Gabista Capsule 100 Milligrams (Gabapentin)

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients aged 13 years and older To reach a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows: - Day 1: Take 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: Take one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3: Take 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, as a starting dose, one 300 mg capsule of this medicine may be taken 3 times daily (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.) 3) The duration of treatment should be determined according to clinical need. Treatment of epilepsy generally requires long-term administration. 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 this medicine must be discontinued or is used concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) Adults (18 years and older): To reach a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows: - Day 1: Take 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: Take one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3: Take 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, as a starting dose, one 300 mg capsule of this medicine may be taken 3 times daily (gabapentin 900 mg/day). If needed, 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. 2) The safety and efficacy of treatment for neuropathic pain for periods exceeding 5 months have not been evaluated. 3. Debilitated patients: In debilitated patients with low body weight or patients who have undergone transplantation, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dose adjustment may be needed 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: 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: 3 × 100 mg should be administered 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) Swallow this medicine whole with plenty of fluid. It may be taken 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 (more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be taken to make up for the missed dose. 3) When taking this medicine with antacids containing magnesium or aluminum, administer this medicine 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 be determined according to clinical need. If the dose of this medicine is reduced, treatment is discontinued, or the patient is switched to another alternative medicine, this should be done gradually over at least 1 week (a longer period may be needed at the prescriber's discretion). 5) To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day should be taken at bedtime.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors; therefore, any mood changes or behavioral abnormalities should be reported to a healthcare professional immediately. Abruptly discontinuing this medication may cause seizures to occur more frequently or worsen, so dosage should be gradually reduced according to a doctor’s instructions. In animal experiments, a potential risk of some cancers has been observed, but the risk in humans is not yet clear. While there have been reports of sudden and unexpected fatalities during this medication, this falls within the risk range commonly associated with epilepsy patients. If symptoms of pancreatitis (persistent abdominal pain, nausea, recurrent vomiting) develop, discontinue the medication immediately and seek medical attention. Particularly in children, it is important to monitor for neuropsychiatric side effects such as emotional instability, aggression, decreased attention span, and hyperactivity. Taking this medication in conjunction with central nervous system depressants, including narcotics, can result in severe drowsiness, respiratory depression, or coma; therefore, it should only be taken at the minimum required dosage for the shortest time needed, under close medical supervision. Patients with an allergy to this medication or its components, as well as patients with acute pancreatitis or specific types of seizures, should not take this medication. Individuals with poor kidney function, elderly patients, those with a history of psychiatric disorders, and women who are pregnant or planning to become pregnant or breastfeeding should consult their physician before taking this medication. Drowsiness, dizziness, and decreased concentration may occur during treatment; thus, caution should be taken with activities such as driving or operating machinery. This medication may affect the fetus during early pregnancy, so it should not be taken during pregnancy unless specifically warranted, and women of childbearing potential should use effective contraception. Since this medication may be secreted in breast milk, breastfeeding mothers should consult their physician before deciding to take it. Various side effects, including weight gain, vision problems, and skin rashes may occur; any abnormal symptoms should be reported to medical staff immediately. Withdrawal symptoms such as anxiety, insomnia, headache, and tremors may occur upon stopping this medication; therefore, it should be discontinued gradually according to a doctor’s guidance. This medication may interact with other drugs, so all concurrent medications should be disclosed to the prescribing physician, paying particular attention to antacids and narcotics. The safety and efficacy of this medication have not been established in children, particularly those under 3 years of age, and there is insufficient experience with monotherapy in children under 13 years old. This drug should be kept out of reach of children and stored in its original container to prevent misuse or degradation in quality.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is also recommended to store it at room temperature between 1 and 30 degrees Celsius, away from extreme temperatures.

Appearance

Hard capsule with white or off-white powder inside, upper and lower parts white.

Package unit

30 capsules/bottle, 300 capsules/bottle