Neverpentin Capsule 300 Milligrams (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 as gabapentin, titrate the dose over the first 3 days of treatment as follows. - 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 2 times daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: 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 as gabapentin, and the total daily dose must not exceed 2,400 mg as gabapentin.(There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose over the first 3 days of treatment as follows. - 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 2 times daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: 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 necessary, the dose may be increased to 1,800 mg/day as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. When administering this drug, the total daily dose 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: Dose adjustment may be required 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) 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 drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) This drug should be swallowed whole with sufficient fluid and may be administered 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 to prevent recurrence of seizures. 2) If a dose of this drug is missed (if more than 12 hours have passed since the most recent dose), the physician should decide whether an additional dose should be administered to make up for it. 3) When used with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this drug. 4) The duration of administration of this drug should be based on clinical need. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to be discontinued or it is to be used in combination 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 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 administered at bedtime.

Child dose

Children aged 3 to 12 years — Day 1: Administer gabapentin 10 mg/kg body weight; daily dose 10 mg/kg body weight Children aged 3 to 12 years — Day 2: Administer gabapentin 20 mg/kg body weight; daily dose 20 mg/kg body weight Children aged 3 to 12 years — From Day 3: Administer gabapentin 30 mg/kg body weight; maintenance dose 30 mg/day/kg body weight 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 cause mental health issues such as suicidal thoughts or behaviors, therefore, if any symptoms of depression or mood changes occur during treatment, it is important to inform medical personnel immediately. Sudden discontinuation of the medication can lead to increased frequency of seizures or result in a serious epileptic condition, so it must be discontinued gradually according to a doctor's guidance. Some animal studies suggest this drug may be associated with the occurrence of certain cancers, but the risk in humans is not yet clear. There have been reports of unexpected deaths during treatment with this drug, so careful monitoring of the condition during use is advised. If symptoms of pancreatitis such as persistent abdominal pain, nausea, or vomiting appear, the medication should be stopped immediately and medical personnel consulted. Children aged 3 to 12 may experience neuropsychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity, so caution is necessary. The concomitant use of this drug with CNS depressants, including opioids, can lead to severe drowsiness, respiratory depression, comatose states, and death, so they should only be used when absolutely necessary and at the lowest possible dose for a short duration. Patients with a history of allergic reactions to this drug, acute pancreatitis, or certain types of seizures should avoid use. Patients with renal impairment, the elderly, those with a history of psychiatric disorders, children with attention deficit or behavioral disorders, pregnant or planning to become pregnant women, and nursing mothers should use this drug with caution. Dizziness or drowsiness may occur during treatment, so driving or operating dangerous machinery should be avoided. Weight gain may occur, so weight should be checked regularly and dietary adjustments and exercise should be conducted as needed. If ocular symptoms (amblyopia, diplopia, etc.) occur, immediate consultation with medical personnel is necessary, and if severe skin reactions or anaphylaxis symptoms develop, the medication should be stopped immediately. This drug has the potential for dependence or misuse, so patients with a history of substance abuse should be particularly cautious in its use. Abrupt discontinuation can lead to withdrawal symptoms such as anxiety, insomnia, nausea, and tremors, so dosage should be adjusted gradually under medical supervision. There may be interactions with other medications, so it is essential to inform medical personnel about other medications being taken or if alcohol is being consumed. During pregnancy, there may be risks to the fetus, therefore, pregnant or planning to become pregnant individuals must discuss this with medical personnel.

Suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst or dry mouth, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neurosensitivity response, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, allergy, generalized edema, weight loss, chills, feeling foreign, weakness, alcohol intolerance, hangover effect, hypotension, angina pectoris, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, premature ventricular contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, 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 disorder, angular cheilitis, salivary gland hypertrophy, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, increased bleeding time, 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, increased white blood cell count, lymphocytosis, Hodgkin's 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, dreamlike states, aphasia, sensory loss, intracranial hemorrhage, hypotonia, abnormal sensation, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, schizophrenia, depersonalization, altered states of euphoria, hyperesthesia, hallucinatory states, suicidal impulses, mental disorders, chorea, athetosis, peri-oral movement disorders, brain diseases, nerve paralysis, personality disorders, increased libido, organic suppression, apraxia, fine motor control disorders, meningitis, local myoclonus, hypersensitivity, reduced motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspirational pneumonia, hyperventilation, hiccups, laryngitis, nasal obstruction, nasal mucosal erosion, bronchial spasm, hypoventilation, pulmonary edema, alopecia, 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 nodules, darkening of the skin, skin necrosis, localized swelling, hematuria, dysuria, frequency, bladder inflammation, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, amenorrhea, ejaculation abnormalities, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency, dyspareunia, mastalgia, testicular pain, visual abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, meibomian cyst, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disorders, eye twitching, fullness in the ear, eye itching, accommodation abnormalities, tympanic membrane perforation, noise sensitivity, eye focal abnormalities, epiphora, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroidal retinitis, strabismus, Eustachian tube dysfunction, inner ear inflammation, external ear inflammation, olfactory disorders, dehydration, infectious mononucleosis, hepatitis, blood clotting abnormalities, loss of prodromal signs, laryngeal neuralgia, somnambulism, pseudo-croup, hoarseness, injuries due to accidents, cold syndrome, pain, dry mouth, gait abnormalities, confusion, tremors, dizziness, dyspnea, bronchitis, rash, chest pain, soft tissue inflammation, lethargy, cervical pain, allergic reactions, abscess, chills, chills and fever, mucosal abnormalities, body odor, cysts, hernia, abnormal BUN levels, cervical masses, pelvic pain, sepsis, viral infections, syncope, palpitations, congestive heart failure, vasodilation, gastrointestinal inflammation, gastrointestinal abnormalities, oral candidiasis, gastritis, tongue abnormalities, dental abnormalities, stool abnormalities, abnormal liver function test results, 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 hemorrhage, lymphoproliferative response, decreased prothrombin, edema, gout, hypoglycemia, weight loss, increased alkaline phosphatase, diabetic ketoacidosis, increased lactate dehydrogenase, arthritis, arthrosis, leg cramps, myasthenia, shin pain, joint disorders, tendon disorders, neuropathy, decreased libido, speech disorders, dreamlike states, emotional instability, stupor, peri-oral sensory abnormalities, altered euphoria, hyperesthesia, reduced motor function, suicide attempts, agitation, hypertonia, movement disorders, myoclonus, vestibular dysfunction, increased cough, rhinitis, sinusitis, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, skin abnormalities, fungal dermatitis, boil disease, herpes simplex, sweating, vesicular rash, hair abnormalities, maculopapular rash, nail abnormalities, skin cancer, skin thickening, ear pain, eye abnormalities, taste distortion, hearing loss, conjunctival injection, diabetic retinopathy, eye pain, microscopic hemorrhage in the fundus, retinal vein thrombosis, taste loss, urinary tract infections, dysuria, urinary incontinence, vaginal candidiasis, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile enlargement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequency of urination, urgency to urinate, 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 accompanied by systemic symptoms, elevated liver function test results, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea and athetosis, movement disorders, dystonia, sarcoidosis, palpitations, pancreatitis, sexual dysfunction, skin and mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensation, lethargy

This medication must be stored in a tightly sealed container to protect it from exposure to air or moisture. The recommended storage temperature is room temperature, between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and ensure its safe use.

Appearance

A hard capsule filled with a white or grayish-white powder in yellowish coloration.

Package unit

30 capsules/bottle, 200 capsules/bottle