Neurontin Capsule 300 Milligrams (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 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, but 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 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 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 administering this drug, 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 100 mg increments. 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 receiving 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 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 administered 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. 2) If a dose of this drug is missed (if 12 hours or more have elapsed since the most recent dose), whether to administer an additional dose to make up for it should be determined by the physician. 3) When administered with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can greatly reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend on clinical need. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (increased frequency of epileptic seizures following abrupt 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, 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 should be administered at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years - Day 1: Administer gabapentin 10 mg/body weight (kg) - Day 2: Administer gabapentin 20 mg/body weight (kg) - From Day 3 onward: Administer gabapentin 30 mg/body weight (kg) The dose may be increased, if necessary, to a maximum of 40 mg per kg of body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication may pose a risk of causing mental health issues such as suicidal thoughts or behavior, so it is important to closely monitor mood or behavioral changes during treatment. Abrupt discontinuation may result in increased seizure frequency or severe epileptic conditions, so it should be gradually discontinued according to a doctor's instructions. Some animal studies have reported a potential association between this medication and the occurrence of certain cancers; however, this risk is not yet clear in humans. There have been reports of sudden and unexpected deaths during treatment with this medication, so caution is especially necessary for epilepsy patients. If symptoms of pancreatitis (persistent upper abdominal pain, nausea, recurrent vomiting) occur, discontinue the medication immediately and consult a doctor. In pediatric patients, neuropsychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may occur, so close monitoring is advised. Taking this medication with opioids or other central nervous system depressants may lead to severe drowsiness, respiratory suppression, coma, etc., so extreme caution is required when combined. Patients with a history of allergic reactions, acute pancreatitis, specific types of seizures, or lactose intolerance should not take this medication. Patients with impaired renal function, the elderly, those with a history of psychosis, pregnant or planning to become pregnant women, and breastfeeding mothers should exercise special caution when taking this medication. Drowsiness, dizziness, and decreased concentration may occur during treatment; therefore, driving or operating dangerous machinery is not recommended. This medication can cause various side effects including weight gain, visual disturbances, skin rashes, etc., and if any unusual symptoms occur, consult with healthcare professionals. Withdrawal symptoms may occur during treatment, so tapering should be done gradually upon discontinuation under a doctor’s advice. Use during pregnancy may affect the fetus; thus, if you are pregnant or planning to become pregnant, you must consult with a doctor. If breastfeeding, this medication may be excreted in breast milk, so either discontinue breastfeeding or consult with a doctor before taking this medication. Store this medication out of the reach of children and in its original container to prevent misuse or degradation of quality.

• Suicidal thoughts
• suicidal behavior
• depression
• emotional instability
• hostility
• abnormal thinking
• hyperactivity
• abdominal pain
• back pain
• fatigue

This medication may be sensitive to air or moisture, so store it in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the drug's efficacy over time.

Appearance

A hard capsule containing white or grayish powder with a golden-brown body and cap.

Package unit

30 capsules/bottle, 300 capsules/bottle