Dong-A Gabapentin Capsule 300 Milligrams (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: Take 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: Take 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: Take 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, as a starting dose, one 300 mg capsule of this drug may be taken 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: Take 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: Take 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: Take 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, as a starting dose, one 300 mg capsule of this drug may be taken 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. The total daily dose of this drug should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients following transplant surgery, the gabapentin dose should be increased in 100 mg increments. 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 ≤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: Administer 3 × 100 mg every 2 days. For 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 drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) Swallow this drug whole with plenty of fluid. It 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 drug is missed (if more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be taken 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 seizure frequency due to sudden discontinuation of treatment), but sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with 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 longer than 5 months have not been evaluated. 6) To reduce the main adverse effects, including somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be administered at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years to 12 years - Day 1: administer gabapentin 10 mg/kg body weight - Day 2: administer gabapentin 20 mg/kg body weight - From Day 3: administer gabapentin 30 mg/kg body weight 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. There is a risk of developing mental health issues, such as suicidal thoughts or behaviors and depression, during treatment, so patients and caregivers should inform a doctor immediately if any of these symptoms appear. Sudden discontinuation of this medication may worsen seizures or lead to a prolonged state of epilepsy, so it is essential to gradually taper off the medication following a doctor's instructions. Prolonged use may lead to weight gain, drowsiness, dizziness, and ataxia, so regular monitoring is necessary. Particularly, pediatric patients may show neuropsychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity, so caution is advised. Women who are pregnant or planning to become pregnant should consult a doctor before using this medication due to potential risks to the fetus. Lactating women should discuss with a doctor whether to continue breastfeeding, as this medication may be excreted in breast milk. This medication can cause serious side effects like drowsiness and respiratory depression if taken with other central nervous system depressants or narcotics, so caution is advised during concurrent use. Patients with impaired kidney function require dosage adjustments, and any sudden abdominal pain, nausea, or vomiting during medication should be reported to healthcare professionals to rule out pancreatitis. Additionally, this medication may cause severe skin reactions or anaphylactic reactions, so if symptoms like rash, fever, or difficulty breathing occur, the medication should be discontinued immediately, and medical assistance sought. Patients should avoid driving or operating dangerous machinery while on this medication, and caution should be taken to reduce the risk of falls. Medications should be taken exactly as prescribed, and any unusual symptoms during use should be discussed with healthcare providers.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbance, hyperactivity, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst or dryness of the mouth, nausea and vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, abnormal coordination, dizziness, dysarthria, insomnia, neuroexcitation, nystagmus, drowsiness, thought disturbance, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, apathy, facial swelling, hypertension, bloating, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, increased reflex movements, decreased reflex movements, sensory disturbances, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of signs, laryngeal neuralgia, somnambulism, pseudo-croup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, abnormal gait, confusion, sensory loss, tremors, dizziness, shortness of breath, petechiae, anemia, antisocial reactions, suicide attempts, nosebleed, shortness of breath, apnea, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, hematuria, urinary disturbances, frequency, cystitis, urinary retention, incontinence, increased blood creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash accompanied by systemic symptoms, elevated liver function tests, erythema multiforme, falls, systemic edema, breast enlargement in males, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea athetosis, movement disorders, dystonia, myotonic crisis, palpitations, pancreatitis, sexual dysfunction, skin and mucous membrane syndrome, thrombocytopenia, tinnitus, incontinence, tongue paralysis, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensation, apathy

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it should be stored at room temperature, ideally between 1°C and 30°C, avoiding extremes of heat or cold.

Appearance

This medication is a hard capsule containing a white or off-white powder and has a yellowish color on the upper and lower parts.

Package unit

30 capsules/bottle, 200 capsules/bottle