Teva Olanzapine Tablet 15 mg

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Dose increases above the usual recommended daily dose of 10 mg are 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: It is difficult to give a definitive answer regarding how long treatment with this medicine should continue. However, 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 a dose of 10∼20 mg once 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. For 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, treatment with this medicine should continue, together with adjunctive therapy to treat mood symptoms as indicated by clinical signs (optimizing the required dose as needed). 3) For schizophrenia, treatment of 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 once daily based on 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 reduced gradually and cautiously. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5 mg of olanzapine once daily and increase to 10 mg once daily. Administer this medicine at bedtime and adjust the dose appropriately according to age and symptoms; do not exceed a daily dose of 20 mg. This medicine may be taken with or without food, as food does not affect drug absorption. 2. Dosage in special populations 1) Elderly patients Starting at a dose of 5 mg or less once daily may be considered when adequately supported by 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 cautiously. 3) Patients with multiple factors that delay the metabolism of this medicine (female sex, advanced age, and nonsmoking status) may also start at a low dose.

This medication can cause a serious side effect known as neuroleptic malignant syndrome, which may be life-threatening. Therefore, if you notice unusual fever, rigidity of muscles, or changes in mental state, you should discontinue use of the medication immediately. It is not recommended for the treatment of psychosis or behavioral disorders associated with dementia, and especially in elderly patients, there may be an increased risk of death and cerebrovascular disorders. Long-term use may lead to tardive dyskinesia, an involuntary movement disorder, so if symptoms occur, dosage adjustment or discontinuation should be considered. Patients at risk for diabetes or hyperglycemia should regularly check blood sugar and weight, and if there are abnormal symptoms, they should consult a healthcare provider immediately. This medication may cause withdrawal symptoms such as sweating, insomnia, or anxiety if suddenly discontinued, so it is advisable to gradually reduce the dosage before stopping. For patients with Parkinson's disease, attention is needed as symptom worsening and hallucinations may occur. There have been reports of acute cardiac death as a cardiac-related side effect, so patients with cardiovascular disease should be particularly careful. This medication should be used cautiously in patients with certain liver diseases, a history of seizures, cardiovascular diseases, elderly patients, those with diabetes, pregnant women, and nursing mothers, and should not be administered to patients who are allergic to the medication or have closed-angle glaucoma, patients receiving epinephrine, or those with lactose intolerance. Drowsiness or dizziness may occur while taking this medication, so it is advisable to avoid driving or operating dangerous machinery, and regular monitoring of blood pressure and liver function tests is recommended. Additionally, this medication may interact with several drugs, so if you are taking other medications, make sure to inform your healthcare provider and be closely monitored. Women who are pregnant or nursing should always consult a physician before taking this medication, and if breastfeeding, it is recommended to stop breastfeeding. In case of overdose, severe loss of consciousness and cardiac problems may occur, so immediate medical attention should be sought. This medication should be kept out of the reach of children and stored at 15 to 30 degrees Celsius, avoiding direct sunlight and moisture.

High fever, muscle rigidity, changes in mental status, irregular pulse, blood pressure changes, tachycardia, sweating, cardiac arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute renal failure, increased mortality, cerebrovascular adverse reactions, stroke, transient ischemic attack, delayed dyskinesia, drowsiness, weight gain, eosinophilia, increased prolactin, elevated cholesterol, increased blood sugar, elevated triglycerides, diabetes, increased appetite, akathisia, Parkinson's disease, leukopenia, neutropenia, movement disorders, orthostatic hypotension, anticholinergic effects, elevated liver transaminases, rash, asthenia, fatigue, fever, arthralgia, increased alkaline phosphatase, elevated gamma-glutamyl transferase, elevated uric acid, increased creatine phosphokinase, edema, elevated blood glucose levels, increased triglycerides, petechiae, anemia, cyanosis, leukocytosis, lymphadenopathy, neutropenia, hypersensitivity reactions, acidosis, 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 patients, insomnia, depression, dizziness, personality disorder, tremors, muscle rigidity, speech impairment, sensory abnormalities, apathy, confusion, abnormal euphoria, coordination impairment, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenia reactions, motor incapacity, alcohol abuse, antisocial reactions, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, delirium, dementia, depersonalization, stuttering, facial paralysis, sensory loss, hypokinesia, decreased muscle tone, decreased libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, confusion, delayed dyskinesia, vertigo, withdrawal syndrome, suicide attempt, amnesia, seizures, muscle tone abnormalities, restless legs 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, congestive heart failure, cardiac arrest, hemorrhage, migraine, pallor, palpitations, vasodilation, ventricular extrasystole, QTc prolongation, thromboembolism, arteritis, heart failure, pulmonary embolism, ventricular fibrillation, sudden death, diabetes, diabetic acidosis, 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 bloating, excessive salivation, rhinitis, increased cough, pharyngitis, dyspnea, apnea, asthma, nosebleed, hemoptysis, hyperventilation, hypoxia, laryngitis, voice changes, atelectasis, hiccups, respiratory depression, pulmonary edema, stridor, hepatic steatosis, hepatitis, jaundice, sweating, photosensitivity reactions, acne, skin dryness, alopecia, contact dermatitis, eczema, papular rash, pruritus, seborrhea, skin discoloration, skin ulcer, urticaria, vesicular rash, hypertrichosis, pustular rash, drug reaction (DRESS), low back pain, chest pain, toothache, flu syndrome, injection site pain, abdominal enlargement, chills, facial edema, self-harm, lethargy, candidiasis, throat pain, neck stiffness, pelvic pain, hangover, sudden death, joint stiffness, single contraction, 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, ocular inflammation, eye pain, abnormal ocular muscle movement, taste abnormalities, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, macular pigmentation deficiency, pupil constriction, pupil dilation, pigment deposition in the lens, 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, urinary retention, oliguria, uterine fibroid hypertrophy, vaginal bleeding, urinary delay, albuminuria, breast enlargement, mastitis, oliguria in urine, male erectile dysfunction, benign all 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 elevation, neonatal withdrawal symptoms, oculomotor seizures, confusion, myotonic contractions, oculomotor nerve paralysis, headache, abdominal pain, pain, weight loss, bloody stools, convulsions, hypomania, sexual discomfort, neurogenic response, hallucinations, hepatic failure, decreased appetite, urinary obstruction, pyelonephritis, abnormal ECG, pupillary atony, torticollis, tachycardia, agitation, aggression, stuttering, various extrapyramidal symptoms, sedation, decreased level of consciousness, delirium, contractions, respiratory function inhibition, aspiration, hypertension, hypotension, arrhythmia, cardiopulmonary arrest

This medication should be stored in an airtight container with good air circulation, in a cool place between 15 and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication for a longer period.

Appearance

Light blue, oval, biconvex film-coated tablets

Package unit

30 tablets (10 tablets/PTPX3)