Barontin 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 of gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Take 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: Take 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 onward: Take 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 given 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: Take 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: Take 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 onward: Take 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 given 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 taking this drug, the total daily dose must be divided into 3 doses. 3. Frail patients: In frail 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 ≤80 mL/min) 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 given 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 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, 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 (when 12 hours or more have elapsed since the most recent dose), the physician should decide whether an additional dose should be taken to make up for it. 3) When used concomitantly with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after administration of the antacid. This can substantially 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), abrupt 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. 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 of treatment should be taken at bedtime.

Child dose

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

This medication is used for the treatment of epilepsy and neuropathic pain, and there may be an increased risk of suicidal thoughts or behaviors, so patients and caregivers should monitor for these symptoms closely. Abruptly stopping this medication may worsen seizures or lead to status epilepticus, so it should be discontinued gradually under physician supervision. Certain animal studies have reported a potential risk of specific cancers; however, the clear risk to humans has not been established. There have been reports of sudden and unexplained death during the use of this medication, but these occurrences are similar to the level typically observed in epilepsy patients. If symptoms of pancreatitis (persistent abdominal pain, nausea, recurrent vomiting) occur, discontinue use immediately and consult a healthcare professional. Caution is required when administering to children aged 3 to 12, as neuropsychiatric side effects such as emotional instability, hostility, thought disturbances, and hyperactivity may occur. Co-administration with central nervous system depressants, including narcotics, may lead to severe sedation, respiratory depression, coma, or death, so it should be used at the minimum effective dose for the shortest duration while closely monitoring the patient. This medication is not to be administered to patients with hypersensitivity or acute pancreatitis, as well as patients with generalized tonic-clonic seizures. It should be administered with caution in certain patient groups, including those with renal impairment, the elderly, individuals with a psychiatric history, pregnant or lactating women, and children with attention deficit disorders. Drowsiness, dizziness, and ataxia may occur during treatment, so caution should be exercised when driving or operating hazardous machinery. There could be potential risks to the fetus when used during pregnancy, so patients planning to conceive or currently pregnant should consult with a healthcare professional, and caution should also be exercised in breastfeeding situations. This medication may cause withdrawal symptoms, so it should be tapered off gradually according to healthcare provider instructions when discontinuing use. There may be drug interactions with other medications or alcohol during use, so patients should inform healthcare professionals about all medications they are taking and their health status. Store this medication out of reach of children, and keep it in its original container to prevent misuse.

suicidal impulses, suicidal behaviors, depression, abnormal mood and behavior changes, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired cooperation, dizziness, dysarthria, insomnia, hyperreactivity, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, trauma-related injury, low back pain, cold syndrome, infection, pain, dry mouth, bloating, gait abnormalities, confusion, sensory impairment, trembling, vertigo, dyspnea, coagulopathy, loss of warning signs, laryngeal neuralgia, sleepwalking, false croup, hoarseness, allergies, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina pectoris, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, glossitis, gingival bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, hematochezia, fecal incontinence, hepatomegaly, 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 spasms, hyperthyroidism, hypothyroidism, goiter, low estrogen, ovarian insufficiency, epididymitis, testicular swelling, cushingoid appearance, bruising like trauma, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendonitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, decreased or lost reflexes, increased reflexes, anxiety, CNS tumors, syncope, dream disorders, sensory impairment, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased to lost sexual desire, agitation, paranoia, depersonalization, dysphoria, hypersensitivity, suicidal attempts, chorea, athetoid movements, perioral movement disorders, brain disorders, nerve paralysis, personality disorders, increased sexual desire, organic inhibition, apraxia, minor motor control disorders, meningitis, focal myoclonus, sensory hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal sores, 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, seborrheic dermatitis, psoriasis, epidermal peeling, maceration, skin nodules, hyperpigmentation, skin necrosis, localized swelling, hematuria, urinary disorders, nocturia, bladder infections, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual disorders, heavy menstrual bleeding, breast cancer, amenorrhea, ejaculation disorders, kidney pain, leukorrhea, genital itching, kidney stones, acute kidney failure, anuria, diabetes, nephritis, enuresis, pyuria, urgency of urination, pelvic pain, breast pain, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disorders, eyelid tremors, eustachian tube dysfunction, inner ear inflammation, otitis externa, olfactory disorders, increased serum creatine kinase levels, rhabdomyolysis, acute kidney failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, movement disorders, dystonia, myotonic cramps, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensations, lethargy

This medication is prone to be affected by air or moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help to retain the medication's efficacy.

Appearance

A hard capsule with a yellowish hue, containing a white to grayish powder.

Package unit

30 capsules/bottle, 100 capsules/bottle