Neurontin Capsule 400 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 product once daily or one 100 mg capsule of this product three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this product twice daily or two 100 mg capsules of this product three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this product three times daily or three 100 mg capsules of this product three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this product 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 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 sudden discontinuation of treatment); however, sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If this product must be discontinued or used in combination 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 product once daily or one 100 mg capsule of this product three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this product twice daily or two 100 mg capsules of this product three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this product three times daily or three 100 mg capsules of this product three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this product may be administered three 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. When administering this product, the total daily dose should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for periods longer 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 product 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) ≥80: Total daily dosea (mg/day) 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 creatinine clearance. 2) Dosage for hemodialysis patients 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 product on days when hemodialysis is not performed. 6. Method and duration of administration 1) This product 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. 2) If a dose of this product is missed (if 12 hours or more 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 used concomitantly with antacids containing magnesium or aluminum, this product should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this product. 4) The duration of treatment with this product should depend on clinical need. If the dose of this product is reduced, treatment is discontinued, or the patient is switched to another alternative drug, this should be done gradually over at least 1 week (a longer period may be necessary at the prescriber's discretion). 5) To reduce the main adverse reactions, such as drowsiness, dizziness, fatigue, and ataxia, the first dose on Day 1 should be administered at bedtime.

Child dose

2) Adjunctive therapy in 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 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 drug should be divided into 3 doses.

This medication is an antiepileptic drug that helps control seizures. During the course of treatment with this medication, mental health changes such as suicidal thoughts or behaviors, and depression may occur, so if these symptoms appear, consultation with a healthcare professional is necessary. Abruptly stopping the medication may lead to increased seizure frequency or the occurrence of status epilepticus; therefore, it must be reduced gradually under a physician's guidance. There have been reports of a potential increased risk of tumors in some animal studies related to this medication, although the risk in humans is not yet clear. Some reports of sudden and unexpected deaths have occurred in patients taking this medication, but these are within the normal risk range for epilepsy patients. If symptoms of pancreatitis, such as persistent upper abdominal pain, nausea, and vomiting occur, the medication should be stopped immediately, and medical help should be sought. Particularly in children aged 3 to 12 years, neurological and psychiatric side effects such as emotional instability, aggression, thought disorders, and hyperactivity may occur, requiring caution. Co-administration of this medication with central nervous system depressants, including narcotics, may increase the risk of severe drowsiness, respiratory depression, coma, and death, so it should only be taken under physician's guidance. Individuals with allergies or hypersensitivity reactions, those with acute pancreatitis, patients with certain types of seizures, and patients with lactose intolerance should not take this medication. Patients with impaired kidney function, elderly individuals, those with a psychiatric history, children with attention deficit disorders, pregnant women, and nursing mothers should use this medication with caution. Side effects such as dizziness, drowsiness, ataxia, memory loss, mood changes, and vision abnormalities may occur; if these symptoms are severe, a consultation with a physician is recommended. During pregnancy, there may be effects on the fetus; therefore, if planning a pregnancy or already pregnant, it is crucial to consult with a physician. Caution is also necessary when breastfeeding. This medication may impair the ability to drive or operate machinery, so it is advisable to avoid such activities during the initial stages of treatment. While taking this medication, it is essential to adhere strictly to the prescribed dosage and inform healthcare professionals about any other medications or alcohol being consumed. In case of overdose, symptoms such as dizziness, drowsiness, and coma may occur; however, recovery is generally possible with supportive treatment. Keep out of reach of children, and store in the original container to prevent misuse.

suicidal ideation, suicidal behavior, depression, abnormal mood and behavior changes, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbances, hyperactivity, weakness, apathy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, coordination dysfunction, dizziness, dysarthria, insomnia, hyperreactive response, nystagmus, drowsiness, thought disturbances, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, apathy, facial swelling, allergy, generalized edema, weight loss, chills, feeling of unfamiliarity, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, deep venous thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thromboembolism, ventricular extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, 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, salivary gland enlargement, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, hypoestrogenism, ovarian failure, epididymitis, testicular swelling, Cushing's appearance, bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, decreased or absent reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, abnormal dreams, aphasia, decreased sensation, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, benign Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or loss of libido, restlessness, paranoia, depersonalization, abnormal euphoria, hyperesthesia, hallucinatory state, suicidal ideation, mental disorders, chorea, athetoid movements, brain disorders, nerve paralysis, personality disorders, increased libido, substance suppression, apraxia, fine motor control disturbances, meningitis, focal muscle spasm, hypersensitivity, decreased motor ability, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal obstruction, bronchospasm, hypoventilation, pulmonary edema, alopecia, eczema, dry skin, increased perspiration, hives, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photodermatitis, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, melasma, skin necrosis, localized swelling, hematuria, urination disorders, frequent urination, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation abnormalities, renal pain, white discharge, genital itching, 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, eye hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, eyelid twitching, fullness, eye itching, accommodation disturbances, tympanic membrane perforation, noise sensitivity, eye focus abnormalities, watering, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroid retina inflammation, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory abnormalities, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of symptoms, laryngeal neuralgia, somnambulism, pseudo-croup, hoarseness, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, hives, allergic reactions, alopecia, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetoid movements, movement disorders, dystonia, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, apathy

This medication must be stored in a tightly sealed container to avoid exposure to air and moisture. The ideal storage temperature is between 1 and 30 degrees Celsius.

Appearance

Hard capsule with a dark orange color containing white or almost white powder

Package unit

90 capsules (10 capsules/blister x 9)