Gabapentin 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 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 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, as an initial dose, one 300 mg capsule of this drug may be administered 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.) Neuropathic pain 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 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, as an initial dose, one 300 mg capsule of this drug may be administered 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. When taking this drug, the total daily dose should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose 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 necessary 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 hemodialysis patients 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. Method and duration of administration This drug should be swallowed whole with sufficient fluids and may be administered 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, in order to prevent recurrence of seizures. If a dose of this drug is missed (if 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 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. The duration of treatment with this drug should depend on clinical need. Treatment of epilepsy generally requires long-term administration. There is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to sudden discontinuation of treatment), but sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to be discontinued or it is to be used concomitantly with another antiepileptic drug, the change 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 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 body weight/day, titrate during 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 onward: Administer gabapentin 30 mg/kg body weight. The dose may be increased, if necessary, to a maximum of 40 mg/kg body weight per day. The total daily dose should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behavior, so if mood changes or symptoms of depression appear during treatment, the healthcare provider should be informed immediately. Sudden discontinuation of this medication can worsen seizures or lead to status epilepticus, so the dosage should be reduced gradually according to the physician's instructions. Long-term use may result in weight gain, so it is important to periodically monitor weight and manage diet and exercise as needed. This medication may cause central nervous system symptoms such as drowsiness, dizziness, and impaired motor coordination, so care should be taken when driving or operating dangerous machinery. Particularly in children, the elderly, and patients with reduced kidney function, adverse reactions may occur more readily, so careful observation is necessary. During pregnancy, this medication may affect the fetus; therefore, women who are planning to become pregnant or are pregnant should consult a doctor, and caution should also be exercised when breastfeeding. Taking this medication with other central nervous system depressants or narcotics may increase the risk of sedation and respiratory depression, so it is essential to consult a healthcare provider if taking them together. If symptoms of pancreatitis, such as persistent upper abdominal pain, nausea, or vomiting occur, stop taking the medication immediately and visit a medical facility. This medication can cause allergic reactions or severe skin reactions (such as Stevens-Johnson syndrome), so if symptoms such as skin rash, fever, or swollen lymph nodes appear, stop taking it immediately. If any abnormal symptoms or suspected side effects occur during use, inform the healthcare provider without delay to receive appropriate measures.

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

Store this medication in a tightly sealed container to avoid contact with air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. Storing in this way will help maintain the medication's efficacy and safety for a long time.

Appearance

A solid capsule of light yellow color containing white or grayish-white powder or granules.

Package unit

30 Capsules/Bottle, 100 Capsules/Bottle