Gabaone Capsule 300 mg (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 of gabapentin, titrate gradually 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 three 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 three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug may be administered three 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.) 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 (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 drug must be discontinued, or if it is administered concomitantly with another antiepileptic drug, changes 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 of gabapentin, titrate gradually 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 three 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 three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug may be administered three times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day of gabapentin within 1 week, and the total daily dose must not exceed 3,600 mg of gabapentin. When administering this drug, the total daily dose should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. 3. Debilitated patients: In debilitated 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 necessary due to age-related decline in renal function (see table). 5. Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients undergoing 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: 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) 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. 6. Method and duration of administration 1) Swallow this drug whole with plenty of 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. 2) If a dose of this drug is missed (12 hours or more have elapsed since the most recent dose), the physician should determine whether an additional dose should be taken to make up for it. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after the antacid. This can substantially reduce the decrease in 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 the drug is replaced with another alternative, this should be done gradually over at least 1 week (a longer period may be necessary at the prescriber's discretion). 5) 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

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

This drug may increase the risk of suicidal thoughts or behavior, so if any mood changes or symptoms of depression occur during treatment, consult a doctor immediately. Abrupt discontinuation of this drug may lead to more frequent or severe seizures, so the dosage should be gradually reduced according to the doctor's instructions. Long-term use may result in side effects such as weight gain or visual disturbances, so it is important to regularly monitor the patient's condition. In particular, children aged 3 to 12 years may exhibit neuropsychiatric adverse reactions such as emotional instability, hostility, decreased concentration, or hyperactivity, so caution is advised. Taking this medication with central nervous system depressants, including narcotics, may lead to severe drowsiness, respiratory depression, or coma, so it should only be used for necessary short-term cases at the minimum dose. Patients with impaired renal function or the elderly may need to adjust the dosage, and women who are pregnant or planning to become pregnant should consult a doctor before taking this medication. This medication is not to be administered to patients with acute pancreatitis, certain types of seizures, or lactose intolerance. If symptoms of pancreatitis such as persistent upper abdominal pain, nausea, or vomiting occur during treatment, discontinue the medication immediately and seek medical attention. Dizziness or drowsiness may occur while taking this medication, so it is advisable to avoid driving or operating hazardous machinery. If serious allergic reactions such as sudden skin rash, fever, difficulty breathing, or swelling of the face or neck occur, stop taking the medication immediately and seek emergency care. This medication has potential for dependence or misuse, so patients with a history of substance abuse should use it with extra caution. When discontinuing, withdrawal symptoms such as anxiety, insomnia, headache, and tremors may occur, so dosage should be gradually reduced according to the doctor's instructions. Inform healthcare providers if taking other medications or consuming alcohol, as interactions may occur. Store this drug out of reach of children and keep it in its original container for safety.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, abnormal thought, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, abnormality of teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, dysfunctional cooperation, dizziness, dysarthria, insomnia, neurosensitization, nystagmus, drowsiness, abnormal thought, tremor, monophasic contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, allergy, generalized edema, weight loss, chills, unfamiliar sensation, malaise, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, premature ventricular contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, bloating, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastritis, hemorrhoids, bloody stools, fecal incontinence, liver enlargement, 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, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbance, diminished or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, abnormal dreams, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, diminished proprioception, subdural hematoma, apathy, hallucination, decreased or lost libido, agitation, paranoia, depersonalization, dysphoria, hypersensitivity, hallucinatory state, suicidal thoughts, mental disorders, chorea and athetosis, perioral movement disorder, brain disease, nerve paralysis, personality disorder, increased libido, organic inhibition, apraxia, fine motor control disorder, meningitis, focal myoclonus, hyperalgesia, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, nosebleed, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nose picking, 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, melasma, skin necrosis, localized swelling, hematuria, urinary disturbance, frequent urination, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, heavy menstrual bleeding, breast cancer, anovulation, ejaculation disorders, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, enuresis, pyuria, urgency of urination, vaginismus, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, eye pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear infection, loss of taste, taste abnormalities, eye twitching, eye bulging, eye itching, accommodation abnormalities, tympanic membrane perforation, sensitivity to noise, eye fixation abnormalities, overflow tears, retinal diseases, glaucoma, iritis, corneal disorders, lacrimal dysfunction, retinal degeneration, blindness, retinal detachment, miosis, choroiditis, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory abnormalities, urinary tract infections, urinary disorders, erectile dysfunction, urinary incontinence, vaginal atresia, mastalgia, menstrual abnormalities, polyuria, urinary retention, cystitis, ejaculation disorders, penile enlargement, gynecomastia, enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency of urination, urinary abnormalities, tongue paralysis, increased serum creatine kinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, 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, myotonia, palpitations, pancreatitis, sexual dysfunction, mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This drug should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 degree to 30 degrees Celsius. This will help preserve the effectiveness of the medication and ensure safe usage.

Appearance

A hard capsule with an upper and lower yellowish color containing white or grayish powder.

Package unit

30 capsules/bottle, 100 capsules/bottle