Gabatril 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 as gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer 1 capsule of this medicine 300 mg once daily, or 1 capsule of this medicine 100 mg 3 times daily (gabapentin 300 mg/day) - Day 2: Administer 1 capsule of this medicine 300 mg twice daily, or 2 capsules of this medicine 100 mg 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer 1 capsule of this medicine 300 mg 3 times daily, or 3 capsules of this medicine 100 mg 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, 1 capsule of this medicine 300 mg may be administered 3 times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day as gabapentin, and 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 over the first 3 days of treatment as follows. - Day 1: Administer 1 capsule of this medicine 300 mg once daily, or 1 capsule of this medicine 100 mg 3 times daily (gabapentin 300 mg/day) - Day 2: Administer 1 capsule of this medicine 300 mg twice daily, or 2 capsules of this medicine 100 mg 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer 1 capsule of this medicine 300 mg 3 times daily, or 3 capsules of this medicine 100 mg 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, 1 capsule of this medicine 300 mg may be administered 3 times daily (gabapentin 900 mg/day). If necessary, 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. The total daily dose of this medicine should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, 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 undergoing 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: Administer 3 × 100 mg every 2 days. In patients with creatinine clearance <15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dosage for patients undergoing 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 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 administered with or without food. When administered 3 times daily, take care that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this medicine is missed (12 hours or more have elapsed since the most recent dose), the physician should decide whether an additional dose should be administered to make up for it. 3) When used with antacids containing magnesium or aluminum, administer this medicine 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. Treatment of epilepsy generally requires long-term administration. There is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to sudden discontinuation of treatment), but sudden 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 effects, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be taken at bedtime.

Child dose

1) Adjunctive therapy in children aged 3 to 12 years - Day 1: administer 10 mg/kg of gabapentin - Day 2: administer 20 mg/kg of gabapentin - Day 3 onward: administer 30 mg/kg of gabapentin The dose may be increased, as needed, to a maximum of 40 mg/kg per day. When administering this drug, divide the total daily dose into 3 doses.

This medication is used for the treatment of epilepsy and neuropathic pain. Mental health issues such as suicidal thoughts or behaviors may arise during treatment, so both patients and caregivers should inform their doctor immediately if these symptoms occur. Stopping this medication suddenly can increase the risk of more severe seizures or status epilepticus, so it should be gradually discontinued under the guidance of a physician. Long-term use may cause side effects such as weight gain, drowsiness, dizziness, or movement disorders, so regular monitoring of the patient's condition is necessary. Especially in children aged 3 to 12 years, neurological side effects such as emotional instability, aggression, abnormal thinking, and hyperactivity may occur, requiring caution. This medication can cause serious side effects such as excessive drowsiness or respiratory suppression when taken with central nervous system depressants or opioids; therefore, strict medical supervision is required when combined. Patients with impaired kidney function, the elderly, those with a history of mental illness, pregnant women, or nursing mothers should be especially cautious when using this medication. Additionally, this drug can cause severe allergic reactions such as pancreatitis, serious skin reactions, or anaphylaxis, so discontinue use immediately and consult a healthcare professional if related symptoms appear. If taken during pregnancy, it may affect the fetus, so women planning a pregnancy or who are pregnant should consult their doctor. It is advisable to avoid hazardous activities like driving or operating machinery while taking this medication. Finally, it is important to take the medication exactly as prescribed and consult a healthcare professional immediately if any unusual symptoms arise.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, deep sedation, respiratory suppression, coma, death, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, dysfunction of cooperation, dizziness, dysarthria, insomnia, hypersensitivity reactions, nystagmus, drowsiness, thought disorder, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, bloating, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, increased, decreased, or absent reflex movements, sensory abnormality, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, coagulopathy, loss of precursors, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, injury due to an accident, cold syndrome, infection, pain, dry mouth, gait abnormalities, confusion, tremors, dizziness, dyspnea, rash, weakness, lethargy, facial edema, allergy, generalized edema, weight loss, chills, unfamiliar sensations, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, blood in stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, sialadenosis, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid hypertrophy, low estrogen, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, confusion, depression, hyperexcitability, perceptual abnormalities, insomnia, neuropathy, decreased libido, anxiety, depersonalization, diminished reflexes, speech disorders, dream abnormalities, dysarthria, emotional instability, stupor, perioral sensory abnormalities, euphoric states, hypersensitivity, decreased motor function, suicide attempts, restlessness, increased tension, increased libido, movement disorders, myoclonic jerks, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, urinary tract infection, urination disorders, erectile dysfunction, urinary incontinence, vulvar moniliasis, 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 hypertrophy, chest pain, toxic epidermal necrolysis, eosinophilia, drug eruption 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 contractions, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headaches, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is safest to keep it at room temperature between 1°C and 30°C. This storage will help maintain the efficacy of the drug.

Appearance

Hard capsules of light yellow color containing white or grayish powder or granules

Package unit

30 capsules/bottle, 100 capsules/bottle