Dong-A Gabapentin Capsule 400 mg (Gabapentin)

Adult dose

Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older: To achieve a maintenance dose of 900 mg/day as gabapentin, titration should be carried out 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 2 times 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 a starting 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 as gabapentin, and the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titration should be carried out 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 2 times 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 a starting 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 as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. When administering this drug, the total daily dose should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose should be increased in 100 mg increments. Elderly patients: Dosage adjustment may be necessary due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dosage adjustment is necessary based on the following table. Dosage for patients with renal impairment: Creatinine clearance (mL/min) ≥80: Total daily dose 900∼2,400 mg/day Creatinine clearance (mL/min) 50∼79: Total daily dose 600∼1,800 mg/day Creatinine clearance (mL/min) 30∼49: Total daily dose 300∼900 mg/day Creatinine clearance (mL/min) 15∼29: Total daily dose 150b∼600 mg/day Creatinine clearance (mL/min) <15: Total daily dose 150b∼300 mg/day a: The total daily dose should be divided into 3 doses. b: Administer as 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. 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, and do not administer this drug on days when hemodialysis is not performed. This drug should be swallowed whole with sufficient fluid and may be administered with or without food. When administered 3 times daily, care should be taken to ensure that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. If a dose of this drug is missed (if more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be administered to make up for the missed dose. When this drug is administered concomitantly with antacids containing magnesium or aluminum, it should be administered at least 2 hours after the antacid. 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. The safety and efficacy of treatment for neuropathic pain for periods exceeding 5 months have not been evaluated. 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: To achieve a maintenance dose of gabapentin 30 mg/kg/day, titrate the dose over the first 3 days of treatment as follows. Day 1: administer gabapentin 10 mg/kg; Day 2: administer gabapentin 20 mg/kg; From Day 3: administer gabapentin 30 mg/kg; the dose may be increased as needed to a maximum of 40 mg/kg per day. The total daily dose of this medicine should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors during treatment, so patients and caregivers should inform healthcare professionals immediately if any mood changes or unusual behaviors occur. Abrupt discontinuation of this medication may result in more frequent seizures or severe epilepsy status; therefore, it should be gradually discontinued under medical guidance. In some animal studies, results related to pancreatic cancer have been observed, but the carcinogenic risk in humans has not been clearly established. Sudden and unexpected deaths have been reported during treatment, but this is similar to the levels typically observed in epilepsy patients. If symptoms of pancreatitis such as persistent abdominal pain, nausea, or recurrent vomiting occur while taking this medication, it should be stopped immediately and a physician should be consulted. Caution is required when administering to children over 3 years and under 12 years, as neuropsychiatric adverse reactions, including emotional instability, aggression, decreased concentration, and hyperactivity, may occur. Taking this medication with narcotics or central nervous system depressants may lead to severe drowsiness, respiratory depression, or coma; thus, it should only be used at the minimum necessary dose for a short duration with close monitoring by healthcare professionals. This medication should not be administered to patients with hypersensitivity to it, acute pancreatitis, certain seizure types, or lactose intolerance. Patients with impaired kidney function, the elderly, those with a history of psychiatric disorders, pregnant women or women who may become pregnant, nursing mothers, children, and adolescents should use this medication with caution. While taking this medication, symptoms such as dizziness, drowsiness, or ataxia may occur; thus, caution should be exercised when driving or operating hazardous machinery. This medication may cause side effects such as weight gain, vision abnormalities, or skin rashes; therefore, regular check-ups and immediate consultation with a healthcare professional upon the appearance of unusual symptoms are necessary. Discontinuation of the medication may lead to withdrawal symptoms such as anxiety, insomnia, nausea, or tremors; therefore, it should be tapered slowly according to the physician's instructions. There is a possibility of drug and alcohol interactions while taking this medication; thus, patients must inform healthcare professionals about any other medications or health conditions they have. Taking this medication during pregnancy may affect the fetus; therefore, women who are pregnant or planning to become pregnant should consult a physician before taking it. Nursing mothers should consult with their physician regarding the possibility of this medication being excreted in breast milk and affecting the baby. Children and the elderly may have different responses to this medication; therefore, special attention should be paid to dosage adjustments and monitoring for side effects. This medication must be stored out of the reach of children and kept in its original container to prevent misuse or degradation in quality.

• Suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought abnormalities
• excessive movement
• weakness

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. This helps preserve the medication's effectiveness and allows for safe use.

Appearance

This medication is an orange hard capsule containing white or grayish-white powder.

Package unit

30 capsules/bottle, 200 capsules/bottle