Neurocava 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 three 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 three times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine may be administered three times daily (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 three 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 three times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine 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 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: 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: ≥80 mL/min: 900∼2,400 mg/day 50∼79 mL/min: 600∼1,800 mg/day 30∼49 mL/min: 300∼900 mg/day 15∼29 mL/min: 150b∼600 mg/day <15 mL/min: 150b∼300 mg/day a: The total daily dose should be administered in 3 divided doses. b: The dose should be administered as 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 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 medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine should be swallowed whole with an adequate amount of liquid and 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 (i.e., more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be given to make up for the missed dose. 3) When used concomitantly with antacids containing magnesium or aluminum, this medicine should be administered at least 2 hours after the antacid. This can greatly 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 frequency of epileptic seizures due to abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may precipitate status epilepticus. If treatment with this medicine must be discontinued or it is 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 Day 1 should be taken at bedtime.

Child dose

1) Adjunctive therapy in children aged 3 to 12 years The dosage is gradually titrated over the first 3 days of treatment to a maintenance dose of 30 mg/day of gabapentin per kg of body weight, as follows: - Day 1: 10 mg of gabapentin per kg of body weight - Day 2: 20 mg of gabapentin per kg of body weight - From Day 3 onward: 30 mg of gabapentin per kg of body weight If needed, 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 carries a risk of developing mental health problems such as suicidal thoughts or behavior and depression during treatment. Therefore, it is crucial to inform your healthcare provider immediately if any unusual changes in mood or behavior occur during treatment. Abrupt discontinuation of this medication may lead to increased frequency of seizures or progression to status epilepticus; therefore, the dose should be gradually adjusted according to a doctor's instructions. This medication may cause serious side effects such as pancreatitis; if persistent upper abdominal pain, nausea, or vomiting occurs, stop taking it immediately and consult a healthcare provider. In children and adolescents, there is a risk of neuropsychiatric adverse reactions such as emotional instability, hostility, decreased concentration, and hyperactivity. Special caution is required. Concurrent use with central nervous system depressants, including narcotic drugs, can cause severe drowsiness, respiratory depression, or coma, so caution is advised and the minimum dose for the shortest duration is recommended. This medication should not be administered to patients with certain genetic disorders or acute pancreatitis, or patients with generalized tonic-clonic seizures. Patients with impaired kidney function, the elderly, those with a history of psychiatric disorders, pregnant women or women who may become pregnant, and nursing mothers should use this medication with special caution. Symptoms such as dizziness, drowsiness, and ataxia may occur during treatment, and caution should be taken to avoid driving or operating machinery. Various side effects such as weight gain, visual disturbances, skin rash, and blood abnormalities may occur, so patients should contact their healthcare provider if unusual symptoms appear. During pregnancy, this medication may affect the fetus, so anyone planning to become pregnant or already pregnant should consult their doctor, and nursing mothers should also take caution when using it. This medication has the potential for abuse and dependence, so patients with a history of substance abuse should be particularly cautious. When discontinuing the medication, do not do so abruptly; dosage should be gradually reduced according to a doctor's instructions, as withdrawal symptoms such as anxiety, insomnia, nausea, and tremors may occur. This medication may interact with other drugs, so be sure to inform your doctor of all medications you are currently taking, especially when taking antacids or narcotic drugs. Store in a place out of the reach of children and keep in the 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 disturbances, hyperactivity, lethargy, apathy, facial swelling, hypertension, constipation, dental anomalies, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, memory loss, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hyperreactivity, nystagmus, drowsiness, thought disturbances, tremors, single contractions, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, allergies, generalized edema, weight loss, chills, feelings of unreality, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular ectopy, 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 stool, fecal incontinence, hepatomegaly, dysphagia, burping, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, cheilitis, salivary gland hyperplasia, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid hypertrophy, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, trauma-induced bruising, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disorders, aphasia, sensory deficits, 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, paranoia, depersonalization, altered states of euphoria, hyperesthesia, hallucination state, suicidal thoughts, mental disorders, chorea, athetosis, oral movement disorders, brain diseases, nerve paralysis, personality disorders, increased libido, substance abuse, apraxia, fine motor control disorders, meningitis, focal myoclonus, sensory hypersensitivity, reduced motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal polyps, bronchospasm, hypoventilation, pulmonary edema, alopecia, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal shedding, maceration, skin nodules, melanosis, skin necrosis, localized swelling, hematuria, urinary disorders, frequency, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, heavy menstrual bleeding, breast cancer, amenorrhea, ejaculation abnormalities, kidney pain, white vaginal discharge, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, dysmenorrhea, breast pain, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, papilloma, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, blepharospasm, eye pressure, itching eyes, accommodation abnormalities, tympanic membrane perforation, auditory hypersensitivity, ocular fixation abnormalities, epiphora, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye atrophy, blindness, retinal atrophy, miosis, chorioretinitis, strabismus, Eustachian tube dysfunction, otitis interna, otitis externa, olfactory abnormalities, asthenia, lethargy, facial swelling, allergic reactions, abscess, chills, chills and fever, mucosal abnormalities, body odor, cysts, hernias, abnormal BUN levels, neck masses, pelvic pain, septicemia, viral infections, syncope, palpitations, migraines, congestive heart failure, vasodilation, angina, heart failure, increased capillary fragility, phlebitis, varicosities, gastrointestinal inflammation, increased appetite, gastrointestinal anomalies, oral candidiasis, gastritis, tongue abnormalities, thirst, dental abnormalities, stool abnormalities, anorexia, abnormal liver function tests, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcers, fecal incontinence, increased gamma-glutamyl transpeptidase, gingivitis, intestinal obstruction, intestinal ulcers, melena, oral ulcers, rectal abnormalities, rectal bleeding, stomatitis, diabetes, petechial bleeding, lymphoproliferative reactions, decreased prothrombin, edema, gout, hypoglycemia, weight loss, increased alkaline phosphatase, diabetic ketoacidosis, increased lactic dehydrogenase, arthritis, arthralgia, myalgia, arthrosis, leg cramps, myasthenia, shin pain, joint disorders, tendon disorders, confusion, depression, hyperreactivity, perceptual abnormalities, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorders, dream alterations, dysarthria, emotional instability, nystagmus, confusion, peri-oral sensory abnormalities, altered states of euphoria, sensory hypersensitivity, reduced motor function, suicide attempts, agitation, hypertonicity, increased libido, movement disorders, myoclonus, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, pulmonary abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, shingles, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular eruptions, acne, hair abnormalities, papular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, vision abnormalities, ear pain, eye abnormalities, taste distortion, hearing loss, conjunctival hyperemia, diabetic retinopathy, ocular pain, microhemorrhage in the fundus, retinal venous thrombosis, taste loss, urinary tract infections, urinary disorders, erectile dysfunction, urinary incontinence, vaginal candidiasis, breast pain, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequency, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, 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 including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, hyperactivity, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal feelings, lethargy

This medication may be sensitive to air or moisture, so it must be stored in a sealed container. It is advisable to maintain the storage temperature between 1 degree Celsius and 30 degrees Celsius at room temperature to prolong the medication's efficacy and prevent degradation.

Appearance

A hard capsule with a white or grayish-white powder inside.

Package unit

30 capsules/bottle, 200 capsules/bottle, 100 capsules/box [10 capsules/PTP X 10]