New Gabapentin Capsule 300 mg (Gabapentin)

Adult dose

Epilepsy, monotherapy and adjunctive therapy in patients 13 years of age 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, in addition to the above methods, the starting dose may be one 300 mg capsule of this drug 3 times daily (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.) Neuropathic pain, adults (18 years of age 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, in addition to the above methods, the starting dose may be one 300 mg capsule of this drug 3 times daily (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. The total daily dose of this drug should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in 100 mg increments. Elderly patients: Dose adjustment may be necessary due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients undergoing hemodialysis: Dose adjustment is required based on the following table. Dosage for patients with renal impairment: ≥80 mL/min: 900∼2,400 mg/day 50∼79 mL/min: 600∼1,800 mg/day 30∼49 mL/min: 300∼900 mg/day 15∼29 mL/min: 150b∼600 mg/day <15 mL/min: 150b∼300 mg/day a: The total daily dose should be divided into 3 doses. b: A dose of 3 × 100 mg should be administered every 2 days. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. Dosage for 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, and do not administer this drug on days when hemodialysis is not performed. Swallow this drug whole with sufficient fluid. It may be taken with or without food. When administered 3 times daily, ensure that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. If a dose of this drug is missed (more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be given to make up for the missed dose. When used concomitantly with antacids containing magnesium or aluminum, administer this drug at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. The duration of treatment with this drug 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 seizure frequency due to abrupt discontinuation of treatment), abrupt 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 concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. To reduce the main adverse effects, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be administered at bedtime.

Child dose

Adjunctive therapy for children aged 3 years to 12 years, day 1: Administer 10 mg/kg of body weight of gabapentin. Adjunctive therapy for children aged 3 years to 12 years, day 2: Administer 20 mg/kg of body weight of gabapentin. Adjunctive therapy for children aged 3 years to 12 years, from day 3 onward: Administer 30 mg/kg of body weight of gabapentin. Adjunctive therapy for children aged 3 years to 12 years: The dose may be increased to a maximum of 40 mg per kg of body weight per day as needed. Divide the total daily dose of this drug into 3 doses.

This medication may increase the risk of suicidal thoughts or behavior, so if there are any mood changes or behavioral abnormalities while taking it, you should consult a doctor immediately. If this medication is abruptly discontinued, seizures may occur more frequently or progress to severe epileptic states, so it should be tapered off gradually according to the doctor's instructions. Reports of possible cancer occurrence have been noted in animal studies, but the risk in humans is not yet clear. There have been reports of sudden and unexpected deaths during the use of this medication, so if any unusual symptoms arise, they should be reported to medical personnel immediately. If symptoms of pancreatitis, such as persistent abdominal pain, nausea, or recurrent vomiting, occur, discontinue use immediately and visit a hospital. Particular caution is needed for children aged 3 to 12 years, as neurological and psychiatric abnormalities such as emotional instability, aggression, decreased concentration, and hyperactivity may occur. Taking this medication with narcotics or central nervous system depressants can cause severe drowsiness, respiratory depression, or coma, so instructions from a doctor must be strictly followed when combined. This medication should not be used in patients with hypersensitivity or acute pancreatitis, specific seizure types, or hereditary lactose intolerance. Patients with compromised renal function, elderly patients, children with a history of mental illness, attention deficit disorder, pregnant women or women who may become pregnant, and nursing mothers should use this medication with caution. Dizziness, drowsiness, or decreased concentration may occur during use, so caution is advised when driving or operating hazardous machinery. This medication may cause various side effects, including weight gain, visual disturbances, and skin rash, so immediate consultation with medical personnel is required if unusual symptoms occur. During pregnancy, this medication may affect the fetus, so it should not be taken unless absolutely necessary, and women planning a pregnancy should use effective contraception. If breastfeeding, this medication can be excreted in breast milk and may affect the baby, so consultation with a doctor is necessary before taking it. Abruptly stopping this medication may result in withdrawal symptoms, such as anxiety, insomnia, nausea, or tremors, so dosage adjustments should be made per the doctor's instructions. There may be interactions with other medications, so you should inform your doctor of all medications you are taking, especially when taking antacids, narcotics, or oral contraceptives. Store this medication out of reach of children and keep it in its original container to prevent misuse or deterioration.

Suicidal thoughts, suicidal behavior, depression, emotional instability, hostility, thought disorder, hyperactivity, abdominal pain, back pain, fatigue, fever, headache, viral infections, vasodilation, constipation, dental anomalies, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neurotic reactions, nystagmus, drowsiness, thought disorder, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial swelling, hypertension, abdominal distension, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity syndrome, increased reflexes, decrease or loss, sensory abnormalities, anxiety, pneumonia, urinary tract infections, visual disturbances, viral infections, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, coagulation disorders, loss of signs, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, injuries due to accidents, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory loss, tremors, vertigo, dyspnea, coagulation disorders, rash, myasthenia, lethargy, facial swelling, allergies, systemic edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraines, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, 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 hemorrhage, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, blood in stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, cheilitis, salivary gland hyperplasia, 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's lymphoma, increased bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, decreased or lost reflexes, CNS tumors, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, parasthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, ataxia, benign Babinski syndrome, decreased proprioception, subarachnoid hemorrhage, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, abnormal euphoria, hyperesthesia, hallucinatory states, suicidal impulses, psychosis, chorea, athetosis, oromotor dysfunction, brain disease, neurological paralysis, personality disorder, increased libido, organic suppression, apraxia, fine motor coordination disorders, meningitis, focal myoclonus, sensory hypersensitivity, hypomania, neurosis, hysteria, antisocial reactions, suicidal behaviors, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal deformity, bronchial spasm, 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, seborrheic dermatitis, psoriasis, epithelial shedding, maceration, skin nodules, necrosis, localized edema, hematuria, urination disorders, frequency, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, anovulation, ejaculation disorders, renal pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, dyspareunia, mastalgia, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disorders, blepharospasm, fullness in the ear, itchy eyes, accommodation disorders, tympanic membrane perforation, noise sensitivity, eye fixation disorders, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disorders, elevated serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myotonic contractions, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensations, lethargy

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It's recommended to maintain room temperature between 1 to 30 degrees Celsius. This helps to preserve the efficacy and safety of the medication.

Appearance

A hard capsule with a white to grayish white powder or granular filling, with a yellowish hue on the top and bottom.

Package unit

200 capsules/bottle, 30 capsules/bottle