Gabatex Capsule 300 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 as 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 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 an initial dose, one 300 mg capsule of this drug 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.) 3) The duration of treatment 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 sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to be discontinued, or if it is to be used concomitantly 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 as 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 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 an initial 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 as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this drug should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for more 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 drug should be increased in 100 mg increments. 4. Elderly patients Dose adjustment may be required 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: 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: A dose of 3 × 100 mg should be administered 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 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 not to allow the interval between doses to exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this drug is missed (more than 12 hours have elapsed since the last dose), the physician should determine 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 the bioavailability of this drug. 4) The duration of treatment with this drug should depend on clinical need. If the dose of this drug is reduced, treatment is discontinued, or it is switched to another alternative drug, this should be done gradually over at least 1 week (a longer period may be required at the prescriber's discretion). 5) To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be taken at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years to 12 years: Day 1: administer 10 mg/kg body weight of gabapentin; Day 2: administer 20 mg/kg body weight of gabapentin; From Day 3: administer 30 mg/kg body weight of gabapentin; if necessary, the dose may be increased up to a maximum of 40 mg/kg body weight per day. When administering this medicine, the total daily dose should be divided into 3 doses.

This medication can increase the risk of suicidal thoughts or behavior; therefore, it is important to consult a doctor immediately if mood or behavioral changes occur while taking this medication. Discontinuing this medication abruptly may lead to more frequent seizures or continuous seizure states; therefore, it should be tapered off under a doctor's direction. Although the possibility of certain cancers has been reported in some animal experiments, the impact on humans is not yet clear. There may be a risk of sudden and unexpected death during treatment; thus, patients should be regularly monitored for any unusual symptoms and consult a healthcare professional immediately if they occur. If symptoms of pancreatitis, such as persistent upper abdominal pain, nausea, or repetitive vomiting appear, stop taking this medication immediately and visit a hospital. Particularly in children, neuropsychiatric side effects such as behavioral changes, emotional instability, aggression, decreased concentration, and hyperactivity may occur, so careful observation is required. When taken with central nervous system depressants, especially opioid analgesics, symptoms like drowsiness, respiratory depression, or coma may occur, so it must be taken strictly under the doctor's instruction and the dosage and duration should be minimized. This medication should not be used in individuals with allergic reactions to it, acute pancreatitis, patients with generalized absence seizures, or those with hereditary lactose intolerance. Patients with impaired kidney function, elderly patients, those with a history of psychiatric illness, children with attention deficit or behavioral disorders, pregnant or potentially pregnant women, and nursing mothers should exercise special caution when using this medication. Dizziness, drowsiness, and decreased concentration may occur during treatment, so it is advisable to avoid driving or operating hazardous machinery. During pregnancy, this medication may affect the fetus; therefore, if planning to become pregnant or if already pregnant, consulting a doctor is imperative, and women of childbearing potential should use effective contraceptive methods. During breastfeeding, this medication may be excreted in breast milk, so consider discussing breastfeeding with a physician. During treatment, weight gain, visual disturbances, skin rash, severe allergic reactions may occur, and any unusual symptoms should be reported to a healthcare professional immediately. Withdrawal symptoms may occur when discontinuing this medication; therefore, it should be tapered off according to a doctor's instructions, and symptoms like anxiety, insomnia, tremors, and headaches may arise. In case of overdose, symptoms such as dizziness, drowsiness, or coma may occur, so it is crucial to adhere to the specified dosage, and suspecting an overdose should prompt an immediate visit to the hospital. This medication should be stored out of reach of children and kept in its original container to prevent misuse or deterioration.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, apathy, 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, speech disorders, insomnia, neural hypersensitivity, nystagmus, drowsiness, thought disorder, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, apathy, facial swelling, allergies, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraines, murmurs, 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, abdominal distention, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased saliva secretion, gastroenteritis, hemorrhoids, hematochezia, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, sialadenosis, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, hypoestrogenism, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, ecchymosis 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 disturbances, diminished or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream abnormalities, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, benign Babinski sign, diminished proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, restlessness, paranoia, depersonalization, euphoria, hypersensitivity, hallucination state, suicidal ideation, psychosis, chorea, athetosis, perioral dyskinesia, brain disease, neuritis, personality disorders, increased libido, inhibition of organic compounds, apraxia, fine motor control disorders, meningitis, local myoclonus, sensory hypersthesia, reduced motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nosebleeds, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal exfoliation, maceration, skin nodules, subcutaneous nodules, acanthosis, skin necrosis, local swelling, hematuria, urination disorders, incontinence, bladder inflammation, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, abnormal ejaculation, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency, vaginismus, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, photophobia, bilateral or unilateral ptosis, eye hemorrhage, chalazia, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disturbance, eyelid spasms, eye fullness, eye itching, accommodation anomalies, tympanic membrane perforation, sensitivity to noise, eye fixation abnormalities, lacrimation, retinopathy, glaucoma, iritis, corneal disorders, tear function disorders, eye degeneration, blindness, retinal degeneration, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbances, tongue paralysis, neuropathy, sleepwalking, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of signs, laryngeal neuralgia, pseudo croup, hoarseness, suicide attempt, suicidal behavior, suicidal ideation, increased serum creatine kinase, rhabdomyolysis, acute renal failure, urticaria, 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, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, palpitations, pancreatitis, sexual dysfunction, mucosal syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensations, apathy

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best stored at room temperature, between 1 to 30 degrees Celsius. It is advisable to avoid excessively hot or cold locations.

Appearance

Hard gelatin capsule filled with white or light gray powder in yellowish to light yellow color.

Package unit

30 capsules/bottle, 100 capsules/bottle