Gabapentin Capsule 300 mg (Gabapentin)

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 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.) 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 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 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 transplantation, the gabapentin dose 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) Dose 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) Dose 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 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 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 it. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can substantially 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 abrupt discontinuation of treatment), abrupt 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 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.

Child dose

Adjunctive therapy in children aged 3 years to 12 years: To achieve a maintenance dose of gabapentin 30 mg/kg/day, titrate gradually over the first 3 days of treatment as follows: - Day 1: Administer gabapentin at 10 mg/kg of body weight - Day 2: Administer gabapentin at 20 mg/kg of body weight - From Day 3 onward: Administer gabapentin at 30 mg/kg of body weight. 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 medicine is a drug used for the treatment of epilepsy and neuropathic pain. There is an increased risk of suicidal thoughts or behaviors during treatment, so patients or caregivers should immediately inform healthcare personnel if mood changes or unusual behaviors occur. Abrupt discontinuation of the medication may lead to worsening of seizures or prolonged seizure status, so it must be tapered off gradually as directed by a physician. This medication may cause pancreatitis, particularly hemorrhagic pancreatitis; therefore, if persistent upper abdominal pain, nausea, or vomiting occurs during use, it should be discontinued immediately and consulted with a doctor. In children, central nervous system adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may occur, so caution is necessary. Concomitant use with central nervous system depressants or narcotics can lead to severe side effects such as drowsiness, respiratory depression, or coma, requiring strict medical supervision when used together. Patients with reduced kidney function or the elderly may require dosage adjustment, and women who are pregnant or planning to become pregnant should consult with a physician before use due to risks to the fetus. This medication may cause various side effects, including drowsiness, dizziness, ataxia, memory impairment, nausea, vomiting, etc., so caution is needed when driving or operating machinery. Additionally, serious allergic reactions such as skin rashes, anaphylaxis, and angioedema may occur, and if any abnormal symptoms arise, the medication should be stopped immediately and healthcare personnel should be informed. Abrupt discontinuation after long-term use may lead to withdrawal symptoms such as anxiety, insomnia, and tremors, so it should be tapered off gradually as directed by a physician. This medication should be stored out of the reach of children, and containers should not be changed or stored improperly.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbances, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, dysfunctional cooperation, dizziness, dysarthria, insomnia, neurogenic response, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, pruritus, rash, amblyopia, diplopia, erectile dysfunction, asthenia, feelings of lethargy, facial swelling, allergy, systemic edema, weight loss, chills, strange sensations, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, deep venous thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stool, fecal incontinence, liver enlargement, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland enlargement, 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, Cushingoid appearance, trauma-induced purpura, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, decreased or absent reflexes, increased reflexes, anxiety, hostility, CNS tumors, fainting, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, delirium, cerebellar dysfunction, benign Babinski syndrome, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, abnormal euphoria, hypersensitivity, hallucinatory state, suicidal thoughts, mental disorders, chorea athetosis, perioral movement disorders, brain diseases, neuropathy, personality disorders, increased libido, organic suppression, apraxia, fine motor control disorders, meningitis, focal myoclonus, hypersensitivity, movement function reduction syndrome, mania, neurosis, hysteria, antisocial response, suicidal behavior, pneumonia, nosebleed, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal polyps, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cystic formations, herpes simplex, shingles, skin discoloration, skin nodules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin subnodules, subcutaneous nodules, melasma, skin necrosis, localized swelling, hematuria, dysuria, urinary frequency, bladder inflammation, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, anovulation, abnormal ejaculation, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, dyspareunia, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, photophobia, bilateral or unilateral ptosis, retinal hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disorders, blepharospasm, fullness in the ear, itching of the eyes, accommodation disorders, tympanic membrane perforation, sensitivity to noise, ocular fixation disorders, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal gland dysfunction, retinal degeneration, blindness, retinal detachment, miosis, choroidal retinitis, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbances, drowsiness, hyperactivity syndrome, hostility, emotional instability, dizziness, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, coagulation disorders, loss of prodromal symptoms, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, tongue paralysis, confusion, loss of consciousness, mental disorders, withdrawal symptoms, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensations, feelings of lethargy, suicide attempts, 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 athetosis, movement disorders, dystonia, myotonic dystrophy, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. The storage temperature should be maintained between 1°C and 30°C. This will help to maintain the efficacy and safety of the medication for a longer time.

Appearance

A hard capsule with yellowish-white or beige powdered or granule content.

Package unit

For internal use - 30 capsules/bottle, For internal use - 100 capsules/bottle