Neugatin M Capsule 300mg (Gabapentin)

Adult dose

Epilepsy 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 three 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 three times daily (gabapentin 600 mg/day) From Day 3 onward: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medicine may be administered 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.) 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 three 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 three times daily (gabapentin 600 mg/day) From Day 3 onward: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medicine may be administered 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. The total daily dose of this medicine should be divided into 3 doses. The safety and efficacy of treatment of neuropathic pain for periods longer than 5 months have not been evaluated. Frailty: In frail patients with low body weight or patients following transplant surgery, the dose of this medicine 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: 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. Dosage 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; do not administer this medicine on days when hemodialysis is not performed. This medicine should be swallowed whole with sufficient fluid and may be taken with or without food. When administered 3 times daily, to prevent recurrence of seizures, ensure that the interval between doses does not exceed 12 hours. If a dose of this medicine is missed (more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be taken to make up for the missed dose. When used 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 be based on clinical need. If the dose of this medicine is reduced, treatment is discontinued, or the medicine is switched to another alternative, this should be done gradually over at least 1 week (a longer period may be required at the prescriber's discretion). To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years: To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate stepwise over the first 3 days of treatment as follows. 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. The dose may be increased to a maximum of 40 mg per kg of body weight per day as needed. The total daily dose of this medicine should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behavior, so any changes in mood or symptoms of depression should be reported to a healthcare professional immediately during treatment. Abruptly discontinuing this medication may cause seizures to occur more frequently or worsen severe epilepsy status, so it should be tapered off gradually under a doctor's guidance. Long-term use may lead to weight gain, so it is advisable to monitor weight regularly and, if necessary, complement it with diet and exercise. This medication can cause neurological side effects such as dizziness, drowsiness, and coordination disorders, so it is safest to avoid driving or operating dangerous machinery in the early stages of treatment. Taking this medication with central nervous system depressants or narcotic analgesics can intensify side effects such as drowsiness or respiratory depression; therefore, dose adjustments and careful monitoring are necessary if such medications are taken concurrently. Patients with impaired kidney function may experience slower excretion of this medication, so dosage adjustments are required, and they should follow their doctor's directions. Pregnant women or those planning pregnancy should consult a doctor before taking this medication, and its use during pregnancy should be avoided if possible. Breastfeeding women need to discuss with their doctor regarding breastfeeding since this medication may be secreted in breast milk. Individuals with hypersensitivity to this medication, acute pancreatitis patients, and those with certain genetic lactose intolerance should not take it. If persistent abdominal pain, nausea, vomiting, or other symptoms of pancreatitis occur during treatment, medication should be discontinued immediately, and medical personnel should be notified. Any unusual skin rashes, fever, or lymph node swelling during treatment may indicate a serious allergic reaction, necessitating immediate consultation with medical personnel. When discontinuing the medication, do not stop suddenly; taper the dosage gradually under a doctor's direction as withdrawal symptoms such as anxiety, insomnia, and tremors may occur.

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, lethargy, 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, irritability, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, injuries caused by accidents, cold syndrome, pain, dry mouth, gait abnormality, confusion, sensory loss, thought disorder, trembling, vertigo, dyspnea, blood clotting abnormalities, loss of warning signs, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, allergy, generalized edema, weight loss, chills, foreign body sensation, asthenia, alcohol intolerance, hangover effects, hypotension, angina pectoris, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, premature ventricular contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased saliva secretion, gastroenteritis, hemorrhoids, melena, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, sialadenosis, lip bleeding, esophagitis, hiatus hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushingoid appearance, ecchymosis due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, abscess, contracture, confusion, depression, irritability, sensory disorders, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorders, dream disorders, dysarthria, emotional instability, nystagmus, stupor, perioral sensory disorders, unusual euphoria, hypersensitivity, decreased motor function, suicide attempt, restlessness, hypertonia, increased libido, movement disorders, muscle spasms, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung 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, papular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, urinary tract infections, urination disorders, erectile dysfunction, urinary incontinence, vaginal schistosomiasis, breast pain, menstrual abnormalities, polyuria, urinary retention, cystitis, ejaculation disorders, penile swelling, gynecomastia, enuresis, pyelonephritis, scrotal swelling, frequency of urination, urgent urination, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, 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, convulsions, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensation, lethargy

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to ensure the long-term effectiveness and safety of the medication.

Appearance

Hard capsule with yellowish-brown upper and lower parts containing white or grayish-white powder

Package unit

30 capsules/bottle, 100 capsules/bottle