Megabitin Capsule 100 milligrams (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: Take one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day) - Day 2: Take one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) - From Day 3: Take one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this drug may be taken three 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.) 3) The duration of treatment should be determined according to clinical need. Long-term treatment is generally required for epilepsy. There is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to sudden discontinuation of treatment); however, sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug must be discontinued, or if it is used in combination 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: Take one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day) - Day 2: Take one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) - From Day 3: Take one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this drug may be taken three times daily as the starting dose (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 drug, the total daily dose should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, increase the dose of this drug in increments of 100 mg. 4. Elderly patients: Dose 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: Dose 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 hemodialysis patients 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) Swallow this drug whole with plenty of fluid. It may be taken with or without food. When administering 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 (more than 12 hours have passed since the last dose), whether to take an additional dose to make up for it should be determined by the physician. 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 be determined according to clinical need. If the dose of this drug 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 necessary at the prescriber's discretion). 5) To reduce the main adverse effects, such as drowsiness, dizziness, fatigue, and ataxia, the first dose on the first day should be taken at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years to 12 years To achieve a maintenance dose of 30 mg/kg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows. - Age 3 years to 12 years: On Day 1, administer gabapentin 10 mg/kg body weight. - Age 3 years to 12 years: On Day 2, administer gabapentin 20 mg/kg body weight. - Age 3 years to 12 years: From Day 3, administer gabapentin 30 mg/kg body weight. Age 3 years to 12 years: 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 medication is used to treat epilepsy and may increase the risk of suicidal thoughts or behaviors in patients; therefore, patients and caregivers should immediately inform healthcare providers if mood changes or unusual actions occur. Sudden discontinuation of the medication may result in more frequent seizures or worsening of the epileptic state; therefore, it is essential to taper off the medication slowly according to the physician’s instructions. Although some animal studies have reported a risk of pancreatic cancer, the risk in humans is still unclear. If symptoms of pancreatitis occur, such as persistent upper abdominal pain, nausea, or recurrent vomiting, the medication should be discontinued immediately, and medical consultation is necessary. Children aged 3 to 12 years may experience central nervous system side effects, including emotional instability, aggression, decreased concentration, and hyperactivity. Co-administration of this drug with central nervous system depressants, such as narcotics, may lead to severe drowsiness, respiratory depression, coma, and potentially death, so extreme caution is required in such combinations, with strict supervision by healthcare providers. This medication should not be used in patients with certain genetic disorders (e.g., galactose intolerance), acute pancreatitis, or specific types of seizures. Patients with impaired kidney function, elderly patients, those with a history of mental disorders, pregnant women, or women planning pregnancy require special precautions when using this medication. Drowsiness, dizziness, or decreased attention may occur while taking this medicine, thus activities such as driving or operating hazardous machinery should be avoided, especially when starting the medication. Use during pregnancy may affect the fetus; therefore, women who are pregnant or planning to become pregnant should discuss this with their doctor for careful consideration. This drug may affect nursing infants, so breastfeeding women should consult their doctor and may need to discontinue breastfeeding if necessary. If any abnormal symptoms or side effects occur during treatment, immediate consultation with a healthcare provider is necessary for appropriate action. There may also be the potential for drug dependence and withdrawal symptoms, so discontinuation should not be done arbitrarily. This medication should be kept out of reach of children and stored in its original container to prevent misuse and degradation of quality.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, apathy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fracture, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neurovegetative reaction, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, apathy, facial edema, allergy, generalized edema, weight loss, chills, strange feelings, lethargy, alcohol intolerance, hangover effect, hypotension, angina pectoris, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular ectopy, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, bloating, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, angular cheilitis, sialadenitis, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushingoid appearance, purplish spots like bruises due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumor, syncope, sleep disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or loss of libido, irritability, schizophrenia, depersonalization, dysphoria, hypersensitivity, hallucination state, suicidal ideation, psychiatric disorders, chorea, athetosis, orofacial movement disorders, brain disorders, neuropathy, personality disorder, increased libido, substance inhibition, ideomotor apraxia, fine motor control disorders, meningitis, focal myoclonus, perceptual hypersensitivity, motor function deficit, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleed, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal polyp, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal detachment, maceration, skin nodules, subcutaneous nodules, acanthosis, skin necrosis, localized swelling, hematuria, urination disorders, hyper urine, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularity, menorrhagia, breast cancer, anovulation, ejaculatory dysfunction, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, enuresis, pyuria, urgency, vaginismus, mastalgia, testalgia, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disturbances, eye twitching, swelling of the eye, eye itching, accommodation disorders, tympanic membrane perforation, noise sensitivity, eye focal abnormalities, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal system dysfunction, eye degeneration, blindness, retinal degeneration, miosis, chorioretinitis, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disturbances, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, prodromal symptoms lost, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injuries due to accidents, cold syndrome, infection, pain, dry mouth, bloating, gait abnormalities, ataxia, confusion, sensory loss, tremors, vertigo, dyspnea, bronchitis, respiratory infection, chest pain, soft tissue inflammation, neck pain, allergic reactions, abscess, chills, chills and fever, mucosal abnormalities, body odor, cysts, hernia, abnormal BUN levels, neck mass, pelvic pain, sepsis, viral infections, syncope, congestive heart failure, increased capillary fragility, phlebitis, varicosities, oral candidiasis, increased liver function tests, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcer, fecal incontinence, increased gamma-glutamyl transpeptidase, lymphoid reactions, decreased prothrombin, edema, gout, hypoglycemia, weight loss, increased alkaline phosphatase, diabetic ketoacidosis, increased lactate dehydrogenase, arthritis, arthrosis, leg cramps, myasthenia gravis, shin pain, joint disorders, tendon disorders, neuropathy, decreased libido, speech disorders, dysarthria, stupor, sensory disturbances around the mouth, dysphoria, suicide attempt, restlessness, increased tension, movement disorders, myoclonus, vestibular dysfunction, increased cough, sinusitis, asthma, pulmonary disorders, nasal bleeding, hemoptysis, degeneration, skin ulcers, fungal dermatosis, furunculosis, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinoma, skin thickening, ear pain, eye abnormalities, taste disorders, hearing loss, conjunctival congestion, diabetic retinopathy, ocular pain, microhemorrhages in the fundus, retinal vein thrombosis, taste loss, urinary tract infections, urination disorders, vaginal candidiasis, mastalgia, polyuria, urinary retention, cystitis, ejaculatory dysfunction, penile swelling, gynecomastia, nocturia, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, increased liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity with systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, movement disorders, dystonia, myoclonus, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a sealed container to be protected from air and moisture, and it is safe to store at room temperature between 1 and 30 degrees Celsius.

Appearance

Hard capsules with white or light gray powder inside, with a white upper and lower part.

Package unit

30 capsules/bottle, 300 capsules/bottle