Neurontin Capsule (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, 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 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3: 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, as an initial dose, one 300 mg capsule of this medicine 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.) 2. Neuropathic pain Adults (18 years 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 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3: 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, as an initial dose, one 300 mg capsule of this medicine may be administered 3 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. When taking this medicine, the total daily dose should be divided into 3 doses. 3. Debilitated patients : In debilitated patients with low body weight or patients following 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 ≤80 mL/min) 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: 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 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, 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 (more than 12 hours have elapsed since the most recent dose), whether to administer an extra dose to make up for the missed dose should be determined by a physician. 3) When used 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. There is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to sudden discontinuation of treatment); however, sudden discontinuation of anticonvulsants in patients with epilepsy may cause status epilepticus. If treatment with this medicine is to be discontinued, or if it is to be used in combination with another anticonvulsant, 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 taken at bedtime.

Child dose

Adjunctive therapy for children aged 3 years to 12 years: To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate gradually over the first 3 days of treatment as follows. Day 1: Administer 10 mg/kg of body weight of gabapentin; day 2: Administer 20 mg/kg of body weight of gabapentin; from day 3 onward: Administer 30 mg/kg of body weight of gabapentin. The dose may be increased to a maximum of 40 mg per kg of body weight per day as needed. Divide the total daily dose of this drug into 3 doses.

This medication is a type of antiepileptic agent used for the treatment of epilepsy or neuropathic pain. Negative changes in mental health, such as suicidal thoughts or behaviors, and depression may occur during treatment, so patients and caregivers should report any such symptoms to healthcare providers immediately. Abruptly discontinuing this medication can lead to an increase in seizure frequency or worsen into a prolonged seizure state, so it should be gradually reduced in dosage according to a physician's instructions. Serious side effects, such as pancreatitis, may rarely occur, so if persistent upper abdominal pain, nausea, or recurrent vomiting occurs, immediate discontinuation of the medication and medical attention is necessary. Particularly when administered to children, there is a need for careful observation for potential neuropsychiatric side effects, such as mood swings, aggression, decreased concentration, and hyperactivity. Co-administration with central nervous system depressants, such as narcotic analgesics, can lead to dangerous symptoms like drowsiness or respiratory depression, so it must only be used at the lowest effective dose for a short duration after consulting a physician. This medication should not be used in patients with certain genetic diseases, acute pancreatitis, or specific types of seizures. Patients with impaired kidney function, the elderly, those with a history of mental illness, pregnant or breastfeeding women should use this medication cautiously, and dose adjustments may be necessary. During treatment, side effects such as dizziness, drowsiness, ataxia, nausea, vomiting, weight gain, visual disturbances, etc., may occur; patients should inform healthcare providers of such symptoms. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, and caution is also necessary while breastfeeding. This medication is recommended for children aged 3 years and older, and for children under 13 years, a physician's judgment is necessary due to insufficient experience with monotherapy. In cases of overdose, symptoms such as dizziness, drowsiness, or coma may occur, but generally supportive treatment can lead to recovery. This medication should be stored out of reach of children and kept in its original container to prevent misuse or deterioration of quality.

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, persistent seizure state, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, deep sedation, respiratory depression, coma, death, abdominal pain, back pain, fatigue, fever, headache, vasodilation, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired cooperation, dizziness, dysarthria, insomnia, neural hyperreactivity, nystagmus, drowsiness, thought disorder, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial swelling, hypertension, abdominal distension, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, increased, decreased or absent reflexes, sensory disturbances, anxiety, pneumonia, urinary tract infection, visual impairment, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of warning signs, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injury from accident, cold syndrome, infection, pain, dry mouth, abdominal distension, gait abnormalities, confusion, sensory loss, tremors, vertigo, dyspnea, blood coagulation disorders, rash, weakness, lethargy, facial swelling, allergy, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thromboembolism, ventricular extrasystole, bradycardia, premature atrial contraction, 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, dental discoloration, angular cheilitis, salivary gland hypertrophy, 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, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, confusion, depression, neural hyperactivity, perceptual disturbances, insomnia, neuropathy, decreased sex drive, anxiety, depersonalization, diminished reflexes, speech disorders, dream disturbances, dysarthria, emotional instability, stupor, perioral sensory disturbances, abnormal euphoria, hypersensitivity, decreased motor function, suicide attempt, agitation, tension, increased libido, motor disorders, muscle fasciculations, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, nasal bleeding, hemoptysis, degeneration, itching, skin ulcers, dry skin, shingles, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, urinary tract infection, voiding disorders, erectile dysfunction, urinary incontinence, vulvovaginal candidiasis, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile engorgement, gynecomastia, nocturia, pyelonephritis, scrotal swelling, frequency of urination, urgency, urinary abnormalities, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reaction, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, drug rash with eosinophilia and systemic symptoms (DRESS), 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, myotonic spasm, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome (mucocutaneous syndrome), thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tongue paralysis

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius at room temperature. This will help maintain the medication's effectiveness for a longer period.

Appearance

A hard capsule containing white or grayish-white powder with a yellowish-brown cap and body.

Package unit

30 capsules/bottle, 100 capsules/bottle