Generic Olanzapine

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Olanzapine is an atypical antipsychotic used to treat schizophrenia and bipolar disorder, including acute manic episodes and maintenance treatment to prevent relapse. The medication helps calm hallucinations, delusions, and disorganized thinking by balancing dopamine and serotonin in the brain.
The usual starting dose for adults is 5 mg to 10 mg once daily. Your doctor will adjust the dose based on how you respond, usually within a range of 5 mg to 20 mg per day. For acute mania, a common starting dose is 10 mg to 15 mg once daily. For preventing relapse in bipolar disorder, the starting dose is 10 mg daily.
The administration form is film-coated tablets in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg strengths. Orally disintegrating tablets are also available in 5 mg, 10 mg, 15 mg, and 20 mg. Do not confuse the two, as they are not interchangeable milligram for milligram.
Olanzapine does not work overnight. Some calming effects may appear within the first few days, but the full benefit for schizophrenia and bipolar symptoms usually takes several weeks of steady dosing.
Alcohol should be avoided during treatment. It adds to the drowsiness and dizziness that olanzapine can cause, and it can worsen the metabolic and neurological side effects of antipsychotics.
The most common side effects are weight gain, drowsiness, increased appetite, and dry mouth.
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Common Use Olanzapine

Olanzapine is a thienobenzodiazepine antipsychotic. It works by blocking dopamine D2 receptors and serotonin 5-HT2A receptors in the brain, which helps reduce hallucinations, delusions, and disorganized thinking. It also has affinity for muscarinic, histamine H1, and alpha-1 adrenergic receptors, which explains its sedative and anticholinergic effects. Health Canada has approved olanzapine for schizophrenia and related psychotic disorders, as well as for bipolar disorder. For bipolar disorder, it is used to treat acute manic or mixed episodes, and as maintenance therapy to prevent relapse. It can be used alone or in combination with lithium or valproate. Olanzapine is also sometimes prescribed off-label for agitation, delirium, and chemotherapy-induced nausea, though those uses are not formally approved. It is not approved for treating dementia-related psychosis in elderly patients, and it carries a boxed warning about increased mortality in that population.

Basic Olanzapine Information

• INN (International Nonproprietary Name): Olanzapine
• Brand names available in Canada: Zyprexa® (original brand); generics include Apo-Olanzapine, Teva-Olanzapine, Sandoz Olanzapine, pms-Olanzapine, Jamp-Olanzapine FC, Mar-Olanzapine, Mylan-Olanzapine, Mint-Olanzapine, Riva-Olanzapine, AG-Olanzapine FC, NRA-Olanzapine, Ran-Olanzapine, and others. Orally disintegrating tablets (ODT) are sold as Zyprexa Zydis and generics including Apo-Olanzapine ODT, ACT Olanzapine ODT, Sandoz Olanzapine ODT, and AG-Olanzapine ODT.
• ATC Code: N05AH03
• Forms and dosages: Film-coated tablets – 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg. Orally disintegrating tablets – 5 mg, 10 mg, 15 mg, and 20 mg. An intramuscular injection is also available for acute agitation.
• Manufacturers in Canada: Eli Lilly Canada Inc. (Zyprexa, original brand), Cheplapharm Arzneimittel GmbH (current Zyprexa distributor), Apotex Inc., Teva Canada Limited, Sandoz Canada Inc., Pharmascience Inc., Jamp Pharma Corporation, Marcan Pharmaceuticals Inc., Mylan Pharmaceuticals ULC, Mint Pharmaceuticals Inc., Riva Pharmaceuticals, Angita Pharma Inc., Nora Pharma Inc., Ranbaxy Pharmaceuticals Canada Inc., and others.
• Registration status in Canada: Approved by Health Canada. Multiple DINs exist, including 02229285 (Zyprexa 10 mg), 02243087 (Zyprexa Zydis), 02281805 (Apo-Olanzapine 5 mg), 02276712 (Teva-Olanzapine 2.5 mg), 02310341 (Sandoz Olanzapine 2.5 mg), 02417243 (Jamp-Olanzapine FC 2.5 mg), 02421232 (Mar-Olanzapine 2.5 mg), 02337878 (Mylan-Olanzapine 2.5 mg), 02410176 (Mint-Olanzapine 7.5 mg), 02337126 (Riva-Olanzapine 2.5 mg), 02385864 (Olanzapine Sivem 2.5 mg), 02487659 (AG-Olanzapine FC 20 mg), 02545624 (NRA-Olanzapine 2.5 mg), 02403064 (Ran-Olanzapine 2.5 mg), and 02303116 (pms-Olanzapine 2.5 mg).
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take olanzapine once daily, with or without food. The tablet can be taken at any time of day, but taking it in the evening may help with drowsiness. For schizophrenia in adults, the recommended starting dose is 5 mg to 10 mg once daily. The dose is then adjusted based on your response, usually within a range of 5 mg to 20 mg per day. Some people need up to 20 mg daily. For acute manic episodes in bipolar disorder, the starting dose is usually 10 mg to 15 mg once daily, either alone or with lithium or valproate. For maintenance treatment to prevent relapse, the recommended starting dose is 10 mg once daily. If you have liver or kidney problems, your doctor may start you on a lower dose, usually 5 mg daily. If you are elderly, the starting dose is typically 5 mg daily. If you take fluvoxamine or ciprofloxacin, which inhibit the liver enzyme that clears olanzapine, your doctor should start you on a lower dose. If you smoke, you may need a higher dose, because smoking speeds up the breakdown of olanzapine. Do not stop olanzapine suddenly without talking to your doctor. Tapering is usually recommended to avoid withdrawal symptoms such as insomnia, agitation, and nausea. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once.

Precautions

Olanzapine can cause significant weight gain and metabolic changes. In clinical trials, about 17 percent of patients gained at least 7 percent of their baseline body weight during acute treatment, and long-term studies show an average weight gain of about 5.6 kg. The medication can also raise blood sugar, cholesterol, and triglycerides. Your doctor should check your weight, waist circumference, blood pressure, fasting glucose, and lipid levels before you start and periodically during treatment. If you have diabetes or a family history of diabetes, tell your doctor, because olanzapine can worsen blood sugar control. Neuroleptic malignant syndrome (NMS) is a rare but life-threatening reaction that has been reported with olanzapine. It causes high fever, severe muscle rigidity, confusion, and autonomic instability. Stop the medication and seek emergency care if these symptoms occur. Tardive dyskinesia is another serious concern. It causes involuntary, repetitive movements of the tongue, lips, face, and sometimes the limbs. The risk increases with longer treatment and higher total doses, and it can be irreversible. Olanzapine can cause orthostatic hypotension, a drop in blood pressure when standing up, leading to dizziness and falls. This is more common early in treatment and in elderly patients. Tell your doctor if you faint or feel dizzy when standing. The medication can cause drowsiness, so do not drive or operate machinery until you know how it affects you. Olanzapine can increase prolactin levels, which may cause breast enlargement, milk production, and menstrual irregularities. It can also cause a condition called priapism, a prolonged and painful erection that requires emergency medical attention. Olanzapine is not recommended for elderly patients with dementia-related psychosis, because studies show an increased risk of death, mostly from cardiovascular causes or infections like pneumonia. Antidepressants, including olanzapine, can increase suicidal thoughts and behaviours in children, adolescents, and young adults under 25, especially during the first weeks of treatment or after dose changes. If you or someone you care for notices worsening mood, new or increased thoughts of self-harm, or unusual behaviour changes, get help immediately. Olanzapine can cause severe skin reactions, including a condition called drug reaction with eosinophilia and systemic symptoms (DRESS), which can involve fever, rash, swollen lymph nodes, and organ inflammation. Stop the medication and seek immediate care if you develop a rash with fever or swelling. Olanzapine is not recommended during pregnancy unless the benefit clearly outweighs the risk. It can cause extrapyramidal and/or withdrawal symptoms in a newborn if used in the third trimester. It passes into breast milk, so breastfeeding is not recommended during treatment. Women who could become pregnant should use effective contraception.

Contraindications

Do not take olanzapine if you have had an allergic reaction to olanzapine or any of the inactive ingredients in the tablet. Signs of an allergic reaction include skin rash, itching, shortness of breath, or swelling of the face, lips, or tongue. Olanzapine is contraindicated in patients with narrow-angle glaucoma, because its anticholinergic effects can raise intraocular pressure and trigger an acute attack. The medication should not be used in elderly patients with dementia-related psychosis, because of the increased risk of death. Olanzapine is not approved for use in children under 13 years of age for schizophrenia or bipolar mania, and safety has not been established in younger children. Do not take olanzapine if you are pregnant or breastfeeding unless your doctor specifically advises it. If you have severe liver impairment, olanzapine should be used with caution and at a reduced dose. Do not take olanzapine with other drugs that are known to prolong the QT interval without close medical supervision, because the combination can increase the risk of dangerous heart rhythms.

Possible Side Effects

More than 1 in 10 people experience weight gain, drowsiness, increased appetite, dry mouth, and dizziness. These are the most common effects and are often dose-related. Weight gain is a major concern with olanzapine and can be substantial, especially with long-term use. Other common side effects include constipation, nausea, vomiting, fatigue, and swelling of the hands and feet. Some people notice increased salivation, especially at night, or a rash. These effects often persist rather than fade, but they can be managed. Serious side effects require immediate medical attention. Neuroleptic malignant syndrome presents with high fever, severe muscle rigidity, confusion, and unstable blood pressure. Tardive dyskinesia causes involuntary movements of the face, tongue, or limbs. Metabolic changes such as high blood sugar and high cholesterol can develop gradually and may not cause symptoms at first. Orthostatic hypotension can cause fainting. Priapism, a prolonged erection, is a medical emergency. Severe skin reactions such as DRESS syndrome can cause fever, rash, swollen lymph nodes, and organ inflammation. Suicidal thoughts or behaviour can emerge, especially in young people. Blood clots in the veins, including deep vein thrombosis and pulmonary embolism, have been reported with olanzapine. If you notice leg swelling, calf pain, sudden shortness of breath, or chest pain, seek medical attention right away. Most side effects from olanzapine are manageable, but any symptom that concerns you should be reported to your doctor.

Drug Interaction

Olanzapine is metabolized mainly by the liver enzyme CYP1A2, so drugs that affect this enzyme can change its levels. Fluvoxamine, a strong CYP1A2 inhibitor, significantly increases olanzapine levels. In one study, fluvoxamine increased olanzapine peak concentration by 54 percent in female non-smokers and 77 percent in male smokers. If you take fluvoxamine or another CYP1A2 inhibitor such as ciprofloxacin, your doctor should start you on a lower dose of olanzapine and monitor you closely. Smoking and carbamazepine induce CYP1A2, which lowers olanzapine levels and may require a higher dose. If you start or stop smoking while taking olanzapine, your doctor may need to adjust your dose. Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60 percent, so take it at least 2 hours before or after olanzapine. Fluoxetine, antacids containing aluminum or magnesium, and cimetidine do not significantly affect olanzapine levels. Olanzapine can counteract the effects of dopamine agonists, such as those used for Parkinson's disease. It does not inhibit the major CYP450 enzymes in vitro, so it is not expected to affect the metabolism of other drugs. No interactions were found when olanzapine was given with lithium or biperiden. Avoid alcohol and other central nervous system depressants, because they add to olanzapine's sedative effects. Tell your doctor and pharmacist about every medication you take, including over-the-counter products and supplements.

Missed Dose

If you miss a dose of olanzapine, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Your body may need time to readjust, and your doctor may want you to start at a lower dose again. Missing doses can increase the risk of symptom relapse, so try to take the medication at the same time each day.

Overdose

Overdose with olanzapine can cause severe drowsiness, fast heart rate, agitation, confusion, and extrapyramidal symptoms such as muscle stiffness or tremors. Other symptoms may include low blood pressure, irregular heartbeat, and in severe cases, coma. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of heart rhythm and vital signs. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store olanzapine tablets at room temperature between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit). Brief exposure to temperatures between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit) is acceptable. Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. For orally disintegrating tablets, keep them in the original blister pack until use, and do not push them through the foil. Peel back the foil and place the tablet on your tongue; it will dissolve within seconds. Keep all forms of olanzapine out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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