Neurogafen Capsule 100 mg (Gabapentin)

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients 13 years of age 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 onward: 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, 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 of age 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 onward: 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, 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; 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. Debilitated patients: In debilitated 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 of 80 mL/min or less) 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 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) This medicine should be swallowed whole with sufficient 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 medicine is missed (12 hours or more have elapsed since the last dose), the physician should decide whether an additional dose should be administered to make up for it. 3) When used concomitantly with antacids containing magnesium or aluminum, administer this medicine 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 (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 medicine 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. 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 the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years: To achieve a maintenance dose of gabapentin 30 mg/day per kg of body weight, titrate as follows over the first 3 days of treatment: - Day 1: gabapentin 10 mg/kg body weight - Day 2: gabapentin 20 mg/kg body weight - From day 3 onward: gabapentin 30 mg/kg body weight. The dose may be increased as needed 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 cause suicidal thoughts or behaviors and worsening symptoms of depression during use, so patients and caregivers should carefully monitor for these changes. Sudden discontinuation of this medication may increase the risk of seizures or lead to status epilepticus, so it should only be discontinued under the direction of a physician. Some animal studies have reported a possibility of certain types of cancer occurring with this medication, but effects in humans are still unclear. There have been rare reports of sudden and unexpected deaths during the use of this medication, so careful observation is necessary while taking it. If symptoms of pancreatitis such as persistent upper abdominal pain, nausea, or repeated vomiting occur during use, the medication should be stopped immediately and medical advice should be sought. Children aged 3 to 12 years should be monitored carefully for neuropsychiatric adverse reactions such as emotional instability, aggression, concentration issues, and hyperactivity while taking this medication. Taking this medication with central nervous system depressants, including narcotics, can lead to severe drowsiness, respiratory depression, coma, or death; thus, it must be taken under strict medical guidance. This medication should not be administered to patients with a known allergy to it or its components, as well as those with acute pancreatitis or primary generalized seizures. Patients with impaired kidney function, elderly individuals, those with a history of psychiatric disorders, children with attention deficit or behavioral disorders, pregnant women or those who might become pregnant, and lactating women should use this medication with heightened caution. During use, side effects such as dizziness, drowsiness, ataxia, memory impairment, nausea, vomiting, and weight gain may occur. It is advisable to avoid driving or operating machinery during these times. This medication may affect the fetus if used during early pregnancy, so it should generally not be taken unless under special circumstances during pregnancy. If planning to become pregnant, consult with a physician. This medication may be excreted in breast milk; therefore, breastfeeding mothers should consult with a physician before deciding whether to take it. There may be interactions with other medications or alcohol during the use of this medication, so it is essential to inform healthcare providers of all medications being taken and whether alcohol is consumed. The use of this medication must follow a physician’s prescription and guidance, and one should not abruptly stop taking or change the dosage without medical consultation. Keep it out of reach of children and ensure it is stored in its original container without transferring it to another one.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, apathy, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, indigestion, increased appetite, thirst, nausea and vomiting, leukopenia, peripheral edema, weight gain, fracture, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neuroexcitability, nystagmus, drowsiness, tremor, single contraction, 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 effect, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thromboembolism, ventricular ectopic contraction, 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, blood in stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, angular 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, purplish skin lesions 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, contractures, dizziness, hyperactivity, sensory disturbances, diminished or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disturbances, aphasia, sensory deficits, intracranial hemorrhage, hypotonia, altered sensation, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, benign Babinski syndrome, reduced proprioception, intracranial hematoma, flat affect, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, altered states of euphoria, hyperesthesia, states of hallucinations, suicidal thoughts, mental disorders, chorea, athetosis, perioral movement disorders, brain disorders, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, localized muscle cramp, sensory hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, nosebleed, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal ulcer, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, hives, male-pattern hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin nodules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin micro-nodules, subcutaneous nodules, hyperpigmentation, skin necrosis, localized swelling, hematuria, urinary disorders, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, aplastic anemia, abnormal ejaculation, renal pain, leucorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginismus, mastalgia, orchalgia, visual disturbances, cataracts, conjunctivitis, dry eyes, ocular pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, auditory loss, ear pain, tinnitus, inner ear inflammation, inflammation of the ear, taste loss, taste disorder, eyelid spasms, ocular fullness, eye irritation, accommodative disturbances, tympanic membrane perforation, sensitivity to noise, ocular accommodation disorder, epiphora, retinopathy, glaucoma, iritis, corneal disorders, lacrimal gland dysfunction, eye atrophy, blindness, retinal degeneration, mydriasis, choroidal retinitis, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disturbances, urinary tract infection, urinary disorders, erectile dysfunction, urinary incontinence, vaginismus, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile erection, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency to urinate, urinary disorders, tongue paralysis, increased serum creatine phosphokinase activity, rhabdomyolysis, acute renal failure, hives, allergic reactions, hair loss, 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, athetosis, motor disorders, dystonia, metabolic muscle cramps, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, malaise

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is safely stored at room temperature between 1 degree and 30 degrees Celsius. This ensures the prolonged effectiveness of the medication.

Appearance

A white or off-white powder or granules packed in white hard capsules (upper and lower part).

Package unit

30 capsules/bottle, 100 capsules/bottle