Gabakai Capsule 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, as an initial dose, one 300 mg capsule of this product 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.) 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, as an initial dose, one 300 mg capsule of this product 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 one week; the total daily dose must not exceed 3,600 mg of gabapentin. When administering this product, the total daily dose should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose should be increased in 100 mg increments. 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 undergoing 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: 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. 2) Dosage for patients undergoing 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) Swallow this product whole with sufficient fluid. It may be taken with or without food. When administering 3 times daily, take care 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 12 hours or more have elapsed since the last dose), whether to administer an additional dose to make up for it should be determined by the physician. 3) When used concomitantly with antacids containing magnesium or aluminum, administer this product at least 2 hours after the antacid. This can substantially 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 sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this product must be discontinued or if it is 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, such as 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: To achieve a maintenance dose of gabapentin 30 mg/kg body weight/day, titrate gradually over the first 3 days of treatment as follows. - First day: Administer gabapentin 10 mg/body weight (kg) - Second day: Administer gabapentin 20 mg/body weight (kg) - From the third day onward: Administer gabapentin 30 mg/body weight (kg). 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 behaviors, so if there are any changes in mood or behavior during treatment, you should consult your doctor immediately. Abruptly stopping this medication may lead to an increase in the frequency or severity of seizures, so the dosage should be adjusted slowly according to your doctor's instructions. If symptoms of pancreatitis (persistent upper abdominal pain, nausea, recurrent vomiting) occur during treatment, you should stop taking the medication immediately and consult your healthcare provider. Particularly in children, there may be neuropsychiatric abnormalities such as emotional instability, aggression, decreased concentration, and hyperactivity, so careful observation is required. Taking this medication with narcotics or other central nervous system depressants can lead to severe drowsiness, respiratory depression, or coma; therefore, it should only be used at the minimal dosage for a short duration if absolutely necessary, and the patient's condition must be closely monitored. Patients with hypersensitivity to this medication or those who have acute pancreatitis or specific types of seizures should not take it. Patients with decreased kidney function, elderly patients, those with a history of psychiatric disorders, children with behavioral disorders, pregnant women or women who may become pregnant, and nursing mothers should use this medication with caution. During treatment, dizziness, drowsiness, and motor coordination disturbances may occur, so it is advisable to avoid driving or operating hazardous machinery. Weight gain may occur, so it is important to monitor weight regularly, and if obesity is a concern, diet and exercise should be managed. This medication can affect the fetus if used early in pregnancy; therefore, women who are pregnant or planning to conceive should consult their physician and use effective contraceptive methods. Nursing mothers should be aware that this medication may affect their baby; therefore, breastfeeding should be discontinued or you should consult your doctor during treatment. There may be interactions with other medications or alcohol during the use of this drug, so inform your doctor of all medications you are taking and whether you consume alcohol. Do not change or stop the dosage arbitrarily, and if abnormal symptoms occur, inform your healthcare provider immediately.

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

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius (room temperature) to preserve the medication's effectiveness.

Appearance

A white or off-white hard capsule filled with powder or granules.

Package unit

30 capsules/bottle, 100 capsules/bottle