Hanwha Gabapentin Capsule 100 mg

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 medication once daily, or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication twice daily, or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medication 3 times daily, or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medication may be administered 3 times daily as the starting dose (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 medication once daily, or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication twice daily, or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medication 3 times daily, or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medication may be administered 3 times daily as the starting dose (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 medication should be divided into 3 doses. 3. Debilitated patients : In debilitated patients with low body weight or patients after transplant surgery, 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. 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 medication on days when hemodialysis is not performed. 6. Method and duration of administration 1) Swallow this medication whole with plenty of fluid. 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 medication is missed (more than 12 hours 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 this medication is used concomitantly with antacids containing magnesium or aluminum, administer this medication at least 2 hours after the antacid. This can greatly reduce the decrease in the bioavailability of this medication. 4) The duration of treatment with this medication 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 following abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medication must be discontinued, or if it is to be used concomitantly with another antiepileptic drug, the change 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 the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years: On day 1, administer gabapentin 10 mg/kg of body weight; on day 2, administer gabapentin 20 mg/kg of body weight; from day 3 onward, administer gabapentin 30 mg/kg of body weight. If needed, the dose may be increased to a maximum of 40 mg/kg of body weight per day. When administering this medicine, divide the total daily dose into 3 doses.

This medication is used as an anticonvulsant, and may affect mental health by causing suicidal thoughts or behaviors, depression, etc., so patients and caregivers should carefully observe for these symptoms. Abrupt discontinuation can lead to exacerbation of seizures or progression to status epilepticus, so it should be gradually discontinued according to a physician's instructions. Serious side effects, such as pancreatitis, may occur with this medication, so if persistent upper abdominal pain, nausea, or repeated vomiting occurs while taking it, stop taking it immediately and consult a healthcare professional. Particularly in children aged 3 years to 12 years, emotional instability, hostility, thought abnormalities, and hyperactivity may occur as neuropsychiatric adverse reactions, so caution is required. The risk of sedation, respiratory depression, and coma may increase if this medication is taken with central nervous system depressants, including narcotics, so the decision of whether to use it in combination should be made according to physician's instructions, and careful monitoring is necessary during co-administration. It should not be administered to patients with a known hypersensitivity or acute pancreatitis, and caution is needed for those with renal impairment, elderly patients, or patients with a history of mental illness. Dizziness, drowsiness, and ataxia may commonly occur as central nervous system side effects; therefore, it is advised to avoid driving or operating hazardous machinery after taking this medication. Women who are pregnant or planning to become pregnant, as well as nursing mothers, should consult a physician before taking this medication, and it is recommended to stop nursing if taking it during lactation. Various side effects such as weight gain, visual disturbances, skin rashes, and blood abnormalities have been reported, so notify a healthcare professional immediately if any unusual symptoms occur. Strict compliance with prescribed dosages and regimens is required, and one should not arbitrarily discontinue or alter the dosage.

• Suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought disorder
• hyperactivity
• deep sedation

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the efficacy of the medication.

Appearance

A hard capsule that is white or light gray filled with powder.

Package unit

30 capsules/bottle, 100 capsules/bottle, 300 capsules/bottle