(oh lan' za peen)
P / L : Caution during pregnancy but contraindicated in lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSISElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine for Injection is not approved for the treatment of patients with dementia-related psychosis.
|Indication(s) & Dosage||
Renal impairment: Initiate at lower dose (5 mg) and increase cautiously
Hepatic impairment: Dose adjustments may be needed.
|Administration||Immediate-release: Should be taken on an empty stomach. Take Â½ hr before meals.
Extended-release: Should be taken with food. Swallow whole, do not chew/crush/divide.
|Overdose||Symptoms: Tachycardia, agitation/aggressiveness, dysarthria, extrapyrimidal symptoms, sedation/coma. Induction of emesis is not recommended, gastric lavage and admin of activated charcoal may be effective. Monitor closely and treat symptomatically.|
|Contraindications||Angle-closure glaucoma; lactation. IM: History of CVS disease, heart surgery.|
|Special Precautions||Impaired renal, hepatic, cardiovascular function; prostatic hypertrophy; paralytic ileus; DM; parkinsonism; pregnancy. History of blood dyscrasias, myelosuppression, seizures; dementia; dyslipidaemia. IM: Hypotension, bradyarrhythmia, hypoventilation; monitor BP carefully. Caution when used in adolescents due to increased risk of weight gain and hyperlipidaemia. Efficacy and safety have not been established in paediatric patients <13 yr.|
|Adverse Drug Reaction(s)||Postural hypotension; constipation; dizziness; wt gain; agitation; insomnia; akathisia; tremor; personality disorders; oedema; somnolence; increased appetite; antimuscarinic effects; speech difficulty; exacerbation of Parkinson's disease; hallucinations; asthenia; increased body temperature; bradycardia; hyperprolactinaemia; QT prolongation (uncommon); asymptomatic elevations of hepatic transaminases.
Potentially Fatal: Exacerbation of preexisting diabetes sometimes leading to ketoacidosis. Neuroleptic malignant syndrome.
|Drug Interactions||Olanzapine may antagonise the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucuronyl transferase enzymes e.g. omeprazole and rifampicin, may increase olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit olanzapine elimination. Carbamazepine may increase the clearance of olanzapine. Concomitant admin of activated charcoal reduced the oral bioavailability of olanzapine by 50-60%. Caution should be taken when olanzapine is administered with centrally acting drugs and alcohol. Please consult detailed prescribing information before prescribing.|
|Pregnancy Category (FDA)||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Intramuscular: Store at 15-30Â°C. Oral: Store at 15-30Â°C.|
|Pharmacology||Olanzapine is an atypical antipsychotic with affinity for serotonin 5-HT2A/2C, dopamine, muscarinic M1-M5, histamine H1 and adrenergic Î±1 receptors.
Absorption: Well absorbed from the GI tract (oral); peak plasma concentrations after 5-8 hr (oral) or 15-45 min (IM).
Distribution: Protein-binding: 93%.
Metabolism: Extensively hepatic by direct glucuronidation and oxidation.
Excretion: Urine (as metabolites), faeces; 30-38 hr (elimination half-life).
|ATC Classification||N05AH03 - olanzapine; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics. Used in the management of psychosis.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|DEPREX 10||Square Pharmaceuticals Ltd.||Olanzapine 10mg||Tablet||5x10's: 225.50 MRP|
|DEPREX 5||Square Pharmaceuticals Ltd.||Olanzapine 5mg||Tablet||5x10's: 125.50 MRP|
|LOPEZ||General Pharmaceuticals Ltd||Olanzapine INN 5mg & 10mg||Tablet||50's each: 125.50 & 226.00 MRP|
|Olanap 10||Incepta Pharmaceuticals Limited||Olanzapine INN 10mg||tablet||10x5's:MRP 225 Tk|
|Olanap 5||Incepta Pharmaceuticals Limited||Olanzapine INN 5mg||Tablet||10x5's :MRP 125 Tk|
|OLEANZ||Sun Pharmaceutical (Bangladesh) Ltd.||Olanzapine INN 5mg & 10mg||Tablet||50's each: 127.50 & 227.50 MRP|
|PERICAM 10||Beximco Pharmaceuticals Ltd||Olanzapine||Tablet (Oro?dispersible)||100's: 251.00 MRP|
|PERICAM 5||Beximco Pharmaceuticals Ltd||Olanzapine||Tablet (Oro?dispersible)||100's: 150.00 MRP|
|XYTREX||ACI Ltd.||Olanzapine INN 5mg & 10mg||Tablet||50's each: 125.50 & 225.00 MRP|
Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as olanzapine have an increased chance of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment.
Olanzapine is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking olanzapine. For more information visit the FDA website: http://www.fda.gov/Drugs
Why is this medication prescribed?
Olanzapine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used to treat bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods) in adults and teenagers 13 years of age and older. Olanzapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
How should this medicine be used?
Olanzapine comes as a tablet and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. It is usually taken once a day with or without food. Take olanzapine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take olanzapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Do not try to push the orally disintegrating tablet through the foil. Instead, use dry hands to peel back the foil packaging. Immediately take out the tablet and place it in your mouth. The tablet will quickly dissolve and can be swallowed with or without liquid.
Your doctor may start you on a low dose of olanzapine and gradually increase your dose.
Olanzapine may help control your symptoms, but it will not cure your condition. It may take several weeks or longer before you feel the full benefit of olanzapine. Continue to take olanzapine even if you feel well. Do not stop taking olanzapine without talking to your doctor. Your doctor will probably want to decrease your dose gradually.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor for more information.
What special precautions should I follow?
Before taking olanzapine,
- tell your doctor if you are allergic to olanzapine or any other medications.
- tell your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; antihistamines; carbamazepine (Tegretol); dopamine agonists such as bromocriptine, cabergoline, levodopa, pergolide and ropinirole; fluoroquinolone antibiotics including ciprofloxacin, gatifloxacin, levofloxacin, norfloxacin, ofloxacin, others; fluvoxamine; ipratropium; medications for anxiety, high blood pressure, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; omeprazole (Prilosec); rifampin; sedatives; sleeping pills; ticlopidine and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you use or have ever used street drugs or have overused prescription medications and if you have or have ever had a stroke, a mini-stroke, heart disease or a heart attack, an irregular heartbeat, seizures, breast cancer, any condition that makes it difficult for you to swallow, high or low blood pressure, a high level of fats (cholesterol and triglycerides) in your blood, a low number of white blood cells, liver or prostate disease, paralytic ileus (condition in which food cannot move through the intestine); glaucoma (an eye condition), or high blood sugar, or if you or anyone in your family has or has ever had diabetes. Tell your doctor if you have severe vomiting or diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects.
- tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking olanzapine, call your doctor. Olanzapine may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking olanzapine.
- you should know that olanzapine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking olanzapine.
- tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.
- you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking olanzapine or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking olanzapine: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
- you should know that olanzapine may cause fast or slow heartbeat, dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking olanzapine. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- you should know that olanzapine may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.
- if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the orally disintegrating tablets contain aspartame that forms phenylalanine.
- you should know that when olanzapine is used to treat teenagers, it must be used as part of a total treatment program that may include counseling and educational support. Make sure that your child follows all of the doctor's and/or therapist's instructions.
What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.
Be sure to drink plenty of water every day while you are taking this medication.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Olanzapine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
difficulty falling asleep or staying asleep
pain in arms, legs, back, or joints
breast enlargement or discharge
late or missed menstrual periods
- decreased sexual ability
Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section or the SPECIAL PRECAUTIONS section, call your doctor immediately:
changes in vision
swelling of the arms, hands, feet, ankles, or lower legs
unusual movements of your face or body that you cannot control
sore throat, fever, chills, and other signs of infection
very stiff muscles
fast or irregular heartbeat
difficulty breathing or swallowing
Olanzapine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
Taking olanzapine may cause the level of fats in your blood to increase. Talk to your doctor about the risks of taking olanzapine.
Teenagers who take olanzapine are more likely than adults who take olanzapine to gain weight, have increased levels of fat in their blood, develop liver problems, and experience side effects such as sleepiness, breast enlargement, and discharge from the breasts. Talk to your child's doctor about the risks of treating your child with olanzapine. Your child's doctor may choose to first prescribe a different medication that does not have these risks.
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Always store the orally disintegrating tablets in their sealed package, and use them immediately after opening the package. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
Symptoms of overdose may include:
sudden movements that you cannot control
coma (loss of consciousness for a period of time)
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
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