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Indications:

OLANZAPINE is indicated for the treatment of schizophrenia and for the treatment of acute mixed or manic episodes associated with Bipolar I Disorder

Contraindications:

Pharmacodynamics Olanzapine is a selective monoaminergic antagonist with high affinity binding to the following receptors: serotonin 5HT2A/2C , 5HT6 , dopamine.

Adverse reactions:

Body as a Whole — Frequent: dental pain and flu syndrome; Infrequent: abdomen enlarged, chills, face edema, intentional injury, malaise, moniliasis, neck pain, neck rigidity, pelvic pain, photosensitivity reaction, and suicide attempt; Rare: chills and fever, hangover effect, and sudden death. Cardiovascular System — Frequent: hypotension; Infrequent: atrial fibrillation, bradycardia, cerebrovascular accident, congestive heart failure, heart arrest, hemorrhage, migraine, pallor, palpitation, vasodilatation, and ventricular extrasystoles; Rare: arteritis, heart failure, and pulmonary embolus. Digestive System — Frequent: flatulence, increased salivation, and thirst; Infrequent: dysphagia, esophagitis, fecal impaction, fecal incontinence, gastritis, gastroenteritis, gingivitis, hepatitis, melena, mouth ulceration, nausea and vomiting, oral moniliasis, periodontal abscess, rectal hemorrhage, stomatitis, tongue edema, and tooth caries; Rare: aphthous stomatitis, enteritis, eructation, esophageal ulcer, glossitis, ileus, intestinal obstruction, liver fatty deposit, and tongue discoloration. Endocrine System — Infrequent: diabetes mellitus; Rare: diabetic acidosis and goiter. Hemic and Lymphatic System — Infrequent: anemia, cyanosis, leukocytosis, leukopenia, lymphadenopathy, and thrombocytopenia; Rare: normocytic anemia and thrombocythemia. Metabolic and Nutritional Disorders — Infrequent: acidosis, alkaline phosphatase increased, bilirubinemia, dehydration, hypercholesteremia, hyperglycemia, hyperlipemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, lower extremity edema, and upper extremity edema; Rare: gout, hyperkalemia, hypernatremia, hypoproteinemia, ketosis, and water intoxication. Musculoskeletal System — Frequent: joint stiffness and twitching; Infrequent: arthritis, arthrosis, leg cramps, and myasthenia; Rare: bone pain, bursitis, myopathy, osteoporosis, and rheumatoid arthritis. Nervous System — Frequent: abnormal dreams, amnesia, delusions, emotional lability, euphoria, manic reaction, paresthesia, and schizophrenic reaction; Infrequent: akinesia, alcohol misuse, antisocial reaction, ataxia, CNS stimulation, cogwheel rigidity, delirium, dementia, depersonalization, dysarthria, facial paralysis, hypesthesia, hypokinesia, hypotonia, incoordination, libido decreased, libido increased, obsessive compulsive symptoms, phobias, somatization, stimulant misuse, stupor, stuttering, tardive dyskinesia, vertigo, and withdrawal syndrome; Rare: circumoral paresthesia, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid hemorrhage, and tobacco misuse. Respiratory System — Frequent: dyspnea; Infrequent: apnea, asthma, epistaxis, hemoptysis, hyperventilation, hypoxia, laryngitis, and voice alteration; Rare: atelectasis, hiccup, hypoventilation, lung edema, and stridor. Skin and Appendages — Frequent: sweating; Infrequent: alopecia, contact dermatitis, dry skin, eczema, maculopapular rash, pruritus, seborrhea, skin discoloration, skin ulcer, urticaria, and vesiculobullous rash; Rare: hirsutism and pustular rash. Special Senses — Frequent: conjunctivitis; Infrequent: abnormality of accommodation, blepharitis, cataract, deafness, diplopia, dry eyes, ear pain, eye hemorrhage, eye inflammation, eye pain, ocular muscle abnormality, taste perversion, and tinnitus; Rare: corneal lesion, glaucoma, keratoconjunctivitis, macular hypopigmentation, miosis, mydriasis, and pigment deposits lens. Urogenital System — Frequent: vaginitis*; Infrequent: abnormal ejaculation*, amenorrhea*, breast pain, cystitis, decreased menstruation*, dysuria, female lactation*, glycosuria, gynecomastia, hematuria, impotence*, increased menstruation*, menorrhagia*, metrorrhagia*, polyuria, premenstrual syndrome*, pyuria, urinary frequency, urinary retention, urinary urgency, urination impaired, uterine fibroids enlarged*, and vaginal hemorrhage*; Rare: albuminuria, breast enlargement, mastitis, and oliguria.

