Youngil Gabapentin Capsule 100 mg

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients aged 13 years and older To reach a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer 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: Administer 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: Administer 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 administered 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 reach a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer 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: Administer 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: Administer 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 administered 3 times daily (gabapentin 900 mg/day). If needed, 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 medicine 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: 3 × 100 mg should be administered 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, 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 sufficient fluid and may be taken with or without food. When administered 3 times daily, take care not to allow more than 12 hours between doses to prevent recurrence of seizures. 2) If a dose of this medicine is missed (if more than 12 hours have elapsed since the most recent dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When coadministered with antacids containing magnesium or aluminum, administer this medicine at least 2 hours after the antacid. This can substantially 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 (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 medicine is to be discontinued or 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 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 Day 1 should be taken at bedtime.

Child dose

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

This drug is an anticonvulsant and should be monitored closely for changes in mental health, such as suicidal thoughts or behavior and depression while taking it. Abrupt discontinuation may worsen seizures, so it must be tapered off gradually as directed by a doctor. This drug can cause serious side effects like pancreatitis, so if severe abdominal pain, nausea, or vomiting occurs, discontinue immediately and consult a healthcare provider. Additionally, caution should be exercised when administering to children aged 3 to 12, as neurological and psychiatric adverse reactions such as emotional instability, hostility, decreased concentration, and hyperactivity may appear. The risk of sedation, respiratory suppression, coma, and death can increase when taken with central nervous system depressants including narcotics, so careful administration and close observation of the patient are essential when used together. This medication should not be given to patients with certain conditions, such as acute pancreatitis or certain types of seizures, and those with reduced kidney function, the elderly, patients with a history of psychiatric disorders, pregnant or breastfeeding women should consult a healthcare provider before use. Dizziness, drowsiness, and ataxia may occur during treatment, so it is advisable to avoid driving or operating hazardous machinery until accustomed to the medication. Various side effects such as weight gain, visual disturbances, and skin rashes have been reported, so any abnormal symptoms should be reported to a healthcare provider immediately. During pregnancy, there is a potential risk to the fetus, so women who are pregnant or planning to become pregnant should consult a healthcare provider before use, and caution is also necessary while breastfeeding. This medication should strictly adhere to the prescribed directions and dosage, and interactions may occur if taken with other medications or alcohol. If other medications are being taken, be sure to inform the healthcare provider. Finally, this medication has the potential for dependence and abuse, so patients with a history of drug abuse should use it with caution, and withdrawal symptoms may occur upon discontinuation, so it should be tapered off gradually under a doctor's direction.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, 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, fracture, myalgia, amnesia, ataxia, confusion, impairment of coordination, dizziness, speech disorder, insomnia, neurotic responses, nystagmus, drowsiness, thought disorder, tremor, 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 reflexes, sensory abnormality, anxiety, pneumonia, urinary tract infection, visual disturbance, viral infection, drowsiness, hostility, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of warning signs, laryngeal neuralgia, sleepwalking, pseudo croup, hoarseness, injury from accident, cold syndrome, pain, dry mouth, gait abnormality, confusion, sensory impairment, tremor, dizziness, dyspnea, rash, tongue paralysis, weakness, lethargy, facial edema, allergy, generalized edema, weight loss, chills, feelings of unreality, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thromboembolism, ventricular extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, glossitis, gum bleeding, thirst, stomatitis, increased saliva secretion, gastroenteritis, hemorrhoids, bloody stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, angular cheilitis, salivary gland enlargement, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, hypoestrogenism, 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, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, confusion, depression, neuroexcitation, perceptual abnormality, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech impairment, dream disorder, speech disorder, emotional instability, stupor, perioral sensory abnormality, ecstatic feelings, hypersensitivity, decreased motor function, suicide attempt, anxiety, heightened tension, increased libido, movement disorders, muscle cramps, vestibular disorders, increased coughing, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcer, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, boil formation, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, papular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, hematuria, urination disorders, frequency, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, heavy menstrual bleeding, breast cancer, anovulation, ejaculation abnormalities, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, dyspareunia, mastalgia, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, blepharospasm, otorrhagia, conjunctival injection, diabetic retinopathy, eye pain, microhemorrhage in the fundus, retinal vein thrombosis, taste loss, urinary tract infection, urination disorders, erectile dysfunction, incontinence, vulvar hyperplasia, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile swelling, gynecomastia, nocturia, pyelonephritis, scrotal swelling, pollakiuria, urgency, urinary abnormalities, tongue paralysis, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensations, confusion, loss of consciousness, mental disorders, falls, generalized edema, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myotonic contractions, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It should be kept at room temperature, between 1 to 30 degrees Celsius.

Appearance

Hard capsules with white or grayish white powder inside, both the upper and lower parts are white.

Package unit

30 capsules/bottle, 300 capsules/bottle