Hanwha Gabapentin Capsule 300 mg

Adult dose

1. Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older To achieve a maintenance dose of 900 mg/day of gabapentin, titrate gradually 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 three 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 three times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, instead of the above titration schedules, the starting dose may be one 300 mg capsule of this drug three 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.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day of gabapentin, titrate gradually 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 three 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 three times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, instead of the above titration schedules, the starting dose may be one 300 mg capsule of this drug three 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. 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: Dosage adjustment may be necessary due to age-related decline in renal function. 5. Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dosage 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. For patients with creatinine clearance <15 mL/min, the dose should be reduced in proportion to creatinine clearance. Dosage for hemodialysis patients 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 This drug should be swallowed whole with sufficient fluid and 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 drug is missed (more than 12 hours have elapsed since the last dose), whether to administer an additional dose to make up for it should be determined by the physician. When taken with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. If treatment with this drug is to be discontinued or it is to be used in combination with other antiepileptic drugs, changes should be made gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 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 to 12 years To achieve a maintenance dose of gabapentin 30 mg/kg of body weight/day, titrate the dose over the first 3 days of treatment as follows: - Day 1: Administer gabapentin 10 mg/kg of body weight - Day 2: Administer gabapentin 20 mg/kg of body weight - From day 3 onward: Administer gabapentin 30 mg/kg of body weight If needed, the dose may be increased to a maximum of 40 mg/kg of body weight per day. When administering this medicine, divide the total daily dose into 3 doses.

This medication is an anticonvulsant used for the treatment of epilepsy and neuropathic pain. During treatment, the risk of mental health issues such as suicidal thoughts, suicidal behavior, and depression may increase, so patients and guardians should immediately inform healthcare providers of any such symptoms. Abruptly discontinuing this medication may worsen seizures or lead to persistent status epilepticus; thus, it should be withdrawn only under a doctor's guidance. If persistent upper abdominal pain, nausea, or recurrent vomiting, which are symptoms of pancreatitis, occur, the medication should be discontinued immediately, and medical attention should be sought. Caution is required when administering this medication to children aged 3 to 12 years, as it may cause central nervous system adverse effects such as emotional instability, hostility, impaired concentration, and hyperactivity. Taking this medication together with central nervous system depressants, including narcotics, may cause severe drowsiness, respiratory depression, and coma, thus careful observation and dose adjustment by healthcare providers are necessary. Patients with impaired kidney function must have their dosage adjusted, and elderly patients, those with a history of psychiatric disorders, pregnant or breastfeeding women, and children with attention deficit or behavioral disorders should be treated with caution. While taking this medication, side effects such as dizziness, drowsiness, ataxia, memory impairment, nausea, and vomiting may occur, so caution is advised when driving or operating dangerous machinery. This medication may have reduced absorption when taken with aluminum or magnesium antacids; therefore, it is recommended to take it at least 2 hours after taking an antacid. Women who are pregnant or planning to become pregnant should consult a physician before use, and the same careful judgment is required during breastfeeding. The safety and efficacy of this medication in children under 3 years old have not been established, and experience with monotherapy in children under 13 years is insufficient, so caution is necessary. This medication should be stored out of the reach of children, and kept in its original container to prevent misuse or quality deterioration.

• Suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• persistent seizure state
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought abnormalities
• hyperactivity

This medication may be sensitive to air or 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 safely preserve the medication's effectiveness.

Appearance

An opaque capsule with a yellowish hue containing a white or light gray powder

Package unit

30 capsules/bottle, 100 capsules/bottle