Garotincapsule 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 as gabapentin, titrate the dose 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 twice 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, one 300 mg capsule of this medicine may be administered 3 times daily as the starting dose (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.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose 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 twice 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, one 300 mg capsule of this medicine 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 as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this medicine should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients following transplantation, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dosage 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: Dosage 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. For 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; 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, 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 most recent dose), whether to administer an additional dose to make up for the missed dose should be determined by the physician. 3) When administered concomitantly with antacids containing magnesium or aluminum, this medicine should be taken 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 depend on clinical need. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (increased seizure frequency due to sudden discontinuation of treatment), sudden 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 used concomitantly 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 beyond 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 should be administered at bedtime.

Child dose

Adjunctive therapy in children aged 3 years and older and 12 years and younger - 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 If necessary, the dose may be increased to a maximum of 40 mg/kg body weight per day. When administering this drug, divide the total daily dose into 3 doses.

This medication may lead to suicidal thoughts or behaviors and mental health issues such as depression during treatment, so both patients and caregivers should notify healthcare providers immediately if such symptoms arise. Abruptly discontinuing this medication can worsen seizures or lead to status epilepticus; therefore, it should be discontinued slowly according to a doctor's instructions. Long-term use may lead to weight gain, so it is recommended to regularly check weight and maintain dietary control or exercise if necessary. This medication may cause drowsiness, dizziness, and difficulty concentrating, therefore it is advised to avoid driving or operating hazardous machinery during the initial phases of treatment. Particularly, children, the elderly, and patients with impaired kidney function may require adjusted dosages and should be monitored closely as adverse reactions may occur more frequently. Serious adverse reactions such as pancreatitis, severe skin reactions, and anaphylaxis may occur very rarely, so if symptoms such as abdominal pain, skin rash, or difficulty breathing arise, immediate notification to healthcare providers is necessary. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, and caution is advised for breastfeeding women as well. The risk of drowsiness and respiratory depression may increase if this medication is taken in combination with other central nervous system depressants or narcotics; therefore, careful monitoring by healthcare providers is required when used concomitantly. Patients with a history of allergic reactions to this medication or its ingredients, those with acute pancreatitis, or those with certain types of seizures should not take this medication. During treatment, patients must adhere to the prescribed time and dosage, and avoid arbitrary discontinuation or dosage increments.

Suicidal thoughts, suicidal behavior, depression, abnormal mood and behavior changes, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, apathy, facial edema, 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, neuroirritability, nystagmus, drowsiness, thought disorders, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, fatigue, facial edema, allergy, systemic edema, weight loss, chills, feeling of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, murmurs, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, premature ventricular contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, blood in stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, stomatitis vesicles, dental discoloration, angular cheilitis, salivary gland hypertrophy, 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, Cushing's syndrome, bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendonitis, 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 disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, dysphoria, hyperesthesia, altered perception, suicidal thoughts, psychiatric symptoms, chorea, athetosis, perioral movement disorders, brain disease, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, focal clonic seizures, hypersensitivity, decreased motor function syndrome, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nosebleed, bronchospasm, 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 shedding, maceration, dermal nodules, melanoma, skin necrosis, localized swelling, hematuria, urination disorders, frequent urination, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, amennorrhea, ejaculation disorders, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency, vulvodynia, mastalgia, testicular pain, vision disturbances, cataracts, conjunctivitis, dry eye, eye pain, glare, ptosis, eye hemorrhage, pinguecula, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disturbances, blepharospasm, ocular fullness, eye itching, accommodation disorder, tympanic membrane perforation, hyperacusis, abnormal eye fixation, epiphora, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, inner ear inflammation, otitis externa, olfactory disturbances, drowsiness, hypersomnia, hostility, viral infections, fever, nausea, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, lost signs, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, tongue paralysis, elevated serum creatine kinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash accompanied by systemic symptoms, elevated liver function tests, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic responses, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, movement disorders, dystonia, myotonic contractions, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, apathy

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius. This ensures the medication's efficacy is safely preserved.

Appearance

A white or grayish-white powder contained in white hard capsules.

Package unit

30 capsules/bottle, 300 capsules/bottle