Gabacare Capsule 300 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 the dose 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 three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medicine 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.) 2. 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 medicine once daily, or one 100 mg capsule of this medicine three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medicine 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. The total daily dose of this medicine 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 increments of 100 mg. 4. Elderly patients: Dosage 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: Dosage 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: 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) Dosage for 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 medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine should be swallowed whole with sufficient liquid 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 medicine is missed (12 hours or more have elapsed since the most recent dose), the physician should determine whether an additional dose should be taken to make up for the missed dose. 3) When used 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. 4) The duration of treatment with this medicine should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to sudden discontinuation of treatment), sudden 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, changes 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 main adverse effects, including somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be administered at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years: Administer gabapentin 10 mg/body weight (kg) on the first day, 20 mg/body weight (kg) on the second day, and 30 mg/body weight (kg) from the third day onward; the dose may be increased as needed to a maximum of 40 mg per kg of body weight per day. Divide the total daily dose of this medicine into 3 doses.

This medication may increase the risk of suicidal thoughts or actions, so if mood or behavior changes occur during treatment, you must consult a doctor immediately. Abrupt discontinuation can lead to more frequent seizures or severe status epilepticus; therefore, it should be gradually reduced under a doctor's direction. Long-term use may result in weight gain, so regular weight checks are recommended, and dietary adjustments or exercise should be considered if necessary. This medication may affect the nervous system, causing dizziness, drowsiness, or motor coordination issues; driving or operating machinery should be done cautiously. Particularly, children, the elderly, and patients with reduced kidney function should be more cautious when taking this medication, and dosage adjustments may be necessary if required. Women who are pregnant or planning to become pregnant should consult a doctor before taking this drug, and breastfeeding women should also seek professional advice before use. Taking this medication in conjunction with central nervous system depressants, especially opioid analgesics, can lead to serious side effects such as drowsiness or respiratory depression; caution is advised when used together. If symptoms of pancreatitis (persistent upper abdominal pain, nausea, vomiting) occur, stop taking this medication immediately and inform a healthcare professional. If symptoms such as skin rash, fever, or lymphadenopathy occur, this could indicate a serious allergic reaction, and immediate medical attention is required. This medication carries a risk of drug dependency or abuse; thus, individuals with a history of substance abuse should exercise special caution and follow the doctor's instructions. During treatment, strictly adhere to the prescribed dosage and schedule; do not arbitrarily change or discontinue medication.

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

This medicine should be stored in a tightly closed container to prevent exposure to air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

A hard capsule with a white or grayish-white powder or granules, with a light yellowish body.

Package unit

30 capsules/bottle, 100 capsules/bottle