Gabatec Capsule 100 mg (Gabapentin)

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients aged 13 years and older To reach 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 3 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 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug 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 reach 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 3 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 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug 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. The total daily dose of this drug should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, 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 receiving 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: 3 × 100 mg should be administered every 2 days. For patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to the 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 drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) This drug should be swallowed whole with sufficient fluid and may be taken with or without food. When administered 3 times daily, care should be taken not to allow the interval between doses to exceed 12 hours to prevent recurrence of seizures. 2) 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 taken to make up for the missed dose. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug 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 drug is to be discontinued or if it is to be administered 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 reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be taken at bedtime.

Child dose

1. Epilepsy 2) Adjunctive therapy in children aged 3 years or older and 12 years or younger - 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) To achieve a maintenance dose of gabapentin 30 mg/kg body weight/day, titrate gradually over the first 3 days of treatment as follows. If necessary, the dose may be increased to a maximum of 40 mg/kg body weight/day. The total daily dose of this medicine should be divided into 3 doses.

This drug is used for the treatment of epilepsy or neuropathic pain. During treatment with this drug, suicidal thoughts or behaviors, depression, and changes in mood and behavior may occur; if these symptoms arise, do not hesitate to inform your healthcare provider. Sudden discontinuation of the medication can lead to increased seizure frequency or a risk of status epilepticus, so it is essential to stop taking it under medical guidance. This drug may cause pancreatitis, especially hemorrhagic pancreatitis, so if you experience persistent upper abdominal pain, nausea, or recurrent vomiting, stop taking the medication immediately and visit a hospital. Neurological side effects such as dizziness, drowsiness, ataxia, memory impairment, emotional instability, and hostility may occur, so caution is advised when driving or operating dangerous machinery. Particularly in children and adolescents, changes in emotions, behavioral issues, reduced concentration, and hyperactivity may occur, so parental observation is required. When combined with central nervous system depressants, including narcotics, there is a risk of severe sedation, respiratory depression, coma, or even death, so it is critical to be very cautious and strictly manage dose and duration according to a physician's instructions. This drug should not be administered to patients with certain genetic disorders or those with acute pancreatitis or generalized tonic-clonic seizures. Patients with impaired kidney function, the elderly, those with a history of mental illness, pregnant and breastfeeding women should consult a physician before use, as it may affect the fetus during pregnancy and requires special caution. Weight gain, visual disturbances, skin rashes, and allergic reactions may occur during treatment; therefore, if any of these symptoms arise, immediately notify a healthcare provider and take appropriate measures. This medication has the potential for dependence and misuse, so patients with a history of drug abuse should exercise extra caution, as withdrawal symptoms such as anxiety, insomnia, and tremors may occur when discontinuing treatment. Always adhere to the prescribed timing and dosage, and do not arbitrarily discontinue or increase the dosage; inform your healthcare provider when using other drugs or alcohol concurrently. Keep out of reach of children and store it in its original container to prevent misuse or degradation of quality.

• Suicidal thoughts
• suicidal behavior
• depression
• emotional instability
• hostility
• abnormal thinking
• hyperactivity
• abdominal pain
• lower back pain
• fatigue

This medication may be sensitive to air or moisture and should be stored in a tightly closed container. It is best to keep the storage temperature between 1 and 30 degrees Celsius to safely maintain the drug's efficacy.

Appearance

White hard capsule containing white or off-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle