Gabatin Capsule 400 Milligrams (Gabapentin)

Adult dose

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 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 2 times 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 an initial 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 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.) 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 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 2 times 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 an initial 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 of gabapentin within one week; the total daily dose must not exceed 3,600 mg of 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: Creatinine clearance (mL/min) ≥80: Total daily dose 900∼2,400 (mg/day) Creatinine clearance (mL/min) 50∼79: Total daily dose 600∼1,800 (mg/day) Creatinine clearance (mL/min) 30∼49: Total daily dose 300∼900 (mg/day) Creatinine clearance (mL/min) 15∼29: Total daily dose 150b∼600 (mg/day) Creatinine clearance (mL/min) <15: Total daily dose 150b∼300 (mg/day) a: The total daily dose should be divided into 3 doses. b: A dose of 3 × 100 mg should be administered every 2 days. For patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. Dosage for patients receiving hemodialysis Initial dose: Gabapentin 300∼400 mg is recommended. Maintenance dose: Administer gabapentin 200∼300 mg 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, ensure that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. If a dose of this medicine 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 the missed dose. When this medicine is taken concomitantly with antacids containing magnesium or aluminum, administer this medicine 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. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine is to be discontinued or another antiepileptic drug is to be used concomitantly, the change should be made gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain for more 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 administered at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years: Titrate over the first 3 days of treatment to achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight. Day 1: Administer 10 mg/kg of body weight of gabapentin; day 2: Administer 20 mg/kg of body weight of gabapentin; from day 3 onward: Administer 30 mg/kg of body weight of gabapentin. If necessary, the dose may be increased to a maximum of 40 mg/kg of body weight per day. When administering this drug, divide the total daily dose into 3 doses.

This drug may increase the risk of suicidal thoughts or behaviors, and if mood or behavioral changes occur while taking it, consult a doctor immediately. Discontinuing the drug suddenly may lead to more frequent seizures or severe episodes; therefore, dosage should be reduced gradually according to a doctor's instructions. Long-term use may cause side effects such as weight gain or vision disturbances, so it is important to have regular check-ups. Particularly in children aged 3 to 12, symptoms such as emotional instability, aggression, decreased concentration, and hyperactivity may occur, necessitating caution. When taken with other central nervous system depressants, including narcotics, severe drowsiness, respiratory depression, and coma may occur; therefore, consultation with a doctor before concurrent use is necessary. Patients with poor kidney function or the elderly may require dosage adjustments, thus they must consult healthcare personnel before taking the medication. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication as it may affect the fetus; caution is also advised during breastfeeding. This drug may cause allergic reactions or severe skin reactions (e.g., rash, fever, lymph node swelling), so if unusual symptoms occur, discontinue use immediately and inform a doctor. Dizziness or drowsiness may occur during use, so it is advisable to avoid driving or operating dangerous machinery. Overdosage may lead to a decrease in consciousness or coma, so the prescribed dosage and regimen must be strictly followed. Finally, this drug has potential for dependence or abuse; therefore, do not change or discontinue the dosage arbitrarily without a doctor's advice.

Suicidal impulses, suicidal behavior, depression, abnormal mood and behavioral changes, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbance, hyperactivity, weakness, fatigue, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, indigestion, increased appetite, dry mouth, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, dyscoordination, dizziness, dysarthria, insomnia, neurotic reactions, nystagmus, drowsiness, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, injury due to accident, cold syndrome, infection, pain, xerostomia, distension, gait abnormalities, confusion, sensory loss, trembling, vertigo, dyspnea, pneumonia, hair loss, hives, thrombocytopenia, tinnitus, incontinence, anxiety, suicide attempt, hallucinations, hallucinatory state, mental disorder, chorea, anaphylaxis, angioedema, hypotension, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash, elevated liver function tests, hepatitis, generalized edema, gynecomastia, sexual dysfunction, thrombocytopenia, withdrawal symptoms (anxiety, insomnia, nausea, pain, sweating, trembling, headache, depression, abnormal sensations, fatigue)

This medication may be sensitive to air or moisture; therefore, it must be stored in a tightly sealed container. It is important to maintain a room temperature between 1 to 30 degrees Celsius to preserve the drug's effectiveness.

Appearance

Hard yellow capsules containing white or gray-white powder or granules

Package unit

30 capsules/bottle, 100 capsules/bottle