Gabatin Capsule 100 Milligrams (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 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 2 times daily or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: 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, instead of the methods above, one 300 mg capsule of this drug may be administered 3 times daily as the starting dose (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 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 2 times daily or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: 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, instead of the methods above, one 300 mg capsule of this drug may be administered 3 times daily as the starting dose (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 drug, the total daily dose should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients who have undergone transplantation, the gabapentin dose should be increased in increments of 100 mg. 4. Elderly patients: Dosage 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: Dosage 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: 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. 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, and 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 sufficient fluid and may be administered 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 more than 12 hours have elapsed since the most recent dose), the physician should determine whether an additional dose should be administered to make up for the missed dose. 3) When this drug is used concomitantly with antacids containing magnesium or aluminum, it should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. 4) The duration of administration of 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 frequency of epileptic seizures due to abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug 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 more 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 3 to 12 years of age - 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 If necessary, the dose may be increased to a maximum of 40 mg per kg of body weight per day. The total daily dose of this medicine 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 while taking it; therefore, patients and caregivers should immediately inform healthcare providers if there are mood changes or unusual behaviors. Sudden discontinuation of this medication may worsen seizures or lead to a continuous state of epilepsy, so the dosage should be adjusted gradually according to a doctor's instructions. This medication may cause pancreatitis, especially hemorrhagic pancreatitis, so if symptoms like upper abdominal pain, nausea, or vomiting occur, it should be discontinued immediately and consultation with a physician is necessary. For children aged 3 to under 12 years, it may cause central nervous system adverse reactions such as emotional instability, aggression, thought disorders, and hyperactivity, so they should be closely monitored. Taking this medication together with central nervous system depressants, including narcotics, may increase the risks of sedation, respiratory depression, coma, and death; therefore, if combined, it should be administered at the minimum dose for a short duration while carefully monitoring the patient. Caution should be exercised when administering to specific patient populations, such as those with renal dysfunction, the elderly, individuals with a history of mental illness, pregnant and breastfeeding women, and it should only be used during pregnancy if absolutely necessary due to potential risks to the fetus. While taking this medication, side effects such as dizziness, drowsiness, ataxia, memory impairment, nausea, vomiting, weight gain, edema, visual disturbances, etc., may occur, and care should be taken in daily life, especially caution should be exercised while driving or operating machinery. This medication can induce allergic reactions, severe skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis), anaphylaxis, and angioedema; if symptoms such as rash, fever, or difficulty breathing occur, it should be stopped immediately and healthcare providers should be contacted. Sudden discontinuation after long-term use may lead to withdrawal symptoms such as anxiety, insomnia, tremors, headaches, depression, etc.; therefore, the discontinuation should be discussed with healthcare providers for gradual tapering. The dosage may need adjustment based on renal function, and when taken with antacids, absorption may decrease, so it is advisable to adjust the dosing intervals. Keep out of reach of children and store in the original container to prevent misuse or degradation of quality.

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hyperexcitability, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, wear, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, allergy, generalized edema, weight loss, chills, unfamiliar sensation, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, premature ventricular contractions, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody 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, goiter, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, trauma-induced bruising, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendonitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbance, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, intracranial hemorrhage, apathy, hallucinations, decreased or lost libido, agitation, paranoid disorder, depersonalization, dysphoria, hyperesthesia, hallucinations, suicidal thoughts, mental disorders, chorea, athetosis, oral motor disorders, brain disease, 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, pneumonia, nosebleed, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal obstruction, bronchospasm, hypopnea, 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, maceration, skin nodules, subcutaneous nodules, acanthosis, skin necrosis, localized swelling, hematuria, urinary disorders, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, amenorrhea, ejaculation disorders, renal pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency, vaginal pain, breast pain, testicular pain, vision abnormalities, cataract, conjunctivitis, dry eye, eye pain, photophobia, bilateral or unilateral ptosis, intraocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disturbance, eye twitching, overflow, eye itching, accommodative disturbance, tympanic membrane perforation, noise sensitivity, ocular fixation abnormalities, overflow, retinopathy, glaucoma, iritis, corneal disorders, tear function disorders, eye degeneration, blindness, retinal degeneration, mydriasis, choroidal retinopathy, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disturbances, urinary tract infections, urinary disorders, erectile dysfunction, urinary incontinence, vaginal molluscum contagiosum, breast pain, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation disorders, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function test results, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity reaction with systemic response, hyponatremia, jaundice, loss of consciousness, chorea and athetosis, motor disorders, dystonia, hypertensive emergencies, palpitations, pancreatitis, sexual dysfunction, mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly closed container to prevent air or moisture from entering and is best kept at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps preserve the medication's effectiveness for a longer time.

Appearance

A white or grayish-white powder or granules inside a white hard capsule with a white upper and lower part.

Package unit

30 capsules/bottle, 100 capsules/bottle