Samsung Gabapentin Capsule 100mg

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 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 a starting 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.) 2. 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 a starting 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 one week, and 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 after transplant surgery, the dose of gabapentin 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 undergoing 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: Administer 3 × 100 mg every 2 days. In patients with creatinine clearance <15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) 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, and 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 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 more than 12 hours have elapsed since the last dose), whether an additional dose should be taken to make up for it should be determined by the physician. 3) When used concomitantly with antacids containing magnesium or aluminum, this drug should be administered 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. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (an increase in the 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 if it is 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 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

1) Adjunctive therapy in children aged 3 years to 12 years: To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate gradually over the first 3 days of treatment as follows. Day 1: administer 10 mg/kg of body weight of gabapentin; Day 2: administer 20 mg/kg of body weight of gabapentin; From Day 3: administer 30 mg/kg of body weight of gabapentin. The dose may be increased, if necessary, to a maximum of 40 mg/kg of body weight per day. When administering this medicine, divide the total daily dose into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors, so mood changes or abnormal behaviors should be closely monitored during treatment. Discontinuing this medication abruptly may lead to more severe seizures or a prolonged seizure state, so it must be tapered off gradually according to a doctor's instructions. This medication can cause serious side effects such as pancreatitis; therefore, if persistent upper abdominal pain, nausea, or vomiting occurs during treatment, you should stop taking it immediately and notify your healthcare provider. Especially in children, neuropsychiatric side effects such as emotional instability, aggression, decreased concentration, and hyperactivity may occur, so caregivers must monitor closely. Taking this medication with central nervous system depressants, including narcotics, may lead to severe drowsiness, respiratory depression, or comatose states; if necessary, it should be used at the minimum dose for a short period under strict medical supervision. This medication should not be administered to patients with certain genetic disorders, acute pancreatitis, or primary generalized seizures, and caution should be exercised in elderly patients or those with a history of mental illness, pregnant or nursing women. Various side effects such as dizziness, drowsiness, ataxia, memory impairment, nausea, vomiting, and weight gain may occur; consult your doctor if any unusual symptoms arise. During pregnancy, it may affect the fetus, so women planning to become pregnant or who are pregnant should consult their physician before taking this medication, and nursing women should also follow their doctor's instructions. It is advisable to avoid driving or operating hazardous machinery while taking this medication, and do not discontinue it arbitrarily; adhere to the prescribed usage and dosage. In case of overdose, symptoms such as dizziness, drowsiness, or coma may appear, but recovery generally occurs with supportive treatment, so seek immediate medical attention for proper care. This medication should be stored out of the reach of children and kept in its original container to prevent misuse or deterioration of quality.

Suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, lethargy, facial edema, hypertension, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neuro-excitability responses, nystagmus, drowsiness, thought disorders, tremors, single contractions, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial edema, allergy, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular ectopy, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, decreased appetite, bloating, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, sialadenosis, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity syndrome, sensory abnormalities, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, benign Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoid personality disorder, depersonalization, abnormal euphoria, hypersensitivity, hallucinatory state, suicidal impulses, mental disorders, chorea, athetosis, peri-oral movement disorders, brain disease, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, focal myoclonic spasms, sensory hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal discharge, bronchospasm, hypopnea, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, melanosis, skin necrosis, localized swelling, hematuria, urination disorders, polyuria, cystitis, retention of urine, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, heavy menstruation, breast cancer, galactorrhea, ejaculation abnormalities, kidney pain, leukorrhea, genital itching, kidney stones, acute kidney failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency in urination, vaginismus, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eye, eye pain, glare, bilateral or unilateral ptosis, retinal hemorrhage, milia, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, eyelid twitching, hypersensitivity, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of prodrome, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, tongue paralysis, increased serum creatine phosphokinase levels, rhabdomyolysis, acute kidney failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, drug eruption accompanied by eosinophilia and 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, motor disorders, dystonia, predictable palpitations, pancreatitis, sexual dysfunction, skin and mucosal syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. It's important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help to keep the medication effective.

Appearance

Hard capsule with a white or off-white powder inside, white on the top and bottom

Package unit

30 capsules/bottle, 100 capsules/bottle