Gabawon Capsule 100mg (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 twice daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) From Day 3: 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, as a starting dose, one 300 mg capsule of this drug may be administered 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.) 3) The duration of treatment should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in the 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 needs to be discontinued, or if it is administered concomitantly with another antiepileptic drug, the dose should be changed gradually over at least 1 week. 2. Neuropathic pain 1) 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 twice daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) From Day 3: 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, as a starting dose, one 300 mg capsule of this drug may be administered 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. The total daily dose of this drug should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in increments of 100 mg. 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 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 on 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 plenty of fluids 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 drug is missed (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 administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend on clinical need. If the dose of this drug is reduced, treatment is discontinued, or the drug is switched to another alternative, this should be done gradually over at least 1 week (a longer period may be necessary 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 of treatment should be taken at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years to 12 years 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, if necessary, up to a maximum of 40 mg per kg of body weight per day. When administering this medicine, divide the total daily dose into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, patients should be closely monitored for mood changes or abnormal behaviors while taking it. Discontinuation of this medication should not be done abruptly as it may worsen seizures or lead to a prolonged seizure state; gradual tapering should follow the physician's instructions. This medication can cause pancreatitis; if persistent abdominal pain, nausea, or vomiting occurs, it should be stopped immediately and medical advice sought. In pediatric patients, emotional instability, hostility, decreased concentration, and hyperactivity may occur, requiring observation by guardians. Caution is advised when taking this medication with central nervous system depressants, including narcotics, as severe sedation or respiratory depression and coma may result from interactions. If allergic reactions, severe skin rashes, shortness of breath, or swelling of the lips or face occur, discontinue use immediately and seek emergency care. Due to potential effects on the fetus, if pregnancy is planned or if a patient is pregnant, consultation with a doctor is necessary before use. Caution is also required while breastfeeding. Activities requiring concentration such as driving or operating machinery should be avoided during the early stages of treatment or when symptoms are present. Dosing adjustments or careful administration is necessary for patients with impaired renal function, elderly patients, and those with a history of psychiatric disorders. Weight gain, vision disturbances, drowsiness, and dizziness may occur while taking the medication, so regular monitoring of the patient's condition is necessary. Patients should strictly adhere to prescribed dosages and inform their physician about any other medications or health conditions.

• suicidal impulse
• 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 closed container to avoid exposure to air or moisture, and it is safe to store at room temperature between 1°C and 30°C. Proper storage will maintain the effectiveness of the medication and prevent deterioration.

Appearance

A hard capsule containing white or grayish-white powder.

Package unit

30 capsules/bottle, 300 capsules/bottle