Neurontin Capsule 300 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: Take one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day). - Day 2: Take one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day). - From Day 3 onward: Take one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day). Alternatively, as an initial dose, one 300 mg capsule of this drug may be taken three times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin. 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: Take one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day). - Day 2: Take one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day). - From Day 3 onward: Take one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day). Alternatively, as an initial dose, one 300 mg capsule of this drug may be taken three times daily (gabapentin 900 mg/day). If needed, the dose may be increased to 1,800 mg/day of gabapentin within one week. The total daily dose must not exceed 3,600 mg of gabapentin. When taking this drug, the total daily dose 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 increments of 100 mg. 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 of 80 mL/min or less) 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: A dose of 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 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 drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) This drug should be swallowed whole with plenty of fluid and may be taken with or without food. When administered 3 times daily, take care that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this drug 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. 3) When this drug is taken with antacids containing magnesium or aluminum, administer this drug at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend 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 cause status epilepticus. If treatment with this drug is to be discontinued or it is to be used in combination 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 longer 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 the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years — Day 1: Administer 10 mg/kg body weight of gabapentin Adjunctive therapy in children aged 3 to 12 years — Day 2: Administer 20 mg/kg body weight of gabapentin Adjunctive therapy in children aged 3 to 12 years — From Day 3: Administer 30 mg/kg body weight of gabapentin Adjunctive therapy in children aged 3 to 12 years — The dose may be increased, if needed, to a maximum of 40 mg per kg body weight daily. The total daily dose should be divided into 3 doses.

This medication is used for the treatment of epilepsy and neuropathic pain, and there may be an increased risk of suicidal thoughts or behaviors during use, so patients and caregivers should carefully monitor for mood changes or unusual behavior. Abrupt discontinuation can increase seizures or lead to severe status epilepticus, so the dosage should be adjusted gradually according to the physician's instructions. This medication can rarely cause serious side effects such as pancreatitis, so if persistent abdominal pain, nausea, or vomiting occurs, inform the doctor immediately. In children and adolescents, neurological and psychiatric adverse reactions such as emotional instability, hostility, hyperactivity, and decreased concentration may occur, requiring caution. When taken with central nervous system depressants including narcotics, severe sedation or respiratory depression may occur, thus careful monitoring and dose adjustment are necessary. Patients with impaired kidney function, the elderly, those with a history of psychiatric disorders, pregnant or potentially pregnant women, and nursing mothers should use this medication with special caution and consult a physician if necessary. Common side effects such as drowsiness, dizziness, and ataxia may occur, so it is advisable to avoid hazardous activities such as driving or operating machinery until accustomed to the medication. Additionally, this medication can cause various side effects, including weight gain, visual disturbances, skin rashes, and blood abnormalities, so any unusual symptoms should be reported to healthcare professionals immediately. During early pregnancy, it may affect the fetus, so use during pregnancy should be avoided, and women planning pregnancy should consult with a doctor. While taking this medication, adhere strictly to prescribed dosage and administration, and do not arbitrarily discontinue or alter the dosage.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbance, hyperactivity, weakness, lethargy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, abnormal coordination, dizziness, speech disorder, insomnia, neural hypersensitive reaction, nystagmus, drowsiness, thought disturbance, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness syndrome, low back pain, cold syndrome, headache, infection, pain, dry mouth, abdominal distension, abnormal gait, ataxia, confusion, sensory reduction, trembling, vertigo, dyspnea, blood coagulation abnormalities, dehydration, infectious mononucleosis, hepatitis, loss of warning signs, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, allergy, generalized edema, weight loss, chills, sense of unfamiliarity, lethargy, alcohol intolerance, hangover effect, hypotension, angina pectoris, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ectopic heartbeat, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, angular cheilitis, salivary gland hyperplasia, lip hemorrhage, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian insufficiency, epididymitis, testicular swelling, Cushing's syndrome, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, costochondritis, osteoporosis, bursitis, contracture, hyperactivity syndrome, increased, decreased, or absent reflexes, sensory abnormality, anxiety, hostility, CNS tumor, syncope, dream abnormality, aphasia, sensory reduction, intracranial hemorrhage, hypotonia, abnormal sensation, incomplete paralysis, dystonia, hemiparesis, facial paralysis, confusion, cerebellar dysfunction, benign Babinski syndrome, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased libido, agitation, paranoia, depersonalization, altered states of euphoria, hyperesthesia, hallucinatory state, suicidal impulses, mental disorders, chorea, athetosis, perioral movement disorders, brain diseases, nerve paralysis, personality disorders, increased libido, organic suppression, apraxia, fine motor control disorders, meningitis, focal focal seizures, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, nosebleed, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal polyps, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cyst, herpes simplex, shingles, skin discoloration, skin papules, photophobia, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, subcutaneous nodules, acanthosis, skin necrosis, localized swelling, hematuria, urination disorders, incontinence, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, irregular menstruation, heavy menstruation, breast cancer, anovulation, abnormal ejaculation, kidney pain, leucorrhea, genital itching, kidney stones, acute kidney failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginal pain, breast pain, testicular pain, visual disturbances, cataracts, conjunctivitis, dry eyes, eye pain, sensitivity to light, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disturbance, eyelid spasm, ear fullness, eye itching, accommodation disorders, tympanic membrane perforation, noise sensitivity, ocular fixation abnormalities, excessive tearing, retinopathy, glaucoma, iritis, corneal disorders, nasolacrimal duct dysfunction, eye degeneration, blindness, retinal degeneration, mydriasis, choroidal retinitis, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbances, tongue paralysis, elevated serum creatine phosphokinase, rhabdomyolysis, acute kidney failure, urticaria, allergic reactions, 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, systemic hypersensitivity reactions including allergy, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, motor disorders, dystonia, palpitations, pancreatitis, sexual dysfunction, sicca syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensation, lethargy

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be kept between 1 degree and 30 degrees Celsius at room temperature to maintain its effectiveness.

Appearance

Light yellow hard capsule containing white or grayish powder

Package unit

30 capsules/bottle, 300 capsules/bottle