Olanzapine

What is Olanzapine?

• Olanzapine (Zyprexa) is an atypical antipsychotic used currently in the treatment of schizophrenia and bipolar illness.

Olanzapine Structural Formulea V.2

Olanzapine3Dan2

What are the uses of this medicine?

Olanzapine (Zyprexa) is a prescription medicine used to treat: schizophrenia in people age 13 or older.

bipolar disorder, including:

• manic or mixed episodes that happen with bipolar I disorder in people age 13 or older.
• manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate, in adults.
• long-term treatment of bipolar I disorder in adults.
• episodes of depression that happen with bipolar I disorder, when used with the medicine fluoxetine (Prozac ®) in people age 10 or older.
• episodes of depression that do not get better after 2 other medicines, also called treatment resistant depression, when used with the medicine fluoxetine (Prozac), in adults.

Schizophrenia:

• The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn.

Bipolar I disorder :

• The symptoms of bipolar I disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.

Treatment resistant depression:

• The symptoms of treatment resistant depression include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior.

How does this medicine work?

• Olanzapine (oh lan' za peen) is a thienobenzodiazepine derivative which appears to act as a dopamine (D1-4) and serotonic (5-HT2A/2C and 5-HT6) receptor antagonist.

What drug interactions can this medicine cause?

• The co-administration of diazepam with olanzapine potentiated the orthostatic hypotension observed with olanzapine.
• Higher daily doses of carbamazepine may cause an even greater increase in olanzapine clearance.
• The co-administration of alcohol (i.e., ethanol) with olanzapine potentiated the orthostatic hypotension observed with olanzapine.
• Lower doses of olanzapine should be considered in patients receiving concomitant treatment with fluvoxamine.
• Fluvoxamine may increase olanzapine levels.
• When using olanzapine and fluoxetine in combination, also refer to the Drug Interactions section of the package insert for Symbyax.
• Omeprazole and rifampin may cause an increase in olanzapine clearance.
• Olanzapine should be used with caution in patients receiving medications having anticholinergic (antimuscarinic) effects.
• Given the primary CNS effects of olanzapine, caution should be used when olanzapine is taken in combination with other centrally acting drugs and alcohol.
• Olanzapine, because of its potential for inducing hypotension, may enhance the effects of certain antihypertensive agents.
• Olanzapine may antagonize the effects of levodopa and dopamine agonists.
• When using olanzapine in combination with lithium or valproate, refer to the Drug Interactions sections of the package insert for those products.

Is this medicine FDA approved?

• Olanzapine was approved for use in schizophrenia in the United States in 1996 and continues to be used for this indication.
• Olanzapine is also used in mood disturbances of bipolar I disorder and in combination with other agents for treatment of resistant depression in adults.

How should this medicine be used?

Recommended dosage: Schizophrenia in adults :

• Oral: Start at 5 to 10 mg once daily; Target: 10 mg/day within several days.

Schizophrenia in adolescents:

• Oral: Start at 2.5 to 5 mg once daily; Target: 10 mg/day.

Bipolar I Disorder (manic or mixed episodes) in adults:

• Oral: Start at 10 or 15 mg once daily.

Bipolar I Disorder (manic or mixed episodes) in adolescents:

• Oral: Start at 2.5 to 5 mg once daily;
• Target: 10 mg/day.

Bipolar I Disorder (manic or mixed episodes) with lithium or valproate in adults:

• Oral: Start at 10 mg once daily.

Depressive Episodes associated with Bipolar I Disorder in adults:

• Oral in combination with fluoxetine: Start at 5 mg of oral olanzapine and 20 mg of fluoxetine once daily.

Depressive Episodes associated with Bipolar I Disorder in children and adolescents:

• Oral in combination with fluoxetine: Start at 2.5 mg of oral olanzapine and 20 mg of fluoxetine once daily.

Treatment Resistant Depression in adults Oral in combination with fluoxetine:

• Start at 5 mg of oral olanzapine and 20 mg of fluoxetine once daily.

Administration:

• Take olanzapine tablets exactly as prescribed. Your doctor may need to change (adjust) the dose of olanzapine tablets until it is right for you.
• If you miss a dose of olanzapine tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of olanzapine tablets at the same time.
• To prevent serious side effects, do not stop taking olanzapine tablets suddenly. If you need to stop taking olanzapine tablets, your doctor can tell you how to safely stop taking them.
• Olanzapine tablets can be taken with or without food.
• Olanzapine tablets are usually taken one time each day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets (not scored): 2.5, 5, 7.5, 10, 15, 20 mg.

This medicine is available in fallowing brand namesː

• Zyprexa

What side effects can this medication cause?

