Ganutin Capsule 300mg (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 2 times 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, the starting dose may be one 300 mg capsule of this drug 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 2 times 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, the starting dose may be one 300 mg capsule of this drug 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 divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, 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 of 80 mL/min or less) or patients undergoing 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 the 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, 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 plenty of fluid and may be taken 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), the physician should decide whether an additional dose should be taken to make up for it. 3) When coadministered with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after administration of 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. Long-term treatment is generally required for epilepsy. There is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to abrupt discontinuation of treatment), but 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 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 more 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 Day 1 should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years: The dose is gradually titrated over the first 3 days of treatment to a maintenance dose of 30 mg/kg/day of gabapentin, as follows. Day 1: 10 mg/kg of gabapentin; Day 2: 20 mg/kg of gabapentin; From Day 3 onward: 30 mg/kg of gabapentin. If necessary, the dose may be increased to a maximum of 40 mg/kg/day. The total daily dose of this medicine should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behavior, so patients should be closely monitored for signs of depression, mood changes, or abnormal behavior while taking it. Sudden discontinuation of the medication may worsen seizures or lead to status epilepticus, so it should be gradually tapered under a doctor's guidance. Certain animal studies have reported a potential risk of specific cancers, but the risk to humans is not yet clear. There have been reports of sudden and unexpected deaths during the course of treatment with this medication, especially in patients with epilepsy. If symptoms of pancreatitis such as persistent abdominal pain, nausea, or recurring vomiting occur, treatment should be stopped immediately and medical assistance sought. Children aged 3 years to 12 years may experience neuropsychiatric side effects such as emotional instability, aggression, decreased concentration, and hyperactivity. Taking this medication with narcotics or central nervous system depressants can cause severe drowsiness, respiratory depression, or coma, so it should only be used in the minimum necessary dosage for a short duration when needed. It should not be administered to patients with allergic reactions or hypersensitivity, acute pancreatitis, or specific types of seizures. Patients with impaired kidney function, elderly individuals, those with a history of psychosis, and women who are pregnant or may become pregnant, as well as breastfeeding mothers, should use this medication cautiously and may require dose adjustments. Side effects such as dizziness, drowsiness, memory impairment, and motor coordination difficulties may occur, so caution is necessary while driving or operating hazardous machinery. This medication can cause weight gain and vision abnormalities, so it is advisable to regularly monitor weight and eye health. Severe skin reactions or anaphylaxis (acute allergic reactions) may occur; if symptoms such as rash, fever, or difficulty breathing arise, treatment should be stopped immediately and medical assistance sought. After long-term use, abrupt discontinuation may lead to withdrawal symptoms such as anxiety, insomnia, nausea, and tremors; therefore, it should only be tapered off gradually in consultation with healthcare professionals. During pregnancy, it may affect the fetus, so if pregnancy is planned or if a woman is pregnant, consultation with a doctor prior to use is essential, and effective contraception should be used by women of childbearing potential. During breastfeeding, this medication can be excreted in breast milk and may affect the baby, so it's essential to inform a doctor about breastfeeding to make a decision on whether to use it.

• suicidal thoughts
• suicidal behavior
• depression
• abnormal mood and behavior changes
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought disturbances
• hyperactivity
• abdominal pain

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is important to keep it at cool room temperature between 1°C and 30°C.

Appearance

Yellow hard capsule containing white or grayish-white powder

Package unit

30 capsules/bottle, 100 capsules/bottle