Ospentin Capsule 100 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 of 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 twice 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 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.) 2. Neuropathic pain Adults (18 years and older): To achieve 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 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 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 of gabapentin within one week, and the total daily dose must not exceed 3,600 mg of gabapentin. When administering this drug, the total daily dose should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients following transplantation, 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) 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: 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 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) This drug should be swallowed whole with sufficient 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 drug is missed (if 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. 3) When coadministered with antacids containing magnesium or aluminum, this drug should be administered 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. 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 abrupt discontinuation of treatment), abrupt 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 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 reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be administered at bedtime.

Child dose

1. Epilepsy 2) Adjunctive therapy in children aged 3 to 12 years - 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 ideation or behavior, so mood changes or depressive symptoms should be carefully monitored during treatment. Abruptly discontinuing this medication may lead to increased seizure frequency or status epilepticus, so it should be tapered off slowly according to the physician's instructions. This medication can cause serious side effects like pancreatitis, so if symptoms such as upper abdominal pain, nausea, or vomiting occur, it should be discontinued immediately and medical consultation should be sought. In children, neurological and psychiatric adverse reactions such as emotional instability, aggressiveness, decreased concentration, and hyperactivity may occur, so caregivers should monitor them closely. Taking this medication with central nervous system depressants, including narcotics, can lead to severe drowsiness, respiratory depression, or coma, so caution is necessary when used together. This medication can lead to various side effects including allergic reactions, cardiovascular issues, gastrointestinal problems, neurological abnormalities, and skin rashes, so any unusual symptoms should be reported to a healthcare professional immediately. Women who are pregnant or planning to become pregnant should consult with a physician before taking this medication due to potential risks to the fetus, and caution is also needed during breastfeeding. Patients with reduced kidney function or the elderly may require dose adjustments, and weight gain or visual disturbances may occur during treatment, so regular monitoring is necessary. Activities requiring concentration such as driving or operating hazardous machinery should be avoided during the initial period of treatment with this medication or until symptoms are well controlled. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as anxiety, insomnia, and tremors, so dosage adjustments should be made under a physician's guidance. If there are plans to take other medications or alcohol during the course of this treatment, it is essential to inform healthcare professionals and be cautious about possible drug interactions. Children, the elderly, patients with a history of mental illness, pregnant women, and nursing mothers require special caution, and any unusual symptoms should be discussed with a healthcare professional immediately.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, fatigue, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, muscle pain, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hyperreactive neuro response, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, allergy, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effect, hypotension, angina pectoris, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular ectopy, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, appetite suppression, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, blood in stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, stomatitis vesicles, dental discoloration, angular cheilitis, salivary gland enlargement, lip hemorrhage, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, goiter, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, trauma-induced purpura, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, fainting, dream disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiparesis, facial paralysis, confusion, cerebellar dysfunction, benign Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, restlessness, schizophrenia, depersonalization, dysphoria, hyperesthesia, suicidal ideation, psychosis, chorea, dystonia around the mouth, brain disease, nerve paralysis, personality disorder, increased libido, organic inhibition, apraxia, fine motor control disorder, meningitis, local myoclonic seizures, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial response, suicidal behavior, pneumonia, nosebleed, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal obstruction, nasal deformity, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photophobia, leg ulcers, scalp seborrhea, psoriasis, epidermal detachment, maceration, cutaneous nodules, subcutaneous nodules, acanthosis, skin necrosis, local swelling, hematuria, urinary disorders, polyuria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, aspermia, ejaculation disorders, kidney pain, white vaginal discharge, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency, dyspareunia, breast pain, testicular pain, visual disturbances, cataracts, conjunctivitis, dry eyes, eye pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, pinguecula, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, loss of taste, taste disturbances, blepharospasm, fullness in the ears, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of prodromal signs, laryngeal neuralgia, somnambulism, pseudo croup, hoarseness, trauma-induced injury, cold syndrome, infection, pain, abdominal distension, dry mouth, gait abnormalities, confusion, tremors, vertigo, dyspnea, bronchitis, respiratory infections, tongue abnormalities, dental abnormalities, petechiae, edema, gout, hypoglycemia, weight loss, increased alkaline phosphatase, diabetic ketoacidosis, increased lactate dehydrogenase, leg cramps, myasthenia gravis, shin pain, joint disorders, tendon disorders, neuropathy, decreased libido, depersonalization, speech disorders, dysarthria, confusion, perioral sensory disturbances, dysphoria, hypersensitivity, decreased motor function, suicide attempts, restlessness, hypertonia, movement disorders, myoclonic seizures, vestibular disorders, increased coughing, sinusitis, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, skin ulcers, fungal dermatitis, furunculosis, skin carcinoma, skin thickening, ear pain, eye abnormalities, taste dysgeusia, hearing loss, conjunctival congestion, diabetic retinopathy, eye pain, retinal microhemorrhage, retinal vein thrombosis, loss of taste, urinary tract infection, urinary disorders, vaginal myelitis, breast pain, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation disorders, penile engorgement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine kinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast hypertrophy, chest pain, toxic epidermal necrolysis, eosinophilia, systemic symptoms with drug rash, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, movement disorders, dystonia, muscle cramps, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to prevent contact with air or moisture and is best kept at room temperature between 1°C and 30°C to maintain its efficacy for a longer period.

Appearance

Capsule with a hard shell in white or off-white color, containing white or grayish-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle