Neurontin Capsule 100 mg (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 drug once daily, or one 100 mg capsule of this drug three 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 three times daily (gabapentin 600 mg/day). - From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day). Alternatively, as a starting dose, one 300 mg capsule of this drug 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 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 drug once daily, or one 100 mg capsule of this drug three 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 three times daily (gabapentin 600 mg/day). - From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day). Alternatively, as a starting dose, one 300 mg capsule of this drug may be administered three times daily (gabapentin 900 mg/day). If needed, 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 drug should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in increments of 100 mg. 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 of 80 mL/min or less) or patients undergoing 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: Administer 3 × 100 mg every 2 days. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to the creatinine clearance. 2) Dosage for patients undergoing 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 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 taken with or without food. When administered 3 times daily, take care that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this drug is missed (12 hours or more have elapsed since the last dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When used concomitantly with antacids containing magnesium or aluminum, administer this drug 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. Treatment of epilepsy generally requires long-term administration. There is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to sudden discontinuation of treatment), but sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If this drug must be discontinued, or if it is to be used concomitantly with another antiepileptic drug, changes should be made gradually over at least 1 week. 5) The safety and efficacy of treatment for neuropathic pain for periods longer 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 Day 1 should be administered at bedtime.

Child dose

1. Epilepsy 2) Adjunctive therapy in children 3 to 12 years of age - Day 1: Administer gabapentin 10 mg/body weight (kg) - Day 2: Administer gabapentin 20 mg/body weight (kg) - From day 3: Administer gabapentin 30 mg/body weight (kg) The dose may be increased, if necessary, up to a maximum of 40 mg per kg of body weight per day. The total daily dose of this drug should be divided into 3 doses.

This medication is used to treat epilepsy and neuropathic pain and can increase the risk of suicidal thoughts or behaviors in patients; therefore, patients and caregivers should closely monitor mood changes or unusual behavior. Abruptly stopping the medication can worsen seizures or lead to status epilepticus, so the dosage must be gradually adjusted according to doctor's instructions. In some animal studies, an increased risk of certain cancers has been reported; however, the risk in humans is unclear. Sudden and unexpected death cases have been reported during the treatment, but this falls within the range of risks commonly associated with epilepsy patients. If symptoms of pancreatitis (persistent abdominal pain, nausea, recurrent vomiting) occur, discontinuation of the medication must be immediate and consultation with a healthcare professional should be sought. Particularly in children aged 3 years and older to 12 years, central nervous system adverse reactions such as emotional instability, aggression, thought disorder, and hyperactivity may occur, thus caution is needed. When taken with central nervous system depressants, including narcotics, there is a risk of severe sedation, respiratory depression, coma, or death; careful dosage adjustment and close monitoring of the patient are required when combined. It should not be administered to patients with hypersensitivity, acute pancreatitis, or generalized absence seizures, and dosage must be cautiously administered to those with renal impairment, elderly patients, or those with a history of mental illness. Side effects may occur, including dizziness, drowsiness, ataxia, amnesia, nausea, vomiting, weight gain, fatigue, etc., and if these symptoms appear, consultation with a healthcare professional is necessary. During pregnancy, especially in the first trimester, it may affect the fetus, so women who are pregnant or planning to become pregnant must consult a doctor before taking it. Caution is also needed for breastfeeding women. It is advisable to avoid activities requiring concentration, such as driving or operating machinery, during treatment, and informing the prescribing doctor about any other medications or alcohol is important due to potential interactions.

suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperkinesia, weakness, lethargy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, dysfunction of coordination, dizziness, speech disorder, insomnia, neurogenic hyperreactivity, nystagmus, drowsiness, thought disorder, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial swelling, hypertension, loss of appetite, gingivitis, arthralgia, dizziness, hyperkinesia, sensory disturbance, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, viral infection, fever, weight gain, fatigue, drowsiness, hostility, emotional instability, hyperkinesia, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, coagulopathy, loss of symptoms, laryngeal neuralgia, sleepwalking, false croup, hoarseness, weakness, low back pain, cold syndrome, headache, infection, pain, constipation, diarrhea, dry mouth, indigestion, abdominal distension, nausea, vomiting, peripheral edema, weight gain, gait disturbance, amnesia, ataxia, confusion, dizziness, sensory loss, drowsiness, thought disorder, tremors, vertigo, dyspnea, pharyngitis, rash, amblyopia, chest pain, soft tissue infection, lethargy, neck pain, allergic reaction, abscess, chills, mucosal abnormalities, body odor, cyst, hernia, elevated BUN levels, neck mass, pelvic pain, sepsis, viral infection, syncope, palpitations, migraine, hypotension, peripheral vascular disorder, cardiovascular disorder, cerebrovascular accident, congestive heart failure, myocardial infarction, vasodilation, angina, heart failure, increased capillary fragility, phlebitis, thrombophlebitis, varicose veins, gastroenteritis, increased appetite, gastrointestinal disorder, oral moniliasis, gastritis, tongue abnormalities, thirst, dental abnormalities, changes in stool, loss of appetite, abnormal liver function test results, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcer, fecal incontinence, increased gamma-glutamyl transferase, gingivitis, intestinal obstruction, intestinal ulcer, melena, oral ulcer, rectal abnormalities, rectal bleeding, stomatitis, diabetes, petechiae, anemia, lymphadenopathy, thrombocytopenia, lymphadenopathy, lymphoproliferative response, reduced prothrombin, edema, gout, hypoglycemia, weight loss, increased alkaline phosphatase, diabetic ketoacidosis, increased lactate dehydrogenase, confusion, depression, neurogenic hyperreactivity, perceptual abnormalities, insomnia, neuropathy, decreased libido, anxiety, depersonalization, reduced reflexes, speech disorders, dream abnormalities, speech disorder, emotional instability, nystagmus, confusion, perceptual abnormalities around the mouth, altered euphoria, hypersensitivity, reduced motor function, suicide attempts, agitation, hypertonia, increased libido, movement disorders, myoclonus, vestibular dysfunction, increased coughing, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcer, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, abscesses, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, papular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, urinary tract infection, voiding disorders, erectile dysfunction, incontinence, vulvar moniliasis, mastalgia, menstrual abnormalities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile engorgement, gynecomastia, enuresis, pyelonephritis, scrotal engorgement, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reaction, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function test results, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, hypersensitivity with systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, hypertensive crisis, pancreatitis, sexual dysfunction, mucous membrane syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1°C and 30°C.

Appearance

A white or grayish-white powder contained in a white hard capsule with upper and lower parts.

Package unit

30 capsules/bottle, 100 capsules/bottle