Teva Olanzapine Tablet 2.5 mg

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Increases above the usual recommended daily dose of 10 mg are recommended only after an appropriate clinical assessment. 1. Adults 1) Schizophrenia (1) The initial recommended dose is 5∼10 mg of olanzapine once daily. (2) Maintenance treatment: Although there is no clear answer as to how long treatment with this medicine should continue, its efficacy was demonstrated in a placebo-controlled study in patients with schizophrenia whose symptoms had stabilized after taking this medicine for approximately 8 weeks and who 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 with lithium or valproate. (2) Prevention of recurrence in bipolar disorder The initial recommended dose is 10 mg once daily. Patients who have been receiving this medicine to treat mania should continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, treatment with this medicine should continue, along with adjunctive therapy to treat mood symptoms according to clinical indications (optimizing the required doses as needed). 3) For the treatment of schizophrenia and manic and mixed episodes associated with bipolar I disorder, and prevention of recurrence in bipolar disorder, the daily dose may be adjusted within the range of 5 mg to 20 mg daily based on clinical condition. Increases above the initial recommended dose are recommended only after an appropriate clinical assessment, and the dose should generally be increased at intervals of 24 hours or more. If treatment with this medicine is discontinued, the dose should be reduced gradually and cautiously. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5mg of olanzapine once daily and increase to 10mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms; the daily dose should not exceed 20mg. Since food does not affect drug absorption, this medicine may be taken with or without food. 2. Administration in special populations 1) Elderly patients Starting at a dose of 5 mg or less daily may be considered when there is sufficient evidence based on 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 the dose should be increased cautiously. 3) Patients with multiple factors that delay the metabolism of this medicine (female sex, older age, nonsmoking status) may also be started at a lower dose.

This medication may cause serious and life-threatening side effects known as neuroleptic malignant syndrome, so if there are symptoms like abnormal high fever, muscle rigidity, or changes in mental status, discontinue use immediately and seek medical attention. It is not approved for the treatment of psychoses or behavioral disorders related to dementia, and caution is needed as there may be an increased risk of mortality and cerebrovascular disorders in dementia patients taking this medication. Long-term use may lead to movement disorders known as tardive dyskinesia, so if abnormal movements occur while on this medication, dose adjustments or discontinuation should be considered. There may be an increased risk of diabetes or difficulty in blood sugar control, so regular monitoring of weight and blood sugar levels and attention to hyperglycemic symptoms are necessary. This medication can cause drowsiness and dizziness; exercise caution when driving or operating hazardous machinery. Liver function may be abnormal, so patients with liver dysfunction symptoms should be given this medication carefully, along with liver function tests. For those with cardiovascular diseases or elderly individuals, monitoring of blood pressure and heart condition is necessary as there may be drops in blood pressure or heart irregularities. Pregnant or nursing women should consult a physician before administration as side effects may occur in the fetus and newborn. It is also recommended to stop breastfeeding when taking this medication. Abruptly stopping this medication may lead to withdrawal symptoms such as insomnia, anxiety, and nausea, so tapering off the dosage gradually is safer. There may be drug interactions, so especially when combined with drugs that affect liver metabolism or when using epinephrine or dopamine agents, guidance from a professional should be obtained. In cases of overdose, severe side effects may occur, and immediate emergency care is required. There is no specific antidote, so treatment should be received at the appropriate medical institution. This medication should be kept out of reach of children and stored away from light and moisture between 15-30 degrees Celsius.

