Canagabapentin Capsule 400mg (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: 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 twice daily or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3: 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, instead of the above regimens, one 300 mg capsule of this medicine 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.) 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: 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 twice daily or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3: 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, instead of the above regimens, one 300 mg capsule of this medicine 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. The total daily dose of this medicine 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 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: Administer 3 × 100 mg every 2 days. In patients with creatinine clearance <15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) 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 medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine 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 in order to prevent recurrence of seizures. 2) If a dose of this medicine is missed (if 12 hours or more have elapsed since the most recent dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When this medicine is administered with antacids containing magnesium or aluminum, it should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. 4) The duration of treatment with this medicine 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), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine is to be discontinued or it is to be used in combination 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, including somnolence, dizziness, fatigue, and ataxia, the first dose on the first day should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 years or older and 12 years or younger: To achieve a maintenance dose of gabapentin 30 mg/day per kg of body weight, titrate gradually over the first 3 days of treatment as follows. Day 1: administer gabapentin 10 mg/kg body weight; Day 2: administer gabapentin 20 mg/kg body weight; From Day 3: administer gabapentin 30 mg/kg body weight. If necessary, the dose may be increased 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 may increase the risk of suicidal thoughts or behaviors, so notify healthcare professionals immediately if mood changes or symptoms of depression occur during treatment. Abrupt discontinuation of this medication may result in more frequent seizures or a prolonged state of epilepsy; therefore, it is essential to gradually taper off under a physician's guidance. Weight gain may occur with long-term use, so regular monitoring of weight is necessary, and dietary control along with exercise should be considered if needed. This medication can affect the central nervous system, causing dizziness, drowsiness, and ataxia, so it is safe to avoid driving or operating dangerous machinery during the initial dosing period. Caution is especially required when this medication is used in conjunction with narcotics or central nervous system depressants, as it may lead to respiratory depression or severe sedation. If symptoms of pancreatitis emerge (persistent upper abdominal pain, nausea, recurrent vomiting), discontinue use immediately and seek medical attention. This medication can cause allergic reactions or severe skin reactions (such as Stevens-Johnson syndrome), so if symptoms such as rash or fever occur, immediate consultation with a physician is necessary. During pregnancy, it may affect the fetus, so consult with a physician before taking if there is a possibility of pregnancy or if already pregnant, and effective contraceptive methods should be used in conjunction. If breastfeeding, this medication may be excreted in breast milk and affect the baby, so it is important to discuss breastfeeding with a physician. Patients with impaired kidney function or the elderly may require dose adjustments, and should take the medication under medical supervision. In children, especially those aged 3 years to 12 years, behavioral changes such as emotional instability, aggression, and hyperactivity may occur, hence close observation is warranted. Drug interactions may occur when taking this medication with other drugs or alcohol, so inform healthcare professionals of all medications being taken. Adhere strictly to the prescribed dosage and dosing regimen, and do not increase or discontinue the treatment without consultation.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, abnormal thinking, hyperactivity, weakness, apathy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, muscle pain, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neuroexcitability, nystagmus, drowsiness, abnormal thinking, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, boredom, facial swelling, allergy, generalized edema, weight loss, chills, feeling strange, lethargy, alcohol intolerance, hangover effects, hypotension, angina pectoris, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, abdominal distension, 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, cheilitis, sialadenosis, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, decreased or absent reflexes, increased reflexes, anxiety, hostility, CNS tumor, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, benign Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, psychosis, depersonalization, euphoria, hyperacusis, hallucinatory states, suicidal thoughts, mental disorders, chorea, athetosis, oromotor dysfunction, brain disorders, neuropathy, personality disorder, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, focal myoclonus, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial response, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal obstruction, rhinorrhea, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, melanoma, skin necrosis, localized edema, hematuria, urinary disorders, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual abnormalities, menorrhagia, breast cancer, anovulation, ejaculation abnormalities, renal pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, testicular pain, vision abnormalities, cataract, conjunctivitis, dry eye, ocular pain, photophobia, bilateral or unilateral ptosis, subconjunctival hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, loss of taste, taste disturbances, eyelid twitching, exophthalmia, eye itching, accommodative dysfunction, tympanic membrane perforation, noise sensitivity, ocular fixation disorders, overflow tears, retinopathy, glaucoma, iritis, corneal abnormalities, tear function disorders, eye degeneration, blindness, retinal degeneration, miosis, choroiditis, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disturbances, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of appetite, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, trauma-related injuries, cold syndrome, infection, pain, gait abnormalities, confusion, trembling, vertigo, dyspnea, bronchitis, rash, urinary tract infection, chest pain, soft tissue inflammation, cervical pain, allergic reaction, abscess, chills, chills and fever, mucosal abnormalities, body odor, cysts, hernia, abnormal BUN levels, neck masses, pelvic pain, sepsis, viral infection, syncope, palpitations, congestive heart failure, vasodilation, gastrointestinal inflammation, gastrointestinal abnormalities, oral candidiasis, gastritis, tongue abnormalities, dental abnormalities, stool abnormalities, abnormal liver function tests, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcer, fecal incontinence, increased gamma-glutamyl transferase, gingivitis, intestinal obstruction, intestinal ulcers, melena, oral ulcers, rectal abnormalities, rectal bleeding, stomatitis, diabetes, petechial hemorrhage, lymphoproliferative reaction, decreased prothrombin, edema, gout, hypoglycemia, weight loss, increased alkaline phosphatase, diabetic ketoacidosis, elevated lactate dehydrogenase, arthritis, arthrosis, leg cramps, myasthenia, shin pain, joint disorders, tendon disorders, neuropathy, decreased libido, speech disorders, dream disturbances, emotional instability, confusion, perceptual disturbances around the mouth, euphoria, hypersensitivity, decreased motor function, suicide attempts, anxiety, heightened tension, movement disorders, myoclonus, vestibular dysfunction, increased coughing, sinusitis, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, fungal dermatitis, furunculosis, hair abnormalities, papulopustular rash, nail abnormalities, skin carcinoma, skin hypertrophy, urinary tract infection, urinary disorders, oromycotic syndrome, mastalgia, 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, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, 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 including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, movement disorders, dystonia, hyperkinetic muscle spasms, palpitations, pancreatitis, sexual dysfunction, skin and mucosal syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensations, fatigue

Store this medication in a tightly closed container to prevent exposure to air and moisture, and it is safe to keep at room temperature between 1 to 30 degrees Celsius. This will help to maintain the efficacy of the medication for an extended period.

Appearance

Yellow hard capsules containing white or pale gray powder or granules

Package unit

30 capsules/bottle, 100 capsules/bottle