Fenmix Gabapentin Capsule 100 mg

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, a starting dose of one 300 mg capsule of this medicine 3 times daily may be used (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, a starting dose of one 300 mg capsule of this medicine 3 times daily may be used (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 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 increments of 100 mg. 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: The dose should be administered as 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) 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 medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) Swallow this medicine whole with plenty of fluid. It 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 medicine is missed (more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When administered concomitantly with antacids containing magnesium or aluminum, this medicine should be taken 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 be determined according to 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 abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine is to be discontinued, or if 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 longer 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 the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years: Titrate over the first 3 days of treatment as follows to achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight. Day 1: administer 10 mg/kg of gabapentin; Day 2: administer 20 mg/kg of gabapentin; From Day 3: administer 30 mg/kg of gabapentin. If necessary, the dose may be increased 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 to treat epilepsy and neuropathic pain, and the risk of suicidal thoughts and behaviors may increase during treatment; therefore, patients and caregivers should carefully observe for mood changes or abnormal behavior. Abrupt discontinuation can worsen seizures or lead to status epilepticus, so the dosage must be titrated gradually according to the doctor's instructions. Although certain animal studies have reported a potential for tumorigenesis, the carcinogenic risk in humans is unclear. Sudden and unexpected death cases have been reported during treatment, but these are considered within the general risk range for epilepsy patients. If any severe pancreatitis symptoms, such as hemorrhagic pancreatitis, occur, medication should be stopped immediately, and medical consultation should be sought. Particularly, in children aged 3 to 12 years, neuropsychiatric adverse reactions such as emotional instability, hostility, thought disorder, and hyperactivity may occur, requiring careful monitoring. When taken with central nervous system depressants, including narcotics, this medication may increase the risk of respiratory depression, profound sedation, coma, and death; therefore, it should be used at minimal effective doses for short periods, with close patient monitoring. It should not be administered to patients with hypersensitivity, acute pancreatitis, specific types of seizures, or patients with hereditary lactose intolerance. Patients with impaired renal function, elderly patients, those with a history of psychiatric disorders, children with attention deficit disorder or behavioral disorders, and pregnant or nursing women should use this medication cautiously, particularly weighing the risks to the fetus during pregnancy. Drowsiness, dizziness, and ataxia may occur during treatment, so driving or operating hazardous machinery should be avoided, and weight gain or visual disturbances should be monitored periodically. This medication has the potential for drug dependence and abuse; therefore, patients with a history of drug abuse should be monitored more carefully. Withdrawal symptoms such as anxiety, insomnia, nausea, and tremors may occur, requiring medical guidance during drug cessation. This medication may interact with antacids, certain analgesics, oral contraceptives, etc., so patients should inform their doctor of any other medications being taken.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, aggression, thought disturbances, hyperactivity, weakness, fatigue, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neuroexcitable reactions, nystagmus, drowsiness, tremors, single contractions, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, allergy, generalized edema, weight loss, chills, feeling of strangeness, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep venous thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, extrasystole, bradycardia, immature atrial contractions, 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, angular cheilitis, sialadenosis, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasms, hyperthyroidism, hypothyroidism, goiter, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, contusions caused by trauma, anemia, lymphadenopathy, thrombocytopenia, elevated white blood cell count, lymphocytosis, non-Hodgkin lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, reduced or absent reflexes, increased reflexes, anxiety, aggression, CNS tumors, syncope, dream disorders, aphasia, sensory impairment, 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, restlessness, paranoid personality disorder, depersonalization, abnormal euphoria, hyperesthesia, hallucinosis, suicidal thoughts, mental disorders, chorea, athetosis, perioral movement disorders, brain diseases, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disturbances, meningitis, focal clonic seizures, hypersensitivity, decreased motor function, mania, neuroses, hysteria, antisocial responses, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal deformities, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, androgenic alopecia, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, melanosis, skin necrosis, localized swelling, hematuria, urinary disturbances, lichen sclerosus, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual abnormalities, menorrhagia, breast cancer, anovulation, ejaculatory abnormalities, renal pain, leucorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, testicular pain, visual disturbances, cataracts, conjunctivitis, dry eyes, ocular pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disturbances, eyelid spasms, visual discomfort, eye itching, accommodation abnormalities, tympanic membrane perforation, hypersensitivity to noise, eye focus abnormalities, watering eyes, retinal diseases, glaucoma, iritis, corneal disorders, tear function disorders, eye degeneration, blindness, retinal degeneration, miosis, chorioretinal inflammation, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disturbances, drowsiness, hyperactivity syndrome, hostility, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of prodrome, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, 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 allergic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea and athetosis, movement disorders, dystonia, myopathy, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensation, lethargy

This medication should be stored in a sealed container to protect it from air and moisture. The storage temperature should ideally be maintained between 1 and 30 degrees Celsius. This helps maintain the medication's efficacy.

Appearance

A hard capsule containing white or grayish powder or granules with a white upper and lower shell.

Package unit

30 capsules/bottle, 100 capsules/bottle