Sandoz Olanzapine Tablet 2.5 mg

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Any increase above the usual recommended daily dose of 10 mg is recommended only after an appropriate clinical evaluation. 1. Adults 1) Schizophrenia (1) The recommended initial dose is 5∼10 mg of olanzapine once daily. (2) Maintenance treatment: Although it is difficult to give a definitive answer as to how long treatment with this medicine should continue, its efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this medicine for approximately 8 weeks received maintenance treatment at doses of 10∼20 mg daily for 8 months. The need for maintenance treatment at an appropriate dose should be assessed periodically. 2) Bipolar disorder (1) Treatment of manic and mixed episodes associated with bipolar I disorder The initial dose is 15 mg of this medicine once daily as monotherapy, or 10 mg once daily as adjunctive therapy to lithium or valproate. (2) Prevention of recurrence in bipolar disorder The recommended initial dose is 10 mg once daily. In patients who have received this medicine to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, continue this medicine with adjunctive therapy to treat mood symptoms, as clinically indicated, optimizing the required dose as necessary. 3) For the treatment of schizophrenia and manic and mixed episodes associated with bipolar I disorder, and for prevention of recurrence in bipolar disorder, the daily dose may be adjusted within the range of 5 mg to 20 mg daily according to the clinical condition. Increases above the recommended initial dose are advised only after an appropriate clinical evaluation and should generally be made at intervals of at least 24 hours. If treatment with this medicine is discontinued, the dose should be gradually reduced with care. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5mg of olanzapine once daily, then increase to 10mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms, but do not exceed a daily dose of 20mg. This medicine may be taken with or without food, as food does not affect drug absorption. 2. Administration in special populations 1) Elderly patients Starting at a dose of 5 mg or less daily may be considered when supported by sufficient clinical factors. 2) Patients with renal or hepatic impairment A low initial dose (5 mg) should be considered. In moderate hepatic impairment (cirrhosis, Child-Pugh class A or B), the initial dose is 5 mg and should be increased with caution. 3) A low starting dose may also be used in patients with a combination of factors that delay the metabolism of this medicine (female sex, advanced age, and nonsmoking status).

This medication may cause a life-threatening serious side effect called neuroleptic malignant syndrome, so if symptoms like high fever, muscle rigidity, or changes in mental status occur, usage should be stopped immediately and medical attention sought. Additionally, it is not approved for the treatment of dementia-related psychosis or behavioral disorders, and its use may increase mortality and the risk of cerebrovascular accidents in dementia patients; thus, it is best not to use this medication in such patients. Long-term use may lead to tardive dyskinesia, a movement disorder, and dosage adjustments or discontinuation should be considered if symptoms arise. Improvements in symptoms may take several days to weeks initially, so patients should be closely monitored. New-onset or worsening diabetes or hyperglycemia may occur, so blood sugar and weight should be checked regularly and reported to a doctor if symptoms appear. Abrupt discontinuation of this medication can lead to symptoms like sweating, insomnia, anxiety, and nausea, so when stopping, the dosage should be gradually reduced. Women who are pregnant or breastfeeding should consult a doctor, as side effects may occur in the fetus or newborn; it is safest to discontinue breastfeeding. This medication can cause drowsiness and dizziness, requiring caution when driving or operating hazardous machinery. Patients with impaired liver function or a history of seizures should take this medication with caution, and regular blood tests to monitor white blood cell counts are needed. There may be interactions with other medications, so if other medications are being taken, it is important to inform the doctor or pharmacist. Severe side effects can occur with overdose, so it is crucial to adhere to the prescribed dosage, and seek medical attention immediately if unusual symptoms occur. This medication should be kept out of reach of children and stored in a cool, dry place between 15-30 degrees Celsius, away from direct sunlight and moisture.

Hyperthermia, muscle rigidity, changes in mental state, irregular pulse, blood pressure changes, tachycardia, sweating, cardiac arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute renal failure, increased mortality rate, cerebrovascular adverse reactions, stroke, transient ischemic attacks, tardive dyskinesia, drowsiness, weight gain, eosinophilia, elevated prolactin, increased cholesterol, elevated blood sugar, increased triglycerides, diabetes, increased appetite, inability to sit still, Parkinson's disease, leukopenia, neutropenia, movement disorders, orthostatic hypotension, anticholinergic effects, increased liver transaminases, rash, asthenia, fatigue, fever, arthralgia, increased alkaline phosphatase, elevated gamma-glutamyl transferase, increased uric acid, elevated creatine phosphokinase, edema, elevated blood glucose levels, elevated triglycerides, petechiae, anemia, cyanosis, leukocytosis, lymphadenopathy, neutropenia, hypersensitivity reactions, acidosis, increased alkaline phosphatase, hyperbilirubinemia, dehydration, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, lower limb edema, upper limb edema, hyperkalemia, ketoacidosis, coma, gout, hypernatremia, hypoproteinemia, ketosis, water intoxication, hypothermia, dizziness, abnormal gait in Alzheimer's disease, insomnia, depression, vertigo, inability to sit still, movement disorders, personality disorders, tremors, hypertonia, dysarthria, sensory disturbances, apathy, confusion, euphoria, coordination disorders, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenia reactions, incapacitated movements, alcohol abuse, antisocial reactions, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, nonsense speech, dementia, depersonalization, stuttering, facial paralysis, sensory loss, reduced muscle activity, decreased libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, confusion, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempts, amnesia, seizures, muscle tension disorders, restless leg syndrome, peri-oral paralysis, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid hemorrhage, tobacco abuse, malignant syndrome of neuroleptics, withdrawal symptoms, orthostatic hypotension, tachycardia, hypertension, hypotension, syncope, bradycardia, atrial fibrillation, cerebrovascular accidents, congestive heart failure, cardiac arrest, hemorrhage, migraine, pallor, palpitations, vasodilation, ventricular ectopic contractions, QTc prolongation, thromboembolism, arteritis, heart failure, pulmonary embolism, ventricular fibrillation, sudden death, diabetes mellitus, diabetic acidosis, goiter, constipation, thirst, dyspepsia, vomiting, increased salivation, dysphagia, esophagitis, fecal incontinence, gastritis, gastroenteritis, gingivitis, melena, oral ulcers, nausea, oral candidiasis, periodontal abscess, rectal bleeding, stomatitis, tongue swelling, dental caries, diarrhea, abdominal distension, excessive salivation, aphthous stomatitis, enteritis, belching, esophageal ulcer, glossitis, intestinal obstruction, bowel obstruction, discoloration of the tongue, pancreatitis, rhinitis, increased coughing, pharyngitis, shortness of breath, apnea, asthma, epistaxis, hemoptysis, hyperventilation, hypoxemia, laryngitis, voice changes, atelectasis, hiccups, respiratory depression, pulmonary edema, stridor, fatty liver, hepatitis, jaundice, sweating, photosensitivity reactions, acne, dry skin, alopecia, contact dermatitis, eczema, papular rash, itching, seborrhea, skin discoloration, skin ulcers, urticaria, vesicular rash, hirsutism, pustular rash, drug reaction (DRESS), low back pain, chest pain, toothache, flu-like syndrome, injection site pain, lethargy, candidiasis, throat pain, neck stiffness, pelvic pain, hangover, sudden death, joint stiffness, single twitch, arthritis, arthrosis, leg cramps, myasthenia, arthralgia, bone pain, bursitis, myopathy, osteoporosis, rheumatoid arthritis, rhabdomyolysis, amblyopia, visual disturbances, conjunctivitis, abnormal accommodation, blepharitis, cataract, hearing loss, diplopia, dry eyes, ear pain, ocular hemorrhage, eye inflammation, eye pain, abnormalities of eye muscles, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, macular pigmentary degeneration, miosis, mydriasis, lens pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, breast pain, cystitis, decreased menstruation, urination disorders, female galactorrhea, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, frequent urination, urine retention, oliguria, uterine fibroid hypertrophy, vaginal bleeding, urinary hesitancy, albuminuria, breast enlargement, mastitis, reduced urine output, male erectile dysfunction, benign libido decrease, female amenorrhea, galactorrhea, breast enlargement, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine phosphokinase, elevated gamma-glutamyl transferase, increased uric acid, total bilirubin increase, neonatal withdrawal syndrome, ocular movement disorders, confusion, muscle spasms, oculomotor nerve paralysis, headache, abdominal pain, pain, weight loss, bloody stools, convulsions, hypomania, sexual discomfort, hypersensitivity reactions, auditory hallucinations, liver failure, decreased appetite, urinary retention, pyelonephritis, abnormal electrocardiogram findings, pupil asymmetry, torticollis, tachycardia, excitement, aggression, stuttering, various extrapyramidal symptoms, decreased consciousness level, nonsense speech, convulsions, respiratory function suppression, aspiration, hypertension, hypotension, arrhythmia, cardiopulmonary arrest

This medication should be stored in a tightly closed container to prevent air from entering, ideally at room temperature between 15 and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy and prevents deterioration.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle