Gabapentin 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 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 onward: 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.) 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: 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 onward: 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 one week, and 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. 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 because of 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: The dose should be administered as 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 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) This medicine should be swallowed whole with sufficient 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 medicine is missed (if more than 12 hours have elapsed since the most recent dose), the decision on whether to administer an additional dose to make up for the missed dose should be made by a physician. 3) When administered concomitantly with antacids containing magnesium or aluminum, this medicine should be taken 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 depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (increased frequency of epileptic seizures following abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine must be discontinued or it is used concomitantly 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 gabapentin 10 mg/kg body weight - Day 2: Administer gabapentin 20 mg/kg body weight - From day 3 onward: Administer gabapentin 30 mg/kg body weight The dose may be increased, if necessary, to a maximum of 40 mg/kg body weight per day. The total daily dose should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behavior, so if any mood changes or unusual behaviors occur during treatment, immediate consultation with a physician is necessary. Abrupt discontinuation of this medication may worsen seizures, so dosage must be gradually reduced according to a doctor's instructions. Prolonged or high-dose use may cause weight gain, so regular weigh-ins are necessary, and dietary and exercise management should be performed if needed. Dizziness, drowsiness, and motor coordination difficulties may occur, so caution is advised when driving or operating machinery. If used with central nervous system depressants or narcotics, respiratory depression or severe sedation may occur; thus, it should be taken under a doctor's guidance at the minimum dose. Patients with impaired kidney function may require dosage adjustments; women who are pregnant or planning to become pregnant must consult a physician. This medication may cause serious adverse reactions such as pancreatitis, severe skin reactions, and anaphylaxis, so if symptoms such as abdominal pain, skin rash, or respiratory difficulties occur, immediate notification to medical personnel is required. Pediatric and elderly patients should be particularly careful of adverse reactions, with children possibly exhibiting mood instability or aggression. There is a potential for interactions with other medications or alcohol while using this medication, so all medications currently being taken should be disclosed to the physician. During use, it is crucial to adhere to the prescribed usage and dosage, and to avoid arbitrarily stopping or altering it.

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, abnormal thinking, hyperactivity, abdominal pain, low back pain, fatigue, fever, headache, vasodilation, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disorder, insomnia, neurogenic hypersensitivity, nystagmus, drowsiness, abnormal thinking, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, abdominal distension, anorexia, gingivitis, purpura, arthralgia, hyperactivity, increased reflex activity, decreased reflex activity, sensory abnormalities, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infections, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of prodromal symptoms, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, gait abnormalities, confusion, tremors, vertigo, dyspnea, blood coagulation abnormalities, rash, weakness, lethargy, facial edema, allergy, generalized edema, weight loss, chills, strange sensations, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, venous thromboembolism, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, premature ventricular contractions, bradycardia, immature atrial contractions, 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, dental discoloration, angel's kiss, salivary gland hypertrophy, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, increased bleeding time, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, estrogen deficiency, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, increased bleeding time, tendonitis, arthritis, joint stiffness, joint swelling, positive Romberg's test, costochondritis, osteoporosis, pouchitis, contracture, syncope, dream abnormalities, sensory impairment, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, anxiety, paranoid disorder, depersonalization, abnormal euphoria, hyperesthesia, hallucinatory states, suicidal thoughts, mental disorders, chorea, athetosis, perioral movement disorder, brain diseases, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, focal myoclonus, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal obstruction, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, blisters, skin nodules, necrosis, localized swelling, hematuria, urinary disorders, frequency, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, heavy menstruation, breast cancer, anorgasmia, ejaculation abnormalities, kidney pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, enuresis, pyuria, urgency, dyspareunia, mastalgia, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, blepharospasm, lacrimal duct obstruction, eye itching, accommodation disorders, tympanic membrane perforation, noise sensitivity, ocular focal misalignment, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, retinal degeneration, blindness, retinal degeneration, miosis, choroiditis, strabismus, Eustachian tube dysfunction, inner ear inflammation, otitis externa, olfactory abnormalities, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, 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, Klinefelter syndrome, hallucinations, hepatitis, hypersensitivity reactions with systemic effects, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help preserve the medication’s efficacy for a longer time.

Appearance

A white or grayish-white powder or granule contained in an upper and lower white hard capsule.

Package unit

30 capsules/bottle, 100 capsules/bottle