Gabarex Capsule 100mg (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 gradually over the first 3 days of treatment as follows. Day 1: Administer one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine 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.) 3) The duration of treatment 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 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 medicine is to be discontinued, or if it is to be administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) 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 medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine 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 medicine should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, the dose of this medicine 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 of 80 mL/min or less) or patients receiving hemodialysis: Dose adjustment is necessary 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: 3 × 100 mg should be administered 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 receiving hemodialysis Initial dose: 300~400 mg of gabapentin is recommended. Maintenance dose: Administer 200~300 mg of gabapentin after 4 hours of hemodialysis, and 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 plenty of 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 medicine is missed (if more than 12 hours have elapsed since the last dose), whether to administer an additional dose to make up for the missed dose should be determined by the physician. 3) When this medicine is administered concomitantly with antacids containing magnesium or aluminum, it should be administered 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. If the dose of this medicine is reduced, treatment is discontinued, or the patient is switched to another alternative medicine, this should be done gradually over at least 1 week (a longer period may be needed at the prescriber's discretion). 5) To reduce the main adverse reactions, 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: Administer gabapentin 10 mg/kg body weight on day 1; 20 mg/kg body weight on day 2; and 30 mg/kg body weight from day 3 onward. If necessary, the dose may be increased up to a maximum of 40 mg/kg body weight per day. The total daily dose should be administered in 3 divided doses.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, any signs of depression or mood changes during treatment should be reported to a healthcare professional immediately. Additionally, abrupt discontinuation of the medication may lead to an increase in seizures or progress to a prolonged state of epilepsy, so it should be tapered off gradually under a physician's guidance. Serious side effects such as pancreatitis may occur; thus, if abdominal pain, nausea, or recurrent vomiting occurs during treatment, the medication should be stopped immediately, and consultation with a physician is necessary. Special caution is needed for children, as they may exhibit emotional instability, aggression, or decreased concentration as psychiatric reactions. Concomitant use of this medication with central nervous system depressants or narcotics may pose risks of drowsiness, respiratory depression, or coma, and should only be used at minimal doses for short durations under close observation by healthcare professionals when necessary. Patients with impaired kidney function or the elderly may require dosage adjustments, and women who are pregnant or planning to become pregnant should consult their healthcare provider due to potential fetal effects. Moreover, this medication contains lactose and should not be taken by patients with lactose intolerance; those with allergic reactions or acute pancreatitis should also avoid it. Symptoms such as dizziness, drowsiness, or ataxia may occur during treatment, so it is advisable to avoid driving or operating machinery. When discontinuing this medication after long-term use, withdrawal symptoms such as anxiety, insomnia, or headaches may appear, so it should be discontinued gradually according to a healthcare professional’s instructions. Finally, this medication should be kept out of reach of children, should not be removed from its original container, and there may be interaction potentials with other medications or alcohol, so patients should inform their healthcare provider before taking it.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, 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, impaired coordination, dizziness, dysarthria, insomnia, hyperexcitability, nystagmus, drowsiness, thought disorders, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, impotence, myasthenia, feelings of apathy, facial edema, allergy, generalized edema, weight loss, chills, feelings of strangeness, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thromboembolism, ventricular premature contraction, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increase in salivation, gastroenteritis, hemorrhoids, bloody stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, sialadenomatosis, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, goiter, low estrogen, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, contusions from trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, 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, dysphoria, hyperesthesia, suicidal impulses, mental disorders, chorea-athetosis, oral-motor disorders, brain diseases, nerve paralysis, personality disorders, increased libido, physical inhibition, apraxia, subtle motor coordination disorder, meningitis, local dystonic spasms, sensory hypersensitivity, motor function deterioration, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, intranasal bleeding, bronchospasm, hypopnea, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, seborrheic dermatitis, psoriasis, epidermal peeling, maceration, skin nodules, hyperpigmentation, skin necrosis, localized swelling, hematuria, dysuria, frequency, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual abnormalities, menorrhagia, breast cancer, amenorrhea, ejaculatory abnormalities, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, scrotal pain, visual disturbances, cataracts, conjunctivitis, dry eyes, eye pain, photophobia, bilateral or unilateral ptosis, retinal hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, loss of taste, taste disturbances, blepharospasm, fullness sensation, eye itching, accommodation abnormalities, tympanic membrane perforation, sensitivity to noise, abnormal eye focus, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal gland dysfunction, retinal degeneration, blindness, retinal detachment, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbances, dehydration, infectious mononucleosis, hepatitis, coagulation abnormalities, loss of precursors, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, chest pain, soft tissue infection, feelings of apathy, cervical pain, allergic reactions, abscess, chills, chills and fever, mucosal abnormalities, body odor, cysts, fever, hernia, abnormal BUN levels, cervical lump, pelvic pain, sepsis, viral infection, syncope, palpitations, migraine, congestive heart failure, myocardial infarction, vasodilation, increased capillary fragility, phlebitis, varicose veins, gastroenteritis, gastrointestinal abnormalities, oral candidiasis, gastritis, tongue abnormalities, dental abnormalities, bowel abnormalities, liver function test abnormalities, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcer, fecal incontinence, increased gamma-glutamyl transferase, gingivitis, intestinal obstruction, intestinal ulcer, melena, oral ulcers, rectal abnormalities, rectal bleeding, stomatitis, diabetes, petechial hemorrhage, lymph proliferative responses, decreased prothrombin, edema, gout, hypoglycemia, weight loss, increased alkaline phosphatase, diabetic ketoacidosis, increased lactate dehydrogenase, arthritis, arthrosis, leg cramps, myasthenia, tibial pain, joint disorders, tendon disorders, confusion, depression, hyperexcitability, sensory abnormalities, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorders, dream disturbances, dysarthria, emotional instability, confusion, perioral sensory abnormalities, dysphoria, hypersensitivity, motor function deterioration, suicide attempts, restlessness, hypertonia, increased libido, motor disorders, dystonia, vestibular dysfunction, increased cough, bronchitis, rhinitis, sinusitis, asthma, pulmonary abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, papular eruptions, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, visual disturbances, ear pain, eye abnormalities, taste disturbances, hearing impairment, conjunctival congestion, diabetic retinopathy, eye pain, microhemorrhages in the fundus, retinal vein thrombosis, loss of taste, urinary tract infections, urinary disorders, impotence, urinary incontinence, vaginal candidiasis, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculatory abnormalities, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, urinary frequency, urinary urgency, 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 eruption with systemic symptoms, increased liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity reactions including systemic responses, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, motor disorders, dystonia, hypertensive crisis, palpitations, pancreatitis, sexual dysfunction, skin and mucosal syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, feelings of apathy

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, ideally at a temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its effectiveness over time.

Appearance

A hard capsule consisting of white or grayish-white powder in both the upper and lower parts.

Package unit

30 capsules/bottle, 300 capsules/bottle