Gabapentin Capsule 100 mg

Adult dose

Epilepsy — Monotherapy and adjunctive therapy in patients aged 13 years and older The dose should be titrated over the first 3 days of treatment as follows to achieve a maintenance dose of 900 mg/day as gabapentin. 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: 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 an initial 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.) Neuropathic pain — Adults (18 years and older) The dose should be titrated over the first 3 days of treatment as follows to achieve a maintenance dose of 900 mg/day as gabapentin. 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: 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 an initial 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, and the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this medicine should be divided into 3 doses. The safety and efficacy of treatment for neuropathic pain for periods exceeding 5 months have not been evaluated. Frailty In frail patients with low body weight or patients following transplantation, the dose of this medicine should be increased in increments of 100 mg. Elderly patients Dose 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 for patients with renal impairment: Renal function, creatinine clearance (mL/min) ≥80: Total daily dosea (mg/day) 900 ~ 2,400 Renal function, creatinine clearance (mL/min) 50 - 79: Total daily dosea (mg/day) 600 ~ 1,800 Renal function, creatinine clearance (mL/min) 30 - 49: Total daily dosea (mg/day) 300 ~ 900 Renal function, creatinine clearance (mL/min) 15 - 29: Total daily dosea (mg/day) 150b~600 Renal function, creatinine clearance (mL/min) < 15: Total daily dosea (mg/day) 150b~300 a: The total daily dose should be divided into 3 doses. b: Administer 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. 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 This medicine should be swallowed whole with plenty of fluids 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. If a dose of this medicine is missed (if 12 hours or more have elapsed since the last dose), the physician should decide whether an additional dose should be administered to make up for it. 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. The duration of treatment with this medicine should depend on clinical need. When reducing the dose of this medicine, discontinuing it, or switching to another alternative medicine, 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 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 or older and 12 years or younger — Day 1: Administer gabapentin at 10 mg/kg body weight Adjunctive therapy in children aged 3 years or older and 12 years or younger — Day 2: Administer gabapentin at 20 mg/kg body weight Adjunctive therapy in children aged 3 years or older and 12 years or younger — From Day 3 onward: Administer gabapentin at 30 mg/kg body weight Adjunctive therapy in children aged 3 years or older and 12 years or younger — The dose may be increased as needed to a maximum of 40 mg/kg body weight daily. Adjunctive therapy in children aged 3 years or older and 12 years or younger — The total daily dose of this drug should be divided into 3 doses.

This drug is used to treat epilepsy and may increase the risk of suicidal thoughts or behavior, so changes in mental state should be monitored closely during use. Stopping the medication suddenly may worsen seizures, so the dosage should be reduced gradually under a doctor's guidance. Long-term use may lead to side effects such as weight gain or vision problems, so it is important to monitor the condition regularly. Dosage adjustments may be needed for children, older adults, and patients with impaired kidney function, and particularly in children, symptoms such as behavioral changes or hyperactivity may occur. There is a risk of drowsiness or respiratory depression when taken with central nervous system depressants or narcotics, so caution should be exercised when used together. During pregnancy, it may affect the fetus, so women of childbearing potential should consult a doctor before taking it, and it should be used cautiously during breastfeeding. If severe rash, difficulty breathing, swelling of the lips or face occurs while taking this medication, it should be stopped immediately and medical advice sought. It is safer to avoid activities requiring attention, such as driving or operating machinery, during the early stages of treatment. Strictly follow the doctor's directions while taking the medication and report any side effects or unusual symptoms to medical personnel immediately.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, lethargy, apathy, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, dry mouth, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hyperreactive nerve response, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lumbago, cold syndrome, headache, infection, pain, dry mouth, bloating, gait disturbance, confusion, sensory deficits, thought disorder, tremor, vertigo, dyspnea, rash, dehydration, infectious mononucleosis, hepatitis, coagulopathy, loss of signs, laryngeal neuralgia, sleepwalking, croup-like syndrome, hoarseness, allergy, generalized edema, weight loss, chills, strange feelings, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, premature ventricular contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, blood in stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland hypertrophy, 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, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, increased bleeding time, arthralgia, tendonitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, diverticulitis, contractures, diminished or absent reflexes, increased reflexes, anxiety, CNS tumor, syncope, dream abnormalities, sensory deficits, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, muscle dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, diminished proprioception, subdural hematoma, apathy, hallucinations, reduced or lost libido, restlessness, paranoia, depersonalization, altered euphoria, hyperesthesia, hallucinatory state, suicidal thoughts, psychosis, chorea, athetoid movements, oral-motor disorders, brain diseases, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, focal myoclonus, sensory hypersensitivity, mania, neurosis, hysteria, antisocial responses, suicidal behavior, nosebleed, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, scab, bronchospasm, hypoventilation, pulmonary edema, alopecia, eczema, skin dryness, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin pigmentation, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal desquamation, maceration, skin subnodules, subcutaneous nodules, acanthosis, skin necrosis, localized swelling, hematuria, urinary dysfunction, oliguria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, hypermenorrhea, breast cancer, amenorrhea, ejaculation abnormalities, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginismus, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, eye pain, glare, ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, eyelid spasms, excess tearing, itchy eyes, accommodation disorders, tympanic membrane perforation, hyperacusis, eye focal abnormalities, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, dysfunction of lacrimal glands, eye degeneration, blindness, retinal degeneration, mydriasis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disturbances, tongue paralysis, increased serum creatine kinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash accompanied by systemic symptoms, elevated liver function test results, erythema multiforme, falls, generalized edema, feminization, hallucinations, hepatitis, hypersensitivity reactions including systemic responses, hyponatremia, jaundice, loss of consciousness, chorea, athetoid movements, movement disorders, muscle dystonia, cardiopulmonary hyperactivity, pancreatitis, sexual dysfunction, mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius. Proper storage will help ensure the safe effectiveness of the medication.

Appearance

A white to off-white powder inside a white opaque hard capsule.

Package unit

30 capsules/bottle