Gabapentin Capsule 100 mg (Gabapentin)

Adult dose

Monotherapy and adjunctive therapy in patients aged 13 years and older: To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose over the first 3 days of treatment as follows. Day 1: Administer 1 capsule of this medicine 300 mg once daily, or 1 capsule of this medicine 100 mg 3 times daily (gabapentin 300 mg/day) Day 2: Administer 1 capsule of this medicine 300 mg twice daily, or 2 capsules of this medicine 100 mg 3 times daily (gabapentin 600 mg/day) Starting on Day 3: Administer 1 capsule of this medicine 300 mg 3 times daily, or 3 capsules of this medicine 100 mg 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, 1 capsule of this medicine 300 mg may be administered 3 times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day as gabapentin, and the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) Neuropathic pain, adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose over the first 3 days of treatment as follows. Day 1: Administer 1 capsule of this medicine 300 mg once daily, or 1 capsule of this medicine 100 mg 3 times daily (gabapentin 300 mg/day) Day 2: Administer 1 capsule of this medicine 300 mg twice daily, or 2 capsules of this medicine 100 mg 3 times daily (gabapentin 600 mg/day) Starting on Day 3: Administer 1 capsule of this medicine 300 mg 3 times daily, or 3 capsules of this medicine 100 mg 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, 1 capsule of this medicine 300 mg may be administered 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day as gabapentin within one week; the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this medicine should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose should be increased in 100 mg increments. Elderly patients: Dosage 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 receiving hemodialysis: Dosage adjustment is required based on the following table. Dosage for patients with renal impairment: Creatinine clearance ≥80 mL/min: Total daily dose 900∼2,400 mg/day Creatinine clearance 50∼79 mL/min: Total daily dose 600∼1,800 mg/day Creatinine clearance 30∼49 mL/min: Total daily dose 300∼900 mg/day Creatinine clearance 15∼29 mL/min: Total daily dose 150b∼600 mg/day Creatinine clearance <15 mL/min: Total daily dose 150b∼300 mg/day 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. Dosage for hemodialysis patients 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 medicine on days when hemodialysis is not performed. This medicine should be swallowed whole with an adequate amount 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 medicine is missed (more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be taken to make up for the missed dose. When used with antacids containing magnesium or aluminum, this medicine should be taken at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. The duration of treatment with this medicine should be determined according to clinical need. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (an increase in seizure frequency due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine must be discontinued or it is used concomitantly with another antiepileptic drug, changes should be made gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain lasting longer than 5 months have not been evaluated. To reduce the major adverse effects, including somnolence, dizziness, fatigue, and ataxia, the first dose on the first day should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years: Day 1: Administer gabapentin at 10 mg/kg of body weight Adjunctive therapy in children aged 3 years to 12 years: Day 2: Administer gabapentin at 20 mg/kg of body weight Adjunctive therapy in children aged 3 years to 12 years: From Day 3 onward: Administer gabapentin at 30 mg/kg of body weight 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 medicine should be divided into 3 doses.

This drug is used for epilepsy treatment, and there is an increased risk of suicidal thoughts or actions during use, so patients and caregivers should immediately inform a physician if these symptoms occur. Stopping this medication suddenly can worsen seizures or progress to status epilepticus, so it should be gradually reduced under a doctor's guidance. In some animal studies, the potential for certain cancers has been reported, but the clinical significance in humans is unclear. There have been rare reports of sudden and unexpected deaths during use, which may be related to the risks of epilepsy itself. This drug can cause severe pancreatitis symptoms, such as hemorrhagic pancreatitis, so if persistent upper abdominal pain or vomiting occurs, the medication should be discontinued immediately and a doctor consulted. Caution is necessary for children aged 3 to 12 years due to possible central nervous system adverse reactions such as emotional instability, aggression, thought disorder, and hyperactivity. Using this drug with CNS depressants, including narcotics, can cause severe drowsiness, respiratory depression, and coma; therefore, it should be used at the minimum dose for a short period, with careful monitoring of the patient. This drug should not be given to patients with specific allergic conditions or acute pancreatitis, nor to patients with lactose intolerance. Patients with renal impairment, the elderly, those with a history of psychiatric illness, pregnant women, nursing mothers, and children with behavioral disorders should be administered cautiously, and dosage adjustments may be necessary if needed. Common side effects include dizziness, drowsiness, coordination difficulties, nausea, and vomiting, so caution is advised when driving or operating hazardous machinery. During pregnancy, especially in the first trimester, there may be risks to the fetus, so women who are pregnant or plan to become pregnant must consult a physician before taking this medication. Nursing mothers should consult a physician regarding breastfeeding, as this medication may be excreted in breast milk. In cases of overdose, symptoms may include dizziness, drowsiness, and coma, but recovery is generally possible with supportive care. This medication should be kept out of reach of children and stored in its 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 disturbances, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst or dry mouth, nausea and vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, delirium, impaired coordination, dizziness, dysarthria, insomnia, hyperreactive response, nystagmus, drowsiness, thought disturbances, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial swelling, hypertension, anorexia, gingivitis, arthralgia, dizziness, hyperactivity, increased reflex movements, reduction or absence, sensory abnormalities, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, drowsiness, hostility, emotional instability, dizziness, hyperactivity, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of signs, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, weakness, lethargy, facial swelling, injury due to accident, cold syndrome, headache, infection, pain, dry mouth, dyspepsia, abdominal distension, nausea, vomiting, peripheral edema, weight gain, gait abnormalities, amnesia, ataxia, confusion, dizziness, sensory loss, drowsiness, thought disturbances, tremors, vertigo, dyspnea, pharyngitis, rash, amblyopia, weakness, lethargy, facial swelling, chest pain, soft tissue inflammation, allergic reactions, abscess, chills, mucosal abnormalities, body odor, cyst, hernia, abnormal BUN level, cervical mass, pelvic pain, sepsis, viral infection, syncope, palpitations, migraine, hypotension, peripheral vascular disorders, cardiovascular disorders, congestive heart failure, myocardial infarction, vasodilation, angina, heart failure, increased capillary fragility, phlebitis, thrombophlebitis, varicose veins, glossitis, gum bleeding, thirst, stomatitis, increased saliva secretion, gastritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, sialadenosis, lip bleeding, esophagitis, hiatal hernia, hemoptysis, rectitis, 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, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, delirium, depression, hyperreactivity, perceptual abnormalities, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorder, dream disturbances, dysarthria, emotional instability, nystagmus, confusion, perioral sensory abnormalities, unusual euphoria, hypersensitivity, decreased motor function, suicide attempt, restlessness, tension, increased libido, movement disorders, muscle fasciculations, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, furunculosis, simplex herpes, 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, incontinence, vulvovaginal disorders, mastalgia, menstrual disorders, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile swelling, gynecomastia, nocturia, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum 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 tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea and athetosis, movement disorders, dystonia, metabolic cramping, palpitations, pancreatitis, sexual dysfunction, skin and mucous membrane syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to prevent contact with air and moisture. It is best to store it at room temperature, between 1 degree and 30 degrees Celsius, to help maintain its effectiveness for a longer period.

Appearance

A hard capsule filled with white or grayish-white powder or granules with a white upper and lower part.

Package unit

Domestic use - 30 capsules/bottle, Domestic use - 100 capsules/bottle