Gabatine 800 mg (Gabapentin)

Adult dose

For the initial dose of this medicine, 100 mg, 300 mg, and 400 mg capsules may be used. For maintenance dosing, 600 mg and 800 mg tablets and 300 mg and 400 mg capsules may be used; 100 mg capsules may be used in patients requiring hemodialysis. There is no difference between the capsule and tablet dosage forms in terms of therapeutic effect. The dose should be determined by the physician based on each patient's individual tolerability and efficacy. 1. Epilepsy Monotherapy and adjunctive therapy in patients 13 years of age and older: This medicine is effective at doses of 900～2,400 mg/day as gabapentin. The titration to the initial maintenance dose and subsequent dose increases, if needed, may be carried out relatively quickly. Initial dose: To achieve a maintenance dose of 900 mg/day as gabapentin, titrate 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: 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) 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, it is recommended to administer 600 mg tablets three times daily for a dose of 1,800 mg/day as gabapentin, or 800 mg tablets three times daily 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 of age and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate 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: 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, one 300 mg capsule of this medicine may be administered three times daily as the starting dose (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day as gabapentin within one week; the total daily dose should not exceed 3,600 mg as gabapentin. The total daily dose of this medicine should be divided into 3 doses. 4. Frail patients: In frail patients with low body weight or patients following transplant surgery, the dose of this medicine should be increased in increments of 100 mg. 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) Dosage in 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 the creatinine clearance. 2) Dosage in 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; 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, 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 (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 it. 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 (an increase in the 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 medicine is to be discontinued or it is to be used concomitantly with another antiepileptic drug, changes should be made gradually over at least 1 week. 5) In the treatment of neuropathic pain, the safety and efficacy of treatment for more than 5 months have not been evaluated. 6) To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be administered at bedtime.

Child dose

Aged 3 to 12 years: For adjunctive therapy, the low-strength 100 mg, 300 mg, and 400 mg capsules may be used instead of the high-strength tablets of this drug.

This medication is used for the treatment of epilepsy and neuropathic pain. There may be an occurrence of mental health issues such as suicidal thoughts, suicidal behaviors, and depression during treatment, so patients and caregivers should inform healthcare providers immediately if these symptoms appear. Abrupt withdrawal of this medication may lead to more frequent seizures or persistent status epilepticus; therefore, discontinue use only after consulting a doctor. If symptoms of pancreatitis occur, such as persistent abdominal pain, nausea, or repeated vomiting, stop taking the medication immediately and visit a hospital. Taking this medication together with narcotics or central nervous system depressants may lead to sedation, respiratory depression, or coma; thus, very cautious use is recommended when used in combination, and it should be taken at the minimum dose for a short period as directed by a physician. This medication can cause serious side effects such as allergic reactions, severe skin rashes, and anaphylaxis; if skin rashes, difficulty breathing, or swelling in the face or neck occur, stop taking the medication immediately and seek emergency treatment. During pregnancy, there may be effects on the fetus, so women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, and breastfeeding women should also determine whether to take it after consulting a doctor. Dizziness, drowsiness, memory impairment, and motor coordination issues may occur, so it is advisable to avoid driving or operating dangerous machinery while taking this medication. Patients with reduced kidney function should have their dose adjusted, and elderly patients, those with a history of mental illness, and children should take this medication with more caution. During treatment, side effects such as weight gain, visual disturbances, nausea, vomiting, fatigue, and headaches may occur, and if these symptoms persist or worsen, consult a healthcare provider. Drug interactions can occur when taking this medication with other drugs or alcohol; therefore, inform healthcare providers about all medications being taken and any alcohol consumption.

suicidal thoughts, suicidal behavior, depression, seizures, status epilepticus, hemorrhagic pancreatitis, deep sedation, respiratory depression, coma, abdominal pain, low back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disturbance, emotional instability, insomnia, nervous hyperreactivity, nystagmus, drowsiness, cognitive disturbance, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, bloating, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, abnormal reflex movements, sensory abnormalities, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, myasthenia, injury due to accidents, cold syndrome, pain, dry mouth, gait disturbance, confusion, tremor, vertigo, dyspnea, rash, tongue paralysis, myasthenia, lethargy, facial edema, allergy, generalized edema, weight loss, chills, feelings of strangeness, prostration, 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, gingival bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth 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, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, costochondritis, osteoporosis, bursitis, contracture, hyperactivity, decreased or loss of reflexes, increased reflexes, CNS tumor, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, abnormal sensation, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, benign Babinski's sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or loss of libido, agitation, paranoia, depersonalization, anomalous euphoria, hyperesthesia, hallucinatory state, suicidal thoughts, mental disorders, chorea, athetosis, perioral movement disorders, 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, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal crusting, 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 desquamation, maceration, skin nodules, subcutaneous nodules, hyperpigmentation, skin necrosis, localized swelling, hematuria, urination disorders, oliguria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation disorders, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vulvodynia, breast pain, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disturbances, blepharospasm, eye fullness, eye itching, accommodation abnormalities, tympanic membrane perforation, noise sensitivity, eye focal point abnormalities, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimation dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroidal retinitis, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disturbances, elevated 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, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea and athetosis, movement disorders, dystonia, muscular tensions, heart palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, tongue paralysis, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly closed container to prevent exposure to air or moisture and at a cool temperature below 25 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer time.

Appearance

White oval film-coated tablets

Package unit

30 tablets, 100 tablets / Plastic bottle