Gabapentin 100 mg Capsule

Adult dose

Epilepsy — 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 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, as an initial dose, one 300 mg capsule of this drug 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.) The duration of treatment should be determined according to 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 must be discontinued, or if it is administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. Neuropathic pain — Adults (18 years 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: 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, as an initial dose, one 300 mg capsule of this drug may be administered 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day of gabapentin within 1 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. The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. Frailty In frail patients with low body weight or patients after transplant surgery, the dose of this drug should be increased in increments of 100 mg. Elderly patients Dose adjustment may be necessary due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients undergoing hemodialysis: Dose adjustment is required based on the following table. 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 below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 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; do not administer this drug on days when hemodialysis is not performed. Method and duration of administration This drug should be swallowed whole with plenty of 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. If a dose of this drug is missed (more than 12 hours have elapsed since the most recent dose), the physician should determine whether an additional dose should be given to make up for the missed dose. When administered concomitantly with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. The duration of treatment with this drug should be determined according to clinical need. If the dose of this drug is reduced, treatment is discontinued, or the drug is switched to another alternative, this should be done gradually over at least 1 week (a longer period may be needed at the prescriber's discretion). To reduce the main adverse reactions, 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: To achieve a maintenance dose of 30 mg/day per kg body weight of gabapentin, titrate gradually over the first 3 days of treatment as follows. Day 1: administer 10 mg/kg body weight of gabapentin; Day 2: administer 20 mg/kg body weight of gabapentin; From Day 3: administer 30 mg/kg body weight of gabapentin. If necessary, the dose may be increased up to a maximum of 40 mg/kg body weight per day. When administering this medicine, the total daily dose should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts and behaviors, so if mood changes or symptoms of depression occur during treatment, it must be reported to healthcare professionals immediately. Discontinuation of this drug suddenly can worsen seizures or lead to a continuous state of epilepsy, thus it should be tapered off gradually according to the physician's instructions. Serious adverse effects such as pancreatitis may occur with long-term use, so if symptoms like abdominal pain, nausea, or vomiting occur, the medication should be stopped immediately, and medical attention should be sought. In pediatric patients, neuropsychiatric adverse effects such as emotional instability, hostility, reduced concentration, and hyperactivity may occur, so guardians should monitor carefully. Co-administration of this drug with narcotics or other central nervous system depressants may lead to severe drowsiness or respiratory depression, so it's essential to follow the physician's advice in such cases. If any allergic reactions, skin rashes, or difficulty breathing arise, the medication should be stopped immediately, and emergency treatment should be obtained. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, and it is generally safer not to use it during pregnancy unless in special circumstances. Women who are breastfeeding should also consult a professional as this drug may be secreted in breast milk and may need to be discontinued temporarily while on treatment. Elderly patients or those with reduced kidney function may require dosage adjustments, so it should be taken under medical supervision. Dizziness or drowsiness may occur while taking this medication, so caution is advised when driving or operating machinery. This medication can cause side effects such as weight gain, vision disturbances, and memory impairments, necessitating regular health check-ups. Overdosage may result in coma or severe symptoms, so strict adherence to prescribed doses is crucial, and immediate medical care should be sought if overdose is suspected. When storing this medication, keep it out of reach of children and store it in the original container to prevent misuse or degradation of quality.

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, abnormal coordination, dizziness, dysarthria, insomnia, nervous hypersensitivity, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, impotence, asthenia, lethargy, facial swelling, hypertension, anorexia, gingivitis, arthralgia, dizziness, hyperactivity, increased reflex movements, decrease or absence, sensory abnormalities, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, viral infections, fever, drowsiness, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of prodrome, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, asthenia, low back pain, cold syndrome, headache, infection, pain, dry mouth, indigestion, bloating, nausea, vomiting, peripheral edema, weight gain, gait abnormalities, amnesia, ataxia, confusion, dizziness, sensory decrease, drowsiness, thought disorder, tremors, vertigo, dyspnea, pharyngitis, rash, amblyopia, asthenia, lethargy, facial swelling, allergy, systemic edema, weight loss, chills, feelings of strangeness, 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, ventricular extrasystole, bradycardia, 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, liver enlargement, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, angular cheilitis, salivary gland hypertrophy, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, goiter, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, ecchymosis due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, tendinitis, arthritis, joint rigidity, joint swelling, benign Romberg test, costochondritis, osteoporosis, pouchitis, contracture, confusion, depression, nervous irritability, perceptual abnormalities, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorders, dream disturbances, dysarthria, emotional instability, nystagmus, confusion, perioral sensory abnormalities, abnormal euphoria, hypersensitivity, decreased motor function, suicide attempt, anxiety, hypertonia, increased libido, movement disorders, fasciculations, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulceration, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin malignancy, skin discoloration, skin thickening, visual disturbances, ear pain, eye abnormalities, taste disturbance, hearing loss, conjunctival injection, diabetic retinopathy, ocular pain, microhemorrhage in the fundus, retinal vein thrombosis, taste loss, urinary tract infection, micturition disorders, impotence, incontinence, vulvar molluscum contagiosum, mastalgia, menstrual abnormalities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile engorgement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, lingual paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reaction, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic responses, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, hepatic myoclonus, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This drug must be stored in a tightly closed container to prevent air or moisture intrusion, and it should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage maintains the drug's effectiveness and prevents deterioration.

Appearance

Hard capsule with white or pale gray powder inside, both ends white.

Package unit

30 capsules/bottle, 300 capsules/bottle