Gabaking Capsule 300mg (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 be determined according to 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), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug must be discontinued or it is administered 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 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 1 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 more than 5 months have not been evaluated. 3. Debilitated patients In debilitated patients with low body weight or patients after transplantation, the dose of this drug should be increased in increments of 100 mg. 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) 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: A dose of 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; 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 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 (more than 12 hours have elapsed since the most recent dose), the physician should determine whether an additional dose should be administered to make up for the missed dose. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should be determined according to clinical need. If the dose of this drug is reduced, treatment is discontinued, or the patient is switched to another alternative medication, 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, including 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 and older to 12 years: To achieve a maintenance dose of gabapentin 30 mg/kg/day, titrate the dose 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: Administer gabapentin 30 mg/kg body weight The dose may be increased as needed up to a maximum of 40 mg/kg body weight per day. The total daily dose of this drug should be administered in 3 divided doses.

This medication may increase the risk of suicidal thoughts or behavior, so if any symptoms of depression, mood changes, or abnormal behavior occur while taking it, immediate consultation with a doctor is necessary. Abruptly stopping this medication can increase the frequency of seizures or lead to severe epilepsy status, so dosage should be gradually reduced as directed by a physician. This drug can cause serious side effects, such as pancreatitis. If persistent abdominal pain, nausea, or vomiting occurs, immediately stop taking the medication and inform healthcare personnel. When administered to children aged 3 to 12, caution should be taken as neuropsychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may occur. Simultaneous use of this medication with central nervous system depressants, including narcotics, can lead to severe drowsiness, respiratory depression, and coma, so it should only be given at the minimal effective dosage for a short time, with careful monitoring by a physician. Patients with allergic reactions or hypersensitivity, acute pancreatitis, certain types of seizures (typical absence seizures), or lactose intolerance should not use this medication. Patients with impaired kidney function, elderly patients, those with a history of mental illness, children with attention deficit disorders, pregnant women or those planning to become pregnant, and nursing mothers should be administered this drug with caution and may require dosage adjustments. During treatment, be cautious as dizziness, drowsiness, impaired motor control, memory loss, nausea, vomiting, weight gain, and swelling may occur, which could affect daily life. This medication may impact the fetus if used in early pregnancy. Therefore, women who are pregnant or planning to become pregnant should consult a physician, and similar caution should be exercised for nursing mothers. Avoid driving or operating hazardous machinery while taking this medication, and ensure to take it exactly as prescribed without discontinuing it arbitrarily. In case of overdose, symptoms may include decreased consciousness, drowsiness, and dizziness; however, recovery generally occurs with supportive care, and severe cases may require medical attention. Store this medication out of reach of children and keep it in its original container to prevent misuse or degradation of quality.

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

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to ensure the medication's effectiveness and safe use.

Appearance

A hard gelatin capsule filled with a white or light gray powder.

Package unit

30 capsules/bottle, 100 capsules/bottle