Neupentin Capsule 100 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, 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 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, one 300 mg capsule of this medicine 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. 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 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) 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. For patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to the 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; 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 sufficient fluids and 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 (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 the missed dose. 3) 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. 4) The duration of treatment with this medicine should depend on clinical need. Long-term treatment is generally required for epilepsy. There is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to abrupt discontinuation of treatment); however, abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine is to be discontinued, or if 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 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 Day 1 should be taken at bedtime.

Child dose

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

This medication is an anticonvulsant, and mental changes such as suicidal thoughts or behaviors and depression may occur during treatment, so careful observation is required. Abrupt discontinuation of the medication can increase the severity of seizures or put the patient at risk of prolonged seizure status, so it must be gradually discontinued according to a doctor’s instructions. Some animal studies have reported a possible increase in the likelihood of certain cancers, but the clinical significance in humans is not yet clear. Sudden and unexpected deaths have been reported during the use of this medication; however, this may be related to the risks associated with epilepsy itself. If symptoms of severe pancreatitis such as hemorrhagic pancreatitis occur, the medication should be discontinued immediately and the doctor should be consulted. In particular, children aged 3 years to 12 years may experience neuropsychiatric adverse reactions such as emotional instability, hostility, thought disturbances, and hyperactivity, so caution is advised. When this drug is taken together with narcotics or other central nervous system depressants, there is a risk of profound sedation, respiratory depression, coma, and death, so the lowest effective dose should be used for the shortest duration necessary, and the patient should be closely monitored. Patients with hypersensitivity to this medication, acute pancreatitis, primary generalized seizures, or congenital lactose intolerance should not take it. Patients with reduced kidney function, elderly patients, those with a history of mental illness, children with attention deficit hyperactivity disorder or behavioral disorders, pregnant or breastfeeding women, and those requiring long-term use should use this medication cautiously. During treatment, dizziness, drowsiness, ataxia, nausea, vomiting, weight gain, and visual disturbances may occur, therefore it is advisable to avoid driving or operating hazardous machinery during the initial phase of treatment. During pregnancy, it may pose a risk to the fetus, therefore women of childbearing potential should use effective contraception, and breastfeeding women should consult a doctor before taking it. In case of overdose, symptoms such as dizziness, drowsiness, and decreased consciousness may occur, and immediate medical attention is needed, as patients with severely impaired kidney function may require hemodialysis. This medication should be stored out of the 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 disorders, hyperactivity, weakness, lethargy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, dry mouth, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impairment of coordination, dizziness, dysarthria, insomnia, hyperreactive response, nystagmus, drowsiness, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, injury due to trauma, low back pain, cold syndrome, headache, infection, pain, dry mouth, abdominal distension, gait abnormality, ataxia, confusion, sensory loss, thought abnormality, tremor, vertigo, dyspnea, bronchitis, respiratory infections, allergies, generalized edema, weight loss, chills, unfamiliar feeling, lethargy, alcohol intolerance, hangover effect, hypotension, angina pectoris, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular ectopic beats, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, blood in stool, fecal incontinence, liver enlargement, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland hypertrophy, 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, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, diminished or absent reflex, increased reflexes, anxiety, hostility, CNS tumor, syncope, dream disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, abnormal sensation, incomplete paralysis, muscle tone abnormalities, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski's sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, psychopathy, depersonalization, altered states of ecstasy, hyperesthesia, hallucinatory state, suicidal thoughts, mental disorders, chorea, athetosis, perioral movement disorders, brain disease, nerve paralysis, personality disorder, increased libido, organic inhibition, apraxia, fine motor dysfunction, meningitis, focal myoclonus, sensory hypersensitivity, motor function decrease, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal sores, 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 peeling, maceration, skin nodules, melanoma, skin necrosis, localized swelling, hematuria, urinary difficulty, pollakiuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, asthenia, ejaculation abnormalities, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency to urinate, dyspareunia, mastalgia, scrotal pain, vision abnormalities, cataracts, conjunctivitis, dry eye, ocular pain, photophobia, bilateral or unilateral ptosis, eye hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, eye twitching, fullness in the ear, itching of the eye, accommodation abnormalities, tympanic membrane perforation, sensitivity to noise, abnormalities in eye fixations, epiphora, retinopathy, glaucoma, iritis, corneal disorders, lacrimal function disorders, retinal degeneration, blindness, retinal detachment, miosis, choroid retinopathy, strabismus, Eustachian tube dysfunction, inner ear inflammation, otitis externa, olfactory dysfunction, urinary tract infection, urinary difficulty, erectile dysfunction, urinary incontinence, vaginal moniliasis, mastalgia, menstrual disorders, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile enlargement, gynecomastia, nocturia, pyelonephritis, scrotal swelling, pollakiuria, urgency, urinary abnormalities, tongue paralysis, increased serum creatine kinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function test values, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, muscle tone abnormalities, muscular hypotonia, palpitations, pancreatitis, sexual dysfunction, mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensation, lethargy

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness and safety of the medication for a longer period.

Appearance

A hard capsule with a yellow upper half and a white lower half containing white or grayish-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle