Osgabacapsule 100 mg (Gabapentin)

Adult dose

1. Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose gradually over the first 3 days of treatment as follows: - Day 1: Take one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Take one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Take one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medicine may be taken 3 times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day as gabapentin, but the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose gradually over the first 3 days of treatment as follows: - Day 1: Take one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Take one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Take one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medicine may be taken 3 times daily (gabapentin 900 mg/day). If needed, the dose may be increased to 1,800 mg/day as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. When taking this medicine, the total daily dose 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 100 mg increments. 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 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 divided into 3 doses. b: The dose should be administered as 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 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 plenty of fluid and may be taken with or without food. When administered 3 times daily, care should be taken to 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 last dose), the physician should decide whether an additional dose should be taken to make up for the missed dose. 3) When used with antacids containing magnesium or aluminum, this medicine should be taken at least 2 hours after the antacid. This can greatly 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 (an increase in the frequency of epileptic seizures following sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine needs to be discontinued, or if it is to be used 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 more 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 should be taken at bedtime.

Child dose

Adjunctive therapy for children aged 3 years to 12 years — Day 1: Administer gabapentin 10 mg/body weight (kg) Adjunctive therapy for children aged 3 years to 12 years — Day 2: Administer gabapentin 20 mg/body weight (kg) Adjunctive therapy for children aged 3 years to 12 years — From Day 3 onward: Administer gabapentin 30 mg/body weight (kg) Adjunctive therapy for children aged 3 years to 12 years — The dose may be increased as needed to a maximum of 40 mg per kg of body weight daily. When administering this medicine, divide the total daily dose into 3 doses.

This medication may cause mental health issues such as suicidal thoughts or behavior; therefore, patients should be carefully monitored for changes in mood or behavior while taking it. Discontinuation should not be abrupt, as seizures may increase in frequency; doses should be gradually reduced according to a physician's instructions. Weight gain can occur with prolonged use, so weight should be monitored regularly, and dietary and exercise management should be employed as necessary. This medication can cause drowsiness and dizziness, so driving or operating hazardous machinery after taking it is advised against. In particular, children may exhibit neuropsychiatric symptoms such as emotional instability, hyperactivity, and decreased concentration, so caregivers should observe them closely. Patients with impaired kidney function or the elderly may require dose adjustments, and women who are pregnant or planning pregnancy should consult their physician. Caution is required when taking this medication with other central nervous system depressants, especially opioid analgesics, due to the increased risk of sedation or respiratory depression. If symptoms such as abdominal pain, nausea, or vomiting persist, it may indicate serious side effects like pancreatitis, and medical attention should be sought immediately. Additionally, if symptoms such as skin rash, fever, or swollen lymph nodes occur, it may indicate a severe allergic reaction, and the medication should be discontinued immediately, consulting a doctor afterward. This medication can cause drug dependence, so a history of drug abuse should be confirmed and managed carefully before and after use.

Suicidal ideation, suicidal behavior, depression, abnormal mood and behavior changes, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, apathy, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysphonia, insomnia, hyperreactivity, nystagmus, drowsiness, thought disorders, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, apathy, facial swelling, decreased appetite, gingivitis, arthralgia, dizziness, hyperactivity, increased or decreased reflexes, sensory abnormalities, anxiety, hostility, pneumonia, urinary tract infection, visual abnormalities, viral infections, fever, drowsiness, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of signs, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory loss, tremor, vertigo, dyspnea, thrombocytopenia, hematuria, urinary disorders, urgency, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anorgasmia, ejaculation problems, neuropathy, decreased libido, depersonalization, insomnia, suicide attempt, anxiety, tension, increased libido, movement disorders, muscle cramps, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, asthma, pneumonia, epistaxis, itching, skin ulcers, dry skin, shingles, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, increased serum creatine phosphokinase levels, rhabdomyolysis, acute kidney failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, 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, myotonic syndromes, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensations, apathy

This medication should be kept in a tightly closed container, protected from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White hard capsule containing white or grayish-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle