Neuros Capsule (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 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: 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, as a starting dose, one 300 mg capsule of this medicine may be administered three 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.) 3) 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), 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. 2. Neuropathic pain 1) 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: 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, as a starting dose, one 300 mg capsule of this medicine may be administered three times daily (gabapentin 900 mg/day). If needed, the dose may be increased to 1,800 mg/day of gabapentin within 1 week. 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. 2) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 3. Frail patients In frail patients with low body weight or patients after transplantation, the dose of this medicine 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 undergoing 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: 3 × 100 mg should be administered every 2 days. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) 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, and do not administer this medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) Swallow this medicine whole with plenty of fluids. 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. 2) If a dose of this medicine is missed (12 hours or more have elapsed since the last dose), the physician should decide whether an additional dose should be taken to make up for the missed dose. 3) When used concomitantly with antacids containing magnesium or aluminum, this medicine should be administered 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 be determined according to clinical need. When reducing the dose of this medicine, discontinuing treatment, or switching to another alternative medicine, this should be done gradually over at least 1 week (a longer period may be needed at the prescriber's discretion). 5) 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: On the first day, administer gabapentin 10 mg/body weight (kg) Adjunctive therapy in children aged 3 years to 12 years: On the second day, administer gabapentin 20 mg/body weight (kg) Adjunctive therapy in children aged 3 years to 12 years: From the third day onward, administer gabapentin 30 mg/body weight (kg) Adjunctive therapy in children aged 3 years to 12 years: The dose may be increased as needed up to a maximum of 40 mg per kg of body weight daily. The total daily dose of this drug should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, it is crucial to closely monitor for mood changes or symptoms of depression during use. Abrupt discontinuation may lead to more frequent seizures or status epilepticus; thus, do not stop the medication without the doctor's guidance. Serious side effects such as pancreatitis may occur with this medication; if persistent upper abdominal pain, nausea, or vomiting arises, discontinue use immediately and consult a healthcare professional. In children, symptoms of central nervous system changes such as emotional instability, hostility, decreased concentration, or hyperactivity may occur, and guardians should observe carefully. This medication can commonly cause side effects affecting the central nervous system, such as drowsiness, dizziness, and motor coordination impairments; therefore, it is advisable to avoid driving or operating hazardous machinery during the initial administration or when dosage is changed. When taken in conjunction with narcotics or other central nervous system depressants, respiratory depression or severe sedation may occur, requiring strict medical supervision. Patients with impaired kidney function or the elderly may need dose adjustment due to delayed drug excretion; women who are pregnant or plan to become pregnant should consult a physician before use. This medication can cause allergic reactions or emergencies such as severe skin rash, anaphylaxis, so discontinue immediately and seek emergency treatment if rash, breathing difficulties, or swelling of the face or neck occurs. Weight gain may occur during treatment, so regular weight management and, if necessary, dietary adjustments and exercise are advisable. Withdrawal symptoms may appear upon cessation, so dosage should be gradually reduced in consultation with a healthcare professional. Inform healthcare professionals about any other medications, supplements, or alcohol intake during treatment, and consult immediately with a specialist if any unusual symptoms arise.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, abnormal thoughts, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, memory loss, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neuroexcitable reactions, nystagmus, drowsiness, abnormal thoughts, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, allergy, generalized edema, weight loss, chills, strange sensations, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraines, noises, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accidents, pulmonary thrombosis, ventricular ectopic contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, decreased appetite, bloating, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, stomatitis with vesicles, dental discoloration, angular cheilitis, salivary gland enlargement, 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, cushingoid appearance, traumatic bruising, anemia, lymphadenopathy, thrombocytopenia, increased leukocyte count, lymphocytosis, non-Hodgkin lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, abnormal dreams, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, flat affect, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, abnormal euphoria, hyperesthesia, hallucinatory states, suicidal thoughts, psychiatric disorders, chorea, athetosis, perioral movement disorders, brain disorders, nerve paralysis, personality disorders, increased libido, substance suppression, apraxia, fine motor coordination disorders, meningitis, focal clonic seizures, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal picking, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, male pattern hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photophobia, leg ulcers, scalp seborrhea, psoriasis, epidermolysis, maceration, skin nodules, melanosis, skin necrosis, localized swelling, hematuria, urination disorders, frequency of urination, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation disorders, kidney pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, enuresis, pyuria, urgency, vaginismus, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, glare, bilateral or unilateral ptosis, ocular hemorrhage, papilledema, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, eye twitching, fullness in the ear, eye itching, accommodation abnormalities, tympanic membrane perforation, noise sensitivity, eye fixation disorders, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, tear function disorders, eye degeneration, blindness, retinal degeneration, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory abnormalities, urinary tract infections, urination disorders, erectile dysfunction, urinary incontinence, vulvar minutely, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation disorders, penile enlargement, gynecomastia, enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, confusion, loss of consciousness, mental disorders, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, drug rash accompanied by eosinophilia and 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, muscular spasms, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication may be sensitive to air and moisture, so it must be stored in a sealed container. It is important to maintain room temperature between 1 and 30 degrees Celsius to ensure the drug's efficacy is preserved.

Appearance

A hard capsule of yellowish to light brown color containing white or light gray powder.

Package unit

30 capsules/bottle, 100 capsules/bottle