Gunspentin 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 as 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) - From 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, one 300 mg capsule of this drug may be administered three times daily as the starting dose (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day as gabapentin; the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as 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) - From 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, one 300 mg capsule of this drug may be administered three times daily as the starting dose (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day as gabapentin within one week; the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this drug 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: 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 patients receiving 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: 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; 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, care should be taken to ensure that the interval between doses does not exceed 12 hours in order 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), whether to administer an additional dose to make up for it should be determined 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 (increased frequency of epileptic seizures resulting from 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 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 longer than 5 months have not been evaluated. 6) To reduce the main adverse effects, including somnolence, dizziness, fatigue, and ataxia, the first dose on the first day should be taken at bedtime.

Child dose

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

This drug is used for treating epilepsy, and during treatment, there is an increased risk of suicidal thoughts or behaviors; thus, patients and caregivers should carefully monitor mood changes or behavioral abnormalities. Sudden discontinuation of the drug may lead to worsened seizures or status epilepticus, so it should be tapered gradually under the guidance of a physician. Animal studies have reported certain cancer occurrences, but the risk in humans remains unclear. During treatment with this drug, there have been rare reports of sudden and unexpected deaths, so it is necessary to continuously monitor health conditions. If symptoms of pancreatitis such as persistent abdominal pain, nausea, or recurrent vomiting occur, the medication should be stopped immediately, and medical attention must be sought. Children aged 3 to 12 may experience central nervous system adverse reactions such as emotional instability, aggression, difficulty concentrating, and hyperactivity; therefore, caution is required. Caution is advised as co-administration of this medication with central nervous system depressants, including narcotics, can cause severe drowsiness, respiratory depression, and coma. This medication should not be used by individuals with hypersensitivity to it, acute pancreatitis, primary generalized seizures, or lactose intolerance. Patients with impaired renal function, the elderly, those with a history of psychiatric disorders, pregnant women or those planning to become pregnant, and nursing mothers require special attention when administering this drug. Side effects such as dizziness, drowsiness, motor control disorders, memory impairment, depression, nausea, vomiting may occur, which can impact daily life. During pregnancy, it may pose risks to the fetus, hence women of childbearing potential must consult with their physician before taking it, and nursing mothers should also administer it with caution. This drug may impair the ability to drive or operate dangerous machinery, so attention must be paid during the initial phase of treatment or when dosing is changed. In cases of overdose, symptoms such as dizziness, drowsiness, or coma may appear; however, recovery is generally achieved through supportive care, and severe cases may require medical intervention. This medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation in quality.

• Suicidal thoughts
• suicidal behavior
• depression
• emotional instability
• hostility
• thought disorder
• hyperactivity
• abdominal pain
• back pain
• fatigue

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

Appearance

Hard gelatin capsule with a light yellow color containing white or grayish-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle