Gabapentin Capsule 100mg (Gabapentin)

Adult dose

Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older To reach a maintenance dose of 900 mg/day as gabapentin, titrate gradually over the first 3 days of treatment as follows. Day 1: Administer one 300 mg capsule of this product once daily, or one 100 mg capsule of this product three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this product twice daily, or two 100 mg capsules of this product three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this product three times daily, or three 100 mg capsules of this product three times daily (gabapentin 900 mg/day) Alternatively, the initial dose may be one 300 mg capsule of this product three times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day as gabapentin, and the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) The duration of treatment should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to sudden discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this product must be discontinued, or if it is to be used in combination with another antiepileptic drug, the change should be made gradually over at least 1 week. Neuropathic pain Adults (18 years and older): To reach a maintenance dose of 900 mg/day as gabapentin, titrate gradually over the first 3 days of treatment as follows. Day 1: Administer one 300 mg capsule of this product once daily, or one 100 mg capsule of this product three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this product twice daily, or two 100 mg capsules of this product three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this product three times daily, or three 100 mg capsules of this product three times daily (gabapentin 900 mg/day) Alternatively, the initial dose may be one 300 mg capsule of this product three times daily (gabapentin 900 mg/day). If needed, the dose may be increased to 1,800 mg/day as gabapentin within 1 week; the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this product should be divided into 3 doses. The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose should be increased in 100 mg increments. Elderly patients: Dose adjustment may be necessary due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is required based on the following table. 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. Dosage for hemodialysis patients 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 product on days when hemodialysis is not performed. Method and duration of administration Swallow this product whole with plenty of fluid. It 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. If a dose of this product is missed (more than 12 hours have passed since the most recent dose), the physician should decide whether an additional dose should be taken to make up for it. When used with antacids containing magnesium or aluminum, administer this product at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this product. The duration of treatment with this product should depend on clinical need. If the dose of this product is reduced, treatment is discontinued, or the patient is switched to another alternative drug, this should be done gradually over at least 1 week (a longer period may be necessary at the prescriber's discretion). To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be taken at bedtime.

Child dose

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 onward: 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 may increase the risk of suicidal thoughts or behaviors; therefore, if symptoms of depression or mood changes occur during treatment, the patient should consult a physician immediately. Discontinuation of this medication suddenly may lead to more frequent seizures or status epilepticus, so it is important to gradually taper off under a physician's guidance. While some animal studies have reported an increased risk of cancer, the effects in humans are unclear, so caution is advised in long-term use. Unexpected sudden deaths have been reported during the use of this medication, so it is important to regularly monitor health status while taking it. If symptoms of pancreatitis, such as persistent abdominal pain, nausea, or repetitive vomiting occur, the medication must be discontinued immediately, and medical evaluation should be sought. When administering this medication to children, close observation is required for potential neuropsychiatric effects such as emotional instability, aggression, diminished concentration, and hyperactivity. Taking this medication together with central nervous system depressants, including opioids, can lead to severe drowsiness, respiratory depression, coma, and even death, necessitating strict medical supervision when combined. Patients with a history of allergic reactions to this medication or those with acute pancreatitis, certain types of seizures, or lactose intolerance should not take it. Patients with poor kidney function, elderly patients, those with a history of mental illness, pregnant women, and breastfeeding mothers should consult a physician before use and should take it with caution. During treatment, dizziness, drowsiness, and diminished concentration may occur, and caution is advised when driving or operating machinery. If these symptoms are severe, activities should be limited. Various side effects may arise during treatment, including weight gain, visual disturbances, skin rashes, and blood abnormalities, so regular health check-ups are necessary, and any abnormal symptoms must be reported to healthcare professionals immediately. Taking the medication during pregnancy may affect the fetus, so women who are pregnant or planning to become pregnant should consult a physician before use and should use effective contraception. Breastfeeding women should consult a physician regarding breastfeeding as this medication may be excreted in breast milk. Do not adjust or discontinue dosages arbitrarily; it should be taken consistently as prescribed, and any adverse effects should be reported to healthcare professionals immediately. Overdose may lead to dizziness, drowsiness, and decreased consciousness, but recovery is usually possible through supportive care; however, severely impaired renal patients may require special treatment. This medication should be kept out of the reach of children and stored in its original container to prevent quality deterioration.

