Hyundai Gabapentin Capsule 300 Milligrams

Adult dose

1. Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older: Titrate gradually over the first 3 days of treatment to a maintenance dose of 900 mg/day of gabapentin. 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 twice 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 an initial 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 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.) The duration of treatment should be based on clinical need. Long-term treatment is generally required for epilepsy. If treatment with this drug is to 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. 2. Neuropathic pain Adults (18 years and older): Titrate gradually over the first 3 days of treatment to a maintenance dose of 900 mg/day of gabapentin. 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 twice 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 an initial dose, one 300 mg capsule of this drug may be administered 3 times daily (gabapentin 900 mg/day). If needed, 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 drug should be divided into 3 doses. The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 3. Frail patients In frail patients with low body weight or patients after transplant surgery, the dose of this drug should be increased in 100 mg increments. 4. Elderly patients Dosage adjustment may be necessary due to age-related decline in renal function. 5. 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 a Creatinine clearance 50 - 79 mL/min: total daily dose 600 ~ 1,800 mg/day a Creatinine clearance 30 - 49 mL/min: total daily dose 300 ~ 900 mg/day a 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: 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. Dosage for patients receiving hemodialysis Initial dose: Gabapentin 300~400 mg is recommended. Maintenance dose: Administer gabapentin 200~300 mg after 4 hours of hemodialysis; do not administer this drug on days when hemodialysis is not performed. 6. Method and duration of administration Swallow this drug 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. If a dose of this drug is missed (12 hours or more have elapsed since the last dose), whether to take an additional dose to make up for it should be determined by the physician. When used concomitantly with antacids containing magnesium or aluminum, administer this drug at least 2 hours after the antacid. The duration of treatment with this drug should be based on clinical need. Dose reduction, discontinuation, or switching to another alternative drug should be carried out gradually over at least 1 week (a longer period may be required at the prescriber's discretion). To reduce the main adverse reactions, 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 years to 12 years: Day 1: Administer gabapentin 10 mg/kg Adjunctive therapy in children aged 3 years to 12 years: Day 2: Administer gabapentin 20 mg/kg Adjunctive therapy in children aged 3 years to 12 years: From Day 3: Administer gabapentin 30 mg/kg Adjunctive therapy in children aged 3 years to 12 years: The dose may be increased, if necessary, up to a maximum of 40 mg/kg/day. The total daily dose should be divided into 3 doses.

This medication is used to treat epilepsy; hence, suicidal thoughts, behavioral changes, or depression may occur during treatment, necessitating careful observation. Abrupt discontinuation can lead to increased seizures or a serious status epilepticus risk, so it should be gradually reduced according to the doctor's instructions. Some animal studies have reported a possibility of pancreatic cancer development, but the risk to humans is still unclear. Rarely, sudden and unexpected death cases have been reported, possibly related to the risks of epilepsy itself. If symptoms of pancreatitis (persistent abdominal pain, nausea, repeated vomiting) appear, discontinue the medication immediately and consult a doctor. Particularly in children, neurological and psychiatric side effects such as emotional instability, aggression, decreased concentration, and hyperactivity may appear, necessitating caution. Concurrent use with central nervous system depressants or narcotics can cause severe drowsiness, respiratory suppression, or coma, so caution is essential during co-administration. Individuals with allergic reactions to this medication, those with acute pancreatitis, certain types of seizures, or lactose intolerance should not take this medication. Patients with impaired renal function, elderly patients, children with a history of mental illness or Attention Deficit Hyperactivity Disorder, pregnant and breastfeeding women must consult a doctor before taking the medication. Dizziness, drowsiness, and decreased concentration may occur during treatment, so it's advisable to avoid driving or operating dangerous machinery. Regular checks are required for potential weight gain or visual disturbances. During pregnancy, especially in early stages, there could be effects on the fetus; therefore, women of childbearing potential should ensure effective contraception, and consult their doctor if taking the medication during pregnancy. Breastfeeding mothers should be cautious as this medication may excrete into breast milk, necessitating consultation with a doctor for safe intake or potential cessation of breastfeeding. Interaction with other medications or alcohol should be monitored while taking this drug, and any abnormal symptoms should be reported to healthcare professionals immediately.

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

This medication should be stored in a tightly sealed container to prevent contact with air and moisture. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

A yellowish hard capsule containing a white to pale gray powder

Package unit

30 capsules/bottle, 100 capsules/bottle