New Gaba Capsule 100mg (Gabapentin)

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients 13 years of age 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 three times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medicine may be administered three 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 of age 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 three times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medicine 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 must not exceed 3,600 mg of gabapentin. The total daily dose of this medicine should be administered in 3 divided doses. 3. Frail patients: In frail patients with low body weight or patients following transplant surgery, the gabapentin dose should be increased in increments of 100 mg. 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 of 80 mL/min or less) 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 administered in 3 divided doses. b: A dose of 3 × 100 mg should be administered 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. 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 an adequate amount of 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), the physician should determine whether an additional dose should be taken to make up for the missed dose. 3) When administered with antacids containing magnesium or aluminum, this medicine should be taken 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. 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 treatment with this medicine is to be discontinued, or if 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 longer than 5 months have not been evaluated. 6) To reduce the main adverse reactions, including somnolence, dizziness, fatigue, and ataxia, the first dose on the first day should be taken at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years to 12 years: Day 1: Administer 10 mg/kg of body weight of gabapentin Adjunctive therapy in children aged 3 years to 12 years: Day 2: Administer 20 mg/kg of body weight of gabapentin Adjunctive therapy in children aged 3 years to 12 years: From Day 3 onward: Administer 30 mg/kg of body weight of gabapentin Adjunctive therapy in children aged 3 years to 12 years: The dose may be increased as needed up to a maximum of 40 mg/kg of body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors, so if mood changes or symptoms of depression occur during treatment, a physician should be consulted immediately. Additionally, stopping this medication abruptly may result in more frequent seizures or worsen epilepsy status, so dosage should be gradually reduced under the guidance of a physician. Long-term use may lead to symptoms such as weight gain, visual disturbances, drowsiness, and dizziness, so it is important to regularly monitor the patient's condition. This medication should be used with caution in patients with impaired kidney function, elderly patients, pregnant women, breastfeeding women, and patients with certain genetic disorders. When co-administered with central nervous system depressants or narcotic analgesics, there may be a risk of respiratory depression or severe sedation, so these medications should be taken under medical supervision. If sudden abdominal pain, nausea, or vomiting occurs, it could indicate pancreatitis, and the medication should be discontinued immediately, followed by consultation with medical staff. This medication may cause allergic reactions or severe skin rashes, including anaphylaxis, so if symptoms such as rashes or difficulty breathing occur, it should be discontinued immediately and medical assistance sought. In children, central nervous system symptoms such as emotional instability, aggression, and decreased concentration may occur, so caregivers should observe closely. During pregnancy, it may affect the fetus, so it is essential to consult a physician before taking it if pregnancy is planned or if one is pregnant, and careful consideration is needed during breastfeeding. Avoid driving or operating dangerous machinery while on this medication, as dizziness or drowsiness may occur after taking it. Overdose may lead to symptoms such as dizziness, drowsiness, and coma, but generally, supportive care leads to recovery; however, patients with severe renal failure may require dialysis. Finally, this medication should be kept out of reach of children, and stored in its original container to prevent misuse or degradation of quality.

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, abdominal pain, back pain, fatigue, fever, headache, viral infections, vasodilation, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, dysfunction of coordination, dizziness, dysarthria, insomnia, neurodermal response, nystagmus, drowsiness, thought disorders, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial swelling, hypertension, bloating, anorexia, gingivitis, purpura, arthralgia, hyperactivity, abnormal reflex movements, sensory disturbances, anxiety, pneumonia, urinary tract infection, visual disturbances, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of warning signs, laryngeal neuralgia, sleepwalking, pseudo croup, hoarseness, myasthenia, injuries due to accidents, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory deficits, trembling, vertigo, shortness of breath, thrombocytopenia, anaphylaxis, angioedema, urticaria, alopecia, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myotonic cramps, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, Stevens-Johnson syndrome, tinnitus, incontinence, withdrawal symptoms (anxiety, insomnia, nausea, pain, sweating, trembling, headache, depression, abnormal sensations, dizziness, lethargy)

This medication must be stored in a tightly closed container to protect it from exposure to air or moisture. Recommended storage temperature is between 1 degree Celsius and 30 degrees Celsius.

Appearance

Hard capsules filled with a white to grayish-white powder or granules

Package unit

30 capsules/bottle, 200 capsules/bottle