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, abnormal thinking, 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, dyscoordination, dizziness, dysarthria, insomnia, neuroanxiety reactions, nystagmus, drowsiness, abnormal thinking, tremors, single contractions, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, fatigue, facial swelling, 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, thromboembolic venous inflammation, deep venous thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, 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, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland hyperplasia, 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, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contractures, dizziness, hyperactivity, paraesthesia, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, abnormal dreams, aphasia, sensory impairment, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski's sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or loss of libido, restlessness, schizophrenia, depersonalization, abnormal euphoria, hypersensitivity, hallucinatory state, suicidal thoughts, mental disorders, chorea-athetosis, oral motor disorders, brain disease, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, focal myoclonus, sensory hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal obstruction, rhinorrhea, bronchial spasm, hypoventilation, 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, subcutaneous nodules, melanosis, skin necrosis, localized swelling, hematuria, dysuria, oliguria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, amenorrhea, abnormal ejaculation, renal pain, leukorrhea, genital itching, nephrolithiasis, acute kidney failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency, vaginismus, mastalgia, testicular pain, visual disturbances, cataracts, conjunctivitis, dryness of the eyes, ocular pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, pinguecula, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disorders, blepharospasm, eye fullness, itching of the eyes, accommodation anomalies, tympanic membrane perforation, sensitivity to noise, abnormal eye fixation, lacrimation, retinopathy, glaucoma, iriditis, corneal disorders, rhinorrhea dysfunction, ocular degeneration, blindness, retinal degeneration, miosis, choroidal retinitis, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disorders, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of warning signs, laryngeal neuralgia, narcolepsy, pseudocroup, hoarseness, traumatic injury, cold syndrome, infection, pain, xerostomia, abdominal distension, gait abnormalities, confusion, tremors, vertigo, dyspnea, rash, urinary tract infection, chest pain, soft tissue infection, fatigue, pain in the neck, allergic reaction, abscess, chills, mucosal abnormalities, body odor, cysts, hernias, abnormal BUN levels, neck masses, pelvic pain, sepsis, viral infections, syncope, palpitations, congestive heart failure, vasodilation, cholecystitis, cholelithiasis, duodenal ulcers, fecal incontinence, gamma-glutamyl transpeptidase elevation, diabetes, purpura, lymphadenopathy, lymphoproliferative reaction, reduced prothrombin, edema, gout, hypoglycemia, weight loss, increased alkaline phosphatase, diabetic ketoacidosis, increased lactate dehydrogenase, arthritis, arthrosis, leg cramps, myasthenia gravis, tibial pain, joint disorders, tendon disorders, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorders, abnormal dreams, dysarthria, confusion, perioral sensory disturbances, abnormal euphoria, suicide attempts, restlessness, increased tension, movement disorders, myoclonus, increased cough, bronchitis, rhinitis, sinusitis, asthma, pulmonary abnormalities, epistaxis, hemoptysis, degeneration, skin ulcers, fungal dermatitis, carbunculosis, hair abnormalities, papulovesicular rash, nail abnormalities, skin carcinoma, skin thickening, urinary incontinence, vulvar dermatopathy, mastalgia, polyuria, urinary retention, cystitis, abnormal ejaculation, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequency of urination, urgency, abnormal urination, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute kidney failure, urticaria, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast hypertrophy, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash accompanied by systemic symptoms, increased liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity with systemic responses, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, movement disorders, dystonia, muscular hypertonia, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, fatigue

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to keep it at room temperature, between 1°C and 30°C. This will help maintain the effectiveness of the medication for a longer period.

Appearance

Opaque white capsules containing white or off-white powder.

Package unit

30 capsules/bottle, 300 capsules/bottle