Neurontin 800 mg (Gabapentin)

Adult dose

For the initial dose of this medication, 100 mg, 300 mg, and 400 mg capsules may be used. For 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 dosage forms in terms of therapeutic effect. The dose should be determined by the physician based on each patient’s individual tolerability and efficacy. 1. Epilepsy 1) 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. (1) Initial dose: 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 medication once daily, or one 100 mg capsule three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this medication twice daily, or two 100 mg capsules three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this medication three times daily, or three 100 mg capsules three times daily (gabapentin 900 mg/day) (2) Maintenance dose: Initial efficacy of this medication can be assessed at doses of 900∼1,200 mg/day of gabapentin. If higher doses are required, it is recommended to administer a 600 mg tablet three times daily for a gabapentin dose of 1,800 mg/day, or an 800 mg tablet three times daily for a gabapentin dose of 2,400 mg/day. 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) 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 (an increase in the 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 medication must be discontinued or it is to be administered with another antiepileptic drug, the change 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, titrate the dose 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 three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this medication twice daily, or two 100 mg capsules three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this medication three times daily, or three 100 mg capsules three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medication may be administered three 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; the total daily dose should not exceed 3,600 mg of gabapentin. The total daily dose of this medication 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. 4. Frail patients: In frail patients with low body weight or patients following transplant surgery, the dose of this medication should be increased in 100 mg increments. 5. Elderly patients: Dose adjustment may be required due to age-related decline in renal function (see table). 6. Patients with renal impairment (creatinine clearance ≤ 80 mL/min) 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 dose a (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 receiving 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 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 taken with or without food. When administered 3 times daily, take care not to allow intervals between doses to exceed 12 hours in order to prevent recurrence of convulsions. 2) If a dose of this medication is missed (when more than 12 hours 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 administered with antacids containing magnesium or aluminum, this medication should be taken at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medication. 4) The duration of treatment with this medication should depend on clinical need. Any dose reduction, discontinuation, or switch to another alternative medication should be carried out 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

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

This medication may increase the risk of suicidal thoughts or behavior; careful observation of mood or behavioral changes is necessary during treatment. Stopping this medication suddenly may lead to more frequent seizures or severe epileptic conditions, so the dosage should be reduced gradually under medical supervision. Some animal studies have reported a potential risk of cancer, but the risk in humans is still unclear. While unexpected sudden death cases have been reported during the use of this medication, this risk is generally within the range observed in epilepsy patients. If symptoms of pancreatitis (persistent abdominal pain, nausea, recurrent vomiting) occur, stop taking the medication immediately and consult a doctor. Taking this medication in combination with narcotics or other central nervous system depressants can cause severe drowsiness, respiratory depression, coma, and risk of death; therefore, it should only be taken in the minimum dose for a short period when absolutely necessary, under close medical observation. This medication should not be administered to patients with hypersensitivity, acute pancreatitis, or generalized tonic-clonic seizures. Caution is needed when administering to patients with impaired kidney function, the elderly, those with a history of mental illness, pregnant or potentially pregnant women, nursing mothers, children, and during long-term use. Dizziness, drowsiness, and coordination difficulties may occur; driving or operating dangerous machinery is not recommended during treatment. Various side effects such as weight gain, visual disturbances, and skin rashes may occur; immediate consultation with a doctor is necessary if abnormal symptoms arise. During pregnancy, this medication may affect the fetus, so patients planning a pregnancy or who are pregnant should consult a doctor before use, as should those who are nursing. Withdrawal symptoms may occur, so do not stop taking suddenly; dosage should be reduced gradually according to a doctor’s instructions. There may be interactions with other medications taken, including alcohol; inform the doctor of all medications being taken, and it is advisable to take antacids at intervals from this medication. Children or elderly patients may be more prone to side effects, requiring special attention. This medication should be kept out of reach of children and stored in its original container to prevent misuse or deterioration in quality.

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, status epilepticus, hemorrhagic pancreatitis, deep sedation, respiratory depression, coma, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst or dry mouth, nausea and vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disorder, emotional instability, insomnia, nervous hyperresponsiveness, nystagmus, drowsiness, abnormal thinking, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, fatigue, facial edema, hypertension, abdominal distension, anorexia, gingivitis, purpura, arthralgia, hyperactivity, increased reflex movements, decreased or absent reflexes, sensory abnormalities, anxiety, hostility, pneumonia, urinary tract infection, visual disturbance, myasthenia, cold syndrome, trauma from accident, gait disturbance, confusion, trembling, dizziness, respiratory distress, rash, chest pain, soft tissue infection, allergic reaction, abscess, chills, body odor, cyst, hernia, abnormal BUN level, neck mass, pelvic pain, sepsis, viral infection, syncope, palpitations, migraine, congestive heart failure, myocardial infarction, vasodilation, gastroenteritis, gastrointestinal abnormalities, oral candidiasis, gastritis, abnormal tongue, thirst, dental abnormalities, abnormal stools, abnormal liver function test results, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcer, fecal incontinence, increased gamma-glutamyl transpeptidase, gingivitis, intestinal obstruction, intestinal ulcer, melena, oral ulcer, rectal abnormalities, rectal bleeding, stomatitis, diabetes, purpura, anemia, lymphadenopathy, decreased prothrombin, edema, gout, hypoglycemia, weight loss, increased alkaline phosphatase, diabetic ketoacidosis, increased lactate dehydrogenase, confusion, depression, irritability, abnormal perception, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorders, dream abnormalities, speech disorder, emotional instability, confusion, perioral sensory abnormalities, euphoria, hypersensitivity, decreased motor function, suicide attempt, agitation, tension, increased libido, movement disorders, fasciculations, vestibular dysfunction, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcer, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, papular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, visual disturbances, ear pain, eye abnormalities, taste disorder, hearing loss, conjunctival hyperemia, diabetic retinopathy, ocular pain, retinal microhemorrhage, retinal vein thrombosis, taste loss, urinary tract infection, urination disorders, erectile dysfunction, urinary incontinence, vulvovaginal candidiasis, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation disorders, penile engorgement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, drug rash associated with eosinophilia and systemic symptoms, increased liver function test results, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myopathy, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensations, fatigue

This medication may be sensitive to air and moisture, so it should be stored in an airtight container. Additionally, keep it away from direct sunlight and store it in a cool room, ideally at temperatures below 25 degrees Celsius.

Appearance

White oval film-coated tablet

Package unit

100 tablets (10 tablets/blister X 10)