Gabain Capsule 300 mg (Gabapentin)

Adult dose

1. Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older To achieve a maintenance dose of 900 mg/day as 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 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, 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 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.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as 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 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, 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 as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this medicine 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 increments of 100 mg. Elderly patients: Dose 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: Dose adjustment is required based on the following table. Dosage in patients with renal impairment: ≥80 mL/min: Total daily dose 900∼2,400 mg/day 50∼79 mL/min: Total daily dose 600∼1,800 mg/day 30∼49 mL/min: Total daily dose 300∼900 mg/day 15∼29 mL/min: Total daily dose 150b∼600 mg/day <15 mL/min: Total daily dose 150b∼300 mg/day a: The total daily dose should be divided into 3 doses. b: The dose 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 in 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 medicine on days when hemodialysis is not performed. This medicine should be swallowed whole with sufficient fluid and may be taken with or without food. When administered 3 times daily, care should be taken not to allow the interval between doses to exceed 12 hours to prevent recurrence of seizures. If a dose of this medicine is missed (when more than 12 hours have elapsed since the most recent dose), whether an additional dose should be taken to make up for the missed dose should be determined by a physician. When administered concomitantly with antacids containing magnesium or aluminum, this medicine should be taken at least 2 hours after the antacid. The duration of treatment with this medicine should depend on clinical need. Long-term treatment is generally required for epilepsy. If treatment with this medicine is to be discontinued or it is to be administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 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 years to 12 years Day 1: Administer gabapentin 10 mg/body weight (kg) Day 2: Administer gabapentin 20 mg/body weight (kg) From day 3: Administer gabapentin 30 mg/body weight (kg) If necessary, the dose may be increased up to a maximum of 40 mg per kg of body weight 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 behavior, so it is essential to inform a healthcare professional immediately if any mood or behavior changes occur during treatment. Discontinuation of this medication should not be abrupt, as it may lead to more frequent seizures or severe epilepsy, so it must be tapered gradually under medical guidance. Animal studies have reported some potential for cancer development, but the effects on humans are not yet clearly defined. While there have been reports of sudden and unexpected deaths during treatment, this falls within the general risk range typical for epilepsy patients. Pancreatitis may occur; if persistent upper abdominal pain or nausea and vomiting symptoms develop, the medication should be discontinued immediately, and a doctor should be consulted. Children may experience neurological and psychiatric side effects such as emotional instability, aggression, reduced attention, and hyperactivity, thus careful monitoring is needed. Combining this drug with narcotics or central nervous system depressants may cause severe drowsiness, respiratory depression, or coma. Therefore, use should be limited to the minimum effective dose for the shortest duration necessary, and strict medical supervision is required. Patients with hypersensitivity, acute pancreatitis, certain types of seizures, and lactose intolerance should not take this medication. Patients with reduced kidney function, the elderly, children with a history of psychiatric illness or attention deficit disorders, pregnant women, and nursing mothers should use this medication cautiously. Common side effects include drowsiness, dizziness, fatigue, nausea, vomiting, weight gain, and ataxia, and serious side effects should be reported to a healthcare professional immediately. During pregnancy, this medication may affect the fetus; therefore, those planning to become pregnant or who are currently pregnant should consult with a physician, and caution is necessary while breastfeeding as well. This medication may impair the ability to drive or operate machinery, so caution is advised following use. Interactions may occur with other medications or alcohol during treatment, so inform your healthcare provider of any other medications or alcohol use. In case of overdose, symptoms may include drowsiness, coma, and dizziness, and immediate medical attention is required, including possible blood dialysis. This medication should be stored out of reach of children and in its original container to prevent misuse or deterioration of quality.

• Suicidal impulses
• suicidal behavior
• depression
• abnormal mood and behavior changes
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought disorders
• hyperactivity
• weakness

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The recommended storage temperature is at room temperature between 1 and 30 degrees Celsius. This helps to maintain the drug's efficacy and safety over time.

Appearance

A hard capsule with a beige color, containing white or off-white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle