Gabapentin Capsule 300 mg (Gabapentin)

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 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, one 300 mg capsule of this medicine 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 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, one 300 mg capsule of this medicine may be administered 3 times daily as the starting dose (gabapentin 900 mg/day). If needed, 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 medicine should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplantation, the gabapentin dose should be increased in increments of 100 mg. 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 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 medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine should be swallowed whole with plenty of fluid and may be administered 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 to prevent recurrence of seizures. 2) 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 it. 3) When administered concomitantly with antacids containing magnesium or aluminum, this medicine should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. 4) The duration of treatment with this medicine should be based 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 abrupt 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 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

2) 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: Administer gabapentin 30 mg/kg of body weight. The dose may be increased, as needed, up to a maximum of 40 mg per kg of body weight per day. Divide the total daily dose into 3 doses.

This medication is an antiepileptic drug that may increase the risk of suicidal thoughts or behaviors and mental health issues such as depression during treatment. Therefore, patients and guardians should immediately inform healthcare providers if such symptoms occur. Abruptly discontinuing this medication can worsen seizures or lead to a prolonged epileptic state, so the dosage should be gradually reduced as directed by a physician. Serious side effects like pancreatitis may occur; therefore, if persistent upper abdominal pain, nausea, or repeated vomiting occurs, take this medication immediately and seek hospital treatment. When administering to children, monitor for behavioral changes, emotional instability, aggression, decreased attention, or hyperactivity, as these neurological and psychiatric side effects may arise. Concurrent use with narcotics or central nervous system depressants can cause severe drowsiness, respiratory depression, or coma, so it is essential to follow a doctor's instructions carefully. In case of symptoms of an allergic reaction or severe skin rash, breathing difficulties, or swelling of the lips or tongue, discontinue use immediately and seek emergency treatment. Women who are pregnant or planning pregnancy must consult a physician before administration due to risks to the fetus, and caution is also needed for breastfeeding women. Elderly patients or those with reduced renal function should follow the dosage adjustments as directed by a physician. This medication may cause dizziness, drowsiness, or coordination issues at the beginning of treatment or when changing dosages, so driving or operating hazardous machinery should be avoided. Weight gain may occur during treatment, so regular weight monitoring and dietary or exercise adjustments may be necessary. Always adhere to the prescribed dosage and consult healthcare professionals immediately if any concerning symptoms arise.

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbance, hyperactivity, abdominal pain, low back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disturbance, insomnia, neurotic response, nystagmus, drowsiness, thought disturbance, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, abdominal distension, decreased appetite, gingivitis, arthralgia, dizziness, hyperactivity disorder, reflex movement changes, sensory disturbances, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, drowsiness, hostility, emotional instability, hyperactivity disorder, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of signs, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory reduction, tremors, vertigo, dyspnea, rash, suicidal ideation, suicidal behavior, tongue paralysis, anaphylaxis, angioedema, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, 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, muscular hypertrophy syndrome, palpitations, pancreatitis, sexual dysfunction, skin and mucosal syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, depression, abnormal sensations, lethargy

Store this medication in a tightly closed container to protect it from air and moisture, preferably at room temperature between 1 and 30 degrees Celsius. This storage maintains the medication's effectiveness over time and prevents deterioration.

Appearance

A hard capsule with a yellowish color containing white or grayish powder

Package unit

30 capsules/bottle, 200 capsules/bottle