Ospentin Capsule 300mg (Gabapentin)

Adult dose

Epilepsy, 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 gradually over the first 3 days of treatment. Day 1: Take one 300 mg capsule of this medicine once daily or one 100 mg capsule of this medicine three times daily (gabapentin 300 mg/day). Day 2: Take one 300 mg capsule of this medicine twice daily or two 100 mg capsules of this medicine three times daily (gabapentin 600 mg/day). From Day 3: Take one 300 mg capsule of this medicine three times daily or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day). Alternatively, instead of the above regimen, one 300 mg capsule of this medicine may be given three 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.) Neuropathic pain, adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose gradually over the first 3 days of treatment. Day 1: Take one 300 mg capsule of this medicine once daily or one 100 mg capsule of this medicine three times daily (gabapentin 300 mg/day). Day 2: Take one 300 mg capsule of this medicine twice daily or two 100 mg capsules of this medicine three times daily (gabapentin 600 mg/day). From Day 3: Take one 300 mg capsule of this medicine three times daily or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day). Alternatively, instead of the above regimen, one 300 mg capsule of this medicine may be given three 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; 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. 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. Elderly patients: Dosage adjustment may be required due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients undergoing hemodialysis: Dosage adjustment is required based on the following table. Dosage for patients with renal impairment: Creatinine clearance (mL/min) ≥80: Total daily dosea 900∼2,400 mg/day Creatinine clearance (mL/min) 50∼79: Total daily dosea 600∼1,800 mg/day Creatinine clearance (mL/min) 30∼49: Total daily dosea 300∼900 mg/day Creatinine clearance (mL/min) 15∼29: Total daily dosea 150b∼600 mg/day Creatinine clearance (mL/min) <15: Total daily dosea 150b∼300 mg/day 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 creatinine clearance. Dosage for patients undergoing hemodialysis: An initial dose of 300∼400 mg gabapentin is recommended. For the maintenance dose, administer 200∼300 mg gabapentin after 4 hours of hemodialysis; do not administer this medicine on days when hemodialysis is not performed. Swallow this medicine whole with plenty of fluid. It may be taken with or without food. When administered 3 times daily, take care that the dosing interval does not exceed 12 hours to prevent recurrence of seizures. If a dose of this medicine is missed (more than 12 hours have elapsed since the most recent dose), the physician should decide whether an additional dose should be given to make up for the missed dose. When taken with antacids containing magnesium or aluminum, administer this medicine at least 2 hours after the antacid. In patients with epilepsy, if treatment with this medicine is to be discontinued or if it is to be administered with another antiepileptic drug, the change should be made gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain lasting more than 5 months have not been evaluated. The first dose on Day 1 should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years: Titrate gradually over the first 3 days of treatment to a maintenance dose of gabapentin 30 mg/kg body weight/day. 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. The dose may be increased, if necessary, to a maximum of 40 mg/kg 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 behavior, so if mood changes or unusual behavior occur during treatment, consult a doctor immediately. Abruptly stopping this medication can worsen seizures, so when discontinuing, it must be gradually reduced according to the doctor's instructions. This medication can cause serious side effects such as pancreatitis; therefore, if continuous upper abdominal pain, nausea, or vomiting occurs, it should be discontinued immediately and medical attention should be sought. Particularly in children, the elderly, and patients with impaired kidney function, caution is needed when taking this medicine, and any adverse reactions should be reported immediately. This medication can cause central nervous system side effects such as drowsiness, dizziness, and motor coordination disorders; therefore, it is advisable to avoid driving or operating hazardous machinery during the initial stages of treatment. When used in conjunction with narcotics or other central nervous system depressants, respiratory depression or unconsciousness may occur, so strict adherence to medical advice is essential during concurrent use. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, and caution is needed when breastfeeding. Patients with hypersensitivity to this medication or with certain genetic metabolic disorders, patients with acute pancreatitis, and patients with specific types of seizures should not be treated with this medication. While taking this medication, unusual symptoms such as weight gain, vision changes, or skin rash may occur, so regular monitoring of status is necessary, and any abnormalities should be reported to a doctor. This medication may cause withdrawal symptoms, so when discontinuing, consult healthcare providers to taper off gradually.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, abnormal thoughts, 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 disturbance, insomnia, neuro-excitatory reactions, nystagmus, drowsiness, abnormal thoughts, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, allergy, generalized edema, weight loss, chills, feeling of unfamiliarity, listlessness, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thromboembolic venous disease, deep venous thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, premature ventricular contraction, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, abdominal distention, gingivitis, glossitis, gum 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 hypertrophy, 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, bruise-like purple spots due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, reduced or absent reflexes, increased reflexes, anxiety, hostility, CNS tumor, syncope, abnormal dreams, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, myotonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, proprioceptive loss, subdural hematoma, apathy, hallucinations, reduced or lost libido, restlessness, paranoia, depersonalization, dysphoria, hyperesthesia, hallucinatory state, suicidal thoughts, mental disorders, chorea athetosis, oral motor disorders, brain diseases, neuropathy, personality disorders, increased libido, organic suppression, apraxia, fine motor control disorder, meningitis, focal myoclonus, sensory hypersensitivity, reduced motor function, mania, neurosis, hysteria, antisocial response, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal sores, bronchial spasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hypertrichosis, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, dermal nodules, subcutaneous nodules, hyperpigmentation, skin necrosis, localized swelling, hematuria, urinary disorders, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation abnormalities, renal pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, enuresis, pyuria, urgency, pelvic pain, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, ocular pain, glare, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste abnormalities, eyelid twitching, foreign body sensation, itchy eyes, accommodation disorder, eardrum perforation, sensitivity to noise, abnormal ocular fixation, overflow tears, retinopathy, glaucoma, iritis, corneal disturbances, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, meiosis, choroid retinitis, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory abnormalities, tongue paralysis, elevated serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, 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, myotonia, muscular hypertonus, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the efficacy and safety of the drug.

Appearance

A hard gelatin capsule with a white or grayish white powder inside, with light yellow upper and lower parts.

Package unit

30 capsules/bottle, 100 capsules/bottle