Gabaine Capsule 100mg (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 gradually over the first 3 days of treatment as follows: - Day 1: Administer 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: Administer 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: Administer 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, one 300 mg capsule of this drug may be administered 3 times daily as the starting dose (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin; 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 gradually over the first 3 days of treatment as follows: - Day 1: Administer 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: Administer 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: Administer 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, one 300 mg capsule of this drug may be administered 3 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 drug should be divided into 3 doses. 3. Frail patients: In frail 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: Dose adjustment is required based on the following table. 1) Dosage in 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 below 15 mL/min, the dose should be reduced in proportion to the creatinine clearance. 2) Dosage in 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) This drug should be swallowed whole with sufficient 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 drug is missed (if 12 hours or more have elapsed since the last dose), the physician should determine whether an additional dose should be administered to make up for the missed dose. 3) When used concomitantly with antacids containing magnesium or aluminum, this drug should be administered 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. 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 drug must be discontinued or it is used concomitantly 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

Adjunctive therapy in children aged 3 years to 12 years: On the first day, administer gabapentin 10 mg/body weight (kg). Adjunctive therapy in children aged 3 years to 12 years: On the second day, administer gabapentin 20 mg/body weight (kg). Adjunctive therapy in children aged 3 years to 12 years: From the third day onward, administer gabapentin 30 mg/body weight (kg). Adjunctive therapy in children aged 3 years to 12 years: The dose may be increased as needed up to a maximum of 40 mg per kg of body weight per day. The total daily dose of this drug is administered in 3 divided doses.

This medication may increase the risk of suicidal thoughts or behavior; therefore, if symptoms of depression or mood changes arise during treatment, it is essential to inform a healthcare provider immediately. Abruptly discontinuing the medication can lead to increased seizure frequency or a prolonged seizure state, so the dosage must be gradually reduced under the guidance of a physician. Animal studies have reported a potential risk for certain cancers, but the risk in humans is not yet clear. Sudden and unexpected death cases have been reported during the use of this drug, which may be related to the risks associated with epilepsy itself. If symptoms of pancreatitis (persistent abdominal pain, nausea, vomiting) occur, the medication should be stopped immediately, and medical attention sought. Children aged 3 to 12 years may experience neurological and psychiatric adverse reactions such as emotional instability, aggression, decreased attention, and hyperactivity, thus caution is needed. Concomitant use of this drug with central nervous system depressants, including narcotics, may result in severe drowsiness, respiratory depression, and coma; hence, it should only be used at the minimum effective dose for a short period under close medical supervision when absolutely necessary. Patients with a history of allergic reactions to this medication, acute pancreatitis, general absence seizures, or genetic lactose intolerance should not take this drug. Patients with impaired renal function, the elderly, those with a history of psychiatric disorders, children with attention deficit disorders, and women who are pregnant or nursing should use this medication with caution. When taking this medication, neurological adverse reactions such as dizziness, drowsiness, decreased memory, and coordination disorders may occur; therefore, caution should be exercised when driving or operating hazardous machinery. In case of overdose, symptoms such as dizziness, drowsiness, and coma may occur; however, most recover with supportive care, while severely compromised renal function patients may require dialysis. This medication should be kept out of reach of children and stored in its original container to prevent misuse and degradation of quality.

suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, apathy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disorder, insomnia, neuroirritability, nystagmus, drowsiness, thought disorder, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, apathy, facial edema, hypertension, anorexia, gingivitis, arthralgia, dizziness, hyperactivity, sensory disturbances, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, viral infections, fever, drowsiness, hostility, emotional instability, hyperactivity, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of warning signs, laryngeal neuralgia, sleepwalking, croup-like syndrome, hoarseness, asthenia, low back pain, cold syndrome, headache, infection, pain, constipation, diarrhea, dry mouth, indigestion, abdominal distension, nausea, vomiting, peripheral edema, weight gain, gait abnormalities, amnesia, ataxia, confusion, dizziness, sensory loss, drowsiness, thought disorder, tremors, lightheadedness, shortness of breath, pharyngitis, rash, amblyopia, asthenia, apathy, facial edema, allergy, generalized edema, weight loss, chills, unfamiliar feelings, lethargy, alcohol intolerance, hangover effect, hypotension, angina pectoris, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thromboembolism, premature ventricular contractions, bradycardia, immature atrial contractions, 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, swallowing difficulties, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland enlargement, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushingoid appearance, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, confusion, depression, neuroirritability, perceptual disturbances, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorders, dream disorders, speech disorder, emotional instability, nystagmus, stupor, perioral perceptual disturbances, abnormal euphoria, hypersensitivity, decreased motor function, suicide attempts, restlessness, hypertonia, increased libido, movement disorders, muscle cramping, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, nosebleed, hemoptysis, degeneration, itching, skin ulcers, dry skin, shingles, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, hyperhidrosis, urticaria, vesicular rash, acne, hair abnormalities, papular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, hematuria, dysuria, anuria, bladder infection, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation abnormalities, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, dyspareunia, mastalgia, testicular pain, visual abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, glare, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disturbances, eyelid twitching, fullness in the ear, eye itching, accommodation abnormalities, tympanic membrane perforation, sensitivity to noise, eye focal point abnormalities, watering, retinopathy, glaucoma, iritis, corneal disorders, lacrimal gland dysfunction, eye degeneration, blindness, retinal degeneration, miosis, chorioretinitis, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbances, tongue paralysis, thrombocytopenia, tinnitus, urinary incontinence, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, 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, hypertensive episodes, pancreatitis, sexual dysfunction, mucous membrane syndrome, thrombocytopenia, suicidal impulses, suicidal behavior, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal feelings, apathy

This medication should be stored in a tightly sealed container to avoid exposure to air or humidity. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

A white or off-white powder contained in a hard gelatin capsule with a white upper and lower shell.

Package unit

30 C/bottle, 300 C/bottle