Gabapentin Capsule 100 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: 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, one 300 mg capsule of this drug may be administered 3 times daily as the starting dose (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: 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, one 300 mg capsule of this drug may be administered 3 times daily as the starting dose (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 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 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: 3 × 100 mg should be administered every 2 days. In patients with creatinine clearance <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 sufficient fluid 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 (when more than 12 hours have elapsed since the most recent dose), whether to administer an additional dose to make up for the missed dose should be determined by the physician. 3) When this drug is used concomitantly with antacids containing magnesium or aluminum, it 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 (increased 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 is to be discontinued, or if it is to be 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 major adverse effects, such as somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be administered at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years: Titrate gradually over the first 3 days of treatment to achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight. 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 onward: administer 30 mg/kg of body weight of gabapentin. The dose may be increased as needed 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 may increase the risk of suicidal thoughts or behaviors, so any mood changes or abnormal behaviors during treatment should be reported to a healthcare professional immediately. Discontinuing this medication suddenly may lead to worsening seizures or progress to status epilepticus, so the dosage must be gradually reduced as directed by a physician. In some animal studies, a potential risk of certain cancers has been reported, but the effects on humans are not clear. There have been rare reports of sudden and unexpected deaths during treatment, which may be related to the risk of epilepsy itself. If symptoms of pancreatitis (persistent upper abdominal pain, nausea, recurrent vomiting) occur, this medication should be stopped immediately, and medical advice should be sought. Particularly in children, neurological and psychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may arise, necessitating caution. Taking this drug with central nervous system depressants, including narcotics, can result in sedation, respiratory depression, coma, and in severe cases, death, so it must be taken under a healthcare provider's direction. Patients with hypersensitivity to this drug, acute pancreatitis, certain types of seizures, or lactose intolerance should not take it. Patients with impaired kidney function, the elderly, those with a history of mental illness, children with attention deficit or behavioral disorders, pregnant or planning to become pregnant women, and nursing mothers require special caution when administered. Drowsiness, dizziness, and ataxia may occur, so driving or operating hazardous machinery should be avoided. This drug can cause various side effects, such as weight gain, visual disturbances, skin rashes, blood disorders, and liver function abnormalities, so any unusual symptoms should be reported to a healthcare professional immediately. Abrupt discontinuation after long-term use may induce withdrawal symptoms, so it should be tapered slowly according to a physician's advice. This medication may affect the fetus if used in early pregnancy; therefore, women who are pregnant or planning to become pregnant must consult with a physician, and caution should be taken if nursing. When administering to children and the elderly, dosage adjustment and observation are necessary considering safety and efficacy. In case of overdose, symptoms like decreased consciousness, drowsiness, and dizziness may appear, but generally, recovery occurs with appropriate treatment. This drug may interact with other medications, so patients must inform their healthcare provider about any medications or health conditions, particularly regarding antacids or central nervous system depressants.

suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, apathy, facial swelling, 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, neurogenerative responses, nystagmus, drowsiness, thought disorders, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, feelings of boredom, facial swelling, allergies, generalized edema, weight loss, chills, unfamiliar sensations, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraines, murmurs, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accidents, pulmonary embolism, ventricular extrasystoles, 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, blood in stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland hyperplasia, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasms, hyperthyroidism, hypothyroidism, thyroid enlargement, hypoestrogenism, ovarian failure, epididymitis, testicular swelling, Cushingoid appearance, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, hyperactivity, increased/decreased or absent reflex movements, sensory disturbances, anxiety, hostility, CNS tumors, syncope, altered dreams, aphasia, sensory deficits, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, benign Babinski syndrome, reduced proprioception, subdural hematoma, apathy, hallucinations, decreased or loss of libido, restlessness, schizophrenia, depersonalization, altered euphoria, hypersensitivity, hallucinatory states, suicidal impulses, mental disorders, chorea with athetosis, perioral movement disorder, brain disorders, nerve paralysis, personality disorders, increased libido, organic restraint, apraxia, fine motor control disorders, meningitis, local clonic spasms, tactile hypersensitivity, motor function decrease, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal obstruction, 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 shedding, maceration, skin granulomas, hyperpigmentation, skin necrosis, localized swelling, hematuria, urinary disorders, anuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, amenorrhea, abnormal ejaculation, renal pain, leucorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginismus, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, glare, bilateral or unilateral ptosis, retinal hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disturbances, eye spasm, eye strain, eye itching, accommodation issues, tympanic membrane perforation, sensitivity to noise, abnormal eye focus, lacrimation, retinal diseases, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye atrophy, blindness, retinal degeneration, miosis, choroiditis, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disturbances, urinary tract infections, urinary disorders, erectile dysfunction, urinary incontinence, vaginal myelinosis, mastalgia, menstrual disorders, polyuria, urinary retention, cystitis, ejaculation disorders, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequency of urination, urgency of urination, 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 with systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea with athetosis, movement disorders, dystonia, paroxysmal kinesogenic dyskinesia, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it must be kept at room temperature between 1°C and 30°C to maintain its efficacy.

Appearance

A hard capsule with a white or grayish powder inside, both top and bottom being white.

Package unit

30 capsules/bottle, 300 capsules/bottle