Interactions:

The risks of using Olanzapine in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects of Olanzapine, caution should be used when Olanzapine is taken in combination with other centrally acting drugs and alcohol. Because of its potential for inducing hypotension, Olanzapine may enhance the effects of certain antihypertensive agents. Olanzapine may antagonize the effects of levodopa and dopamine agonists. The Effect of Other Drugs on Olanzapine — Agents that induce CYP1A2 or glucuronyl transferase enzymes, such as omeprazole and rifampin, may cause an increase in Olanzapine clearance. Inhibitors of CYP1A2 could potentially inhibit Olanzapine clearance. Although Olanzapine is metabolized by multiple enzyme systems, induction or inhibition of a single enzyme may appreciably alter Olanzapine clearance. Therefore, a dosage increase (for induction) or a dosage decrease (for inhibition) may need to be considered with specific drugs. Charcoal — The administration of activated charcoal (1 g) reduced the Cmax and AUC of oral Olanzapine by about 60%. As peak Olanzapine levels are not typically obtained until about 6 hours after dosing, charcoal may be a useful treatment for Olanzapine overdose. Cimetidine and Antacids — Single doses of cimetidine (800 mg) or aluminum- and magnesium-containing antacids did not affect the oral bioavailability of Olanzapine. Carbamazepine — Carbamazepine therapy (200 mg bid) causes an approximately 50% increase in the clearance of Olanzapine. This increase is likely due to the fact that carbamazepine is a potent inducer of CYP1A2 activity. Higher daily doses of carbamazepine may cause an even greater increase in Olanzapine clearance. Ethanol — Ethanol (45 mg/70 kg single dose) did not have an effect on Olanzapine pharmacokinetics. Fluoxetine — Fluoxetine (60 mg single dose or 60 mg daily for 8 days) causes a small (mean 16%) increase in the maximum concentration of Olanzapine and a small (mean 16%) decrease in Olanzapine clearance. The magnitude of the impact of this factor is small in comparison to the overall variability between individuals, and therefore dose modification is not routinely recommended. Fluvoxamine — Fluvoxamine, a CYP1A2 inhibitor, decreases the clearance of Olanzapine. This results in a mean increase in Olanzapine Cmax following fluvoxamine of 54% in female nonsmokers and 77% in male smokers. The mean increase in Olanzapine AUC is 52% and 108%, respectively. Lower doses of Olanzapine should be considered in patients receiving concomitant treatment with fluvoxamine. Warfarin — Warfarin (20 mg single dose) did not affect Olanzapine pharmacokinetics. Lithium — Multiple doses of Olanzapine (10 mg for 8 days) did not influence the kinetics of lithium. Therefore, concomitant Olanzapine administration does not require dosage adjustment of lithium. Valproate —In vivo administration of Olanzapine (10 mg daily for 2 weeks) did not affect the steady state plasma concentrations of valproate. Therefore, concomitant Olanzapine administration does not require dosage adjustment of valproate. The co-administration of either diazepam or ethanol with Olanzapine potentiated the orthostatic hypotension observed with Olanzapine. Multiple doses of Olanzapine did not affect the pharmacokinetics of theophylline or its metabolites.

Warnings:

General Hemodynamic Effects — Olanzapine may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. For oral Olanzapine therapy, the risk of orthostatic hypotension and syncope may be minimized by initiating therapy with 5 mg QD. A more gradual titration to the target dose should be considered if hypotension occurs. Olanzapine should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemia, heart failure, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications) where the occurrence of syncope, or hypotension and/or bradycardia might put the patient at increased medical risk. Caution is necessary in patients who receive treatment with other drugs having effects that can induce hypotension, bradycardia, respiratory or central nervous system depression. Seizures —Seizures occurred in 0.9% (22/2500) of Olanzapine-treated patients. There were confounding factors that may have contributed to the occurrence of seizures in many of these cases. Olanzapine should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold, e.g., Alzheimer’s dementia. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older. Hyperprolactinemia — As with other drugs that antagonize dopamine D2 receptors, Olanzapine elevates prolactin levels, and a modest elevation persists during chronic administration. Transaminase Elevations — The incidence of SGPT elevation to >200 IU/L was 2% (50/2381). Again, none of these patients experienced jaundice or other symptoms attributable to liver impairment and most had transient changes that tended to normalize while Olanzapine treatment was continued. Among 2500 patients in oral Olanzapine clinical trials, about 1% (23/2500) discontinued treatment due to transaminase increases. Potential for Cognitive and Motor Impairment — Since Olanzapine has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Olanzapine therapy does not affect them adversely. Body Temperature Regulation — Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing Olanzapine for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration. Dysphagia — Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer’s disease. Olanzapine and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. Suicide — The possibility of a suicide attempt is inherent in schizophrenia and in bipolar disorder, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for Olanzapine should be written for the smallest quantity of Tablets consistent with good patient management, in order to reduce the risk of overdose. Use in Patients with Concomitant Illness — Clinical experience with Olanzapine in patients with certain concomitant systemic illnesses is limited. Olanzapine exhibits in vitro muscarinic receptor affinity. Olanzapine should be used with caution in patients with clinically significant prostatic hypertrophy, narrow angle glaucoma, or a history of paralytic ileus. Laboratory Tests: Periodic assessment of transaminases is recommended in patients with significant hepatic disease. Pregnancy: Pregnancy Category C Nursing Mothers: It is recommended that women receiving Olanzapine should not breast-feed. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: Olanzapine is not approved for the treatment of patients with dementia-related psychosis. If the prescriber elects to treat elderly patients with dementia-related psychosis, vigilance should be exercised. Also, the presence of factors that might decrease pharmacokinetic clearance or increase the pharmacodynamic response to Olanzapine should lead to consideration of a lower starting dose for any geriatric patient.

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Consultants Corner

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Dr. Talal Sabouni UROLOGY AND KIDNEY TRANSPLANT

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