High fever, muscle rigidity, changes in mental status, irregular pulse, changes in blood pressure, tachycardia, sweating, cardiac arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute renal failure, increased mortality rate, stroke, transient ischemic attack, tardive dyskinesia, drowsiness, weight gain, eosinophilia, elevated prolactin, elevated cholesterol, elevated blood sugar, elevated triglycerides, diabetes, increased appetite, akathisia, Parkinsonism, leukopenia, neutropenia, movement disorders, orthostatic hypotension, anticholinergic effects, elevated liver transaminases, rash, weakness, fatigue, fever, arthralgia, increased alkaline phosphatase, elevated gamma-glutamyl transferase, increased uric acid, elevated creatine phosphokinase, edema, blood sugar above 160-200 mg/dL, anemia, cyanosis, leukocytosis, lymphadenopathy, neutropenia, hypersensitivity reactions, acidosis, increased alkaline phosphatase, hyperbilirubinemia, dehydration, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, peripheral edema, upper limb edema, hyperkalemia, ketosis, coma, gout, hypernatremia, hypoalbuminemia, ketosis, water intoxication, hypothermia, dizziness, abnormal gait in Alzheimer's disease, insomnia, depression, vertigo, akathisia, all extrapyramidal abnormalities, personality disorders, tremor, hypertonia, speech disturbances, sensory disturbances, apathy, confusion, abnormal euphoria, coordination disorder, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenia reactions, akinesia, alcohol abuse, antisocial reactions, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, delirium, dementia, depersonalization, stuttering, facial paralysis, sensory impairment, decreased physical activity, decreased muscle tone, decreased libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, stupor, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempt, amnesia, seizures, myotonia, restless leg syndrome, paralysis around the mouth, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid hemorrhage, tobacco abuse, neuroleptic malignant syndrome, withdrawal symptoms, orthostatic hypotension, tachycardia, hypertension, hypotension, syncope, bradycardia, atrial fibrillation, cerebrovascular accident, congestive heart failure, cardiac arrest, bleeding, migraine, pallor, palpitations, vasodilation, ventricular premature contraction, QTc prolongation, thromboembolism, arteritis, heart failure, pulmonary embolism, ventricular fibrillation, sudden death, diabetes, diabetic ketoacidosis, goiter, constipation, thirst, dyspepsia, vomiting, increased salivation, dysphagia, esophagitis, fecal incontinence, gastritis, gastroenteritis, gingivitis, melena, oral ulcer, nausea, oral candidiasis, periodontal abscess, rectal bleeding, stomatitis, tongue swelling, dental caries, diarrhea, abdominal distension, excessive salivation, rhinitis, increased cough, pharyngitis, dyspnea, apnea, asthma, epistaxis, hemoptysis, hyperventilation, hypoxemia, laryngitis, voice changes, atelectasis, hiccups, respiratory depression, pulmonary edema, wheezing, hepatic steatosis, hepatitis, jaundice, sweating, photosensitivity reactions, acne, dry skin, alopecia, contact dermatitis, eczema, papular rash, pruritus, seborrhea, skin discoloration, skin ulcer, urticaria, vesicular rash, hirsutism, pustular rash, drug reaction (DRESS), low back pain, thoracic pain, dental pain, influenza-like syndrome, injection site pain, abdominal enlargement, chills, facial edema, intentional injury, lethargy, candidiasis, throat pain, cervical rigidity, pelvic pain, hangover, sudden death, joint stiffness, single contraction, arthritis, arthrosis, leg cramps, myasthenia gravis, joint pain, bone pain, bursitis, myopathy, osteoporosis, rheumatoid arthritis, rhabdomyolysis, amblyopia, visual disturbances, conjunctivitis, abnormal accommodation, blepharitis, cataracts, hearing loss, diplopia, dry eyes, ear pain, ocular hemorrhage, oculitis, eye pain, abnormal ocular muscle activity, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, decreased macular pigmentation, miosis, mydriasis, lens pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, mastalgia, cystitis, decreased menstruation, urination disorders, galactorrhea, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, frequency of urination, urinary retention, anuria, uterine fibrotic hypertrophy, vaginal bleeding, urinary delay, albuminuria, breast hypertrophy, mastitis, oliguria, male erectile dysfunction, benign decreased libido, female amenorrhea, hyperlactation, breast enlargement, gynecomastia, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine phosphokinase, increased gamma-glutamyl transferase, increased uric acid, total bilirubin increase, neonatal withdrawal symptoms, ocular movement seizures, delirium, myoclonic jerks, ocular motor nerve paralysis, headache, abdominal pain, pain, weight loss, bloody stools, convulsions, hypomania, sexual discomfort, neurogenic hypersensitivity reactions, auditory hallucinations, liver failure, decreased appetite, urinary retention, pyelonephritis, electrocardiographic abnormalities, pupil immobility, torticollis, weight gain, drowsiness, increased appetite, sedation, hypersomnia

This medication should be stored in a tightly sealed container to prevent air exposure, preferably at room temperature between 15°C and 30°C. Storing it this way helps maintain the efficacy and safety of the medication.

Appearance

White, biconvex, round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)