GABATEX Capsule 300 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 of gabapentin, titrate gradually over the first 3 days of treatment as follows: - Day 1: Administer one 300 mg capsule of this product once daily, or one 100 mg capsule of this product three times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this product twice daily, or two 100 mg capsules of this product three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this product three times daily, or three 100 mg capsules of this product three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this product may be administered three 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 gradually over the first 3 days of treatment as follows: - Day 1: Administer one 300 mg capsule of this product once daily, or one 100 mg capsule of this product three times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this product twice daily, or two 100 mg capsules of this product three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this product three times daily, or three 100 mg capsules of this product three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this product may be administered three times daily (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 product should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplantation, 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 ≤80 mL/min) 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 3 × 100 mg 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 product on days when hemodialysis is not performed. 6. Method and duration of administration 1) Swallow this product whole with an adequate amount 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 product is missed (i.e., 12 hours or more have elapsed since the last dose), whether to administer an additional dose to make up for it should be determined by the physician. 3) When used concomitantly with antacids containing magnesium or aluminum, administer this product at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this product. 4) The duration of treatment with this product 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 due to abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this product must be discontinued, or if it is to be used in combination 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 more 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 taken at bedtime.

Child dose

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

This medication is used for the treatment of epilepsy and neuropathic pain. While taking this medication, the risk of developing mental health issues such as suicidal thoughts or behavior and depression may increase, so patients and caregivers should inform healthcare providers immediately if such symptoms occur. Sudden discontinuation of the medication may increase the severity of seizures or lead to a prolonged seizure state, so it must be adjusted according to the physician's instructions. In some animal studies, a potential for certain cancers was observed, but the effects on humans remain unclear. Also, reports of sudden and unexpected deaths have been noted during treatment with this medication; however, these occurrences are within the normal risk range typically seen in patients with epilepsy. If symptoms of pancreatitis such as persistent upper abdominal pain, nausea, or repeated vomiting occur, the medication should be discontinued immediately, and consultation with healthcare providers is necessary. In pediatric patients, central nervous system adverse reactions such as emotional instability, aggression, decreased attention, and hyperactivity may occur, which require careful monitoring. This medication combined with central nervous system depressants such as narcotics can result in sedation, respiratory depression, coma, and potentially death, so when used together, it must be under the supervision of healthcare providers at the lowest effective dose for the shortest duration. This medication is not administered to patients with allergic reactions or drug sensitivities, acute pancreatitis, or certain seizure types. Patients with impaired kidney function, elderly persons, children with a history of psychosis, attention deficit, and behavioral disorders, pregnant women or those who may become pregnant, and nursing mothers should exercise additional caution when using this medication. Dizziness, drowsiness, ataxia, memory impairment, and changes in mood may occur during treatment, so caution is advised when driving or operating machinery. During pregnancy, particularly in the first trimester, there may be risks to the fetus, so women who are pregnant or planning to become pregnant should consult their healthcare provider before taking this medication, and nursing mothers should also exercise caution. Dosage prescribed and dosing intervals must be strictly adhered to, and the medication should not be stopped or the dose changed arbitrarily. Overdose may cause symptoms such as dizziness, drowsiness, or coma, but usually, supportive treatment is sufficient for recovery. Severe cases may require hemodialysis, so immediate medical attention should be sought. This medication must be kept out of reach of children and stored in its original container to prevent quality deterioration or misuse.

suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, cognitive disturbances, hyperactivity, deep sedation, respiratory depression, coma, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disorder, insomnia, nervous hyperreactivity, nystagmus, drowsiness, cognitive disturbances, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, bloating, anorexia, gingivitis, arthralgia, hyperactivity, increased, decreased or absent reflexes, sensory disturbances, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of symptoms, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, injuries from accidents, cold syndrome, pain, dry mouth, gait disturbances, confusion, sensory reduction, tremors, vertigo, shortness of breath, rash, myasthenia, weight loss, chills, unfamiliar feelings, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accidents, pulmonary thromboembolism, ventricular extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, stomatitis, gingival bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, blood in stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, angular cheilitis, sialadenosis, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasms, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, tendonitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, confusion, depression, hyperesthesia, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorder, dream disturbance, speech disorder, emotional instability, nystagmus, confusion, perioral sensory disturbance, abnormal ecstasy, hyperesthesia, decreased motor function, suicide attempts, restlessness, increased tension, increased libido, movement disorders, myoclonus, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, pulmonary abnormalities, epistaxis, hemoptysis, degeneration, 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 carcinoma, skin discoloration, skin thickening, urinary tract infection, urinary disorders, erectile dysfunction, urinary incontinence, vulvar dysesthesia, breast pain, menstrual abnormalities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile enlargement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased blood 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 test results, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea-acanthocytosis, movement disorders, dystonia, myotonic dystrophy, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

Yellowish hard capsule filled with white or grayish-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle