Gabantin Capsule 100 milligrams (Gabapentin)

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients 13 years of age 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: Take one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine three times daily (gabapentin 300 mg/day) - Day 2: Take one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine three times daily (gabapentin 600 mg/day) - From Day 3: Take one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, the initial dose may be one 300 mg capsule of this medicine three times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin; 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: Take one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine three times daily (gabapentin 300 mg/day) - Day 2: Take one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine three times daily (gabapentin 600 mg/day) - From Day 3: Take one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, the initial dose may be one 300 mg capsule of this medicine three times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day of gabapentin within one week. The total daily dose must not exceed 3,600 mg of gabapentin. When taking this medicine, the total daily dose should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplant surgery, the dose of gabapentin 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) 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 the creatinine clearance. 2) Dosage 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 medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine should be swallowed whole with sufficient fluid and may be taken with or without food. When administered 3 times daily, take care that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this medicine is missed (when 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 it. 3) When used with antacids containing magnesium or aluminum, administer this medicine at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. 4) The duration of treatment with this medicine should be determined according to clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in seizure frequency due to abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine must be discontinued, or if it is used in combination with another antiepileptic drug, the change should be made gradually over at least 1 week. 5) The safety and efficacy of treatment for neuropathic pain for longer 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 to 12 years - Children aged 3 to 12 years, day 1: Administer gabapentin 10 mg/kg body weight - Children aged 3 to 12 years, day 2: Administer gabapentin 20 mg/kg body weight - Children aged 3 to 12 years, from day 3 onward: Administer gabapentin 30 mg/kg body weight - Children aged 3 to 12 years: The dose may be increased, if needed, up to a maximum of 40 mg/kg body weight per day. The total daily dose should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, any changes in mood or behavior during treatment should be reported to medical personnel immediately. Discontinuing this medication suddenly may lead to more frequent seizures or severe states of epilepsy, so it should be gradually stopped under a doctor's guidance. Long-term use may result in weight gain, so regular weight checks and dietary and exercise management may be needed. This medication may cause side effects such as drowsiness, dizziness, and motor control problems, so it is advisable to avoid driving or operating hazardous machinery during the initial stages of treatment. Patients, especially children, the elderly, and those with reduced kidney function, may require dose adjustments, and any unusual symptoms should be discussed with a physician. Women who are pregnant or planning to become pregnant must consult medical personnel before taking this medication, and caution is also necessary for nursing mothers. This medication may cause respiratory depression or severe sedation when taken with other central nervous system depressants or narcotics, so careful monitoring by a doctor is necessary when co-administered. In case of severe skin rash, difficulty breathing, or swelling of the face or neck, discontinue the medication immediately and seek emergency treatment. This medication can cause various side effects such as vomiting, abdominal pain, fatigue, headache, memory loss, anxiety, and depression, so if symptoms are severe or persist, notify medical personnel. It is important to take it consistently as directed and not to change or discontinue the dose arbitrarily.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbances, hyperactivity, weakness, apathy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fracture, myalgia, amnesia, ataxia, confusion, abnormal coordination, dizziness, dysarthria, insomnia, hypersensitivity reactions, nystagmus, drowsiness, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, fatigue, facial edema, allergy, generalized edema, weight loss, chills, feelings of strangeness, lethargy, 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 thromboembolism, 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, 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, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasms, hyperthyroidism, hypothyroidism, thyroid enlargement, hypoestrogenism, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, purpuric discoloration due to trauma, 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, bursitis, contracture, dizziness, hyperactivity, paresthesia, decreased or absent reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, abnormal dreams, aphasia, sensory loss, intracranial hemorrhage, hypotonia, abnormal sensations, incomplete paralysis, dystonia, hemiplegia, facial paralysis, delirium, cerebellar dysfunction, positive Babinski's sign, diminished proprioception, intracranial hematoma, apathy, hallucinations, decreased or loss of libido, agitation, schizophrenia, depersonalization, dysphoria, hypersensitivity, hallucinatory state, suicidal thoughts, mental disorders, chorea, athetosis, oral motor dysfunction, encephalopathy, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, focal myoclonic jerks, hypersensitivity, motor dysfunction, mania, neuroses, hysteria, antisocial reactions, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal excoriation, bronchospasm, hypoventilation, pulmonary edema, alopecia, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin nodules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal shedding, maceration, skin necrosis, localized edema, hematuria, urinary dysfunction, frequency, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation abnormalities, renal pain, leukorrhea, genital itching, nephrolithiasis, acute kidney failure, anuria, diabetes, nephritis, enuresis, pyuria, urgency, dyspareunia, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disturbances, blepharospasm, fullness sensation, eye itching, accommodation abnormalities, tympanic membrane perforation, hypersensitivity to noise, ocular fixation abnormalities, epiphora, retinal disease, glaucoma, iritis, corneal disorders, dysfunction of the lacrimal system, eye degeneration, blindness, retinal degeneration, miosis, chorioretinitis, strabismus, Eustachian tube dysfunction, inner ear inflammation, otitis externa, olfactory disturbances, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of prodromal signs, laryngeal neuralgia, somnambulism, pseudo-croup, hoarseness, injury due to accidents, cold syndrome, infection, pain, dry mouth, abdominal distension, gait abnormalities, confusion, tremors, dizziness, vascular edema, anaphylaxis, increased serum creatine phosphokinase, rhabdomyolysis, acute kidney failure, urticaria, allergic reactions, hair loss, toxic epidermal necrolysis, eosinophilia, drug rash accompanied by 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 disturbances, dystonia, tachycardia, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication can be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain storage at room temperature, ideally between 1 and 30 degrees.

Appearance

A hard capsule with white or off-white powder or granules inside, with a white upper and lower part.

Package unit

30 capsules/bottle, 100 capsules/bottle