Dong-A Gabapentin 800 mg Tablet (Gabapentin)

Adult dose

For administration of the initial dose, 100 mg, 300 mg, and 400 mg capsules may be used. For administration of the maintenance dose, 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 formulations in their ability to produce a therapeutic effect. The dose should be determined at the physician’s discretion based on each patient’s tolerability and efficacy. 1. Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older: This drug is effective at doses of 900～2,400 mg/day of gabapentin. The dose may be titrated relatively quickly, first in steps up to the initial maintenance dose and then, if needed, by further dose increases. Initial dose: Titrate gradually to a maintenance dose of 900 mg/day of gabapentin 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) Maintenance dose: The initial efficacy of this drug can be assessed at doses of 900∼1,200 mg/day of gabapentin. If a higher dose is required, it is recommended to administer one 600 mg tablet 3 times daily for a gabapentin dose of 1,800 mg/day, or one 800 mg tablet 3 times daily for a gabapentin dose of 2,400 mg/day. The total daily dose should 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): Titrate gradually to a maintenance dose of 900 mg/day of gabapentin 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 regimen 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 should not exceed 3,600 mg of gabapentin. When administering this drug, the total daily dose should be divided into 3 doses. 4. Debilitated patients : In debilitated patients with low body weight or patients following transplant surgery, the dose of this drug 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 receiving 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 drug on days when hemodialysis is not performed. 7. Method and duration of administration 1) This drug should be swallowed whole with sufficient fluid and may be taken with or without food. When administered 3 times daily, care should be taken to ensure that the dosing interval does not exceed 12 hours in order to prevent recurrence of seizures. 2) If a dose of this drug is missed (when 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 coadministered 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. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (an increase in the 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 it is to be used in combination with another antiepileptic drug, the change should be made gradually over at least 1 week. 5) In the treatment of neuropathic pain, safety and efficacy for treatment durations of 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 the first day of treatment should be administered at bedtime.

Child dose

3. Pediatric patients : When administered as adjunctive therapy to children aged 3 to 12 years, the lower-strength 100 mg, 300 mg, and 400 mg capsules may be used instead of the higher-strength tablet formulation of this drug.

This medication may increase the risk of suicidal thoughts or behavior, so any changes in mood or behavior during use should be communicated to a doctor immediately. Discontinuation should not be abrupt as seizures may worsen; dosage should be reduced slowly under medical supervision. This medication may cause serious side effects such as pancreatitis, so if symptoms like abdominal pain or vomiting occur, use should be stopped immediately and medical advice sought. Taking this medication with other central nervous system depressants or narcotics may result in drowsiness, respiratory depression, or coma; thus, it is essential to inform the doctor about all medications being taken. Patients with allergic reactions to this medication or acute pancreatitis should not take it. Special caution is necessary for patients with decreased kidney function, the elderly, those with a history of mental illness, pregnant or potentially pregnant women, and nursing mothers. During treatment, dizziness, drowsiness, or decreased concentration may occur, so it is advisable to avoid driving or operating hazardous machinery. Long-term usage may lead to weight gain or vision abnormalities, so regular checks of weight and vision are recommended. If severe skin rashes, breathing difficulties, or facial or neck swelling (anaphylaxis) occurs, use should be stopped immediately, and emergency treatment should be sought. This medication may affect the fetus if used in early pregnancy, so women who are pregnant or planning to become pregnant must consult with a doctor. If nursing, it should also be discussed with a doctor as it may be secreted in breast milk. If any abnormal symptoms arise during use, inform healthcare personnel immediately and follow the prescribed dosages strictly.

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, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst or dryness of mouth, nausea and vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, delirium, coordination dysfunction, dizziness, dysarthria, emotional instability, insomnia, neurotic reactions, nystagmus, drowsiness, abnormal thoughts, tremor, monoplegia, 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 movements, decreased or absent reflexes, sensory abnormalities, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, gait abnormalities, confusion, sensory loss, abnormal thoughts, tremors, vertigo, dyspnea, rash, tongue paralysis, weakness, injuries due to accidents, cold syndrome, pain, dry mouth, hypertension, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, bruit, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular extrasystole, 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, tooth discoloration, angular cheilitis, sialadenitis, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushingoid appearance, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, syncope, dream disorder, aphasia, intracranial hemorrhage, hypotonia, abnormal sensations, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subarachnoid hematoma, apathy, hallucinations, decreased or loss of libido, restlessness, paranoia, depersonalization, abnormal euphoria, hypersensitivity, hallucinatory states, suicide attempts, chorea, athetosis, perioral dyskinesia, brain disease, neuropathy, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, local torsade de pointes, hypersensitivity, reduced motor function, mania, neurosis, hysteria, antisocial responses, increased coughing, bronchitis, rhinitis, sinusitis, asthma, pulmonary abnormalities, epistaxis, hemoptysis, degeneration, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, simplex herpes, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal shedding, maceration, skin nodules, melanosis, skin necrosis, localized swelling, hematuria, urination disorders, frequency, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual abnormalities, menorrhagia, breast cancer, infertility, ejaculation abnormalities, renal pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, blepharospasm, fullness of the eyes, itchy eyes, accommodation disorders, tympanic membrane perforation, sensitivity to noise, abnormal eye focus, tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye atrophy, blindness, retinal atrophy, pupil dilation, choroiditis, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory abnormalities, increased serum creatine kinase activity, 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, edema, gynecomastia, hallucinations, hepatitis, hypersensitivity reactions including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, muscular cramps, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headaches, abnormal sensations, lethargy

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is also important to keep it in a cool place below 25 degrees Celsius to maintain its efficacy.

Appearance

White, oval, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle