Kunil Gabapentin Capsule 300 Milligrams

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients 13 years of age and older To reach a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows: - Day 1: Administer one 300 mg capsule of this product once daily, or one 100 mg capsule of this product 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this product twice daily, or two 100 mg capsules of this product 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this product 3 times daily, or three 100 mg capsules of this product 3 times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this product may be administered 3 times daily as the starting dose (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin. 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.) 2. Neuropathic pain Adults (18 years of age and older): To reach a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows: - Day 1: Administer one 300 mg capsule of this product once daily, or one 100 mg capsule of this product 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this product twice daily, or two 100 mg capsules of this product 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this product 3 times daily, or three 100 mg capsules of this product 3 times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this product 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 of gabapentin within one week. The total daily dose must not exceed 3,600 mg of gabapentin. When administering this product, the total daily dose must be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in 100 mg increments. 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 ≤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 should be divided into 3 doses. b: The dose should be administered as 3 × 100 mg every 2 days. For patients with creatinine clearance less than 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 product on days when hemodialysis is not performed. 6. Method and duration of administration 1) This product 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 product is missed (if 12 hours or more have elapsed since the last dose), whether to administer an additional dose to make up for it should be decided by the physician. 3) When used concomitantly with antacids containing magnesium or aluminum, this product should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this product. 4) The duration of treatment with this product should depend on clinical need. Treatment of epilepsy generally requires long-term administration. 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 product 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. 5) The safety and efficacy of treatment of neuropathic pain for more than 5 months have not been evaluated. 6) To reduce the main adverse effects, including somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be administered at bedtime.

Child dose

1. Epilepsy 2) Adjunctive therapy for children aged 3 years or older and 12 years or younger - Day 1: Gabapentin 10 mg/body weight (kg) - Day 2: Gabapentin 20 mg/body weight (kg) - From Day 3: Gabapentin 30 mg/body weight (kg) If needed, the dose may be increased 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, so if there are any changes in mood or behavior during treatment, it is necessary to consult a doctor immediately. Stopping this medication abruptly may worsen seizures or lead to status epilepticus, so the dosage should be gradually adjusted according to a doctor’s instructions. Serious side effects such as pancreatitis may occur, so if there is persistent upper abdominal pain, nausea, or vomiting, it is important to stop taking the medication immediately and seek medical attention. In pediatric patients, central nervous system adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may occur, so caution is necessary. Taking this medication together with narcotics or central nervous system depressants can cause severe drowsiness, respiratory depression, and coma, so it should only be taken after consulting a doctor. Patients with allergic reactions to this medication, acute pancreatitis, specific seizure types, or hereditary lactose intolerance should not take it. Patients with impaired kidney function, elderly individuals, those with a history of psychiatric disorders, and women who are pregnant or breastfeeding should exercise caution when taking this medication. Side effects such as dizziness, drowsiness, nausea, vomiting, weight gain, ataxia, and memory impairment may occur during treatment; if symptoms are severe, it is advisable to consult a doctor. Especially in the early stages of pregnancy, this medication may affect the fetus, so those planning to conceive or who are pregnant must consult a doctor. This medication may impair the ability to drive or operate machinery, so caution should be taken until sufficient adaptation occurs in the early stages of treatment. Strictly follow the usage and dosage prescribed by the doctor and do not stop or change the dosage arbitrarily. Keep this medication out of the reach of children and store it in its original container to prevent misuse or degradation of quality.

Suicidal ideation, suicidal behavior, depression, emotional instability, hostility, cognitive disturbances, 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, memory loss, ataxia, confusion, impaired coordination, dizziness, speech disturbance, insomnia, neurogenic hypersensitivity, nystagmus, drowsiness, cognitive disturbances, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, abdominal distension, anorexia, gingivitis, arthralgia, dizziness, hyperactivity, increased reflexes, decreased reflexes, sensory disturbance, anxiety, pneumonia, urinary tract infection, visual disturbance, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, coagulopathy, loss of symptoms, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, gait disturbances, confusion, tremors, vertigo, respiratory distress, coagulopathy, rash, weakness, lethargy, facial edema, allergy, generalized edema, weight loss, chills, feeling of strangeness, lethargy, alcohol intolerance, hangover effects, hypotension, angina pectoris, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular extrasystole, bradycardia, immature atrial contractions, 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, dental discoloration, cheilitis, salivary gland hypertrophy, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectal inflammation, irritable bowel syndrome, rectal bleeding, esophageal spasms, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian insufficiency, epididymitis, testicular enlargement, cushingoid appearance, bruising-like purpura due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg's test, costochondritis, osteoporosis, pouchitis, contracture, confusion, depression, neurohypersensitivity, perceptual disturbances, insomnia, neuropathy, decreased libido, anxiety, depersonalization, reduced reflexes, speech impairment, dream disturbances, speech disorder, emotional instability, somnolence, perceptual disturbances around the mouth, unusual euphoria, hypersensitivity, decreased motor function, suicide attempts, restlessness, hypertonia, increased libido, movement disorders, myoclonus, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, hematuria, dysuria, frequency of voiding, bladder inflammation, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual abnormalities, menorrhagia, breast cancer, amenorrhea, ejaculation abnormalities, renal pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, inflammation of the ear, taste loss, taste disturbances, eyelid twitching, ear fullness, itching eyes, accommodation disorders, tympanic membrane perforation, sensitivity to noise, ocular fixation disturbances, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, pupillary dilation, choroidal-retinal inflammation, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory disturbances, tongue paralysis, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy, suicidal ideation, suicidal behavior, depression, confusion, loss of consciousness, mental disorders, coma, mild diarrhea, dependence, misuse, withdrawal symptoms, neuropsychiatric adverse reactions, hemorrhagic pancreatitis, pancreatitis, 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, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, movement disorders, dystonia, myotonia, palpitations, sexual dysfunction, skin and mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence

This medication may be sensitive to air and moisture, so it must be stored in a sealed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius, and it is advisable to avoid excessively hot or cold places.

Appearance

Yellowish opaque hard capsules containing white or grayish powdered or granule form

Package unit

30 capsules/bottle, 100 capsules/bottle