Shinil Gabapentin Capsule 100 mg

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, 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 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, 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; 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. Debilitated patients: In debilitated patients with low body weight or patients after transplant surgery, 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 of 80 mL/min or less) 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: Administer 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 hemodialysis patients 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 taken with or without food. When administered 3 times daily, ensure 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 more than 12 hours have elapsed since the last dose), whether to administer an additional dose to make up for the missed dose should be determined by the physician. 3) When used concomitantly with antacids containing magnesium or aluminum, administer this drug at least 2 hours after the antacid. This can substantially reduce the decrease in 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 (an increase in seizure frequency due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to 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, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be administered at bedtime.

Child dose

1) Adjunctive therapy in children aged 3 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 onward: Administer gabapentin 30 mg/kg of body weight The dose may be increased as needed 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 increase the risk of suicidal thoughts or behaviors and mental health issues such as depression, thus patients and caregivers should immediately inform healthcare providers if any mood or behavioral changes occur. This medication should not be abruptly discontinued, as it may increase the frequency of seizures or progress to status epilepticus. Therefore, the dosage must be gradually adjusted according to the physician's instructions. Some animal studies have reported a potential for certain cancers; however, there is no definitive evidence that this medication causes cancer in humans. Some reports of sudden and unexpected deaths have occurred during the use of this medication, but these fall within the general risk range for patients with epilepsy. In rare cases, severe pancreatitis may occur in patients taking this medication; if continuous abdominal pain, nausea, or repetitive vomiting occurs, the patient should immediately discontinue the medication and seek medical attention. In children aged 3 to 12 years, signs of neuropsychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may occur, so careful observation is required. If taken with central nervous system depressants, including narcotics, this medication can cause severe drowsiness, respiratory depression, coma, or death, thus such drugs should only be used concomitantly at the lowest effective dose for the shortest duration as advised by a physician. Patients with hypersensitivity to this medication, acute pancreatitis, certain types of seizures, or genetic lactose intolerance should not take this medication. Patients with impaired renal function, the elderly, those with a history of psychosis, children with attention deficit or behavioral disorders, pregnant or potentially pregnant women, and nursing mothers should use this medication cautiously and determine whether to use it in consultation with a physician. During treatment, symptoms such as dizziness, drowsiness, and decreased concentration may occur, so caution should be exercised when driving or operating hazardous machinery. Additionally, sudden discontinuation of this medication may result in withdrawal symptoms such as anxiety, insomnia, nausea, and tremors, so it must be tapered off gradually in consultation with healthcare providers. Finally, it is important to keep this medication out of the reach of children, store it in its original container, and not transfer it to other containers arbitrarily.

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

This medication must be stored in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. By storing it this way, the medication's effectiveness can be safely maintained.

Appearance

A white to off-white powder in a white hard capsule.

Package unit

30 capsules/bottle, 100 capsules/bottle