Dong-A Gabapentin Tablets 600 mg (Gabapentin)

Adult dose

100 mg, 300 mg, and 400 mg capsules may be used when administering the initial dose of this medicine. For administration of the maintenance dose, 600 mg and 800 mg tablets and 300 mg and 400 mg capsules may be used; 100 mg capsules may be used in patients requiring hemodialysis. The dose should be determined at the physician’s discretion based on each patient’s individual tolerability and efficacy. 1. Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older: This medicine is effective at doses of 900～2,400 mg/day of gabapentin. Initial dose: To achieve a maintenance dose of 900 mg/day of gabapentin, titrate 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 2 times 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) Maintenance dose: The initial efficacy of this medicine can be assessed at doses of 900∼1,200 mg/day of gabapentin. If higher doses are required, it is recommended to administer 600 mg tablets 3 times daily to provide 1,800 mg/day of gabapentin, or 800 mg tablets 3 times daily to provide 2,400 mg/day of gabapentin. The total daily dose should not exceed 2,400 mg of gabapentin. 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day of gabapentin, titrate 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 2 times 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, instead of the method above, 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 should not exceed 3,600 mg of gabapentin. The total daily dose of this medicine should be divided into 3 doses. 4. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the dose of this medicine should be increased in 100 mg increments. 5. Older adults: Dose adjustment may be necessary due to age-related decline in renal function. 6. Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients receiving hemodialysis Dosage for patients with renal impairment Creatinine clearance ≥80 mL/min: Total daily dose 900∼2,400 mg/day Creatinine clearance 50∼79 mL/min: Total daily dose 600∼1,800 mg/day Creatinine clearance 30∼49 mL/min: Total daily dose 300∼900 mg/day Creatinine clearance 15∼29 mL/min: Total daily dose 150b∼600 mg/day Creatinine clearance <15 mL/min: Total daily dose 150b∼300 mg/day a: The total daily dose should be divided into 3 doses. b: It should be administered 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; do not administer this medicine on days when hemodialysis is not performed. 7. Method and duration of administration When administering this medicine 3 times daily, care should be taken to ensure that the interval between doses does not exceed 12 hours, in order to prevent recurrence of seizures. If a dose of this medicine 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 coadministered with antacids containing magnesium or aluminum, this medicine should be administered at least 2 hours after the antacid. If treatment with this medicine is to be discontinued or it is to be used in combination with another antiepileptic medicine, the change should be made gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. The first dose on the first day of treatment should be administered at bedtime.

Child dose

When administered as adjunctive therapy to children aged 3 years to 12 years, the lower-strength 100 mg, 300 mg, and 400 mg capsules may be used instead of the high-strength tablet formulation of this medicine.

This medication carries a risk of suicidal thoughts or behaviors and mental health issues such as depression during use. Patients and caregivers should closely monitor for these symptoms. If this medication is suddenly discontinued, seizures may occur more frequently, or status epilepticus may persist, so it must be gradually reduced according to a doctor's directive. Serious pancreatic conditions like pancreatitis may develop, so if persistent upper abdominal pain, nausea, or recurrent vomiting symptoms appear, stop taking the medication immediately and consult a doctor. Taking this medication with narcotics or central nervous system depressants may cause severe drowsiness, respiratory depression, coma, and even death. Therefore, it must only be taken for a short duration at the minimum dose required and under strict medical supervision. This medication requires special caution for patients with impaired renal function, the elderly, those with a history of mental illnesses, pregnant or planning women, nursing mothers, and children. Consult a doctor in these cases and take the medication carefully. While taking this medication, side effects such as dizziness, drowsiness, motor control disorders, memory impairment, depression, insomnia, vision abnormalities, and weight gain may occur. It is advisable to avoid dangerous activities such as driving or operating machinery. In early pregnancy, there is a risk of congenital defects in the fetus; therefore, it is generally advised not to use this medication during pregnancy, and women who might become pregnant should employ effective contraception during treatment. While breastfeeding, because this medication is secreted in breast milk, consider its potential effects on the baby when deciding to breastfeed, and it is important to discuss this with a doctor. This medication carries the risk of drug dependence and abuse, so patients with a history of substance abuse should take it particularly cautiously and inform healthcare personnel immediately if signs of drug-seeking behavior or dose escalation appear. In case of overdose, symptoms such as dizziness, drowsiness, or coma may occur, but are generally recoverable with supportive care. In patients with renal failure, hemodialysis may be required. When storing this medication, keep it out of reach of children and in its original container to prevent misuse or degradation of quality.

• Suicidal thoughts
• suicidal behavior
• depression
• seizures
• status epilepticus
• hemorrhagic pancreatitis
• deep sedation
• respiratory depression
• coma
• death

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it should be kept at a normal room temperature, avoiding excessively hot or cold locations.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle