Canagabartin Capsules 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 gradually 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: 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, instead of the above regimen, one 300 mg capsule of this drug 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.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day of gabapentin, titrate gradually 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: 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, instead of the above regimen, one 300 mg capsule of this drug 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 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 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 of 80 mL/min or less) or patients undergoing hemodialysis: Dose adjustment is required based on the following table. 1) Dose 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) Dose 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 administered with or without food. When administered 3 times daily, care should be taken to ensure that the interval between doses is not more than 12 hours in order 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), the physician should decide whether an additional dose should be administered to make up for it. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. 4) The duration of administration of 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 due to 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 administered concomitantly 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 the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years: To achieve a maintenance dose of 30 mg/day per kg body weight of gabapentin, titrate gradually over the first 3 days of treatment as follows. - Day 1: administer 10 mg/kg body weight of gabapentin - Day 2: administer 20 mg/kg body weight of gabapentin - From Day 3: administer 30 mg/kg body weight of gabapentin. If necessary, the dose may be increased up to a maximum of 40 mg/kg body weight per day. When administering this medicine, the total daily dose should be divided into 3 doses.

This drug, used for treating epilepsy, may increase suicidal thoughts or behavior, so patients and caregivers should carefully observe for these symptoms. If the medication is suddenly stopped, there is a risk of increased seizure frequency or progression to prolonged seizures, so it should be gradually reduced according to a doctor's instructions. In some animal studies, the possibility of certain cancers has been reported, but the risk in humans is not clear. There have been reports of sudden and unexpected death during treatment, which may be associated with the risk of epilepsy itself, and the exact cause is not certain. If symptoms of pancreatitis, such as persistent upper abdominal pain, nausea, or repeated vomiting occur, discontinue the medication immediately and consult a doctor. In children aged 3 to 12, there may be central nervous system adverse reactions such as emotional instability, aggression, abnormal thoughts, and hyperactivity, so caution is required. Taking this drug with narcotics or other central nervous system depressants can result in severe sedation, respiratory depression, coma, and the risk of death, thus should be used only under strict supervision of a physician at the minimum dosage for a short duration. This drug is not administered to patients with hypersensitivity, acute pancreatitis, certain types of seizures, and lactose intolerance. Patients with impaired kidney function, the elderly, those with a history of psychiatric disorders, children with attention deficit disorders, pregnant and breastfeeding women should use this medication with caution, considering the risks to the fetus during pregnancy. Several adverse reactions such as dizziness, drowsiness, movement disorders, memory impairment, depression, and skin rashes may occur; severe symptoms should prompt consultation with a doctor. This medication may impair the ability to drive or operate dangerous machinery, thus it is recommended to avoid such activities during the initial phase of treatment. Always take this medication exactly as prescribed, do not stop or change the dose arbitrarily, and notify healthcare providers about potential interactions with other medications or alcohol while on treatment. This drug can cause serious side effects, including weight gain, vision disturbances, mood changes, and severe skin reactions, thus regular check-ups and monitoring are necessary. When discontinuing this medication, withdrawal symptoms (anxiety, insomnia, nausea, tremors, etc.) may appear so it should be gradually reduced under a physician's direction. Store this drug out of the reach of children and keep it in its original container to prevent misuse or degradation in quality.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought disorder
• hyperactivity
• lethargy

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Yellow capsules containing a white or light gray powder or granules.

Package unit

30 capsules/bottle, 100 capsules/bottle