Unilonin Capsule 300 Milligrams (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 as gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine may be administered 3 times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day as gabapentin, and the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine may be administered 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day as gabapentin within one week; the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this medicine should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dosage adjustment may be necessary 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 receiving hemodialysis: Dosage 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: A dose of 3 × 100 mg should be administered every 2 days. For patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dosage 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; do not administer this medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine should be swallowed whole with sufficient liquid and 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 medicine is missed (when 12 hours or more have elapsed since the last dose), the physician should determine whether an additional dose should be taken to make up for the missed dose. 3) When used concomitantly with antacids containing magnesium or aluminum, administer this medicine at least 2 hours after the antacid. This can substantially reduce the decrease in bioavailability of this medicine. 4) The duration of treatment with this medicine should depend on clinical need. Treatment of epilepsy generally requires long-term administration. There is no evidence of a rebound phenomenon (increased 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 medicine is to be discontinued, or if it is to be used concomitantly with another antiepileptic drug, changes should be made gradually over at least 1 week. 5) The safety and efficacy of treatment for neuropathic pain for periods exceeding 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 should be administered at bedtime.

Child dose

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

This medication may carry a risk of suicidal thoughts or behaviors during treatment, so patients and caregivers should immediately inform healthcare providers of any mood changes or behavioral abnormalities. Discontinuing this medication suddenly may lead to more frequent seizures or persistent status epilepticus, so it should be tapered off gradually under a doctor's directive. Animal studies have shown a potential for cancer, but the risk in humans is not yet clear. There have been reports of sudden and unexpected deaths during treatment, especially in epilepsy patients, thus careful monitoring is required. Some patients taking this medication may experience pancreatitis, and if persistent upper abdominal pain, nausea, or vomiting occurs, they should stop taking the medication and consult a hospital immediately. Children aged 3 to 12 years taking this medication may show central nervous system side effects such as emotional instability, aggression, decreased attention, and hyperactivity, so caution is necessary. This medication can cause drowsiness, respiratory depression, or coma when taken with central nervous system depressants, so it should only be used at the minimum effective dose for short periods, under careful observation by healthcare providers. Patients with a history of allergic reactions to this medication or its components, those with acute pancreatitis, certain types of seizures, or lactose intolerance should not take this medication. Patients with impaired kidney function, elderly patients, those with a history of psychiatric illness, children with attention deficit or behavioral disorders, pregnant or planning to become pregnant women, and nursing mothers should exercise extra caution when taking this medication. This medication can cause central nervous system side effects such as drowsiness, dizziness, and motor control impairment, so patients should avoid driving or operating dangerous machinery during the early stages of treatment. Weight may increase during treatment, so regular weight checks and adjustments to diet and exercise may be necessary. This medication can cause serious allergic reactions such as severe skin rashes or anaphylaxis, so if symptoms such as a rash, fever, difficulty breathing, or swelling of the face or neck occur, patients should stop taking the medication and inform healthcare providers immediately. Sudden discontinuation may lead to withdrawal symptoms such as anxiety, insomnia, nausea, tremors, and headaches, so it should be tapered off gradually under a doctor's supervision. This medication can interact with other drugs, so patients must inform healthcare providers of any other medications being taken or use of alcohol. During pregnancy, it may affect the fetus, so women who are pregnant or planning to become pregnant should consult with a doctor. If nursing, since this medication may be excreted in breast milk, consult with a doctor regarding breastfeeding. This medication should be kept out of reach of children and stored securely in its original container.

Suicidal ideation, suicidal behavior, depression, abnormal mood and behavioral changes, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, lethargy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired cooperation function, dizziness, dysarthria, insomnia, neuroexcitability, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial edema, allergy, generalized edema, weight loss, chills, feeling of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina pectoris, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thromboembolism, ventricular extrasystole, 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, dental discoloration, angular cheilitis, salivary gland hyperplasia, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, goiter, low estrogen, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, trauma-induced purpura, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbance, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumor, syncope, dream disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, benign Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, restlessness, paranoia, depersonalization, dysphoria, hyperesthesia, suicidal thoughts, mental disorders, chorea athetosis, perioral movement disorder, brain disease, neural paralysis, personality disorder, increased libido, organic inhibition, apraxia, fine motor coordination disorder, 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, rhinitis, bronchospasm, 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, scalp seborrhea, psoriasis, epidermal shedding, maceration, skin nodules, subcutaneous nodules, melasma, skin necrosis, localized swelling, hematuria, urinary dysfunction, frequency, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularity, menorrhagia, breast cancer, amenorrhea, ejaculation disorders, kidney pain, white discharge, genital itching, kidney stones, acute kidney failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginal pain, breast pain, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, glare, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disturbance, eyelid spasms, eye discomfort, eye itching, accommodation disorder, tympanic membrane perforation, sound sensitivity, eyelid abnormality, watering eyes, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroiditis, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbances, tongue paralysis, asthenia, lethargy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired cooperation function, dizziness, dysarthria, insomnia, neuroexcitability, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, viral infection, fever, weight gain, fatigue, drowsiness, hostility, emotional instability, hyperactivity, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of symptoms, laryngeal neuralgia, sleepwalking, false croup, hoarseness, dizziness, ataxia, drowsiness, sensory disturbance, nystagmus, confusion, depression, neuroexcitation, perceptual disturbance, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, language disorders, dream disorders, dysarthria, emotional instability, stupor, perioral sensory disturbance, dysphoria, hypersensitivity, decreased motor function, suicide attempts, restlessness, tension, increased libido, movement disorders, focal myoclonus, vestibular disorder, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, urinary tract infections, urinary dysfunction, erectile dysfunction, urinary incontinence, vulvodynia, breast pain, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation disorders, penile enlargement, gynecomastia, nocturnal enuresis, nephritis, scrotal swelling, frequency, urgency, urinary abnormalities, increased serum creatine phosphokinase, rhabdomyolysis, acute kidney 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 test results, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea athetosis, movement disorders, dystonia, polymyositis, palpitations, pancreatitis, sexual dysfunction, skin and mucosal syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, depression, abnormal sensations, lethargy

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

A yellowish, hard capsule containing a white or grayish powder

Package unit

30 capsules/bottle, 200 capsules/bottle