Hyundai Gabapentin Capsule 100 Milligrams

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients 13 years of age 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 drug once daily, or one 100 mg capsule of this drug three 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 three times daily (gabapentin 600 mg/day) Starting on Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this drug may be administered three 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.) 3) The duration of treatment should be determined according to clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures caused by sudden discontinuation of treatment), 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 in combination with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) 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 drug once daily, or one 100 mg capsule of this drug three 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 three times daily (gabapentin 600 mg/day) Starting on Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this drug may be administered three times daily (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 this drug is administered, the total daily dose should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. 3. Frail patients In frail patients with low body weight or patients following transplantation, the dose of this drug should be increased in increments of 100 mg. 4. Elderly patients Dosage 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 less) or patients undergoing hemodialysis: Dosage 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: 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. 2) Dosage for patients undergoing 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 drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) Swallow this drug whole with sufficient liquid. 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. 2) If a dose of this drug is missed (12 hours or more have elapsed since the most recent dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) 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. 4) 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 necessary at the prescriber's discretion). 5) 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

1. Epilepsy 2) Adjunctive therapy in children aged 3 years to 12 years Day 1: Administer gabapentin 10 mg/kg body weight Day 2: Administer gabapentin 20 mg/kg body weight From day 3: Administer gabapentin 30 mg/kg body weight Titrate gradually over the first 3 days of treatment to achieve a maintenance dose of gabapentin 30 mg/kg body weight/day. If necessary, the dose may be increased to a maximum of 40 mg/kg body weight per day. The total daily dose of this medication should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or actions; thus, if depression or mood changes occur during treatment, consult a physician immediately. Sudden discontinuation may result in an increase in seizure frequency or severity, so dosage must be reduced slowly as directed by a doctor. This medication may cause serious side effects such as pancreatitis; therefore, if persistent upper abdominal pain or nausea and vomiting occurs during use, discontinue and inform healthcare professionals immediately. Particularly in children aged 3 to 12 years, there may be neuro-psychiatric disturbances such as emotional instability, aggression, decreased concentration, and hyperactivity; thus, careful observation is necessary. Severe drowsiness, respiratory depression, and coma may occur when taken with central nervous system depressants including narcotics; hence, it should only be used at the lowest effective dose for a short period, and patient status must be closely monitored. Patients with hypersensitivity, acute pancreatitis, or specific genetic lactose breakdown disorders should avoid this medication. Patients with diminished kidney function, elderly patients, those with a history of mental illness, pregnant women, or breastfeeding women should consult their doctor before use to make decisions cautiously. Dizziness, drowsiness, confusion, etc., may occur while taking this medication, so caution is required when driving or operating dangerous machinery. Weight gain, vision abnormalities, skin rash, allergic reactions, etc., may occur, so report any adverse symptoms to healthcare professionals immediately. When discontinuing the medication, withdrawal symptoms (anxiety, insomnia, tremors, etc.) may occur; therefore, it is safer to taper off gradually under a doctor's guidance. Use during pregnancy may affect the fetus, so women who are pregnant or planning to become pregnant must consult a doctor before taking this medication. This medication has not established safety and efficacy in children, especially those under 3 years of age, thus it is advisable not to use it.

• Suicidal thoughts
• suicidal behaviors
• depression
• abnormal changes in mood and behavior
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought disturbances
• excessive movement
• weakness

This medication may be sensitive to air or moisture; hence, it should be stored in a tightly sealed container. Additionally, it is advisable to keep the medication at room temperature, not too hot or cold, ideally between 1°C and 30°C. This storage method will help safely maintain the medication's effectiveness.

Appearance

Hard capsule with white to off-white powder inside, white upper and lower parts.

Package unit

30 capsules/bottle, 100 capsules/bottle