Shinshin 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, as an initial dose, one 300 mg capsule of this drug may be administered 3 times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin, but 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, as an initial dose, one 300 mg capsule of this drug may be administered 3 times daily (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. Frail patients: In frail patients with low body weight or patients who have undergone 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 ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is necessary 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 <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, 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 an adequate amount 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. 2) If a dose of this drug is missed (if more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be administered to make up for the missed dose. 3) When used 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 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 (increased frequency of epileptic seizures due to sudden discontinuation of treatment), but 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, 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 administered at bedtime.

Child dose

2) Adjunctive therapy for children aged 3 to 12 years - Day 1: Administer gabapentin 10 mg/body weight (kg) - Day 2: Administer gabapentin 20 mg/body weight (kg) - From Day 3 onward: Administer gabapentin 30 mg/body weight (kg) The maintenance dose is 30 mg/day of gabapentin per kg of body weight and may be increased, as needed, up 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 and behaviors; therefore, if mood changes or abnormal behaviors occur during treatment, it is crucial to inform your healthcare provider immediately. Abruptly stopping this medication may result in more frequent seizures or serious epileptic conditions, so it must be tapered slowly as instructed by your doctor. If symptoms of pancreatitis, such as persistent upper abdominal pain, nausea, or repeated vomiting occur, discontinue use and seek medical attention immediately. Exercise caution when administering this medication to children aged 3 to 12, as it may cause adverse neuropsychiatric reactions such as emotional instability, aggression, decreased concentration, and hyperactivity. Taking this medication with narcotics or central nervous system depressants can cause serious side effects such as sedation, respiratory depression, and coma; therefore, it should only be used in minimal doses for short durations under strict medical supervision when absolutely necessary. Patients with hypersensitivity to this medication, acute pancreatitis, certain types of seizures, or genetic lactose intolerance should not take this medication. Patients with reduced kidney function, the elderly, those with a history of psychosis, children with attention deficit or behavioral disorders, pregnant or nursing women should use this medication cautiously; especially pregnant women should consider the risks to the fetus when deciding on its use. Side effects such as dizziness, drowsiness, movement disorders, memory impairment, and depression may occur during use, so caution is advised when driving or operating hazardous machinery. Sudden discontinuation after long-term use can result in withdrawal symptoms such as anxiety, insomnia, nausea, and headaches; thus, the dosage should be gradually reduced as directed by your physician. Various side effects such as weight gain, vision changes, skin rashes, and blood disorders have been reported with this medication, and if any abnormal symptoms arise, immediate consultation with a doctor is required. Use during pregnancy may affect the fetus; therefore, women planning to become pregnant or who are pregnant should consult their healthcare provider, and nursing mothers should also exercise careful judgment prior to use. Store this medication out of reach of children and keep it in the original container, as transferring it to another container increases the risk of misuse or quality deterioration.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

An opaque white or off-white hard capsule containing powder

Package unit

30 capsules/bottle, 100 capsules/bottle