Gabapentina Capsule 100mg (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 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: 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, one 300 mg capsule of this drug may be administered 3 times daily as the starting dose (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.) 2. Neuropathic pain Adults (18 years 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: 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, 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 must not exceed 3,600 mg of gabapentin. When administering this drug, the total daily dose should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients following transplantation, the gabapentin dose 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 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: 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. 2) Dose for patients receiving 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 plenty of fluid and may be taken with or without food. When administered 3 times daily, care should be taken to ensure that the interval between doses is not more than 12 hours to prevent recurrence of seizures. 2) If a dose of this drug is missed (if 12 hours or more have elapsed since the last dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When this drug is administered concomitantly with antacids containing magnesium or aluminum, it should be taken at least 2 hours after the antacid. This can greatly reduce the decrease in the bioavailability of this drug. 4) 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 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 needs to be discontinued or it is to be administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 5) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 6) To reduce the main adverse effects, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years To achieve a maintenance dose of gabapentin 30 mg/kg/day, titrate gradually over the first 3 days of treatment as follows: - Day 1: Administer gabapentin 10 mg/kg - Day 2: Administer gabapentin 20 mg/kg - From Day 3: Administer gabapentin 30 mg/kg The dose may be increased, if necessary, up to a maximum of 40 mg/kg/day. The total daily dose should be divided into 3 doses.

This drug may increase the risk of suicidal thoughts or behavior, so if mood changes or abnormal behavior occur during treatment, medical consultation should be sought immediately. Additionally, abruptly discontinuing this medication may worsen seizures or lead to a continuous state of epilepsy, so the dosage must be reduced gradually according to a doctor's instructions. This medication can cause serious side effects, such as pancreatitis; therefore, if persistent abdominal pain, nausea, or vomiting occurs, the treatment should be stopped immediately, and the patient should be taken to a hospital. For pediatric patients, there may be neuropsychiatric adverse reactions such as emotional instability, aggression, thought disturbances, excessive motor activity, so caregivers should watch closely. This drug may cause respiratory depression or coma when combined with central nervous system depressants; therefore, patients should inform their healthcare provider about any concomitant medications. Patients with specific diseases, such as those with reduced kidney function, elderly patients, individuals with a history of mental illness, pregnant or breastfeeding women, require careful evaluation and consultation before administration of this medication. This drug contains lactose, so patients with galactose intolerance or lactase deficiency should not take it. Drowsiness, dizziness, or decreased concentration may occur during treatment, and caution should be taken while driving or operating hazardous machinery. Various side effects such as weight gain, visual disturbances, skin rashes may occur during treatment, so if any abnormal symptoms appear, immediate consultation with healthcare professionals is necessary. During pregnancy, this medication may affect the fetus, so women of childbearing potential should use effective contraception, and if pregnant or planning to become pregnant, they must inform their healthcare provider. Breastfeeding women should discuss with their healthcare provider regarding the possibility of the drug being excreted into breast milk. This drug has potential for dependence or abuse; therefore, patients with a history of substance abuse should exercise particular caution. Abruptly stopping the medication may lead to withdrawal symptoms such as anxiety, insomnia, nausea, and tremors; therefore, cessation should follow the healthcare provider's directions. There may be interactions with other medications, so all drugs being taken should be accurately reported to healthcare providers. Keep out of reach of children, and store in the original container to prevent misuse or degradation in quality.

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, cognitive disturbance, hyperactivity, weakness, lethargy, facial edema, hypertension, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, muscle pain, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neurogenic hypersensitivity, nystagmus, drowsiness, cognitive disturbance, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial edema, allergy, systemic edema, weight loss, chills, strange sensations, lethargy, alcohol intolerance, hangover effects, hypotension, angina pectoris, peripheral vascular disorders, palpitations, tachycardia, migraine, bruit, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular ectopic beats, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastritis, hemorrhoids, bloody stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland enlargement, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasms, hyperthyroidism, hypothyroidism, goiter, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, bruising from trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonus, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, schizophrenia, depersonalization, altered states of euphoria, hypersensitivity, hallucinatory states, suicidal ideation, mental disturbances, chorea, athetosis, oral motor dysfunction, brain disease, neuropathy, personality disorder, increased libido, mood inhibition, apraxia, fine motor coordination disorder, meningitis, local focal seizures, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial response, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal obstruction, nasal picking, bronchospasm, hypopnea, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, seborrheic dermatitis, psoriasis, epidermal desquamation, maceration, skin nodules, necrosis, localized swelling, hematuria, urination disorders, frequent urination, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation disorders, renal colic, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, enuresis, pyuria, urinary urgency, vulvodynia, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, glare, bilateral or unilateral ptosis, retinal hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disturbances, blepharospasm, ocular discomfort, eye itching, control abnormalities, tympanic membrane perforation, auditory hypersensitivity, ocular fixation abnormalities, lacrimal dysfunction, ocular degeneration, blindness, retinal degeneration, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbances, urinary tract infections, urination disorders, erectile dysfunction, urinary incontinence, vulvodynia, mastalgia, menstrual abnormalities, polyuria, urinary retention, cystitis, ejaculation disorders, penile engorgement, gynecomastia, enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash accompanied by systemic symptoms, elevated liver function test values, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, motor disorders, dystonia, tachycardia, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. The ideal storage temperature is room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold locations.

Appearance

Hard capsule with a yellow upper half and a white lower half containing white or grayish-white powder

Package unit

30 capsules/bottle, 500 capsules/bottle