Shinshin Gabapentin Capsule 300 Milligrams

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: 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 a starting 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, 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: 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 a starting 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, 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: 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: Administer 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 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 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), the physician should decide whether an additional dose should be taken to make up for it. 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 the 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. There is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to abrupt discontinuation of treatment); however, abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to be discontinued, or if 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 the first day of treatment should be administered at bedtime.

Child dose

Adjunctive therapy for children aged 3 to 12 years — Day 1: Administer gabapentin 10 mg/body weight (kg) Adjunctive therapy for children aged 3 to 12 years — Day 2: Administer gabapentin 20 mg/body weight (kg) Adjunctive therapy for children aged 3 to 12 years — From Day 3 onward: Administer gabapentin 30 mg/body weight (kg) Adjunctive therapy for children aged 3 to 12 years — The dose 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 is used for the treatment of epilepsy and neuropathic pain, and there may be suicidal thoughts or behavioral changes during use, so careful observation is necessary. If the medication is suddenly discontinued, seizures may worsen or lead to a persistent state of epilepsy, so it must be tapered gradually as directed by a physician. In animal studies, results related to the development of pancreatic cancer have been reported, but the risk in humans is unclear. If symptoms of hemorrhagic pancreatitis (persistent abdominal pain, nausea, recurrent vomiting) occur during use, the medication should be discontinued immediately, and a doctor should be consulted. In particular, in children aged 3 to 12, neuropsychiatric side effects such as emotional instability, hostility, cognitive abnormalities, and hyperactivity may occur, so caution is needed. Taking this medication with opioids or other central nervous system depressants can lead to severe sedation, respiratory depression, coma, and even death; therefore, when combined, it should be used at the minimum dose for the shortest duration, with close observation. It should not be administered to patients with hypersensitivity to this medication, those with acute pancreatitis, patients with certain types of seizures, or patients with genetic lactose intolerance. Patients with impaired kidney function, elderly individuals, those with a history of psychiatric disorders, children with attention deficit or behavioral disorders, pregnant women or those planning to become pregnant, and nursing mothers should exercise extra caution when using this medication. During use, symptoms such as drowsiness, dizziness, and ataxia may occur, so it is advisable to avoid driving or operating hazardous machinery. Possible side effects during use include weight gain, visual disturbances, skin rashes, allergic reactions, and in severe cases, serious skin reactions such as Stevens-Johnson syndrome; if any unusual symptoms occur, consult a healthcare professional immediately. This medication has the potential for dependency and misuse; withdrawal symptoms such as anxiety, insomnia, headaches, and depression may occur upon discontinuation, so dosing should be adjusted according to a physician's instructions. The drug is generally not used during pregnancy due to potential risks to the fetus; women of childbearing age should use effective contraception while taking this medication. Since this medication is secreted in breast milk, nursing mothers should decide on its use after consulting with their doctor. This medication can interact with other drugs, so patients should inform their physician of all medications they are taking and their health status. Store this medication out of the reach of children and keep it in the original container to ensure safe use.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought disorders
• hyperactivity
• weakness

This medication may be sensitive to air or moisture, so it must be stored in a sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius in a cool and dry place. This will help preserve the efficacy of the medication for a longer duration.

Appearance

Hard capsule in yellowish-brown, containing white to off-white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle