Gabarep 800 mg Tablets (Gabapentin)

Adult dose

(Tablets) 100 mg, 300 mg, and 400 mg capsules may be used when administering the initial dose of this medicine. 600 mg and 800 mg tablets and 300 mg and 400 mg capsules may be used when administering the maintenance dose, and 100 mg capsules may be used in patients requiring hemodialysis. There is no difference between the capsule and tablet formulations in terms of therapeutic effect. The dose should be determined at the physician’s discretion based on each patient’s individual tolerability and efficacy. 1. Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older: This medicine is effective at doses of 900～2,400 mg/day as gabapentin. The process of gradually increasing the dose to the initial maintenance dose and, thereafter, increasing the dose as needed may be carried out relatively quickly. Initial dose: Gradually titrate to a maintenance dose of 900 mg/day as gabapentin 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 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine 2 times 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) Maintenance dose: Initial efficacy of this medicine can be assessed at doses of 900∼1,200 mg/day as gabapentin. If higher doses are required, administration of a 600 mg tablet 3 times daily is recommended for a dose of 1,800 mg/day as gabapentin, and administration of an 800 mg tablet 3 times daily is recommended for a dose of 2,400 mg/day as gabapentin. The total daily dose should 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). 2. Neuropathic pain Adults (18 years and older): Gradually titrate to a maintenance dose of 900 mg/day as gabapentin 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 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine 2 times 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, instead of the above regimen, one 300 mg capsule of this medicine may be administered 3 times daily as the starting dose (gabapentin 900 mg/day). If needed, the dose may be increased to 1,800 mg/day as gabapentin within one week, and the total daily dose should not exceed 3,600 mg as gabapentin. When administering this medicine, the total daily dose should be divided into 3 doses. 4. Frail patients: In frail patients with low body weight or patients after transplant surgery, the dose of this medicine should be increased in 100 mg increments. 5. Elderly patients: Dose adjustment may be necessary due to age-related decline in renal function (see table). 6. Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients undergoing hemodialysis Dose adjustment is required based on the following table. 1) Dose 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) Dose for hemodialysis patients 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. 7. Method and duration of administration 1) This medicine 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 medicine is missed (if more than 12 hours have elapsed since the last dose), whether to administer an additional dose to make up for it should be determined at the physician’s discretion. 3) 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. 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 due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine is to be discontinued or it is to be used concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 5) In the treatment of neuropathic pain, the safety and efficacy of treatment durations exceeding 5 months have not been evaluated. 6) 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

3. Children: For use as adjunctive therapy in children aged 3 years or older and 12 years or younger, the low-dose 100 mg, 300 mg, and 400 mg capsules may be used instead of this drug's high-dose tablet formulation.

This medication is used for the treatment of epilepsy and relief of neuropathic pain. During treatment, suicidal thoughts or behaviors, as well as symptoms of depression may occur, so patients and their guardians must inform medical staff immediately if such changes are observed. Abrupt discontinuation of the drug can result in more severe seizures or status epilepticus, so it should be tapered off under the guidance of a physician. Serious side effects such as pancreatitis may occur, so if persistent upper abdominal pain, nausea, or repeated vomiting occurs, discontinue use immediately and visit a hospital. Exercise caution when taking this medication with central nervous system depressants or narcotic analgesics, as there is a risk of drowsiness, respiratory depression, or coma. Patients with a hypersensitivity to this medication or those with acute pancreatitis and certain types of seizures should not take it. Patients with compromised kidney function, the elderly, those with a history of psychiatric disorders, and pregnant or breastfeeding women should consult their physician before use. Dizziness, drowsiness, memory impairment, and motor coordination disorders may occur, so driving or operating dangerous machinery after taking the medication is advised against. This drug may cause various side effects such as weight gain, vision abnormalities, skin rashes, and blood dyscrasias; immediate consultation with medical staff is necessary if any abnormal symptoms arise. During pregnancy, it could affect the fetus, so consultation with a physician is essential if planning to conceive or if already pregnant. Caution is also required while breastfeeding. Overdose may result in symptoms such as dizziness, drowsiness, and coma, but recovery is generally possible with supportive care. This medication is not confirmed to be safe or effective in children, particularly those under 3 years of age, so caution is necessary for its use. Strictly adhere to the prescribed dosage and regimen, and do not stop or change the medication on your own. During the use of this drug, inform health care providers if taking other medications or consuming alcohol, and be cautious about drug interactions. Finally, this medication should be kept out of reach of children, and it is safer not to transfer it to other containers.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, deep sedation, respiratory depression, coma, death, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst or dry mouth, nausea and vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, dysfunction of coordination, dizziness, speech disorders, emotional instability, insomnia, hypersensitivity reactions, nystagmus, drowsiness, abnormal thinking, tremors, single contractions, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, fatigue, facial edema, hypertension, bloating, anorexia, gingivitis, purpura, arthralgia, hyperactivity, increased reflex movements, decrease or absence, sensory disturbances, anxiety, hostility, pneumonia, urinary tract infections, visual disturbances, gait abnormalities, confusion, sensory reduction, tremor, dizziness, dyspnea, rash, myasthenia, injuries from accidents, cold syndrome, dry mouth, weight loss, allergies, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thromboembolism, ventricular extrasystole, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, glossitis, gum bleeding, thirst, stomatitis, increased saliva secretion, gastroenteritis, hemorrhoids, bloody stools, 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, cushingoid appearance, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, diverticulitis, contracture, hyperactivity, decreased or loss of reflex, increased reflex, CNS tumors, syncope, dream disorders, aphasia, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, myotonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, benign Babinski sign, decreased proprioception, subarachnoid hemorrhage, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, abnormal euphoria, hypersensitivity, hallucinatory states, suicidal thoughts, psychosis, chorea-acanthocytosis, perioral dyskinesia, brain diseases, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor coordination disorders, meningitis, focal myoclonus, sensory hypersensitivity, reduced motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, rhinorrhea, 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, epidermolysis, maceration, skin nodules, subcutaneous nodules, acanthosis, skin necrosis, localized swelling, hematuria, voiding disorders, polyuria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, amenorrhea, abnormal ejaculation, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, vaginismus, breast pain, testicular pain, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disorders, eyelid twitching, eye pressure, itchy eyes, accommodation disorders, tympanic membrane perforation, noise sensitivity, eye focal point abnormalities, overflow, retinopathy, glaucoma, iritis, corneal disorders, lacrimal duct dysfunction, retinal degeneration, blindness, retinal atrophy, miosis, chorioretinitis, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disorders, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, drug rash accompanied by eosinophilia and systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, feminization, hallucinations, hepatitis, hypersensitivity reactions including systemic symptoms, hyponatremia, jaundice, loss of consciousness, chorea-acanthocytosis, movement disorders, myotonia, muscular dystrophy, palpitations, pancreatitis, sexual dysfunction, mucosal syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal feelings, fatigue, myasthenia, abnormal thinking, cold syndrome, dry mouth

This medication should be stored in a tightly sealed container to prevent air and moisture from entering, and it is best to keep it in a cool place at room temperature, below 25 degrees Celsius. This storage method helps maintain the medication's effectiveness for a longer period.

Appearance

White or off-white oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle