Taeguk Gabapentin Capsule

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 3 times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medicine 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.) 3) The duration of treatment 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 abrupt discontinuation of treatment), abrupt 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 administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) 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 3 times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medicine 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 1 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. 2) The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. 3. Frail patients In frail patients with low body weight or patients after transplantation, the dose of this medicine should be increased in increments of 100 mg 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 receiving hemodialysis: Dose adjustment is required based on the following table. 1) Dose 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. 2) Dose 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, and 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 plenty of fluid and may be taken with or without food. When administered 3 times daily, care should be taken not to allow an interval of 12 hours or more between doses to prevent recurrence of seizures. 2) If a dose of this medicine is missed (12 hours or more have passed since the last dose), the physician should decide whether an additional dose should be administered to make up for it. 3) When administered concomitantly with antacids containing magnesium or aluminum, this medicine should be administered 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. If the dose of this medicine is reduced, treatment is discontinued, or the medicine is replaced with another alternative, this should be done gradually over at least 1 week (a longer period may be required at the prescriber's discretion). 5) To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be administered at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years to 12 years: To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate the dose gradually over the first 3 days of treatment as follows. Day 1: administer 10 mg/kg of body weight of gabapentin; Day 2: administer 20 mg/kg of body weight of gabapentin; From Day 3: administer 30 mg/kg of body weight of gabapentin. The dose may be increased as needed to a maximum of 40 mg per kg of body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This drug is an antiepileptic medication, and there is a risk of developing mental health issues such as suicidal thoughts, suicidal behaviors, and depression during treatment. Patients and caregivers should closely monitor for these symptoms. Abrupt discontinuation of this drug may lead to more frequent seizures or status epilepticus, so it should be discontinued only under a doctor's guidance. In animal studies, a potential risk of tumor occurrence has been reported, but its clinical significance in humans is not yet clear. There have been reports of sudden and unexpected deaths during treatment, but these generally fall within the range of risks typically associated with patients suffering from epilepsy. If severe pancreatitis symptoms, such as hemorrhagic pancreatitis, appear, the medication should be stopped immediately, and a doctor consulted. Caution is advised when administering this drug to children aged 3 to 12, as neuropsychiatric adverse effects such as emotional instability, aggression, decreased concentration, and hyperactivity may occur. Concomitant use of this drug with central nervous system depressants, including narcotics, may carry risks of severe sedation, respiratory depression, coma, and death; therefore, it should only be used at the minimum dose for a short period if necessary, and patients must be closely monitored. Patients with a history of allergies to this drug or its components, acute pancreatitis, generalized absence seizures, or certain inherited metabolic disorders should not take it. Patients with reduced kidney function, the elderly, those with a history of psychiatric illness, children with attention deficit or behavioral disorders, pregnant or breastfeeding women should use this medication with caution, and long-term use also requires careful monitoring. During treatment, symptoms such as drowsiness, dizziness, and ataxia may occur; therefore, driving or operating hazardous machinery should be avoided. Various adverse reactions such as weight gain, visual disturbances, skin rash, and blood abnormalities have been reported. If any unusual symptoms occur, medical consultation should be sought immediately. This medication may pose risks to the fetus during pregnancy; hence, individuals planning to conceive or are already pregnant must consult a doctor. During breastfeeding, careful administration is also essential. In case of overdose, symptoms such as dizziness, drowsiness, and coma may appear; however, recovery is generally achieved with supportive care, and patients with renal failure may require dialysis. This drug should be kept out of the reach of children and stored in its original container to prevent misuse or degradation of quality. There may be potential interactions with other medications or alcohol during treatment, so patients must inform their doctor of any medications they are currently taking or planning to take.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• status epilepticus
• hemorrhagic pancreatitis
• emotional instability
• hostility
• abnormal thinking
• hyperactivity

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly closed container. Additionally, to maintain the drug's efficacy, it's important to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

Hard capsules of light yellow color containing white or pale gray powder

Package unit

30 capsules/bottle, 100 capsules/bottle