Osgaba Capsule 300 Milligrams (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 three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this drug may be administered three times daily as the starting dose (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 three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this drug may be administered three 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. The total daily dose of this drug should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients following 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 undergoing 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. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to 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) This drug should be swallowed whole with sufficient fluid and may be taken with or without food. When administered 3 times daily, take care 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 last dose), the physician should decide whether an additional dose should be taken to make up for it. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be taken 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 (increased 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 if it is to be used concomitantly 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 Day 1 should be taken at bedtime.

Child dose

Adjunctive therapy for children aged 3 years to 12 years — Day 1: Administer gabapentin 10 mg/body weight (kg) Adjunctive therapy for children aged 3 years to 12 years — Day 2: Administer gabapentin 20 mg/body weight (kg) Adjunctive therapy for children aged 3 years to 12 years — From Day 3 onward: Administer gabapentin 30 mg/body weight (kg) Adjunctive therapy for children aged 3 years to 12 years — The dose may be increased as needed to a maximum of 40 mg per kg of body weight daily. When administering this medicine, divide the total daily dose into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors, so if there are any mood changes or abnormal behaviors during treatment, medical consultation is necessary immediately. Stopping this medication suddenly can lead to more frequent seizures or a severe status epilepticus; therefore, the dosage should be gradually reduced under a doctor's guidance. Certain animal studies have reported a possibility of specific cancers, but the impact on humans is still unclear. There have been rare reports of sudden and unexpected deaths, though these are at a similar risk level as epilepsy itself. If symptoms of pancreatitis occur, such as persistent abdominal pain, nausea, and recurrent vomiting, the medication should be stopped immediately, and medical advice should be sought. This medication may cause neuropsychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity in children aged 3 to under 12 years, thus caution is needed. When taken with central nervous system depressants or narcotics, severe drowsiness, respiratory suppression, and coma can occur, thus consultation with a doctor before concurrent use is essential. Those with hypersensitivity to this medication, acute pancreatitis, primary generalized seizures, and patients with genetic lactose intolerance should not take this drug. Patients with decreased kidney function, elderly patients, those with a history of psychiatric disorders, children with attention deficit or behavioral disorders, pregnant women, or those who may become pregnant and nursing mothers should take special precautions when using this medication. Side effects such as dizziness, drowsiness, memory impairment, motor control disorders, depression, and insomnia may occur, so it is advisable to avoid driving or operating dangerous machinery. Weight gain may occur; hence regular weight checks are necessary, and dietary management and exercise should be combined as needed. If hypersensitivity symptoms such as skin rash, fever, or lymph node swelling occur, usage should be stopped immediately and the medical team should be informed. During pregnancy, it may affect the fetus, so if there are plans to become pregnant or if already pregnant, consultation with a doctor should be undertaken prior to use, and caution is necessary while breastfeeding. Withdrawal symptoms including anxiety, insomnia, nausea, tremors, and headaches may occur after stopping the medication, so it should be tapered slowly according to the doctor's instructions. There may be interactions when taken with other medications or alcohol; therefore, inform the doctor of any other medications being taken or if alcohol is consumed, and it is advisable to space antacid use by at least 2 hours. This medication should be stored out of reach of children and in its original container to prevent misuse and degradation of quality.

Suicidal thoughts, suicidal behavior, depression, abnormal mood and behavioral changes, hemorrhagic pancreatitis, emotional instability, hostility, abnormal thinking, hyperactivity, weakness, lethargy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired cooperation, dizziness, dysarthria, insomnia, hyperreactivity, nystagmus, drowsiness, abnormal thinking, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, impotence, weakness, lethargy, facial edema, allergy, generalized edema, weight loss, chills, unfamiliar feeling, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, murmur, atrial fibrillation, heart failure, thrombotic venous inflammation, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular premature contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, decreased appetite, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastritis, hemorrhoids, hematochezia, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, stomal vesicles, dental discoloration, cheilitis, salivary gland hypertrophy, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian insufficiency, epididymitis, testicular swelling, Cushing's syndrome, bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumor, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, muscle tone disorders, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, altered euphoria, hypersensitivity, hallucinatory states, suicidal thoughts, mental disorders, chorea, athetosis, perioral movement disorders, brain disease, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disturbances, meningitis, focal myoclonus, tactile hypersensitivity, hypomotor function, mania, neurosis, hysteria, antisocial response, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal polyps, bronchospasms, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, seborrheic dermatitis, psoriasis, exfoliative dermatitis, chafing, skin nodules, subcutaneous nodules, melanosis, skin necrosis, localized swelling, hematuria, urination disorders, pollakiuria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, amenorrhea, ejaculation abnormalities, kidney pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, dyspareunia, mastalgia, testicular pain, vision abnormalities, cataract, conjunctivitis, dry eyes, eye pain, glare, bilateral or unilateral ptosis, eye hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste abnormalities, eye twitching, asthenopia, itchy eyes, accommodation anomalies, tympanic membrane perforation, noise sensitivity, eye focus problems, watering, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory abnormalities, urinary tract infection, urination disorders, impotence, incontinence, vaginal molluscum contagiosum, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile engorgement, gynecomastia, nocturia, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased blood creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, 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, motor disorders, muscle tone disorders, myotonic dystrophy, palpitations, pancreatitis, sexual dysfunction, skin and mucous membrane syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormalities in sensation, 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 degree and 30 degrees Celsius.

Appearance

A yellowish hard capsule containing a white or grayish powder.

Package unit

30 capsules/bottle, 300 capsules/bottle