Shinil Gabapentin Capsule 300 mg

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients 13 years of age and older To achieve a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Take 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: Take one 300 mg capsule of this drug 2 times daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day). - From Day 3: Take 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, as a starting dose, one 300 mg capsule of this drug may be taken 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 of age and older): To achieve a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Take 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: Take one 300 mg capsule of this drug 2 times daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day). - From Day 3: Take 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, as a starting dose, one 300 mg capsule of this drug may be taken 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. When taking this drug, the total daily dose should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients who have undergone transplantation, the dose of gabapentin 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 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 creatinine clearance. 2) Dosage for patients on 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 plenty of fluids 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, in order to prevent recurrence of seizures. 2) If a dose of this drug is missed (if 12 hours or more have elapsed since the most recent dose), the physician should decide whether an additional dose should be taken to make up for the missed dose. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after the antacid. This can greatly 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 (an increase in the frequency of epileptic seizures due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to be discontinued, or if it is to be used concomitantly 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 major 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 gabapentin 10 mg/kg of body weight - Day 2: Administer gabapentin 20 mg/kg of body weight - From Day 3 onward: Administer gabapentin 30 mg/kg of body weight The dose may be increased as needed to a maximum of 40 mg per kg of body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behavior, so mood changes or behavioral abnormalities should be closely monitored during treatment. Abruptly stopping the medication may result in worsening seizures or a prolonged seizure state, so it should be discontinued gradually according to the physician's instructions. This drug may cause pancreatitis, especially hemorrhagic pancreatitis; therefore, if upper abdominal pain or nausea and vomiting occur, the medication should be discontinued immediately and the patient should seek medical attention. In children aged 3 to 12 years, emotional instability, hostility, decreased concentration, and hyperactivity may occur as adverse neuropsychiatric reactions. This medication should be used with caution and only after consulting with a physician when taken in conjunction with narcotics or other central nervous system depressants, as it may result in deep sedation, respiratory depression, coma, or even death. This medication should not be administered to those with allergies to this drug or its ingredients, or to patients with acute pancreatitis or generalized tonic-clonic seizures. Individuals with poor renal function, the elderly, those with a history of mental illness, pregnant women or those who may become pregnant, and nursing mothers should use this medication cautiously and strictly follow the physician's instructions. Dizziness, drowsiness, confusion, and decreased attention may occur during treatment, so it is advisable to avoid driving or operating dangerous machinery. Various side effects such as weight gain, visual disturbances, skin rash, allergic reactions, and liver function abnormalities may occur, so if any abnormal symptoms arise, immediate consultation with healthcare professionals is advised. Use during pregnancy may affect the fetus, therefore, women planning to become pregnant or currently pregnant should consult a physician. Caution is also needed in nursing mothers. This medication has not been established as safe and effective in children, especially those under 3 years of age, and should not be administered. In cases of overdose, dizziness, drowsiness, and diminished consciousness may occur, and in severe cases, proper treatment at a hospital should be sought. Always take this medication according to the physician's prescription and instructions, and be cautious not to arbitrarily discontinue or change the dosage. Keep out of reach of children and store it in the original container to prevent misuse or degradation of quality.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbances, hyperactivity, abdominal pain, low back pain, fatigue, fever, headache, viral infection, vasodilation, 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, neuroexcitability, nystagmus, drowsiness, thought disturbances, tremor, single contractions, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, bloating, loss of appetite, gingivitis, petechiae, joint pain, hyperactivity syndrome, reflex movement changes, sensory disturbances, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infections, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of warning signs, laryngeal neuralgia, somnambulism, pseudo-croup, hoarseness, injuries due to accidents, cold syndrome, pain, dry mouth, walking abnormalities, confusion, sensory loss, tremor, dizziness, dyspnea, rash, tongue paralysis, myasthenia, lethargy, facial edema, allergy, generalized edema, weight loss, chills, strange sensations, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thromboembolic venous disease, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular extrasystole, 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, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, 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, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, costochondritis, osteoporosis, bursitis, contractures, confusion, depression, neuroexcitability, perceptual disturbances, insomnia, neuropathy, decreased libido, anxiety, depersonalization, diminished reflexes, speech disorders, dream disturbances, speech disorders, emotional instability, stupor, perceptual abnormalities around the mouth, anomalous euphoria, hypersensitivity, decreased motor function, suicide attempt, agitation, hypertonia, increased libido, movement disorders, fasciculations, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, shingles, skin abnormalities, fungal dermatitis, boil disease, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinoid, skin discoloration, skin thickening, urinary tract infection, urination disorders, erectile dysfunction, urinary incontinence, vulvar dyslexia, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile swelling, gynecomastia, enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, abnormal urination, tongue paralysis, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensations, lethargy

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is recommended to keep it at room temperature, between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

Appearance

A hard capsule with a yellowish color containing a white to grayish powder.

Package unit

30 capsules/bottle, 100 capsules/bottle