Gabapentin Capsules 100 mg (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 gradually over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this product once daily, or one 100 mg capsule of this product 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this product twice daily, or two 100 mg capsules of this product 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this product 3 times daily, or three 100 mg capsules of this product 3 times daily (gabapentin 900 mg/day) Alternatively, the starting dose may be one 300 mg capsule of this product 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.) 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 product once daily, or one 100 mg capsule of this product 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this product twice daily, or two 100 mg capsules of this product 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this product 3 times daily, or three 100 mg capsules of this product 3 times daily (gabapentin 900 mg/day) Alternatively, the starting dose may be one 300 mg capsule of this product 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day of gabapentin within one week. The total daily dose must not exceed 3,600 mg of gabapentin. The total daily dose of this product should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients who have undergone transplantation, the gabapentin dose should be increased in 100 mg increments. 4. Older adults: 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) Dose in 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 below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dose in patients receiving 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 product on days when hemodialysis is not performed. 6. Method and duration of administration 1) This product 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. 2) If a dose of this product is missed (if 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 the missed dose. 3) When administered with antacids containing magnesium or aluminum, this product should be taken at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this product. 4) The duration of treatment with this product should depend on 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 abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this product is to be discontinued, or if it is to be used in combination with another antiepileptic drug, the change should be made gradually over at least 1 week. 5) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 6) To reduce the major 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 years to 12 years - Day 1: Administer gabapentin 10 mg/body weight (kg) - Day 2: Administer gabapentin 20 mg/body weight (kg) - From Day 3 onward: Administer gabapentin 30 mg/body weight (kg) The dose may be increased, as needed, up 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 may increase the risk of suicidal thoughts or behaviors, so if there are any changes in mood or behavior during use, consult a physician immediately. Abruptly discontinuing medication may lead to worsening seizures or progression to status epilepticus, so dosage adjustments should be made according to a doctor's instructions. Long-term use may cause weight gain, so it is important to check weight regularly and pay attention to diet and exercise as needed. This medication can cause central nervous system side effects such as drowsiness, dizziness, and motor coordination disorders, so caution should be exercised when driving or operating hazardous machinery. Particularly, when taken with central nervous system depressants or narcotics, respiratory depression, severe sedation, and coma may occur; thus, careful monitoring by a physician is required when used in combination. If symptoms of pancreatitis such as persistent upper abdominal pain, nausea, and recurrent vomiting occur, discontinue use immediately and inform a healthcare professional. Women who are pregnant or planning to become pregnant should consult a physician as it may affect the fetus, and effective contraceptive methods should be used. In breastfeeding women, this medication may be secreted into breast milk and affect the baby, so the decision to use it should be made after consulting a physician. It is advisable not to use this medication in children under 3 years of age as safety and efficacy have not been established. Patients with poor kidney function may need dosage adjustments, and elderly patients are at higher risk of side effects and should be cautious. If severe allergic reactions such as skin rash, fever, or swollen lymph nodes occur while taking this medication, discontinue use immediately and seek medical attention. Withdrawal symptoms such as anxiety, insomnia, nausea, and tremors may occur, so dosage should be gradually reduced according to a doctor's instructions when discontinuing. This medicine should be kept out of the reach of children and stored in the original container to prevent quality deterioration or misuse.

• suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• hemorrhagic pancreatitis
• emotional instability
• aggression
• thought disorder
• hyperactivity
• weakness

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain the storage temperature in the range of 1 to 30 degrees Celsius.

Appearance

A white or gray-white powder contained in a white hard capsule with a white top and bottom.

Package unit

30 capsules/bottle, 300 capsules/bottle