Dong-A 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 gradually 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 onward: 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, one 300 mg capsule of this medicine 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; 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 gradually 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 onward: 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, one 300 mg capsule of this medicine 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 medicine should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplantation, 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: 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 an adequate amount of fluid. It may be taken with or without food. When administered 3 times daily, ensure 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 more than 12 hours have elapsed since the most recent dose), whether to administer an additional dose to make up for it should be determined by the physician. 3) When used concomitantly with antacids containing magnesium or aluminum, administer this medicine 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. 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 medicine must be discontinued or it is used 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 longer 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 Day 1 should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years: Administer gabapentin 10 mg/kg of body weight on Day 1; administer gabapentin 20 mg/kg of body weight on Day 2; from Day 3, administer gabapentin 30 mg/kg of body weight. The dose may be increased, as needed, up to a maximum of 40 mg per kg of body weight per day. Divide the total daily dose into 3 doses.

This medication may increase the risk of suicidal thoughts or behavior in patients; thus, patients and caregivers should inform healthcare professionals immediately if mood changes or unusual behaviors occur. Abruptly stopping this medication may lead to more frequent seizures or progression to severe epilepsy; therefore, it must be discontinued gradually according to the physician's instructions. While certain animal studies have reported the potential for specific types of cancer, the carcinogenic risk in humans is not clearly established, so caution is needed. There have been reports of sudden and unexpected deaths during treatment, but no significant difference compared to epilepsy patients not taking this medication; however, careful monitoring is required. If symptoms of pancreatitis appear during treatment, immediate discontinuation and medical evaluation are necessary. Caution is advised when administered to children aged 3 to 12 years due to possible neuropsychiatric adverse effects such as emotional instability, aggression, decreased attention, and hyperactivity. Concomitant use with central nervous system depressants or narcotics may cause severe drowsiness, respiratory depression, or coma; therefore, it should only be used at the lowest effective dose for the shortest duration and under strict medical supervision. It is contraindicated for patients with allergies to this medication or its components, acute pancreatitis patients, patients with certain seizure types, and genetically lactose intolerant patients. Patients with impaired kidney function, older adults, those with a history of psychiatric disorders, pregnant or planning to become pregnant women, breastfeeding mothers, and children with attention deficit or behavioral disorders should use this medication with caution. Drowsiness, dizziness, and ataxia may occur; caution is necessary when driving or operating heavy machinery. Various side effects such as weight gain, visual disturbances, skin rashes, and blood abnormalities may occur; consultation with a healthcare professional is necessary if symptoms persist. Use during pregnancy may pose risks to the fetus; women who may become pregnant should use effective contraception, and breastfeeding mothers should consult with their doctors before use. Abruptly stopping this medication after long-term use may lead to withdrawal symptoms such as anxiety, insomnia, nausea, tremors; therefore, it should be tapered gradually according to the physician's instructions. In case of overdose, dizziness, drowsiness, or coma may occur, but generally, supportive therapy can lead to recovery, although patients with severe renal failure may require hemodialysis. This medication should be kept out of reach of children and should not be stored in a different container from the original to prevent misuse and degradation of quality.

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

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is recommended to store the medication at room temperature between 1 and 30 degrees Celsius, avoiding places that are too hot or too cold.

Appearance

This medication is a hard capsule with a white or off-white powder inside, with a white upper and lower part.

Package unit

30 capsules/bottle, 200 capsules/bottle