Gabarex Capsule 300mg (Gabapentin)

Adult dose

Epilepsy Monotherapy and adjunctive therapy in patients aged 13 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 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: 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, and 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 determined according to clinical need. Treatment of epilepsy generally requires long-term administration. There is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures following abrupt discontinuation of treatment); however, abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug must be discontinued, or if it is used concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 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 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: 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 necessary, the dose may be increased to 1,800 mg/day of gabapentin within 1 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 longer than 5 months have not been evaluated. Frailty: In frail patients with low body weight or patients after transplant surgery, the dose of this drug should be increased in 100 mg increments. Older adults: 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 undergoing hemodialysis Dosage in 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. Dosage in patients undergoing 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. 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, ensure 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 administer an additional dose to make up for the missed dose 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. This can substantially reduce the decrease in the bioavailability of this drug. The duration of treatment with this drug should be determined according to clinical need. If the dose of this drug is reduced, treatment is discontinued, or the patient is switched to another alternative drug, this should be done gradually over at least 1 week (a longer period may be needed at the prescriber's discretion). To reduce the main adverse reactions, 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: To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate gradually over the first 3 days of treatment as follows. Day 1: administer 10 mg/kg of body weight as gabapentin; Day 2: administer 20 mg/kg of body weight as gabapentin; From Day 3 onward: administer 30 mg/kg of body weight as gabapentin. The dose may be increased as needed up to a maximum of 40 mg per kg of body weight daily. The total daily dose of this product should be divided into 3 doses.

This drug is used for the treatment of epilepsy and can increase the risk of suicidal thoughts or behavior, so changes in mood or behavior should be monitored carefully during treatment. If the medication is suddenly stopped, seizures may worsen, so the dosage should be adjusted slowly according to the doctor’s instructions. Some animal studies have shown results related to pancreatic cancer, but the risk in humans is still unclear. Unexpected deaths have been reported during treatment with this drug, so caution is required, especially in patients with epilepsy. If symptoms of hemorrhagic pancreatitis occur, discontinue use immediately and consult medical personnel. When administering to children aged over 3 years and under 12 years, be cautious as neuropsychiatric adverse reactions such as emotional instability, aggression, thought disorder, and hyperactivity may occur. When taken with central nervous system depressants or narcotics, there may be risk of respiratory depression or coma, so careful monitoring and dosage adjustment are necessary when used in combination with such drugs. Patients with allergies to this drug or its components, acute pancreatitis, certain types of seizures, or lactose metabolism disorders should not use this drug. Caution should be used in patients with reduced renal function, elderly patients, those with a history of psychosis, pregnant or potentially pregnant women, and nursing mothers. Symptoms such as dizziness, drowsiness, and ataxia may occur upon administration, so caution should be taken when driving or operating machinery, and weight gain or visual disturbances should also be monitored. This medication may cause serious skin reactions or allergic reactions such as anaphylaxis; if symptoms such as rash, fever, or difficulty breathing occur, discontinue use immediately and consult medical personnel. Sudden discontinuation after long-term use may result in withdrawal symptoms such as anxiety, insomnia, tremors, and headaches, so it should be tapered gradually according to the doctor’s instructions. There may be risks to the fetus when used during pregnancy, so it is essential to consult with medical personnel if planning to become pregnant or during pregnancy, and nursing mothers should use it cautiously. While on this medication, there may be potential drug or alcohol interactions; all medications being taken should be reported to medical personnel. Keep out of reach of children and store in the original container to prevent misuse or deterioration of quality.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal mood and behavior changes
• hemorrhagic pancreatitis
• emotional instability
• hostility
• cognitive disturbances
• hyperactivity
• weakness

This drug should be stored in a tightly closed container to protect it from air and moisture, and at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the drug's efficacy.

Appearance

Hard capsules with a white or grayish-white powder inside, yellowish in color.

Package unit

30 capsules/bottle, 200 capsules/bottle