Samsung Gabapentin Capsule 300mg (Gabapentin)

Adult dosage

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 gradually 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 gradually 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 following transplant surgery, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients : Dosage 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 : Dosage 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 below 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; 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 sufficient 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, to prevent recurrence of seizures. 2) If a dose of this drug is missed (more than 12 hours have elapsed since the last dose), whether to administer an additional dose to make up for it should be determined by the physician. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after the antacid. This can significantly 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 (increased frequency of epileptic seizures due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may induce status epilepticus. If treatment with this drug is to be discontinued, or if it is to be administered 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.

Children's dosage

1) Adjunctive therapy in children aged 3 years to 12 years - Day 1: Administer gabapentin 10 mg/kg body weight - Day 2: Administer gabapentin 20 mg/kg body weight - From Day 3: Administer gabapentin 30 mg/kg body weight The dose may be increased as needed to a maximum of 40 mg/kg body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication is used for the treatment of conditions such as epilepsy and neuropathic pain. During treatment, there is a risk of the occurrence of mental health issues such as suicidal thoughts, suicidal behavior, and depression; thus, it is important that patients and caregivers notify healthcare professionals immediately if such symptoms arise. Abrupt discontinuation of this medication may increase the severity of seizures or lead to status epilepticus, hence it must be tapered gradually under a physician’s guidance. Patients with a history of allergic reactions to this drug or its components, patients with acute pancreatitis, or patients with certain types of seizures should not use this medication. Particular caution is required in patients with impaired kidney function, elderly patients, those with a history of mental illness, and pregnant or breastfeeding women, and they should consult a physician. This medication can cause various side effects including drowsiness, dizziness, fatigue, nausea, vomiting, weight gain, movement disorders, thus such symptoms must be closely monitored during treatment. Especially in children, emotional instability, aggression, decreased concentration, and hyperactivity may occur, necessitating careful observation by guardians. This medication may lead to respiratory depression or significant sedation when taken concurrently with central nervous system depressants, including narcotics; therefore, careful dose adjustment and monitoring are required when co-administered. Taking this medication during pregnancy may affect the fetus, so women who are pregnant or planning to become pregnant should discuss this with their doctor. It is recommended to avoid driving or operating hazardous machinery during treatment until the patient is accustomed to the medication.

Suicidal ideation, 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, neurogenic hypersensitivity, nystagmus, drowsiness, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial edema, allergy, generalized edema, weight loss, chills, feelings of unfamiliarity, malaise, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular ectopic contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, hematochezia, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland hypertrophy, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, trauma-related purplish bruising, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, pouchitis, contractures, dizziness, hyperactivity, sensory disturbances, decreased or absent 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, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, reduced or loss of libido, restlessness, paranoia, depersonalization, dysphoria, hypersensitivity, hallucinatory states, suicidal ideation, mental disorders, chorea athetoides, perioral movement disorders, brain diseases, neuropathy, personality disorders, increased libido, substance inhibition, apraxia, fine motor control disorders, meningitis, localized focal convulsions, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal obstruction, nasal itching, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, excoriation, skin nodules, subcutaneous nodules, acanthosis, skin necrosis, localized swelling, hematuria, urination disorders, frequency, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation anomalies, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginismus, mastalgia, testicular pain, hyperglycemia, hypoglycemia, gynecomastia, chest pain, drug rash with eosinophilia and systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea athetoides, movement disorders, dystonia, myotonic syndrome, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, pain, sweating, tongue paralysis, dizziness, diplopia, unclear speech, loss of consciousness, hypersomnia, coma, diarrhea

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is best kept at room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance

A hard gelatin capsule of yellowish color containing white or grayish powder.

Package unit

30 capsules/bottle, 100 capsules/bottle