Neupentin 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 drug once daily, or one 100 mg capsule of this drug 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this drug 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 drug once daily, or one 100 mg capsule of this drug 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this drug may be administered 3 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 administering this drug, the total daily dose should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients following transplant surgery, the gabapentin dose should be increased in 100 mg increments. 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) Dose 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 below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dose for patients on 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 drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) This drug should be swallowed whole with sufficient 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 drug is missed (if more than 12 hours have elapsed since the most recent dose), the decision on whether to administer an additional dose to make up for the missed dose should be made by the physician. 3) When used concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this drug. 4) The duration of administration of this drug 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 this drug is to be discontinued or administered 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 more 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 years to 12 years Titrate gradually over the first 3 days of treatment as follows to achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight. - Children aged 3 years to 12 years, Day 1: Administer 10 mg/kg of body weight of gabapentin - Children aged 3 years to 12 years, Day 2: Administer 20 mg/kg of body weight of gabapentin - Children aged 3 years to 12 years, from Day 3 onward: Administer 30 mg/kg of body weight of gabapentin The dose may be increased, if necessary, up to a maximum of 40 mg per kg of body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors, so if symptoms of depression or changes in mood and behavior occur during treatment, it is important to consult a doctor immediately. Abrupt discontinuation may lead to worsening seizures or progression to status epilepticus, thus dosage should be reduced gradually under a doctor's guidance. This medication can cause serious side effects such as pancreatitis, so if persistent upper abdominal pain, nausea, or vomiting occurs, discontinue use immediately and visit a hospital. Particularly when administered to children, there may be neurological and psychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity, requiring careful monitoring. This medication can cause drowsiness, dizziness, and movement disorders, so it is advisable to avoid driving or operating dangerous machinery. When combined with central nervous system depressants including narcotics, there is a risk of severe sedation or respiratory depression, so it should only be used together after consulting a doctor. Patients with impaired kidney function or the elderly may require dosage adjustments, and if allergic reactions or severe skin rashes occur, discontinue and visit a medical institution immediately. Women who are pregnant or planning to become pregnant should consult a doctor before taking it as it may affect the fetus, and breastfeeding women should also use it cautiously. This medication contains lactose, thus patients with lactose intolerance or related genetic conditions should not take it. During treatment, weight gain, visual disturbances, gastrointestinal symptoms, etc. may occur, so regular check-ups and monitoring are required. Take this medication exactly as prescribed, and inform your doctor if you are taking any other medications or alcohol.

Suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, status epilepticus, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, deep sedation, respiratory depression, coma, death, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fracture, myalgia, amnesia, ataxia, confusion, impaired cooperation, dizziness, speech disorder, insomnia, neurogenic response, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, bloating, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, increased reflex movements, decreased reflex movements, absence of reflex movements, sensory abnormalities, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of signs, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injury due to accidents, cold syndrome, infection, pain, dry mouth, abnormal gait, confusion, sensory loss, ataxia, tremors, vertigo, shortness of breath, blood coagulation disorders, rash, myasthenia, lethargy, facial edema, allergy, systemic edema, weight loss, chills, unusual sensations, weakness, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, glossitis, gingival bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, angular cheilitis, sialadenosis, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, hypoestrogenism, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint hypertrophy, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, confusion, depression, neuroexcitability, perceptual disturbances, insomnia, neuropathy, decreased libido, anxiety, depersonalization, reduced reflexes, speech disorders, dream disturbances, speech disorders, emotional instability, stupor, perioral sensory disturbances, abnormal euphoria, sensory hypersensitivity, decrease in motor function, suicide attempts, agitation, tension, increased libido, movement disorders, myoclonus, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, pulmonary abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, urinary tract infection, urination disorders, erectile dysfunction, urinary incontinence, vulvovaginitis, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation disorders, penile enlargement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, elevated serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, 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, and finally palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication can be sensitive to air and moisture, so it should be stored in a sealed container. It is also safe to store at a temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain its efficacy.

Appearance

A hard capsule with yellow-orange upper and lower parts containing white or grayish white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle