Newgatine M 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, titration should be carried out as follows over the first 3 days of treatment. Day 1: Administer one 300 mg capsule of this drug once daily or one 100 mg capsule of this drug 3 times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this drug twice daily or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug 3 times daily or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this drug may be administered 3 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.) 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 (an increase in the 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 drug must be discontinued, or if it is used in combination with another antiepileptic drug, changes 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, titration should be carried out as follows over the first 3 days of treatment. Day 1: Administer one 300 mg capsule of this drug once daily or one 100 mg capsule of this drug 3 times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this drug twice daily or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug 3 times daily or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this drug may be administered 3 times daily (gabapentin 900 mg/day). If needed, 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 drug should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. 3. Debilitated patients: In debilitated patients with low body weight or patients following transplant surgery, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dose adjustment may be required 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) 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: 3 × 100 mg should be administered 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 hemodialysis patients 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 drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) This drug should be swallowed whole with plenty of fluid and may be taken 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 drug is missed (when more than 12 hours have elapsed since the most recent dose), whether to administer an additional dose to make up for it should be decided by the physician. 3) When used in combination with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend on clinical need. If the dose of this drug is reduced, treatment is discontinued, or the drug is switched to another alternative, this should be done gradually over at least 1 week (a longer period may be required 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 to 12 years Aged 3 to 12 years: Day 1: Administer gabapentin 10 mg/kg body weight Aged 3 to 12 years: Day 2: Administer gabapentin 20 mg/kg body weight Aged 3 to 12 years: From Day 3: Administer gabapentin 30 mg/kg body weight Aged 3 to 12 years: If necessary, the dose may be increased up to a maximum of 40 mg/kg body weight per day. The total daily dose should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behavior, so patients should be closely monitored for symptoms of depression or unusual mood changes while taking it. Abrupt discontinuation of this medication may lead to more frequent seizures or a severe epileptic state, so dosage should be tapered gradually according to a physician's instructions. Animal studies have reported a potential risk of certain cancers, but the effects on humans are not yet clear. Some patients taking this medication have reported sudden and unexpected deaths, but a direct correlation with the drug has not been established. This medication can cause serious pancreatic diseases such as pancreatitis, so if any persistent upper abdominal pain, nausea, or repeated vomiting occurs while taking it, the patient should stop the medication immediately and consult with a healthcare provider. In children aged 3 to 12 years, there may be neurological and psychiatric abnormalities such as mood swings, aggression, decreased concentration, and hyperactivity, so caution is advised. Patients taking this medication alongside narcotics or other central nervous system depressants may experience drowsiness, respiratory depression, coma, and in severe cases, death, so extreme caution should be exercised, and dosages should be minimized when used in combination. Patients with allergic reactions or hypersensitivity to this medication, acute pancreatitis patients, certain types of seizure patients, and those with genetic lactose metabolism disorders should not take this medication. Patients with impaired kidney function, elderly individuals, those with a history of psychiatric disorders, children with attention deficit hyperactivity disorder or behavioral issues, pregnant women or those who are likely to become pregnant, and nursing mothers should use this medication with special care, and a dosage adjustment or alternative treatment should be considered as necessary. Drowsiness, dizziness, decreased concentration, etc., may occur while taking this medication, so it is recommended to avoid driving or operating hazardous machinery. A range of side effects such as weight gain, visual abnormalities, skin rashes, and blood abnormalities may occur, so if any unusual symptoms appear, immediate consultation with a healthcare provider is necessary. This medication may pose a risk to the fetus in early pregnancy, so women who are pregnant or planning to become pregnant must consult a physician, and it should also be used cautiously during breastfeeding. Abrupt discontinuation of this medication may result in withdrawal symptoms such as anxiety, insomnia, nausea, tremors, and headache, so dosage should be reduced gradually in accordance with a physician's instructions. This medication can interact with other drugs, so patients must inform and consult their healthcare provider about all medications being taken concurrently.

Suicidal thoughts, suicidal behavior, depression, abnormal mood and behavior changes, hemorrhagic pancreatitis, emotional instability, hostility, cognitive disturbances, hyperkinesia, weakness, apathy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea and vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hyperreactive response, nystagmus, drowsiness, cognitive disturbances, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, pruritus, rash, amblyopia, diplopia, erectile dysfunction, asthenia, feelings of apathy, facial swelling, allergies, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effects, 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 extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, blood in stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, angular cheilitis, salivary gland hyperplasia, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectal inflammation, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid hypertrophy, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, confusion, depression, syncope, dream abnormalities, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiparesis, facial paralysis, delirium, cerebellar dysfunction, positive Babinski sign, decreased sense of position, subdural hematoma, apathy, hallucinations, decreased or lost libido, anxiety, paranoid behavior, depersonalization, abnormal euphoria, hyperesthesia, hallucination state, suicidal ideation, psychosis, chorea, athetosis, oral-facial movement disorders, brain disease, nerve paralysis, personality disorder, increased libido, organic suppression, apraxia, fine motor control disorders, meningitis, focal myoclonic seizures, sensory hyperesthesia, decreased motor function, mania, neurosis, hysteria, antisocial response, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nose picking, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin nodules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin subnodules, subcutaneous nodules, acanthosis, skin necrosis, localized swelling, hematuria, urination disorders, frequency, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, heavy menstruation, breast cancer, anovulation, ejaculation abnormalities, renal pain, leukorrhea, genital pruritus, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, glare, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, loss of taste, taste abnormalities, eye twitching, ear fullness, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of warning signs, laryngeal neuralgia, sleepwalking, false croup, hoarseness, traumatic injury, cold syndrome, infection, pain, abdominal distension, dry mouth, gait disturbance, confusion, tremors, dizziness, dyspnea, bronchitis, respiratory infection, chest pain, soft tissue inflammation, feelings of apathy, cervical pain, allergic reaction, abscess, chills, chills and fever, mucosal abnormalities, body odor, cysts, hernia, abnormal BUN levels, cervical mass, pelvic pain, sepsis, viral infection, aphasia, dysarthria, emotional instability, delirium, perioral sensory abnormalities, abnormal euphoria, sensory hyperesthesia, decreased motor function, suicide attempt, anxiety, tension, increased libido, motor disorders, myoclonic seizures, vestibular disorders, increased cough, sinusitis, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, skin ulcers, fungal dermatitis, furunculosis, nail abnormalities, skin carcinoma, skin thickening, ear pain, eye abnormalities, taste disturbances, hearing loss, conjunctival hyperemia, diabetic retinopathy, ocular pain, retinal microhemorrhages, retinal vein thrombosis, loss of taste, urinary tract infection, urination disorders, vulvar dyschromia, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile enlargement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal enlargement, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast hypertrophy, 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, hypertensive episode, pancreatitis, sexual dysfunction, skin and mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headaches, abnormal sensation, feelings of apathy

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

A hard capsule consisting of white or grayish-white powder in the upper and lower sections.

Package unit

30 capsules/bottle, 300 capsules/bottle