Seoul Gabapentin Capsule 300 Milligrams

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 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 three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug may be administered three times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin; 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 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 three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug may be administered three times daily (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. The total daily dose of this drug should 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 increments of 100 mg. 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: Administer 3 × 100 mg 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; 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 sufficient fluid and may be administered with or without food. When administered 3 times daily, care should be taken to 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 (if more than 12 hours have elapsed since the last dose), whether to administer an additional dose to make up for it should be determined by the physician. 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 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 (increased seizure frequency due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to be discontinued, or if it is to be coadministered 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 Day 1 should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years: To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate the dose over the first 3 days of treatment as follows. Day 1: administer 10 mg/kg of body weight as gabapentin; Day 2: administer 20 mg/kg of body weight as gabapentin; From Day 3 onward: administer 30 mg/kg of body weight as gabapentin. The dose may be increased, if necessary, 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 is used for the treatment of epilepsy and may increase the risk of mental health issues such as suicidal thoughts or behavior, and depression, so mood changes or unusual behaviors should be carefully monitored during treatment. Also, if this medication is stopped abruptly, seizures may worsen or exacerbate into a status epilepticus, so it should be discontinued gradually according to the doctor's instructions. In some animal studies, the potential for certain cancers has been reported; however, this risk has not been definitively demonstrated in humans, and the direct correlation with tumor occurrence in clinical trials is unclear. There have been reports of sudden and unexpected deaths during treatment, but this may be related to the risks of epilepsy itself, so caution is advised. If symptoms of pancreatitis, such as persistent upper abdominal pain, nausea, or recurrent vomiting occur during treatment, discontinue use immediately and consult a physician. When administering to children aged 3 to 12 years, it is necessary to carefully monitor for neuropsychiatric side effects such as emotional instability, hostility, thought disorder, and hyperactivity. When taken with central nervous system depressants or narcotics, increased risk of sedation, respiratory depression, coma, and in severe cases, death may occur; thus it should only be used when necessary and at the minimum dosage for a short duration under close observation of the patient. This medication should not be administered to patients with allergies to this medication or its components, or to patients with acute pancreatitis or generalized tonic-clonic seizures. In patients with impaired kidney function, elderly patients, those with a history of psychiatric disorders, children with attention deficit disorders, pregnant women, and nursing mothers, care should be taken during administration, particularly during pregnancy as it may affect the fetus. Always consult with a physician if planning pregnancy or if already pregnant. Drowsiness, dizziness, or ataxia may occur during treatment, thus it is advisable to avoid driving or operating dangerous machinery. Suddenly discontinuing after long-term use may lead to withdrawal symptoms such as anxiety, insomnia, nausea, and tremors, and medication should be adjusted according to the physician's instructions. Various adverse reactions may occur during treatment, including weight gain, vision abnormalities, and skin rashes; if severe skin reactions or anaphylaxis symptoms occur, discontinue use immediately and inform healthcare personnel. This medication should be stored out of the reach of children and kept in its original container to prevent misuse or degradation of quality.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, lethargy, fatigue, facial swelling, 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, neurotic reactions, nystagmus, drowsiness, tremors, single contractions, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, myasthenia, lethargy, facial swelling, allergy, generalized edema, weight loss, chills, feelings of strangeness, weakness, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, murmurs, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ectopic beats, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, decreased appetite, bloating, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased saliva secretion, gastritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland hypertrophy, 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, ecchymosis due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, decreased or absent reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, 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, dysphoria, sensitization, hallucination state, suicidal impulses, mental disorders, chorea, athetosis, oral motor dysfunction, brain diseases, neuropathy, personality disorders, increased libido, substance inhibition, apraxia, fine motor control disorders, meningitis, local myoclonus, hypersensitivity, reduction of motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal obstruction, nasal polyps, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, skin dryness, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal desquamation, maceration, skin nodules, melasma, skin necrosis, localized swelling, hematuria, urination disorders, frequency, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, abnormal menstruation, menorrhagia, breast cancer, amenorrhea, ejaculation disorders, renal pain, leukorrhea, genital itching, nephrolithiasis, acute kidney injury, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginal pain, breast pain, testicular pain, visual disturbances, cataracts, conjunctivitis, dry eye, ocular pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear infection, taste loss, taste disturbances, blepharospasm, fullness in the ear, eye itching, accommodation disturbances, tympanic membrane perforation, sensitivity to noise, ocular fixation abnormalities, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, chorioretinal inflammation, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disturbances, myasthenia, lethargy, facial swelling, allergic reactions, abscess, chills, chills and fever, mucosal abnormalities, body odor, cysts, hernia, abnormal BUN levels, cervical mass, pelvic pain, sepsis, viral infection, syncope, palpitations, congestive heart failure, vasodilation, cholecystitis, cholelithiasis, duodenal ulcer, fecal incontinence, increased gamma-glutamyl transpeptidase, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcer, fecal incontinence, increased gamma-glutamyl transpeptidase, gingivitis, intestinal obstruction, intestinal ulceration, melena, oral ulcers, rectal abnormalities, rectal bleeding, stomatitis, diabetes, edema, gout, hypoglycemia, weight loss, increased alkaline phosphatase, diabetic ketoacidosis, increased lactate dehydrogenase, arthritis, arthralgia, muscle pain, arthropathy, leg cramps, myasthenia gravis, shin pain, joint disorders, tendon disorders, confusion, depression, neuroticism, sensory disturbances, insomnia, neuropathy, decreased libido, anxiety, depersonalization, reduced reflexes, speech disorders, dream disorders, dysarthria, emotional instability, nystagmus, confusion, oral sensory disturbances, dysphoria, sensory sensitization, reduced motor function, suicide attempts, agitation, hypertonia, increased libido, movement disorders, myoclonus, vestibular disorders, increased coughing, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, skin dryness, 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, visual disturbances, ear pain, eye abnormalities, taste disturbance, hearing loss, conjunctival hyperemia, ocular pain, fundal microhemorrhage, retinal venous thrombosis, taste loss, urinary tract infections, urination disorders, erectile dysfunction, urinary incontinence, vaginal marionette syndrome, breast pain, menstrual abnormalities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase levels, rhabdomyolysis, acute kidney injury, urticaria, allergic reactions, alopecia, 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 reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, dysautonomia, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal feelings, lethargy

This medication should be stored in a tightly sealed container to protect it from air and moisture. The optimal storage temperature is between 1 and 30 degrees Celsius at room temperature.

Appearance

Capsules with white or gray-white powder or granules inside, with light yellow hard capsules for the upper and lower parts.

Package unit

30 capsules/bottle, 100 capsules/bottle