Gatin Capsule (Gabapentin)

Adult dose

Monotherapy and adjunctive therapy in patients aged 13 years and older To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine may be administered 3 times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day as gabapentin; the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine may be administered 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day as gabapentin within one week; the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this medicine should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose should be increased in 100 mg increments. Elderly patients: Dose adjustment may be necessary due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is required based on the following table. 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 <15 mL/min, the dose should be reduced in proportion to creatinine clearance. 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; do not administer this medicine on days when hemodialysis is not performed. This medicine 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. If a dose of this medicine is missed (if 12 hours or more have elapsed since the last dose), whether an additional dose should be taken to make up for it should be determined by a physician. When administered concomitantly with antacids containing magnesium or aluminum, this medicine should be taken at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. The duration of treatment with this medicine 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 sudden discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine 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. The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. 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 through 12 years — To achieve a maintenance dose of gabapentin 30 mg/day per kg of body weight, titrate over the first 3 days of treatment as follows. - Day 1: Administer gabapentin 10 mg/body weight (kg) - Day 2: Administer gabapentin 20 mg/body weight (kg) - From Day 3: Administer gabapentin 30 mg/body weight (kg) If necessary, the dose may be increased up to a maximum of 40 mg per kg of body weight per day. When administering this medicine, divide the total daily dose into 3 doses.

This medication may increase the risk of suicidal thoughts or behavior during treatment, so patients and caregivers should notify a doctor immediately if these symptoms, depression, or mood changes occur. Stopping this medication suddenly may lead to more frequent seizures or status epilepticus, so it should be discontinued gradually under a doctor's guidance. If symptoms of pancreatitis such as persistent abdominal pain, nausea, or recurrent vomiting occur, discontinue use of this medication and consult a healthcare professional immediately. Emotional instability, aggressive behavior, impaired concentration, and hyperactivity may occur in pediatric patients, so caution is advised. Severe drowsiness, respiratory depression, or coma may occur if this medication is taken with other central nervous system depressants, especially opioids, and such combinations require strict medical supervision. If allergic reactions, skin rashes, or severe skin conditions (such as Stevens-Johnson syndrome) occur, discontinue use immediately and visit a hospital. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication and should avoid using it during pregnancy if possible. If breastfeeding, consult a doctor about the possibility of this medication being excreted in breast milk. This medication may cause dizziness, drowsiness, or ataxia, so it is advisable to avoid activities requiring alertness, such as driving or operating machinery, during the initial period of taking the medication or when symptoms occur. Patients with impaired kidney function may need to adjust the dosage, and elderly patients may be more susceptible to side effects, requiring close observation. Regular checks of weight and eye health are advised during use of this medication, and any unusual symptoms should be discussed with a healthcare professional immediately. Adhere strictly to the prescribed dosage and dosage interval, and do not discontinue or increase the dosage arbitrarily.

suicidal thoughts, suicidal behavior, depression, emotional instability, hostility, abnormal thinking, hyperkinesia, abdominal pain, low back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hyperreactivity, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, fatigue, facial edema, hypertension, abdominal distension, anorexia, gingivitis, arthralgia, dizziness, hyperkinesia, reflex changes, sensory disturbances, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of symptoms, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, traumatic injury, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory impairment, drowsiness, abnormal thinking, tremor, vertigo, dyspnea, rash, tongue paralysis, increased blood creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, paroxysmal muscle spasm, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensations, fatigue

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to preserve its efficacy.

Appearance

A hard capsule with yellowish-brown color containing white or grayish-white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle