Seoul Gabapentin Capsule 100 mg

Adult dose

Monotherapy and adjunctive therapy for epilepsy 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 medication once daily, or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication 2 times daily, or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medication 3 times daily, or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Alternatively, instead of the above regimen, the starting dose may be one 300 mg capsule of this medication 3 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.) Neuropathic pain in 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 medication once daily, or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication 2 times daily, or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medication 3 times daily, or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Alternatively, instead of the above regimen, the starting dose may be one 300 mg capsule of this medication 3 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. When taking this medication, the total daily dose should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients following transplantation, the gabapentin dose should be increased in 100 mg increments. Elderly patients: Dose 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: Dose adjustment is required based on the following table. Dosage for patients with renal impairment: ≥80 mL/min: 900∼2,400 mg/day 50∼79 mL/min: 600∼1,800 mg/day 30∼49 mL/min: 300∼900 mg/day 15∼29 mL/min: 150b∼600 mg/day <15 mL/min: 150b∼300 mg/day 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 the creatinine clearance. Dosage for patients on 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 medication on days when hemodialysis is not performed. This medication should be swallowed whole with sufficient 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. If a dose of this medication is missed (more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be taken to make up for the missed dose. When administered concomitantly with antacids containing magnesium or aluminum, this medication should be taken at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medication. The duration of treatment with this medication should depend on clinical need. Long-term treatment is generally required for epilepsy. There is no evidence of a rebound phenomenon (increased seizure frequency due to sudden discontinuation of treatment), but sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medication 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. The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. 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 and older through 12 years - Day 1: Administer gabapentin 10 mg/kg body weight Adjunctive therapy in children aged 3 years and older through 12 years - Day 2: Administer gabapentin 20 mg/kg body weight Adjunctive therapy in children aged 3 years and older through 12 years - From Day 3 onward: Administer gabapentin 30 mg/kg body weight Adjunctive therapy in children aged 3 years and older through 12 years - The maintenance dose is 30 mg/day per kg of body weight as gabapentin and may be increased, if necessary, 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. During the use of this medication, there may be occurrences of suicidal thoughts or behaviors, and mental health issues such as depression, so if these symptoms arise, it is essential to consult a doctor immediately. If the medication is discontinued suddenly, seizures may worsen, so it is vital to taper off the medication gradually under a physician's guidance. Some animal studies have reported the potential for tumorigenesis, but the effects on humans are not yet clear. If symptoms of pancreatitis, such as persistent upper abdominal pain or nausea, occur during use, the medication should be stopped immediately, and a physician should be notified. Precautions are necessary for children aged 3 to 12, as side effects such as mood instability, aggression, decreased concentration, and hyperactivity may occur. The concurrent use of this medication with narcotics or central nervous system depressants may lead to respiratory depression, severe drowsiness, or coma, so it's essential to consult a physician. This medication should not be administered to patients with allergic reactions or acute pancreatitis, or those with certain genetic disorders. Patients with renal impairments, the elderly, those with a history of psychotic disorders, and women who are pregnant or breastfeeding should use this medication cautiously and consult a physician if they plan to conceive. Drowsiness or dizziness may occur during use, so caution should be taken in activities such as driving or operating dangerous machinery. If the medication is suddenly discontinued after long-term use, withdrawal symptoms such as anxiety, insomnia, and tremors may arise, so a physician's guidance on gradual cessation is necessary. This medication may interact with other drugs, so all medications being taken should be disclosed to a physician, particularly when combined with antacids, oral contraceptives, or central nervous system depressants. Taking this medication within the first three months of pregnancy may affect the fetus, so consult a physician if currently pregnant or planning to conceive. Women who are breastfeeding should be aware that this medication can pass into breast milk, so they should discuss with a physician whether to discontinue breastfeeding or not. Side effects such as weight gain, visual disturbances, skin rashes, and blood abnormalities may occur, so regular check-ups and monitoring are essential. Children and the elderly have different risks for side effects, requiring special attention. In case of overdose, dizziness, drowsiness, or coma may occur, so keep out of reach of children and adhere strictly to the prescribed dose. It is critical to strictly follow the physician's instructions to use this medication safely, and it is important to report any unusual symptoms immediately to the healthcare provider.

Suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, disordered thinking, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hypersensitivity reactions, nystagmus, drowsiness, disordered thinking, tremors, single contractions, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, malaise, facial swelling, allergy, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraines, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular ectopy, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland enlargement, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, hypoestrogenism, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, contusions from 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, contractures, dizziness, hyperactivity, sensory abnormalities, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, reduced proprioception, subdural hematoma, apathy, hallucinations, reduced or lost libido, agitation, paranoia, depersonalization, altered states of pleasure, hypersensitivity, hallucinatory states, suicidal impulses, mental disorders, chorea, athetosis, orofacial dyskinesia, brain diseases, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, local myoclonus, sensory hypersensitivity, reduced motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behaviors, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, rhinorrhea, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin nodules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal shedding, maceration, skin necrosis, localized swelling, hematuria, urinary disorders, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation abnormalities, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, testicular pain, hyperglycemia, hypoglycemia, gynecomastia, 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, movement disorders, dystonia, hypertonia, tachycardia, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, tongue paralysis, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensations, malaise

This medication should be stored in a tightly closed container to protect it from exposure to air or moisture. It is important to maintain a storage temperature between 1°C and 30°C at room temperature. This storage will ensure the drug's efficacy is preserved safely.

Appearance

White or off-white hard gelatin capsule containing powder or granules.

Package unit

30 capsules/bottle, 100 capsules/bottle