Nelson Gabapentin 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 during 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 twice 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, one 300 mg capsule of this drug may be administered 3 times daily as the starting dose (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 during 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 twice 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, one 300 mg capsule of this drug 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 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 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 less than 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 not to allow more than 12 hours between doses to prevent recurrence of seizures. 2) If a dose of this drug is missed (if more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be administered to make up for the missed dose. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered 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. 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 drug must be discontinued or administered concomitantly 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 longer 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 in children aged 3 to 12 years - Day 1: Administer 10 mg/kg body weight of gabapentin - Day 2: Administer 20 mg/kg body weight of gabapentin - From Day 3: Administer 30 mg/kg body weight of gabapentin The dose may be increased, if necessary, to a maximum of 40 mg/kg body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication is used for the treatment of epilepsy and neuropathic pain, and there may be an increased risk of suicidal thoughts or behaviors during use, so patients and caregivers should carefully monitor for changes in mood or abnormal behavior. Abruptly stopping this medication may lead to more frequent seizures or progression to severe status epilepticus, so the dosage must be gradually reduced according to a doctor's instructions. Some potential for increased incidence of tumors was reported in animal studies, but the risk in humans is still unclear. There have been reports of sudden and unexpected deaths occurring during the use of this medication, but the exact causal relationship is unclear as it may also be related to the risks of epilepsy itself. If serious pancreatitis symptoms, such as hemorrhagic pancreatitis, occur, discontinue the medication immediately and consult medical personnel. In children aged 3 to 12 years, central nervous system adverse reactions such as emotional instability, hostility, thought disorder, and hyperactivity may occur, so caution is warranted. Co-administration with central nervous system depressants, including narcotics, may result in sedation, respiratory depression, coma, or in severe cases, death, so it should only be administered at the minimum dose for short periods when absolutely necessary, while closely monitoring the patient. It should not be administered to patients with hypersensitivity, acute pancreatitis, certain genetic metabolic disorders, or patients with generalized absence seizures. Caution is advised in patients with renal impairment, the elderly, those with a history of psychosis, pregnant or breastfeeding women. Adverse reactions such as dizziness, drowsiness, ataxia, nausea, vomiting, weight gain, mood changes may occur, so care should be taken when driving or operating dangerous machinery. During pregnancy, it may affect the fetus, so those planning to become pregnant or are pregnant should consult medical personnel, and careful judgment is needed for those who are breastfeeding prior to administration. This medication should be kept out of reach of children and should not be transferred to other containers, but stored in the original container for safety.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, abdominal pain, back pain, fatigue, fever, headache, viral infections, vasodilation, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neuroexcitability, nystagmus, drowsiness, thought disorder, tremors, myoclonus, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, malaise, facial edema, hypertension, bloating, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, increased reflexes, decrease or absence, sensory disturbances, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infections, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of prodrome, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injuries due to accidents, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory loss, tremors, vertigo, dyspnea, rash, weakness, thought disorder, vertigo, hematuria, urination disorders, frequency, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual abnormalities, menorrhagia, breast cancer, azoospermia, ejaculation disorders, neuroexcitability, perceptual disturbances, insomnia, neuropathy, decreased libido, anxiety, depersonalization, reduced reflexes, speech disorders, dream disorders, dysarthria, emotional instability, confusion, peri-oral sensory disturbances, hypomania, hypersensitivity, decreased motor function, suicide attempts, restlessness, hypertonia, increased libido, movement disorders, myoclonus, vestibular disturbance, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, pulmonary abnormalities, epistaxis, 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 adenocarcinoma, skin discoloration, skin thickening, visual disturbances, ear pain, eye abnormalities, taste disturbances, hearing loss, urinary tract infection, urination disorders, erectile dysfunction, incontinence, vaginal atresia, mastalgia, menstrual abnormalities, polyuria, urinary retention, cystitis, ejaculation disorders, penile enlargement, gynecomastia, nocturia, pyelonephritis, scrotal enlargement, frequency, 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, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea athetosis, movement disorders, dystonia, macroscopic muscle spasms, palpitations, pancreatitis, sexual dysfunction, skin-mucosal syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, depression, abnormal sensations, malaise

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. This helps to ensure that the medication's effectiveness is maintained and can be used safely.

Appearance

A hard capsule containing white or grayish-white powder with light yellow upper and lower parts.

Package unit

30 capsules/bottle, 100 capsules/bottle