Irova 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: Take one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day). Day 2: Take one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day). From Day 3 onward: Take one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day). Alternatively, as an initial dose, one 300 mg capsule of this drug may be taken three 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 depend on 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 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 it is to be used concomitantly with another antiepileptic drug, changes 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: Take one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day). Day 2: Take one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day). From Day 3 onward: Take one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day). Alternatively, as an initial dose, one 300 mg capsule of this drug may be taken 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. The total daily dose of this drug should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for periods exceeding 5 months have not been evaluated. 3. Frail patients: In frail patients with low body weight or patients following transplant surgery, the gabapentin dose should be increased in increments of 100 mg. 4. Elderly patients: Dose adjustment may be required 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 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: A dose of 3 × 100 mg should be given every 2 days. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dose 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 drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) Swallow this drug whole with plenty of fluid. It may be taken with or without food. When administering 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 drug is missed (if 12 hours or more have elapsed since the most recent dose), whether to take an additional dose to make up for it should be determined by a physician. 3) When used concomitantly with antacids containing magnesium or aluminum, administer this drug at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend on clinical need. If the dose of this drug 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). 5) To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day should be taken at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years to 12 years Day 1: gabapentin 10 mg/kg body weight Day 2: gabapentin 20 mg/kg body weight From Day 3 onward: gabapentin 30 mg/kg body weight The dose may be increased, if necessary, up to a maximum of 40 mg/kg body weight daily. The total daily dose of this medicine should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behavior, so if there are any changes in mood or behavior while taking it, consult a physician immediately. Abruptly stopping the medication may result in more frequent seizures or severe epileptic conditions, so the dosage should be gradually reduced according to the physician's instructions. This medication can have serious side effects such as pancreatitis, so if there are persistent upper abdominal pain, nausea, or vomiting, stop taking it immediately and visit the hospital. Caution is particularly required for children, the elderly, patients with impaired renal function, and those with a history of mental illness; dosage should be based on a physician's instructions. This medication may cause various side effects such as drowsiness, dizziness, movement disorders, emotional changes, so it is advisable to avoid driving or operating hazardous machinery during the early phase of treatment. If taken alongside central nervous system depressants or narcotic analgesics, respiratory depression or severe sedation may occur, thus strict medical supervision is required when co-administered. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, and if breastfeeding, the decision to take it should be carefully considered. Sudden discontinuation of this medication may lead to withdrawal symptoms such as anxiety, insomnia, or headache, so it is necessary to consult a physician to adjust the dosage. Overdose may result in dizziness, drowsiness, or coma, so adhere strictly to the prescribed dosage. This medication should be stored out of reach of children and kept in its original container to prevent misuse or degradation.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, lethargy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disorder, insomnia, neuroirritability, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, pruritus, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial edema, allergy, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effect, hypotension, angina pectoris, peripheral vascular disorder, palpitations, tachycardia, migraine, murmur, atrial fibrillation, heart failure, thrombotic venous inflammation, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thromboembolism, premature ventricular contraction, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, decreased appetite, abdominal distension, gingivitis, glossitis, gingival 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 spasm, hyperthyroidism, hypothyroidism, thyroid hypertrophy, hypoestrogenism, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, ecchymosis due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, diminished or lost reflexes, heightened reflexes, anxiety, hostility, CNS tumors, syncope, dream abnormality, 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, altered euphoria, hyperreactivity, hallucinatory states, suicidal thoughts, mental disorders, chorea, athetosis, perioral movement disorders, brain diseases, nerve paralysis, personality disorders, increased libido, organic inhibition, praxis disorder, fine motor control disorder, meningitis, focal myoclonus, hypersensitivity, decreased motor function, 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, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermolysis, maceration, skin nodules, melasma, skin necrosis, localized swelling, hematuria, urination disorders, frequent urination, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, amenorrhea, ejaculation abnormalities, renal pain, leukorrhea, genital pruritus, kidney stones, acute kidney failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency, dyspareunia, mastalgia, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disorder, blepharospasm, fullness in the ears, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of warning signs, laryngeal neuralgia, somnambulism, pseudocrup, hoarseness, glossoplegia, increased serum creatine phosphokinase, rhabdomyolysis, acute kidney failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea and athetosis, movement disorders, dystonia, glycogen storage disease, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be kept in a tightly closed container to prevent exposure to air or moisture. It is also safe to store the medication at room temperature, between 1 to 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

A hard capsule in white or off-white containing a white or grayish-white powder.

Package unit

30 capsules/bottle, 300 capsules/bottle