The most common side effects of this medicine include:

• lack of energy
• dry mouth
• increased appetite
• sleepiness
• tremor (shakes)
• having hard or infrequent stools
• dizziness
• changes in behavior
• restlessness

Other common side effects in teenagers (13 to 17 years old) include: headache, stomach-area (abdominal) pain, pain in your arms or legs, or tiredness. Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness, as compared with adults.

Serious side effects may happen when you take olanzapine tablets, including:

• hyperglycemia
• High fat levels in your blood (cholesterol and triglycerides)
• Weight gain
• Transient ischemic attacks (TIAs)
• Neuroleptic Malignant Syndrome (NMS)
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
• Tardive Dyskinesia
• Decreased blood pressure
• Difficulty swallowing
• Seizures
• Problems with control of body temperature

What special precautions should I follow?

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
• The possibility of a suicide attempt is inherent in schizophrenia and in bipolar I disorder, and close supervision of high-risk patients should accompany drug therapy; when using in combination with fluoxetine, also refer to the Boxed Warning and Warnings and Precautions sections of the package insert for Symbyax.
• A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including olanzapine. Manage with immediate discontinuation and close monitoring.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with olanzapine exposure. Discontinue if DRESS is suspected.
• Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain.
• A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Discontinue if clinically appropriate.
• Orthostatic hypotension associated with dizziness, tachycardia, bradycardia and, in some patients, syncope, may occur especially during initial dose titration. Use caution in patients with cardiovascular disease, cerebrovascular disease, and those conditions that could affect hemodynamic responses.
• Leukopenia, Neutropenia, and Agranulocytosis has been reported with antipsychotics, including olanzapine. Patients with a history of a clinically significant low white blood cell count (WBC) or drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of olanzapine should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors. '
• During premarketing testing, seizures occurred in olanzapine-treated patients. Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold.
• Somnolence was a commonly reported adverse reaction associated with olanzapine treatment has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery.
• Use with caution with other anticholinergic drugs and in patients with urinary retention, prostatic hypertrophy, constipation, paralytic ileus or related conditions.
• As with other drugs that antagonize dopamine D 2 receptors, olanzapine elevates prolactin levels, and the elevation persists during chronic administration. May elevate prolactin levels.
• When using olanzapine in combination with lithium or valproate, the prescriber should refer to the Warnings and Precautions sections of the package inserts for lithium or valproate
• Monitor fasting blood glucose and lipid profiles at the beginning of, and periodically during, treatment.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• drowsiness
• slurred speech
• agitation/aggressiveness
• dysarthria
• tachycardia
• various extrapyramidal symptoms
• reduced level of consciousness ranging from sedation to coma
• aspiration
• cardiopulmonary arrest
• cardiac arrhythmias
• delirium
• neuroleptic malignant syndrome
• respiratory depression/arrest
• convulsion
• hypertension
• hypotension

Treatment of overdosage:

• If you take too much olanzapine tablets, call your doctor or poison control center at 1-800-222-1222 right away, or get emergency treatment.
• There is no specific antidote to an overdose of olanzapine.
• The possibility of multiple drug involvement should be considered.
• Establish and maintain an airway and ensure adequate oxygenation and ventilation.
• Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.

Can this medicine be used in pregnancy?

• It is not known if olanzapine tablets will harm your unborn baby.
• If you become pregnant while receiving olanzapine tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

Can this medicine be used in children?

• Olanzapine tablets have not been approved for use in children under 13 years of age.
• Olanzapine in combination with fluoxetine has not been approved for use in children under 10 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: olanzapine, USP
• Inactive ingredients: crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

Who manufactures and distributes this medicine?

Distributed by:

• Virtus Pharmaceuticals, LLC
• Langhorne, PA , USA

Manufactured by:

• Qilu Pharmaceutical Co., Ltd.
• Jinan,China

What should I know about storage and disposal of this medication?

• Store olanzapine tablets at room temperature, between 68° to 77°F (20° to 25°C).
• Keep olanzapine tablets away from light.
• Keep olanzapine tablets dry and away from moisture.

Antipsychotic agents

First Generation

• Phenothiazines
  • Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine, Trifluoperazine

• Other
  • Haloperidol, Lithium, Loxapine, Molindone, Pimozide

Second Generation (Atypicals)

• Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Olanzapine, Paliperidone, Pimavanserin, Quetiapine, Risperidone, Ziprasidone

• Dailymed label info on Olanzapine
• FDA Olanzapine

Olanzapine Resources
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Benzodiazipines

• Alprazolam
• Chlordiazepoxide
• Diazepam (Oral)
• Estazolam
• Flurazepam
• Lorazepam
• Midazolam
• Oxazepam
• Quazepam
• Temazepam
• Triazolam

Anticonvulsants Drugs

• Clobazam
• Clonazepam
• Clorazepate
• Diazepam (Intravenous)

Drug class for Olanzapine

Anticonvulsants, and Benzodiazepines]