Neopentin Capsule 100 Milligrams (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 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, as an initial dose, one 300 mg capsule of this drug 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.) The duration of treatment should be determined according to clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (increased 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 must be discontinued or administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 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, as an initial dose, one 300 mg capsule of this drug 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. The total daily dose of this drug should be divided into 3 doses. The safety and efficacy of treatment for neuropathic pain for periods exceeding 5 months have not been evaluated. Debilitated patients In debilitated patients with low body weight or patients after transplantation, the dose of this drug 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 undergoing hemodialysis: dose adjustment is required based on the following table. Dosage for patients with renal impairment: Renal function, creatinine clearance (mL/min) ≥80: Total daily dosea (mg/day) 900 ~ 2,400 Renal function, creatinine clearance (mL/min) 50 - 79: Total daily dosea (mg/day) 600 ~ 1,800 Renal function, creatinine clearance (mL/min) 30 - 49: Total daily dosea (mg/day) 300 ~ 900 Renal function, creatinine clearance (mL/min) 15 - 29: Total daily dosea (mg/day) 150b~600 Renal function, creatinine clearance (mL/min) < 15: Total daily dosea (mg/day) 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 undergoing 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 drug on days when hemodialysis is not performed. Method and duration of administration This drug should be swallowed whole with plenty of fluid 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. If a dose of this drug is missed (if more than 12 hours have passed since the last dose), the physician should decide whether an additional dose should be taken to make up for it. When administered concomitantly with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after the antacid. This can greatly reduce the decrease in the bioavailability of this drug. 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 this drug 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). To reduce the main adverse reactions, such as drowsiness, dizziness, fatigue, and ataxia, the first dose on Day 1 should be taken at bedtime.

Child dose

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

This medication may increase the risk of suicidal thoughts or behavior, so patients taking it should inform their healthcare provider immediately if there are any changes in mood or behavior. Discontinuation of this medication suddenly may lead to an increase in the frequency of seizures or status epilepticus, so it should be adjusted according to the physician's instructions. In animal studies, a possibility of some cancers has been reported, but the effects on humans are still unclear. Unexpected sudden deaths have been reported during use, but these fall within a risk range that may commonly occur in epilepsy patients. If symptoms of pancreatitis (persistent abdominal pain, nausea, recurrent vomiting) appear, the use of the drug should be stopped immediately, and medical consultation is necessary. Children aged 3 to 12 years taking this medication may experience central nervous system adverse reactions, including emotional instability, aggression, thought abnormalities, and hyperactivity, so caution is advised. When taken with narcotics or central nervous system depressants, there is a risk of sedation, respiratory depression, coma, and death, so it should only be taken at the minimum necessary dose for the shortest duration and patients should be closely monitored. Patients who have hypersensitivity to this drug, acute pancreatitis, specific types of seizures, or genetic lactose intolerance should not take it. Patients with impaired renal function, the elderly, those with a history of mental illness, children with attention deficit disorder or behavioral disorders, pregnant women, or women capable of becoming pregnant, and breastfeeding mothers should use this medication with caution. Various side effects such as dizziness, drowsiness, memory impairment, and motor control disorders may occur, so care should be taken to avoid driving or operating hazardous machinery when these symptoms are present. Use of this medication during early pregnancy may affect the fetus, so women who are pregnant or planning to become pregnant should consult their healthcare provider first. Breastfeeding women should either discontinue breastfeeding or consult their healthcare provider when taking this medication, and there may be issues of drug dependence and withdrawal symptoms, so caution is needed when stopping usage. This drug may interact with other medications, so patients should inform their healthcare provider about any other medications they are taking or alcohol consumption. This drug should be kept out of reach of children and stored in its original container to prevent misuse or degradation of quality.

Suicidal impulses, suicidal behavior, depression, abnormal mood and behavior changes, persistent seizure status, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, apathy, facial edema, hypertension, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hyperreactivity, nystagmus, drowsiness, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, pruritus, rash, amblyopia, diplopia, erectile dysfunction, asthenia, feelings of apathy, facial swelling, allergy, generalized edema, weight loss, chills, feelings of strangeness, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thromboangiitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular ectopic contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, decreased appetite, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, hematochezia, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral blisters, dental discoloration, angular cheilitis, salivary gland hypertrophy, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid hypertrophy, low estrogen, ovarian insufficiency, epididymitis, testicular swelling, Cushing's syndrome, ecchymosis from trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, reduced or absent reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, benign Babinski syndrome, decreased proprioception, subdural hematoma, apathy, hallucinations, reduced or absent libido, nervousness, paranoia, depersonalization, abnormal euphoria, hypersensitivity, hallucinatory state, suicidal impulses, mental disturbances, chorea, athetosis, oral movement disorders, brain diseases, neuropathy, personality disorders, increased libido, cognitive inhibition, apraxia, fine motor control disorders, meningitis, focal myoclonic jerks, sensory hyperreactivity, hypomania, neuroses, hysteria, antisocial responses, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal sores, bronchospasm, hypoventilation, pulmonary edema, alopecia, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, melanosis, skin necrosis, localized swelling, hematuria, urination disorders, frequent urination, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculatory abnormalities, renal colic, white discharge, genital pruritus, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginal pain, breast pain, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste abnormalities, eye twitching, visual disturbances, eye itching, accommodation disorders, tympanic membrane perforation, sensitivity to noise, eye fixation abnormalities, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroidal retinopathy, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory abnormalities, urinary tract infections, urination disorders, erectile dysfunction, urinary incontinence, vaginal hyperplasia, breast pain, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculatory abnormalities, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, confusion, consciousness loss, psychiatric disorders, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast hypertrophy, chest pain, toxic epidermal necrolysis, eosinophilia, generalized drug rash with symptoms, elevated liver function test results, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity reactions including systemic reactions, hyponatremia, jaundice, consciousness loss, chorea athetosis, movement disorders, dystonia, metabolic myoclonus, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, apathy

This medication should be stored in a sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius. Proper storage helps maintain the efficacy and safety of the medication.

Appearance

A solid capsule with white or grayish-white powder inside.

Package unit

30 capsules/bottle, 100 capsules/bottle