Gabastil Capsule 300 mg (Gabapentin)

Adult dose

Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older: To achieve a maintenance dose of 900 mg/day as gabapentin, titrate gradually 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 twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) From Day 3: 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, as an initial dose, one 300 mg capsule of this medicine may be administered 3 times daily (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.) The duration of treatment should be based on clinical need. Long-term treatment is generally required for epilepsy. There is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to abrupt discontinuation of treatment), but abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine is to be discontinued, or if it is to be used concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate gradually 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 twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) From Day 3: 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, as an initial dose, one 300 mg capsule of this medicine may be administered 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day as gabapentin within 1 week, and the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this medicine should be divided into 3 doses. The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. Frailty In frail patients with low body weight or patients after transplantation, the dose of this medicine should be increased in 100 mg increments. Elderly patients Dose adjustment may be necessary due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is required based on the following table. 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: Administer 3 × 100 mg every 2 days. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. Dosage for patients on hemodialysis Initial dose: Gabapentin 300~400 mg is recommended. Maintenance dose: Administer gabapentin 200~300 mg after 4 hours of hemodialysis, and do not administer this medicine on days when hemodialysis is not performed. Method and duration of administration 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. 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 administered to make up for it. When taking this medicine concomitantly 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. The duration of treatment with this medicine should be based on clinical need. If the dose of this medicine is reduced, treatment is discontinued, or the medicine is replaced with an alternative, this should be done gradually over at least 1 week (a longer period may be necessary at the prescriber's discretion). To reduce the main adverse reactions, such as drowsiness, dizziness, fatigue, and ataxia, the first dose on Day 1 should be taken at bedtime.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors, so you should immediately inform your healthcare provider if you notice any changes in mood or behavior during treatment. Abruptly stopping this medication can lead to increased seizure frequency or status epilepticus, so it must be discontinued gradually under a doctor's guidance. Animal studies have reported a potential risk for certain tumors, but the risk in humans is still unclear. There have been reports of sudden and unexpected deaths during treatment, but this occurs within the general risk range commonly found in epilepsy patients. If serious symptoms of pancreatitis, such as hemorrhagic pancreatitis, occur, you should stop taking the medication immediately and consult with your healthcare provider. Particularly in children aged 3 to 12, neuropsychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may occur. Caution is required when this drug is taken with narcotics or other central nervous system depressants as it may cause severe drowsiness, respiratory depression, coma, or death. Patients with hypersensitivity to this drug, those with acute pancreatitis, or those with myoclonic seizures should not take it. Patients with impaired kidney function, elderly individuals, those with a history of psychosis, pregnant or possibly pregnant women, and nursing mothers should use this medication with caution, and dosage adjustments may be necessary. While taking this medication, dizziness, drowsiness, decreased memory, and motor coordination disorders may occur, so driving or operating machinery should be avoided. Using this medication during pregnancy may affect the fetus, so you must consult with your doctor if you are planning to become pregnant or are already pregnant. While breastfeeding, this medication may be excreted in breast milk, so you should discuss breastfeeding with your healthcare provider. Weight gain, visual disturbance, skin rash, and allergic reactions may occur, so if any unusual symptoms arise, inform your doctor immediately. Abruptly discontinuing this medication may lead to withdrawal symptoms such as anxiety, insomnia, headache, and tremors, so the dosage should be gradually reduced according to your doctor's instructions.

• suicidal thoughts
• suicidal behavior
• depression
• emotional instability
• hostility
• abnormal thoughts
• hyperactivity
• abdominal pain
• low back pain
• fatigue

Store this medication in a tightly sealed container to protect it from air and moisture. The appropriate storage temperature is room temperature between 1 and 30 degrees Celsius.

Appearance

Hard capsules with light yellowish body filled with white or light gray powder

Package unit

30 capsules/bottle, 100 capsules/bottle