Neverpentin Tablets 600 mg (Gabapentin)

Adult dose

For administration of the initial dose of this medication, 100 mg, 300 mg, and 400 mg capsules may be used. For administration of the maintenance dose, 600 mg and 800 mg tablets and 300 mg and 400 mg capsules may be used; 100 mg capsules may be used in patients requiring hemodialysis. There is no difference between the capsule and tablet formulations in achieving a therapeutic effect. The dose should be determined by the physician based on each patient's individual tolerability and efficacy. 1. Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older: This medication is effective at doses of 900～2,400 mg/day of gabapentin. The process of gradually increasing the dose to the initial maintenance dose, followed by further dose increases as needed, may be carried out relatively quickly. Initial dose: Gradual titration to a maintenance dose of 900 mg/day of gabapentin is carried out over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this medication once daily or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication twice daily or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medication 3 times daily or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Maintenance dose: Initial efficacy of this medication can be assessed at doses of 900∼1,200 mg/day of gabapentin. If higher doses are needed, administration of a 600 mg tablet 3 times daily for a gabapentin dose of 1,800 mg/day or an 800 mg tablet 3 times daily for a gabapentin dose of 2,400 mg/day is recommended. The total daily dose should 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): Gradual titration to a maintenance dose of 900 mg/day of gabapentin is carried out over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this medication once daily or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication twice daily or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medication 3 times daily or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medication 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 should not exceed 3,600 mg of gabapentin. When administering this medication, the total daily dose should be divided into 3 doses. 4. Frail patients: In frail patients with low body weight or patients after transplant surgery, the dose of this medication should be increased in increments of 100 mg. 5. Elderly patients: Dose adjustment may be necessary due to age-related decline in renal function (see table). 6. 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) Dose 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) Dose 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 medication on days when hemodialysis is not performed. 7. Method and duration of administration 1) This medication should be swallowed whole with plenty of fluid and may be administered with or without food. When administered 3 times daily, care should be taken not to allow an interval of more than 12 hours between doses to prevent recurrence of seizures. 2) If a dose of this medication is missed (more than 12 hours have elapsed since the most recent dose), the physician should determine whether an additional dose should be administered to make up for it. 3) When administered with antacids containing magnesium or aluminum, this medication should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in bioavailability of this medication. 4) The duration of treatment with this medication 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 cause status epilepticus. If this medication must be discontinued or used in combination with another antiepileptic drug, changes should be made gradually over at least 1 week. 5) In the treatment of neuropathic pain, the safety and efficacy of treatment for more than 5 months have not been evaluated. 6) To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day should be administered at bedtime.

Child dose

3. Pediatrics: When this medicine is administered as adjunctive therapy to children aged 3 years or older and 12 years or younger, the lower-strength 100 mg, 300 mg, or 400 mg capsules may be used instead of the high-strength tablet formulation.

This medication can increase the risk of suicidal thoughts or behaviors, so if mood changes or symptoms of depression occur during use, you should consult with a healthcare provider immediately. Discontinuing this medication abruptly may lead to worsening seizures or progression to a persistent epileptic state; therefore, dosage should be reduced gradually according to a physician's instructions. In animal studies, some potential for cancer development has been reported, although the effects in humans are still unclear. During the use of this medication, sudden and unexpected deaths have been reported, but these are generally within the risk range commonly observed in epilepsy patients. If symptoms of pancreatitis (persistent abdominal pain, nausea, recurrent vomiting) occur, you should stop taking the medication immediately and visit a hospital. When taken alongside central nervous system depressants or narcotics, there is a risk of severe drowsiness, respiratory depression, or coma, so caution is advised when co-administering these medications. Patients who have hypersensitivity to this medication or have acute pancreatitis, as well as those with seizures including generalized tonic-clonic seizures, should not take this medication. Patients with decreased kidney function, older adults, individuals with a history of mental illness, pregnant or breastfeeding women, and children should take special care when using this medication. During use, side effects such as dizziness, drowsiness, memory impairment, movement disorders, and depression may occur, so caution is advised when driving or operating dangerous machinery. In early pregnancy, it may affect the fetus, so women who are pregnant or planning to conceive should consult with a healthcare provider before use, and breastfeeding mothers are advised to discontinue breastfeeding while taking this medication. This medication may cause withdrawal symptoms, so do not stop abruptly and adjust the dosage according to a physician's instructions. When taking this medication, adhere to the prescribed method and dosage, and inform the healthcare provider if you are taking other medications or alcohol.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, deep sedation, respiratory depression, coma, death, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, emotional instability, insomnia, neurogenic hypersensitivity, nystagmus, drowsiness, abnormal thinking, tremors, single contractions, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, double vision, erectile dysfunction, weakness, lethargy, facial edema, hypertension, distension, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, abnormal reflex movements, sensory disturbances, anxiety, hostility, pneumonia, urinary tract infections, visual impairment, gait abnormalities, confusion, sensory loss, abnormal thought processes, tremor, vertigo, dyspnea, abnormal blood pressure, angina, palpitations, tachycardia, migraine, atrial fibrillation, heart failure, thrombotic venous inflammation, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular ectopic contraction, bradycardia, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, angular cheilitis, salivary gland hypertrophy, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasms, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, costochondritis, osteoporosis, bursitis, contracture, syncope, dream abnormalities, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, myotonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, apathy, hallucinations, decreased libido, anxiety, paranoia, depersonalization, ecstatic states, hyperesthesia, hallucinatory states, suicidal thoughts, psychosis, chorea, athetosis, perioral movement disorders, brain disorder, nerve paralysis, personality disorder, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, focal muscle cramps, sensory hypersensitivity, diminished motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal irritation, bronchospasms, 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 subnodules, subcutaneous nodules, melasma, skin necrosis, localized edema, hematuria, voiding disorders, polyuria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation disorders, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginismus, mastalgia, testicular pain, cataracts, conjunctivitis, dry eyes, ocular pain, photophobia, ptosis, retinal hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disturbances, ocular spasms, eye fullness, conjunctival hyperemia, diabetic retinopathy, ocular pain, microhemorrhage in the fundus, retinal vein thrombosis, taste loss, urinary tract infections, voiding disorders, erectile dysfunction, incontinence, vulvovaginal syndrome, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation disorders, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, pollakiuria, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, 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, systemic edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, myotonia, metabolic syndrome, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is also recommended to store the medication at room temperature between 1 degree and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle