Widerpantin Capsule 300 mg (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 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 2 times daily or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: 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 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 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 2 times daily or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: 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 as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this drug must be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplant surgery, the gabapentin dose 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 ≤80 mL/min) or patients receiving hemodialysis: Dose 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 is administered in 3 divided 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 on 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 administered 3 times daily, care should be taken to ensure that the interval between doses does not exceed 12 hours to prevent seizure recurrence. 2) If a dose of this drug is missed (if more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be administered to make up for the missed dose. 3) When used concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can greatly reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug 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), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to 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. 5) The safety and efficacy of treatment for neuropathic pain for more than 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 of treatment should be administered at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years: To reach a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate over the first 3 days of treatment as follows. Day 1: administer 10 mg/kg of body weight of gabapentin; Day 2: administer 20 mg/kg of body weight of gabapentin; From Day 3 onward: administer 30 mg/kg of body weight of gabapentin. The dose may be increased, as needed, up to a maximum of 40 mg per kg of 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 and mental health issues such as depression while taking it, so patients and caregivers should carefully monitor for these changes. Discontinuing the medication suddenly can result in more frequent seizures or severe epileptic states, so it should be gradually reduced under the guidance of a doctor. Certain animal studies have reported an increased risk of specific cancers, but the risk in humans is not yet clear. There have been reports of unexpected sudden deaths during treatment with this medication, making it important to periodically check the patient's condition. If severe pancreatic illness symptoms such as pancreatitis occur, the medication should be stopped immediately and medical advice sought. In children aged 3 to 12 years, there may be neuropsychiatric issues such as emotional instability, aggression, diminished concentration, and hyperactivity. When taken with narcotics or other central nervous system depressants, there is a risk of increased severe drowsiness, respiratory depression, coma, and death; therefore, it should only be used at the minimal dosage for the shortest period necessary. Patients with allergies to this medication, those with acute pancreatitis, those with specific seizure types, and lactose intolerant individuals should not take this medication. Patients with poor kidney function, elderly individuals, those with a history of mental illness, children with attention deficit disorder, pregnant women, and breastfeeding mothers should use this medication cautiously. Common side effects such as dizziness, drowsiness, memory impairment, and ataxia may occur during treatment; therefore, driving or operating dangerous machinery should be avoided if these symptoms occur. This medication may affect the fetus during early pregnancy, so women who are pregnant or planning to become pregnant should consult a doctor. Women who are breastfeeding may have this medication secreted in breast milk, so caution is needed, and breastfeeding should be discontinued if possible. There may be potential interactions with other medications or alcohol while taking this medication, so it is important to inform healthcare providers of all medications being taken. This medication should be kept out of the reach of children and stored in its original container to prevent misuse or loss of quality.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, abdominal pain, low back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neurotoxic reaction, nystagmus, drowsiness, thought disorder, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, abdominal distension, anorexia, gingivitis, purpura, arthralgia, hyperactivity, increased reflex activity, reduction or absence, sensory abnormalities, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of signs, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injuries due to accidents, cold syndrome, pain, dry mouth, gait abnormalities, confusion, tremor, vertigo, dyspnea, rash, weakness, lethargy, facial edema, allergy, generalized edema, weight loss, chills, feelings of strangeness, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, glossitis, gingival bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth 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 lymphoma, increased bleeding time, tendinitis, arthritis, joint stiffness, joint enlargement, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, reduced or absent reflexes, dream disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, diminished proprioception, subdural hematoma, apathy, hallucinations, decreased or loss of libido, restlessness, paranoid disorder, depersonalization, ecstatic states, hyperesthesia, hallucination status, suicidal ideation, mental disorders, chorea, athetosis, oral motor disorder, brain disease, neuropathy, personality disorder, increased libido, substance suppression, apraxia, fine motor control difficulties, meningitis, focal muscle fasciculations, hypersensitivity, reduced motor function syndrome, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal sores, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, male-pattern hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photodermatitis, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, melanosis, skin necrosis, localized swelling, hematuria, urinary incontinence, frequency, bladder inflammation, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstruation abnormalities, menorrhagia, breast cancer, anorgasmia, ejaculation abnormalities, kidney pain, white discharge, genital itching, kidney stones, acute kidney failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, vaginal pain, mastalgia, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, loss of taste, taste abnormalities, eye twitching, exophoria, eye itching, accommodation disorders, tympanic membrane perforation, noise sensitivity, visual fixation abnormalities, overflow, 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, urinary tract infection, urination disorders, erectile dysfunction, urinary incontinence, vaginismus, mastalgia, menstruation abnormalities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile enlargement, gynecomastia, nocturia, pyelonephritis, scrotal enlargement, frequent urination, urge incontinence, urinary disturbances, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute kidney failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function test values, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, paroxysmal tachycardia, pancreatitis, sexual dysfunction, sicca syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius.

Appearance

Light yellow hard capsules filled with white or grayish-white powder or granules

Package unit

30 capsules/bottle, 100 capsules/bottle