Neupentin Capsule 100 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 as follows over the first 3 days of treatment. 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 a starting dose, one 300 mg capsule of this drug may be administered 3 times daily (gabapentin 900 mg/day). The dose may be increased up 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.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day of gabapentin, titrate the dose as follows over the first 3 days of treatment. 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 a starting 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. The total daily dose should 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 following transplant surgery, 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. 5. Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is required based on the following table. 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: The dose should be administered as 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. 2) Dosage in hemodialysis patients 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, care should be taken to ensure that the interval between doses does not exceed 12 hours, to prevent recurrence of seizures. 2) If a dose of this drug is missed (if 12 hours or more have elapsed since the last dose), the physician should decide whether an additional dose should be given to make up for the missed dose. 3) When used concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in 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 (increased seizure frequency due to abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may precipitate status epilepticus. If treatment with this drug is to be discontinued, or if 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 more than 5 months have not been evaluated. 6) To reduce major 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

2) Adjunctive therapy in children aged 3 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, if necessary, up to a maximum of 40 mg/kg of body weight per day. The total daily dose should be divided into 3 doses.

This drug may increase the risk of suicidal thoughts or behaviors, so it's important to closely monitor mood changes or symptoms of depression during treatment. Suddenly stopping the medication can worsen seizures or lead to status epilepticus, so it should be gradually discontinued under a doctor's guidance. Serious side effects such as pancreatitis may occur; if persistent abdominal pain, nausea, or vomiting arises, notify a doctor immediately. Emotional instability, hostility, abnormal thoughts, or excessive movement may occur in children, so monitor the child's behavior. Using this drug with opioids or other central nervous system depressants can cause severe drowsiness, respiratory depression, or coma, so follow a doctor’s instructions strictly if combined. Patients with hypersensitivity, acute pancreatitis, certain types of seizures, or lactose intolerance should not take this medication. Patients with impaired kidney function, elderly patients, those with a history of mental illness, pregnant women or those planning to become pregnant, and nursing mothers must consult a doctor before use. Dizziness, drowsiness, or ataxia may occur, so caution is needed when driving or operating dangerous machinery. This drug can cause various side effects, including weight gain, visual disturbances, skin rashes, or blood abnormalities; notify medical personnel immediately if any unusual symptoms occur. It may affect the fetus during pregnancy, so extra caution should be taken, especially in the early stages; nursing mothers should also consult a doctor before taking it. Abruptly stopping the medication can lead to withdrawal symptoms, so dosage should be reduced gradually under a doctor’s orders. There may be potential interactions with other medications or alcohol, so inform healthcare providers about all current medications or health conditions.

suicidal impulses, suicidal behaviors, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, apathy, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hyperreactive response, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, boredom, facial edema, allergy, generalized edema, weight loss, chills, feelings of strangeness, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular ectopic beats, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, abdominal distension, 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, rectal inflammation, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, trauma-induced bruising, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream abnormalities, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, diminished proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoid behavior, depersonalization, abnormal euphoria, hypersensitivity, hallucinations, suicidal impulses, mental disorders, chorea, athetosis, perioral movement disorders, brain diseases, neural paralysis, personality disorders, increased libido, substance inhibition, apraxia, fine motor control disorders, meningitis, localized myoclonic spasms, sensory hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal obstruction, rhinorrhea, bronchospasm, hypoventilation, pulmonary edema, alopecia, eczema, skin dryness, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, seborrheic dermatitis, psoriasis, epidermal peeling, maceration, skin nodules, necrosis, localized swelling, hematuria, urination disorders, pollakiuria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulatory cycles, ejaculation abnormalities, renal pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginismus, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eye, eye pain, photophobia, bilateral or unilateral ptosis, eye hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste abnormalities, eye twitching, fullness in the ear, eye itching, accommodation disorders, tympanic membrane perforation, noise sensitivity, eye fixation abnormalities, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, tear duct dysfunction, eye degeneration, blindness, retinal degeneration, miosis, chorioretinitis, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory dysfunction, urinary tract infections, urination disorders, erectile dysfunction, incontinence, vaginismus, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile enlargement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, pollakiuria, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, alopecia, 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 allergic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, palpitations, pancreatitis, sexual dysfunction, epidermal mucosal syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headaches, abnormal sensations, lethargy

This medication should be stored in a sealed container to prevent exposure to air or moisture. It's recommended to keep the storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage preserves the drug's effectiveness and safety.

Appearance

A hard capsule with white or gray-white powder or granules inside, white upper and lower parts.

Package unit

30 capsules/bottle, 100 capsules/bottle