Megabatin 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 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 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.) 3) The duration of treatment should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in the 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 must be discontinued, or if it is administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) 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 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 of gabapentin within one week, and the total daily dose must not exceed 3,600 mg of gabapentin. When taking this medicine, the total daily dose should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, the dose of this medicine should be increased in 100 mg increments. 4. Elderly patients: Dose adjustment may be necessary due to age-related decline in renal function. 5. Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients receiving hemodialysis: Dose adjustment is necessary based on the following table. 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) Dose 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. 6. Method and duration of administration 1) Swallow this medicine whole with an adequate amount of fluid. It 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 medicine is missed (i.e., 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 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. 4) The duration of treatment with this medicine should depend on clinical need. If the dose of this medicine is reduced, treatment is discontinued, or the patient is switched to another alternative medication, this should be done gradually over at least 1 week (a longer period may be required at the prescriber's discretion). 5) 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

2) Adjunctive therapy in children aged 3 years to 12 years Day 1: Administer gabapentin 10 mg/kg body weight. Day 2: Administer gabapentin 20 mg/kg body weight. From Day 3: Administer gabapentin 30 mg/kg body weight. The dose may be increased, if needed, up to a maximum of 40 mg/kg body weight per day. The total daily dose of this drug should be divided into 3 doses.

This drug is used as an anticonvulsant, and there is a risk of increased suicidal thoughts or behaviors, so the patient's mood or behavioral changes should be closely monitored during treatment. Abrupt discontinuation of the medication may worsen seizures or put the patient at risk of status epilepticus, so it must be tapered off gradually according to a doctor's instructions. Some potential for tumor occurrence has been reported in animal studies, but the risk in humans is unclear, warranting caution. While there have been reports of sudden and unexpected death during treatment with this drug, this is believed to be related to the risk of epilepsy itself. If severe pancreatitis symptoms, such as hemorrhagic pancreatitis, occur, discontinue the medication immediately and consult a healthcare professional. Children aged 3 to 12 years may experience central nervous system adverse reactions, so caution is especially warranted as behavioral changes or hyperactivity have been reported. When taken with central nervous system depressants, including narcotics, there is a risk of sedation or respiratory depression, thus requiring careful management in such cases. This drug should not be administered to patients with hypersensitivity or acute pancreatitis, specific seizure types, or lactose intolerance. Patients with renal impairment, elderly patients, those with a history of psychosis, pregnant or potentially pregnant women, and nursing mothers require special attention when prescribed this medication. Drowsiness, dizziness, and ataxia may occur during treatment, so caution is necessary when driving or operating hazardous machinery. During pregnancy, there is a potential risk to the fetus, so women planning to become pregnant should discuss use with their healthcare provider before taking the medication. Nursing mothers should consult their doctor about breastfeeding since this medication may be secreted in milk. It is important to adhere to the prescribed dosage and regularly monitor weight and health status as directed by the doctor and report any abnormal symptoms immediately. This medication should be stored out of reach of children and kept in its original container to prevent misuse or degradation of quality.

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disturbances, insomnia, neuroleptic malignant syndrome, nystagmus, drowsiness, thought disorder, tremor, clonus, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, hypertension, anorexia, gingivitis, arthralgia, dizziness, hyperactivity, increased reflex activity, decrease or absence of reflexes, sensory abnormalities, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, viral infection, fever, drowsiness, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of signs, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, distension, gait abnormalities, confusion, sensory loss, tremor, vertigo, dyspnea, rash, thought disorder, vertigo, hematuria, urination disorder, frequency, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, anorgasmia, ejaculation disorders, neurogenic symptoms, weight gain, suicidal thoughts, suicidal behavior, anxiety, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensations, lethargy, confusion, loss of consciousness, mental disorders, Stevens-Johnson syndrome, 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, skeletal muscle spasm, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, incontinence, tongue paralysis, anaphylaxis, angioedema

This drug must be kept in a tightly sealed container to prevent exposure to air and moisture. It is recommended to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance

Opaque hard capsules with a yellowish-orange color containing a white or light gray powder

Package unit

30 capsules/bottle, 100 capsules/bottle