I-Pentyn Capsule 300mg (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 the dose gradually over the first 3 days of treatment as follows. Day 1: Administer one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug 3 times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this drug 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 sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If this drug must be discontinued or administered 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 the dose gradually over the first 3 days of treatment as follows. Day 1: Administer one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug 3 times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this drug 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 drug should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for more 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 drug should be increased in increments of 100 mg. 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 undergoing 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: 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 the creatinine clearance. 2) Dosage for patients undergoing 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 administered 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 drug is missed (if 12 hours or more have elapsed since the most recent dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When this drug is administered concomitantly with an antacid 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 be determined according to clinical need. If the dose of this drug is reduced, treatment is discontinued, or the patient is switched to another alternative medication, this should be done gradually over at least 1 week (a longer period may be required at the prescriber's discretion). 5) To reduce the major adverse reactions of somnolence, dizziness, fatigue, and ataxia, the first dose on the first day should be taken at bedtime.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors, so you should immediately inform your doctor if you notice any changes in mood or behavior during treatment. Discontinuing this medication suddenly may result in more frequent seizures or lead to severe epilepsy status, so it should be gradually discontinued according to your doctor's instructions. In animal studies, a possibility of certain cancer occurrences has been reported, but the effects on humans are still unclear. While taking this medication, sudden and unexpected death cases have been reported, so symptoms should be monitored closely. If symptoms of pancreatitis (abdominal pain, nausea, vomiting) appear, you should stop taking the medication immediately and consult your doctor. Special caution is warranted when administering to children, as neuropsychological adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may occur. Taking this medication together with central nervous system depressants, including narcotics, can result in severe drowsiness, respiratory depression, and coma, so it should be taken under a doctor's supervision. Patients with hypersensitivity, acute pancreatitis, certain seizure types, and lactose intolerance should not take this medication. Caution is necessary for patients with impaired kidney function, the elderly, those with a history of mental illness, children with attention deficit or behavioral disorders, pregnant women or those who may become pregnant, and nursing mothers. While taking this medication, side effects such as dizziness, drowsiness, ataxia, nausea, and fatigue may occur, and if these symptoms are severe, consultation with a doctor is required. This medication may also cause side effects such as weight gain, vision abnormalities, skin rashes, and allergic reactions, so you should inform your doctor immediately if any unusual symptoms occur. Taking this medication during pregnancy may affect the fetus, so if you are planning to become pregnant or are already pregnant, consult your doctor. Caution is also necessary for nursing mothers. You should avoid driving or operating dangerous machinery while on this medication, and adhere strictly to the prescribed dosage and intervals. In the event of an overdose, symptoms such as dizziness, drowsiness, and coma may occur, so you must adhere to the prescribed dosage, and seek medical attention in severe cases. This medication should be stored out of reach of children in its original container.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, 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, impaired coordination, dizziness, dysarthria, insomnia, neurogenic responses, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, double vision, erectile dysfunction, asthenia, fatigue, facial edema, allergy, generalized edema, weight loss, chills, strange sensations, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary thromboembolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, 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 enlargement, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectal inflammation, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, ecchymosis 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, sensory abnormalities, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, abnormal dreams, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski's sign, decreased proprioception, subdural hematoma, flat affect, hallucinations, decreased or lost libido, restlessness, paranoid disorder, depersonalization, dysphoria, heightened sensitivity, hallucinatory state, suicidal ideation, mental disorders, chorea, athetosis, perioral movement disorder, brain diseases, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor skills disorder, meningitis, focal motor seizures, hypersensitivity, movement dysfunction, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal polyps, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photodermatitis, leg ulcers, seborrheic dermatitis, psoriasis, epidermal desquamation, maceration, skin nodules, melanosis, skin necrosis, localized edema, hematuria, urinary disorders, frequency of urination, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, amenorrhea, ejaculation disorders, renal pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency of urination, vulvar pain, mastalgia, testicular pain, visual abnormalities, cataracts, conjunctivitis, dry eyes, eye pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, eyelid twitching, encumbrance, itching eyes, accommodative dysfunction, tympanic membrane perforation, sensitivity to noise, ocular fixation abnormalities, watering, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, chorioretinitis, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory abnormalities, tongue paralysis, withdrawal symptoms (anxiety, insomnia, nausea, pain, sweating, trembling, headache, depression, abnormal sensations, lethargy), suicide attempts, hallucinations, hepatitis, generalized edema, gynecomastia, thrombocytopenia, urinary incontinence, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia with systemic symptoms drug rash (DRESS), elevated liver function tests, falls, hypersensitivity reactions including systemic responses, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, movement disorders, dystonia, hepatic myoclonus, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome

This medication should be stored in a sealed container to protect it from air and moisture. It should be kept at room temperature between 1°C and 30°C. It should be avoided in very hot or very cold places.

Appearance

Hard capsule with a yellowish color containing white or grayish powder

Package unit

30 capsules/bottle, 100 capsules/bottle