Gabista Capsule 300mg (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 onward: 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 be determined according to 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 coadministered with another antiepileptic drug, the change 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 onward: 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 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. 2) The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in increments of 100 mg. 4. Elderly patients: Dose adjustment may be required due to age-related decline in renal function (see table). 5. 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 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) This drug should be swallowed whole with sufficient fluid and may be administered 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 (if more than 12 hours have elapsed since the last dose), whether to administer an additional dose to make up for the missed dose should be decided by the physician. 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 be determined according to clinical need. If the dose of this drug is reduced, treatment is discontinued, or the patient is switched to another alternative drug, this should be done gradually over at least 1 week (a longer period may be required at the prescriber's discretion). 5) 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

2) Adjunctive therapy in children aged 3 to 12 years Children aged 3 to 12 years - Day 1: Administer 10 mg/kg of body weight as gabapentin Children aged 3 to 12 years - Day 2: Administer 20 mg/kg of body weight as gabapentin Children aged 3 to 12 years - From Day 3: Administer 30 mg/kg of body weight as gabapentin Children aged 3 to 12 years - Maintenance dose: 30 mg/day per kg of body weight as gabapentin Children aged 3 to 12 years - If needed, the dose may be increased up to a maximum of 40 mg per kg of body weight daily. When administering this medicine, the total daily dose should be divided into 3 doses.

This drug may increase the risk of suicidal thoughts and behaviors, so if you experience changes in mood or behavior during treatment, you should inform your doctor immediately. Sudden discontinuation of this medication can result in more frequent seizures or a persistent state of epilepsy, so it should be gradually tapered off under a doctor's direction. Long-term use may lead to weight gain, therefore, regular weight monitoring is necessary, and dietary and exercise management should be considered if needed. This drug can affect the central nervous system, causing dizziness, drowsiness, and coordination problems, so it is advisable to avoid driving or operating dangerous machinery at the beginning of treatment. In particular, children, the elderly, and patients with impaired kidney function may require dose adjustments and should consult healthcare professionals immediately if adverse reactions occur. If severe skin rash, difficulty breathing, or facial swelling occurs, discontinue use immediately and seek emergency medical attention. This drug may pose risks to the fetus during pregnancy, so if you are pregnant or planning to become pregnant, consult your doctor. Breastfeeding mothers should discuss with their doctor as this medication may be excreted in breast milk. Using this drug in combination with other central nervous system depressants or opioid pain relievers may increase the risk of drowsiness or respiratory suppression, so caution is required when used together. During treatment, it is important to adhere to the prescribed dosage and schedule strictly, and not to discontinue or alter the dosage without consulting a healthcare professional.

suicidal impulses, suicidal behavior, depression, abnormal mood and behavior changes, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, memory loss, ataxia, confusion, cooperative dysfunction, dizziness, dysarthria, insomnia, neurogenic reactions, nystagmus, drowsiness, thought disorder, tremors, single contractions, cough, pharyngitis, rhinitis, erosion, acne, pruritus, rash, amblyopia, diplopia, erectile dysfunction, asthenia, malaise, facial swelling, allergy, generalized edema, weight loss, chills, feeling of unfamiliarity, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular premature contraction, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland hypertrophy, 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 symptoms, bruising from trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint rigidity, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contractures, dizziness, hyperactivity, sensory disturbances, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumor, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, benign Babinski syndrome, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, abnormal euphoria, hypersensitivity, hallucinatory states, suicidal impulses, mental disorders, chorea-athetosis, perioral movement disorders, brain diseases, neuritis, personality disorders, increased libido, organic suppression, apraxia, fine motor control disorders, meningitis, focal myoclonus, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal obstruction, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased perspiration, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, subcutaneous nodules, pigmentation, skin necrosis, localized swelling, hematuria, urination disorders, frequency, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation disorders, renal pain, leukorrhea, genital pruritus, nephrolithiasis, acute kidney failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginismus, mastalgia, testicular pain, visual disturbances, cataracts, conjunctivitis, dry eye, eye pain, glare, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disturbances, blepharospasm, ocular fullness, eye pruritus, accommodation disturbances, tympanic membrane perforation, sensitivity to noise, eye fixation abnormalities, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye regression, blindness, retinal degeneration, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, smell disturbances, urinary tract infections, urination disorders, erectile dysfunction, urinary incontinence, vaginal molluscum, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation disorders, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequency, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase levels, rhabdomyolysis, acute kidney failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevation of liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, movement disorders, dystonia, myotonic dystrophy, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Hard capsule containing white or grayish-white powder, yellowish in color.

Package unit

30 capsules/bottle, 100 capsules/bottle