Youngil Gabapentin Capsule 300 mg

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 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 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, 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.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day of 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 2 times 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, and the total daily dose must not exceed 3,600 mg of gabapentin. When taking this medicine, the total daily dose 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 increments of 100 mg. 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: 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. 2) Dosage for patients on 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. 6. Method and duration of administration 1) This medicine should be swallowed whole with plenty of fluid and may be taken with or without food. When administered 3 times daily, care should be taken not to allow an interval of 12 hours or more between doses to prevent recurrence of seizures. 2) If a dose of this medicine is missed (if 12 hours or more have elapsed since the most recent dose), the physician should determine whether an additional dose should be taken to make up for it. 3) When taken concomitantly with antacids containing magnesium or aluminum, this medicine should be taken at least 2 hours after administration of the antacid. This can substantially reduce the decrease in 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 sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine is to be discontinued, or if it is to be 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 the first day of treatment should be taken at bedtime.

Child dose

2) 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 the dose during 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, if needed, to a maximum of 40 mg per kg of body weight per day. Divide the total daily dose into 3 doses.

This drug is used for the treatment of epilepsy and neuropathic pain. Mood changes such as suicidal thoughts or behavior, and depression may occur during treatment, and if any of these symptoms are observed, you should consult with a doctor immediately. Stopping this medication abruptly may increase the frequency of seizures or lead to status epilepticus, so do not stop taking it without the physician's guidance. Long-term use may lead to side effects such as weight gain, drowsiness, dizziness, and impaired motor function, and some side effects may occur more frequently in children or the elderly. Particularly when given to children aged 3 to 12, it is important to be vigilant as emotional instability, aggression, concentration impairment, and hyperactivity may occur. This drug should be used cautiously in patients with reduced kidney function, the elderly, those with a history of psychiatric disorders, women who are pregnant or planning to become pregnant, and nursing mothers. Patients with acute pancreatitis or those who are hypersensitive to this drug or its components, and patients with certain types of seizures (such as generalized absence seizures) should not receive this medication. Concurrent use of this medication with central nervous system depressants, including narcotics, may lead to respiratory depression, severe sedation, and coma, so great caution should be used when combining them. During pregnancy, this medication may affect the fetus, so avoid use if possible during early pregnancy, and effective contraception should be used by women of childbearing potential. Because this medication can be excreted in breast milk, nursing should be stopped or discussed with a doctor while taking it. If sudden skin rash, fever, difficulty breathing, or swelling of the face or neck occurs, stop taking the medication immediately and seek emergency treatment. This drug carries a risk of dependence and abuse, so patients with a history of drug abuse should be particularly cautious when using it, and withdrawal symptoms such as anxiety, insomnia, and tremors may appear upon cessation. Dizziness and drowsiness may occur, so caution should be taken when driving or operating hazardous machinery, and dosing should not be spaced more than 12 hours apart. When storing this medication, keep it out of reach of children and do not transfer it to another container.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best stored at room temperature between 1°C and 30°C. Proper storage will maintain the drug's efficacy and ensure safe use.

Appearance

A hard capsule with a yellowish upper and lower body, containing white or grayish powder.

Package unit

30 capsules/bottle, 100 capsules/bottle, 200 capsules/bottle