up for the missed dose should be determined by the physician. 3) When coadministered with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can greatly 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 (increased frequency of epileptic seizures due to sudden discontinuation of treatment), sudden 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 used in combination 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 the first day of treatment should be administered at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 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 The dose may be increased, if necessary, up to a maximum of 40 mg/kg of body weight per day. When administering this drug, divide the total daily dose into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors, so if there are any changes in mood or behavior during treatment, you should consult your doctor immediately. Abruptly stopping the medication can worsen seizures or lead to a prolonged seizure state, so it should be discontinued gradually as directed by your physician. Long-term use may lead to side effects such as weight gain or vision problems, so it is essential to regularly monitor weight and eye conditions. This medication affects the central nervous system and may cause symptoms such as drowsiness, dizziness, and ataxia, so care should be taken when driving or operating hazardous machinery. Particularly in children aged 3 to 12 years, emotional instability, aggression, hyperactivity, and abnormal thought processes may occur more frequently, necessitating careful observation. Patients with impaired kidney function, elderly patients, those with a history of mental illness, pregnant women, or nursing mothers should consult their doctor before taking this medication. This medication should not be administered to patients with acute pancreatitis, generalized absent seizures, or lactose intolerance. Taking the medication with central nervous system depressants, including narcotics, can lead to respiratory depression or severe sedation, so it is essential to follow your doctor's instructions when combining therapies. If symptoms of pancreatitis, such as persistent upper abdominal pain, nausea, or vomiting appear during use, discontinue the medication immediately and consult healthcare professionals. This medication may pose risks to the fetus if used in early pregnancy, so women who are pregnant or planning to become pregnant should consult their doctor thoroughly before use. Nursing mothers should discuss whether to continue breastfeeding since this medication can be secreted in breast milk. If any abnormal reactions or side effects occur while taking this medication, inform your doctor immediately and seek appropriate measures.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• hemorrhagic pancreatitis
• emotional instability
• hostility
• psychotic symptoms
• hyperactivity
• weakness

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to keep the storage temperature between 1 and 30 degrees Celsius.

Appearance

A hard capsule with white or grayish powder inside, beige colored.

Package unit

Domestic: 200 capsules/bottle, 30 capsules/bottle Export: 50 capsules (10 capsules/PTPX5)