Cileptin Capsule 100mg (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 gradually 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 twice daily, or 2 capsules of this medication, each containing 100 mg, 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medication 3 times daily, or 3 capsules of this medication, each containing 100 mg, 3 times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medication 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.). 3) The duration of treatment should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to sudden discontinuation of treatment), 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 administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) 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 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 twice daily, or 2 capsules of this medication, each containing 100 mg, 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medication 3 times daily, or 3 capsules of this medication, each containing 100 mg, 3 times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medication 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, and the total daily dose must not exceed 3,600 mg of gabapentin. When administering this medication, the total daily dose should be divided into 3 doses. 2) The safety and efficacy of treatment of neuropathic pain for longer than 5 months have not been evaluated. 3. Frail patients In frail patients with low body weight or patients after transplant surgery, the dose of this medication should be increased in 100 mg increments. 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 of 80 mL/min or less) 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. For patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dose for patients on hemodialysis Initial dose: Gabapentin 300~400 mg is recommended. Maintenance dose: Administer gabapentin 200~300 mg after 4 hours of hemodialysis, and do not administer this medication on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medication should be swallowed whole with plenty of fluid and may be taken with or without food. When administered 3 times daily, take care that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this medication is missed (12 hours or more have elapsed since the most recent dose), whether to administer an additional dose to make up for it should be determined by the physician. 3) When administered concomitantly with antacids containing magnesium or aluminum, this medication should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medication. 4) The duration of treatment with this medication should depend on clinical need. When reducing the dose, discontinuing treatment, or switching to another alternative medication, do so gradually over at least 1 week (a longer period may be necessary at the prescriber's discretion). 5) To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be taken at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years through 12 years Titrate over the first 3 days of treatment as follows to achieve a maintenance dose of gabapentin 30 mg/kg/day. - Day 1: Administer gabapentin 10 mg/body weight (kg) - Day 2: Administer gabapentin 20 mg/body weight (kg) - From day 3 onward: Administer gabapentin 30 mg/body weight (kg) If necessary, the dose may be increased to a maximum of 40 mg/kg/day. The total daily dose of this medicine should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors, so mood or behavioral changes should be carefully monitored during treatment. Abruptly stopping this medication may lead to more frequent seizures or progress to status epilepticus, so it should be discontinued only under the guidance of a physician. Long-term use may result in weight gain, so regular weight checks and dietary and exercise measures may be necessary. This medication may cause dizziness, drowsiness, and ataxia, so caution is advised with activities like driving or operating machinery. When taken with narcotics or other central nervous system depressants, there is a risk of sedation or respiratory depression, so strict medical supervision is necessary during concurrent use. If symptoms of pancreatitis (persistent upper abdominal pain, nausea, recurrent vomiting) occur, discontinue use immediately and consult a healthcare professional. Women who are pregnant or planning to become pregnant should consult a physician before using this medication and avoid its use if possible during pregnancy. Those who are breastfeeding should also inform a physician, as this medication can be excreted in breast milk, and appropriate measures should be taken. Patients with impaired kidney function may require dosage adjustments; therefore, they should follow their physician's instructions. This medication has risks of allergic reactions, severe skin rash, and anaphylaxis, so discontinue use and visit a healthcare institution if any unusual symptoms occur. Particular caution is required when administering to children and elderly persons, and if adverse reactions occur, prompt consultation with a healthcare provider is necessary. While taking this medication, it is essential to adhere strictly to the prescribed dosage and frequency, and not to arbitrarily discontinue or change the regimen.

suicidal impulse, suicidal behavior, depression, emotional instability, hostility, thought disorder, hyperactivity, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fracture, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neurogenic sensitivity reaction, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, wear, acne, itching, rash, amblyopia, diplopia, impotence, weakness, lethargy, facial edema, hypertension, abdominal distension, anorexia, gingivitis, purpura, arthralgia, hyperactivity, increased reflex activity, decreased reflex activity, sensory abnormality, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, coagulation disorder, loss of signs, laryngeal neuralgia, somnambulism, pseudo-croup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, abnormal gait, confusion, thought abnormality, tremor, vertigo, dyspnea, rash, weakness, lethargy, facial edema, allergy, systemic edema, weight loss, chills, unfamiliar sensation, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ectopic heartbeat, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland enlargement, 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, anemia, lymphadenopathy, thrombocytopenia, increased leukocyte count, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, decreased reflexes, syncope, dream disorder, aphasia, sensory impairment, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, benign Babinski syndrome, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased libido, agitation, paranoia, depersonalization, dysphoria, hyperesthesia, hallucination state, suicidal impulse, mental disorder, chorea, athetosis, perioral movement disorder, brain disease, nerve paralysis, personality disorder, increased libido, organic inhibition, apraxia, fine motor control disorder, meningitis, local focal seizures, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial response, suicidal behavior, nosebleed, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal ulceration, bronchial spasms, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, hives, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papule, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal shedding, maceration, skin nodules, subcutaneous nodules, melasma, skin necrosis, localized swelling, hematuria, urination disorder, empty urine, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, amenorrhea, ejaculation disorder, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, enuresis, pyuria, urgent urination, dyspareunia, mastalgia, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disturbance, blepharospasm, ear fullness, eye itchiness, accommodation disturbance, tympanic membrane perforation, sensitivity to noise, abnormal eye focus, overflow, retinopathy, glaucoma, iritis, corneal disorder, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroidal retinitis, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disturbance, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, hives, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensation, lethargy

This medication should be stored in a tightly sealed container to protect it from exposure to air or moisture, and it is advisable to store it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy and prevent degradation of the medication.

Appearance

White or light gray powder contained in opaque white hard capsules

Package unit

30 capsules/bottle, 300 capsules/bottle