Neopent Tablet (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, the dose should be titrated 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 twice 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, instead of the above regimens, 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.) 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 (increased frequency of epileptic seizures due to sudden discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may precipitate 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. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day of gabapentin, the dose should be titrated 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 twice 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, instead of the above regimens, 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 1 week, and the total daily dose must not exceed 3,600 mg of gabapentin. The total daily dose of this medicine should be divided into 3 doses. The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. Debilitated patients In debilitated patients with low body weight or patients after transplantation, the dose of this medicine should be increased in 100 mg increments. Elderly patients Dosage adjustment may be necessary due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients receiving hemodialysis Dosage adjustment is required based on the following table. Dosage for patients with renal impairment: Renal function, creatinine clearance (mL/min) ≥80: Total daily dosea (mg/day) 900 ~ 2,400 Renal function, creatinine clearance (mL/min) 50 - 79: Total daily dosea (mg/day) 600 ~ 1,800 Renal function, creatinine clearance (mL/min) 30 - 49: Total daily dosea (mg/day) 300 ~ 900 Renal function, creatinine clearance (mL/min) 15 - 29: Total daily dosea (mg/day) 150b~600 Renal function, creatinine clearance (mL/min) < 15: Total daily dosea (mg/day) 150b~300 a: The total daily dose should be divided into 3 doses. b: 3 × 100 mg should be administered every 2 days. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 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. Method and duration of administration 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 to ensure that the interval between doses does not exceed 12 hours in order to prevent recurrence of seizures. If a dose of this medicine is missed (if more than 12 hours have passed since the last dose), the physician should decide whether an additional dose should be taken to make up for the missed dose. When this medicine is used concomitantly with antacids containing magnesium or aluminum, it should be administered at least 2 hours after the antacid. This can greatly reduce the decrease in bioavailability of this medicine. The duration of treatment with this medicine should be determined according to clinical need. When reducing the dose of this medicine, discontinuing treatment, or switching to another alternative medicine, this should be done gradually over at least 1 week (a longer period may be required at the prescriber's discretion). To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be taken at bedtime.

Child dose

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

This medication may increase the risk of suicidal thoughts or actions, so patients should be closely monitored for signs of depression, mood changes, or unusual behavior during treatment. If this medication is suddenly discontinued, seizures may worsen or result in a prolonged seizure state, so it should be discontinued slowly under the direction of a physician. This drug can induce pancreatitis, so if symptoms of abdominal pain, nausea, or recurrent vomiting occur, immediately stop taking it and consult medical personnel. When administered to pediatric patients, special care should be taken due to the potential for neurological and psychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity. Concurrent use of this medication with narcotics and central nervous system depressants may lead to severe drowsiness, respiratory depression, coma, or even death; therefore, it should be used at the minimum dose for a short period and patients should be closely monitored. This medication should not be used in patients with a hypersensitivity to it, acute pancreatitis, certain seizure types, or lactose intolerance. In patients with reduced kidney function, elderly patients, those with a history of mental illness, pregnant women, lactating women, and children, it should be administered with caution, and in pregnancy, it should only be used if necessary considering the risks to the fetus. This drug can cause a variety of side effects such as drowsiness, dizziness, ataxia, memory impairment, nausea, and vomiting, so it is advisable to avoid driving or operating dangerous machinery during treatment. If unusual symptoms such as weight gain, vision abnormalities, skin rash, or allergic reactions occur during treatment, patients should inform medical personnel immediately and receive appropriate care. When discontinuing this medication, withdrawal symptoms such as anxiety, insomnia, nausea, headache, and tremors may occur, so the dosage should be gradually reduced according to the physician's instructions. There may be interactions with other medications or alcohol during treatment, so patients must inform medical personnel about any other medications they are taking or if they are consuming alcohol. This medication should be stored out of reach of children and kept in its original container to prevent misuse or deterioration of quality.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Storing it this way helps preserve the efficacy and safety of the medication.

Appearance

Hard capsules filled with white to off-white powder in a yellowish-brown container

Package unit

30 capsules/bottle, 100 capsules/bottle