Neurontic Capsule 300 mg (Gabapentin)

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 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.) 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 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 one week, and the total daily dose must not exceed 3,600 mg of gabapentin. The total daily dose of this drug should be administered in 3 divided doses. 3. Debilitated patients: In debilitated patients with low body weight or patients following transplantation, the gabapentin dose should be increased in increments of 100 mg. 4. Older adults: 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 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 administered in 3 divided 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 in 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) This drug should be swallowed whole with sufficient fluid and may be taken with or without food. When administered 3 times daily, care should be taken to 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 (if more than 12 hours have elapsed since the last dose), whether to administer an additional dose to make up for the missed dose should be decided by the physician. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend on 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 due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug must be discontinued or it is to be used concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 5) The safety and efficacy of treatment for neuropathic pain for periods exceeding 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 administered at bedtime.

Child dose

Adjunctive therapy in children 3 to 12 years of age: Titrate during the first 3 days of treatment as follows to achieve a maintenance dose of gabapentin 30 mg/kg body weight/day. 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). The dose may be increased, if necessary, up to a maximum of 40 mg per kg of body weight per day. The total daily dose of this drug should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors, so if any abnormal changes in mood or behavior occur during treatment, the healthcare provider should be notified immediately. Suddenly stopping this medication may result in more frequent seizures or persistent status epilepticus, thus the dosage should be gradually reduced according to the physician's instructions. Some animal studies have reported a potential risk of cancer, but the effects in humans are not yet clear. There have been reports of unexpected and sudden deaths during the treatment with this medication, although they fall within the typical risk range for epilepsy patients. If symptoms of pancreatitis such as persistent upper abdominal pain, nausea, or repeated vomiting occur during use, discontinue the medication immediately and consult a doctor. Caution should be taken when administering this drug to children, as neuropsychiatric effects such as emotional instability, aggression, impaired concentration, and excessive activity may occur. Concurrent use of this medication with central nervous system depressants, including narcotics, can lead to severe drowsiness, respiratory depression, and coma; hence they should only be used in the minimum required dosage under close medical supervision. This medication should not be given to patients with hypersensitivity, acute pancreatitis, or generalized tonic-clonic seizures. Patients with impaired kidney function, the elderly, individuals with a history of psychiatric illness, children with attention deficit or behavioral disorders, women who are pregnant or planning to become pregnant, and nursing mothers should use this medication with caution. Dizziness, drowsiness, and impaired concentration may occur during treatment, necessitating caution when driving or operating hazardous machinery. During pregnancy, it may affect the fetus; therefore, women of childbearing potential should employ effective contraception and must consult a physician if taking this medication while pregnant. Nursing mothers should either discontinue breastfeeding or consult a doctor when taking this medication. This medication may cause various side effects such as weight gain, visual disturbances, skin rashes, and blood abnormalities, so any unusual symptoms should be reported to a healthcare provider immediately. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as anxiety, insomnia, tremors, and headaches, so it should be tapered off gradually according to a physician's guidance. Be mindful of possible interactions with other medications, and inform your healthcare provider or pharmacist about any other drugs being taken. Store out of reach of children, in the original container to prevent misuse or degradation of quality.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought disorders
• hyperactivity
• deep sedation

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

Hard capsule filled with white or grayish-white powder, with a yellowish outer and inner layer.

Package unit

30 capsules/bottle, 100 capsules/bottle