Neuros Capsule 100 mg (Gabapentin)

Adult dose

Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose during 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, as a starting dose, one 300 mg capsule of this medicine may be administered 3 times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day as gabapentin, and the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) The duration of treatment should be based 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 precipitate status epilepticus. If treatment with this medicine is to be discontinued, or if it is to be 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 as gabapentin, titrate the dose during 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, as a starting dose, one 300 mg capsule of this medicine may be administered 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day as gabapentin within one week; the total daily dose must not exceed 3,600 mg as gabapentin. When administering this medicine, the total daily dose should be divided into 3 doses. The safety and efficacy of treatment for neuropathic pain for periods exceeding 5 months have not been evaluated. Frailer patients In frail patients with low body weight or patients following transplantation, the dose of this medicine should be increased in 100 mg increments. Elderly patients Dosage 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: Dosage adjustment is required based on the following table. Dosage for patients with renal impairment: Renal function, creatinine clearance (mL/min) ≥80: Total daily dose 900∼2,400 mg/day Renal function, creatinine clearance (mL/min) 50∼79: Total daily dose 600∼1,800 mg/day Renal function, creatinine clearance (mL/min) 30∼49: Total daily dose 300∼900 mg/day Renal function, creatinine clearance (mL/min) 15∼29: Total daily dose 150b∼600 mg/day Renal function, creatinine clearance (mL/min) <15: Total daily dose 150b∼300 mg/day 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 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. Method and duration of administration Swallow this medicine whole with plenty of fluid. It 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 medicine is missed (12 hours or more have elapsed since the most recent dose), the physician should decide whether an additional dose should be taken to make up for it. When coadministered 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 necessary at the prescriber's discretion). To reduce the main adverse reactions, such as drowsiness, 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 to 12 years — Day 1: Administer gabapentin 10 mg/kg of body weight Adjunctive therapy in children aged 3 to 12 years — Day 2: Administer gabapentin 20 mg/kg of body weight Adjunctive therapy in children aged 3 to 12 years — From Day 3 onward: Administer gabapentin 30 mg/kg of body weight Adjunctive therapy in children aged 3 to 12 years — The dose may be increased as needed to a maximum of 40 mg/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 any signs of depression, mood changes, or unusual behavior during treatment should be reported to healthcare professionals immediately. Discontinuing this medication suddenly may result in more frequent seizures or lead to status epilepticus; therefore, the dosage should be reduced gradually according to the doctor's instructions. Long-term use may lead to weight gain, so regular weight checks are recommended, and dietary management and exercise should be considered as necessary. This medication may cause central nervous system side effects, such as dizziness, drowsiness, and coordination difficulties, so it is advisable to avoid driving or operating hazardous machinery during the initial stages of treatment. Particularly in children, neurological and psychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may occur, so caution is advised. Patients with reduced kidney function may need dosage adjustments, and elderly patients are also at higher risk of side effects, so use with caution. If symptoms of acute pancreatitis (abdominal pain, nausea, vomiting) occur, medication should be stopped immediately and a doctor should be consulted. This medication contains lactose; thus, patients with lactose intolerance or related genetic disorders should not take it. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication and should avoid use as much as possible during pregnancy. Breastfeeding women should be aware that this medication can be excreted in breast milk, so they should discuss breastfeeding and medication use with healthcare professionals. Taking this medication with central nervous system depressants, including narcotics, can result in severe drowsiness, respiratory depression, and unconsciousness; thus, caution is strongly advised when used together. If unusual skin rashes, fever, or lymph node swelling occur, please stop taking the medication immediately and inform healthcare providers. This medication has the potential for dependence or abuse, so it is critical to strictly adhere to the prescribed dosage and duration, and not to stop or modify the dose on your own without consulting a doctor. When stopping the medication, withdrawal symptoms (anxiety, insomnia, nausea, tremors, etc.) may occur, so it should be reduced gradually following healthcare providers’ instructions. During treatment, there may be interactions with other medications or alcohol, so it is important to inform healthcare providers of all medications being taken. This medication should be stored out of reach of children and should ideally be kept in its original container.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, nervous irritability, nystagmus, drowsiness, thought disorders, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, allergy, systemic edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina pectoris, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular extrasystole, 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 stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, sialadenosis, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, bruises caused by trauma, anemia, lymphadenopathy, thrombocytopenia, increased leukocyte count, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbance, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, altered states of euphoria, hypersensitivity, hallucinatory states, suicidal thoughts, psychosis, chorea-athetosis, perioral movement disorders, brain disease, neuropathy, personality disorders, increased libido, organic restraint, apraxia, fine motor control disorders, meningitis, focal myoclonus, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal crusting, 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, acanthosis, skin necrosis, localized swelling, hematuria, urination disorders, frequency of urination, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, amenorrhea, ejaculation disorders, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eye, ocular pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, papilloma, hearing loss, ear pain, tinnitus, inner ear inflammation, ear infection, loss of taste, taste disturbance, blepharospasm, filled eye sensation, eye itching, accommodation abnormalities, tympanic membrane perforation, noise sensitivity, eye fixation abnormalities, tearing, retinopathy, glaucoma, iritis, corneal disorders, tear drainage dysfunction, retinal degeneration, blindness, retinal detachment, miosis, chorioretinitis, strabismus, Eustachian tube dysfunction, inner ear inflammation, otitis externa, olfactory disturbances, tongue paralysis, withdrawal symptoms (anxiety, insomnia, nausea, pain, sweating, tremors, headache, depression, abnormal sensations, lethargy), anaphylaxis, angioedema, hypotension, toxic epidermal necrolysis, eosinophilia and systemic symptoms accompanied drug rash, elevated liver function tests, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, movement disorders, dystonia, metabolic myoclonus, palpitations, pancreatitis, sexual dysfunction, skin and mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence

This medication should be stored in a sealed container to protect it from air and moisture and kept at room temperature between 1 and 30 degrees Celsius. Additionally, this medication can be used for 36 months from the date of manufacture, so it is advisable not to use it after the expiration date.

Appearance

White or light gray powder in a white opaque capsule.

Package unit

30 capsules, 300 capsules/bottle