Unirontin Capsules 100 mg (Gabapentin)

Adult dose

Epilepsy 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 3 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 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.) Neuropathic pain 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 3 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 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; 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. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose should be increased in 100 mg increments. Elderly patients: Dosage 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 receiving hemodialysis: Dosage adjustment is required based on the following table. Dosage in 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: 3 × 100 mg should be administered every 2 days. In patients with creatinine clearance <15 mL/min, the dose should be reduced in proportion to creatinine clearance. Dosage in 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. Method and duration of administration 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 not to exceed 12 hours between doses to prevent recurrence of seizures. If a dose of this drug is missed (more than 12 hours have elapsed since the most recent dose), the physician should determine whether an additional dose should be administered to make up for it. When used concomitantly 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. The duration of treatment with this drug should be determined according to clinical need. Treatment of epilepsy generally requires long-term administration. There is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to sudden discontinuation of treatment), but 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 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 more than 5 months have not been evaluated. To reduce the main adverse effects, including somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be administered at bedtime.

Child dose

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

This medication is used to treat epilepsy and may increase the risk of suicidal thoughts or behaviors and mental health issues, such as depression, during treatment. Therefore, patients and caregivers should report any such symptoms to healthcare professionals immediately. Sudden discontinuation of this medication may lead to increased severity or progression to a prolonged state of epilepsy, hence dosage should be reduced gradually under the physician's guidance. Additionally, serious side effects, such as pancreatitis, may occur; hence, if symptoms such as upper abdominal pain or nausea arise, the medication should be discontinued immediately, and medical attention sought. In pediatric patients, neuropsychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and excessive activity may occur, requiring careful monitoring. Concurrent use of this medication with narcotics or central nervous system depressants may cause severe drowsiness, respiratory depression, or coma, requiring caution. Particularly, patients with impaired kidney function, the elderly, those with a history of mental illness, and pregnant or breastfeeding women should use this medication cautiously. This medication contains lactose, so patients with lactose intolerance should not take it, and it is not effective for patients with generalized tonic-clonic seizures, hence should not be administered to them. Side effects such as dizziness, drowsiness, memory impairment, and motor coordination disorders may occur, so driving or operating hazardous machinery should be avoided. This medication may affect the fetus if used early in pregnancy, so women of childbearing potential should consult a physician, and effective contraceptive methods should be employed. While breastfeeding, since this medication can be excreted in breast milk, consultation with a physician about breastfeeding is necessary. This medication has a risk of drug dependence and abuse; therefore, patients with a history of drug abuse should be especially cautious, and withdrawal may present symptoms such as anxiety, insomnia, and tremors. In cases of overdose, symptoms such as dizziness, drowsiness, or coma may occur, but generally, supportive therapy can result in recovery. This medication should be kept out of reach of children, stored in its original container to prevent misuse or degradation.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, ennui, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, memory loss, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hyperreactivity, nystagmus, drowsiness, thought disorder, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, feelings of ennui, facial swelling, allergies, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effects, 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, loss of appetite, bloating, gingivitis, 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, sialadenosis, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, goiter, low estrogen, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, contusion-like purplish spots due to trauma, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, diminished or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disorder, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski's sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, schizophrenia, depersonalization, abnormal euphoria, hyperesthesia, hallucinatory state, suicidal thoughts, mental disturbances, chorea, athetosis, oral motor disorders, neurological disorders, neuroparalysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor coordination disorder, meningitis, focal myoclonus, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal polyps, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, male-pattern hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, melasma, skin necrosis, localized swelling, hematuria, urination disorders, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, abnormal ejaculation, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency in urination, dyspareunia, mastalgia, testicular pain, visual disturbances, cataracts, conjunctivitis, eye dryness, eye pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, pinguecula, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disturbances, eye twitching, conjunctival hyperemia, eye itching, accommodation abnormalities, tympanic membrane perforation, noise sensitivity, abnormal ocular fixation, epiphora, retinitis, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, chorioretinitis, strabismus, eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbances, urinary tract infection, urination disorders, erectile dysfunction, urinary incontinence, vaginal moniliasis, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, abnormal ejaculation, penile enlargement, gynecomastia, nocturia, pyelonephritis, scrotal swelling, frequent urination, urgency in urination, abnormal urination, tongue paralysis, confusion, loss of consciousness, mental disorders, 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 reactions including systemic responses, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, motor disorders, dystonia, cardiac palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, feelings of ennui

This medication should be stored in a tightly closed container to avoid exposure to air and moisture, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the efficacy of the medication for an extended period.

Appearance

White hard capsules filled with white or off-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle