Gabapentin 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 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 twice 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 a starting 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 sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine must 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. 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 twice 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 a starting 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 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. 2) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 3. Debilitated patients In debilitated patients with low body weight or patients following transplant surgery, the dose of this medicine should be increased in 100 mg increments. 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. In 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) Swallow this medicine whole with sufficient fluids. It may be taken with or without food. When administered 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 medicine is missed (if 12 hours or more have elapsed since the last dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When this medicine is used with antacids containing magnesium or aluminum, administer this medicine at least 2 hours after the antacid. This can greatly 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 switched to another alternative, this should be done gradually over at least 1 week (a longer period may be needed at the prescriber's discretion). 5) 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

2) Adjunctive therapy in children aged 3 years to 12 years The following dose titration schedule should be followed over the first 3 days of treatment to achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight. 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/kg of body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This drug is used for the treatment of epilepsy and neuropathic pain, and changes in mental health, such as suicidal thoughts or behaviors and depression, may occur during use, so careful observation is required. Abrupt discontinuation can exacerbate seizures or put patients at risk of status epilepticus, so it should be tapered off slowly according to a physician's instructions. Long-term use may lead to side effects such as weight gain, drowsiness, dizziness, and ataxia which can affect daily life, so caution is advised. In particular, children aged 3 to 12 years may experience neuropsychiatric side effects such as emotional instability, hostility, thought disorders, and hyperactivity. The risk of sedation, respiratory depression, and coma may increase if this medication is taken in combination with central nervous system depressants or narcotics, therefore consultation with healthcare providers is essential when using these drugs together. Patients with impaired renal function, the elderly, those with a history of mental illness, pregnant women, or lactating women should consult a specialist before taking this drug, and dose adjustments may be necessary as needed. If symptoms of pancreatitis (persistent upper abdominal pain, nausea, recurring vomiting) occur during use, the medication should be discontinued immediately and the healthcare provider notified. This medication can cause severe side effects such as allergic reactions, severe skin reactions, anaphylaxis, and angioedema, so if symptoms such as rash, fever, difficulty breathing, or swelling of the lips or tongue occur, take it immediately and consult a physician. Additionally, this medication may affect the fetus if taken in early pregnancy, so women who are planning to become pregnant or are pregnant should definitely consult a doctor, and caution is necessary for lactating women as well. Drowsiness or dizziness may occur while using this drug, so it's advisable to avoid driving or operating hazardous machinery until familiar with the medication. Strictly adhere to the prescribed dosage and administration guidelines and do not stop or increase the dosage arbitrarily. Finally, this medicine should be stored out of reach of children and kept in its original container to prevent misuse or degradation of quality.

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

This medication may be sensitive to air and light, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius to preserve the medication's effectiveness for a longer period.

Appearance

A hard capsule consisting of a white or nearly white powder with white upper and lower parts

Package unit

30 capsules/bottle, 100 capsules/bottle