Gabapina 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 as 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 as gabapentin, and the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as 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 as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this medicine should be administered in 3 divided 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) 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 administered in 3 divided 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 the creatinine clearance. 2) Dose for patients undergoing 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 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 (when more than 12 hours have elapsed since the most recent dose), the physician should decide whether an additional dose should be taken to make up for it. 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 administration should be based on clinical need. Long-term administration is generally required for the treatment of 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 is to be discontinued or it is to be used concomitantly 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

Adjunctive therapy in children aged 3 years to 12 years: To achieve a maintenance dose of gabapentin 30 mg/kg/day, titrate stepwise over the first 3 days of treatment as follows. - Day 1: Administer gabapentin 10 mg/kg body weight - Day 2: Administer gabapentin 20 mg/kg body weight - From day 3 onward: Administer gabapentin 30 mg/kg body weight The dose may be increased to a maximum of 40 mg/kg body weight per day, as needed. The total daily dose should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts and behavior, so mood changes and abnormal behavior should be closely monitored during use. Abruptly stopping this medication can lead to increased seizure frequency or status epilepticus; therefore, it should be discontinued gradually under a physician's direction. Animal studies have reported a potential increase in certain kinds of cancer; however, this risk has not been clearly established in humans. Sudden and unexpected deaths have been reported during treatment with this medication, but these cases fall within the general risk range for epilepsy patients. If symptoms of severe pancreatitis, such as hemorrhagic pancreatitis, occur, this medication should be discontinued immediately and medical advice sought. In pediatric patients, psychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may occur, requiring caution. Taking this medication together with central nervous system depressants, including narcotics, can lead to severe drowsiness, respiratory depression, and coma, necessitating special care when used in combination. This medication should not be used by those with hypersensitivity to it or by patients with acute pancreatitis or specific types of seizures (generalized absence seizures). Patients with impaired kidney function, the elderly, those with a history of psychiatric disorders, pregnant or nursing women, and children with behavioral disorders should use this medication with caution. Dizziness, drowsiness, confusion, and altered consciousness may occur during treatment, requiring caution when driving or operating hazardous machinery. This medication may affect the fetus during pregnancy, so women who are pregnant or planning to become pregnant must consult a physician. Nursing mothers should either discontinue breastfeeding or consult with a physician when taking this medication. During treatment, symptoms such as weight gain, vision abnormalities, and skin rash may occur, and any unusual symptoms should be discussed with a healthcare provider immediately. Discontinuation of this medication may result in withdrawal symptoms, and it must be tapered off slowly according to a physician's instructions. In cases of overdose, symptoms may primarily include dizziness, drowsiness, and coma, and appropriate medical treatment should be sought if necessary. This medication should be kept out of reach of children and stored 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 disturbances
• hyperactivity
• abdominal pain

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature to preserve the medication's efficacy and prevent degradation.

Appearance

A hard capsule with a yellowish-brown color containing white or grayish-white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle