Formulations and Dosing of ZYPREXA® (olanzapine)
ZYPREXA is available in a Variety of Formulations:
- ZYPREXA Tablets are available in these strengths: 5 mg and 10 mg. ZYPREXA can be taken with or without meals.
- ZYPREXA® Zydis® Orodispersible Tablets are a formulation of ZYPREXA that dissolves in the mouth on contact with saliva. Tablets can also be dispersed in water or beverage immediately before administration. Available in 5-mg and 10-mg, To learn more about ZYPREXA Zydis, click here. (Phenylketonurics: ZYPREXA Zydis contains phenylalanine)
- ZYPREXA® IntraMuscular (olanzapine for injection) is indicated for the treatment of acute agitation associated with schizophrenia and bipolar I mania. Efficacy was demonstrated in 3 short-term (24 hours of IM treatment) placebo-controlled trials in agitated adult inpatients with: schizophrenia or bipolar I disorder (manic or mixed episodes).
"Psychomotor agitation" is defined in DSM-IV as "excessive motor activity associated with a feeling of inner tension." Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation.
Zydis is a registered trademark of Catalent Pharma Solutions.
Broad Range of Oral Indications
Schizophrenia The recommended starting dose is 10mg/day. ZYPREXA should be administered once a day without regard to meals.
Bipolar I Disorder The recommended starting dose is 15mg once a day in monotherapy, or 10mg once a day in combination.
Dosing in Special Populations Elderly patients: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 & over when clinical factors warrant.
Patients with renal and/or hepatic impairment: A lower starting dose (5 mg) should be consdired for such patients. In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
ZYPREXA®Zydis® (olanzapine) Orally Disintegrating Tablets
Prescribing ZYPREXA Zydis
Why ZYPREXA Zydis?
Prescribing ZYPREXA Zydis
Dissolves Rapidly in the Mouth
ZYPREXA Zydis is an orally disintegrating tablet that offers the same efficacy and safety profile as regular ZYPREXA tablets, and is indicated for the same conditions: schizophrenia, maintenance of treatment response in schizophrenia, as monotherapy and in combination with lithium or valproate for acute manic episodes of bipolar I disorder, and maintenance treatment in bipolar I disorder.
Patients who have phenylketonuria should be advised that ZYPREXA Zydis orally disintegrating tablets contain phenylalanine.
Olanzapine is indicated for the treatment of schizophrenia, manic episode and recurrence prevention in bipolar disorder
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day. Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1). Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated. During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day. An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours. Olanzapine can be given without regards for meals as absorption is not affected by food. Gradual tapering of the dose should be considered when discontinuing olanzapine.
For Convenient Administration
Because it is designed to be placed in the mouth and allowed to dissolve, ZYPREXA Zydis provides an important additional option for treating patients in whom oral therapy is appropriate. For example, ZYPREXA Zydis is a dependable way to intervene for patients experiencing breakthrough symptoms associated with schizophrenia or bipolar I mania.
In a Range of Strengths
ZYPREXA Zydis tablets are available in two strengths: 5 mg and 10 mg. ZYPREXA Zydis provides a convenient alternative to liquid formulations of other drugs, and because absorption is not affected by food, it can be taken without regard to meals.
Phenylketonurics: ZYPREXA Zydis Orally Disintegrating Tablets contain phenylalanine. Zydis is a registered trademark of Catalent Health, Inc., or one of its subsidiaries.
ZYPREXA® IntraMuscular (Olanzapine for Injection)
ZYPREXA IntraMuscular is approved for the treatment of agitation associated with schizophrenia and bipolar I mania.
- An injectable formulation that enables you to intervene and calm agitated patients quickly and effectively
- Dose range 2.5, 5, 7.5, and 10 mg:
- For agitation in schizophrenia and bipolar I mania, recommended dose is 10 mg
- After short-term treatment with ZYPREXA IntraMuscular, a person may receive a prescription for oral ZYPREXA for schizophrenia or acute bipolar I mania if clinically indicated
Follow the steps below to reconstitute and use ZYPREXA IntraMuscular:
- Inject 2.1 mL of Sterile Water for Injection into single-packaged vial for up to 10-mg dose.
- 1.Dissolve contents of vial completely; resulting solution should be clear and yellow.
- Use solution within 1 hour; discard any unused portion.
- Refer to table for injection volumes and corresponding doses of ZYPREXA IntraMuscular.
- Immediately after use, dispose of syringe in approved sharps box.
Physical Incompatibility Information
ZYPREXA IntraMuscular should be reconstituted only with Sterile Water for Injection. ZYPREXA IntraMuscular should not be combined in a syringe with diazepam injection because precipitation occurs when these products are mixed. Lorazepam injection should not be used to reconstitute ZYPREXA IntraMuscular as this combination results in a delayed reconstitution time. ZYPREXA IntraMuscular should not be combined in a syringe with haloperidol injection because the resulting low pH has been shown to degrade olanzapine over time.
The recommended initial dose for olanzapine injection is 10 mg.
ZYPREXA powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with ZYPREXA powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate. For intramuscular use. Do not administer intravenously or subcutaneously. ZYPREXA powder for solution for injection is intended for short term use only, for up to a maximum of three consecutive days. The maximum daily dose of olanzapine (including all formulations of olanzapine) is 20 mg.
The recommended initial dose for olanzapine injection is 10 mg, administered as a single intramuscular injection. A lower dose (5 mg or 7.5 mg) may be given, on the basis of individual clinical status, which should also include consideration of medicinal products already administered either for maintenance or acute treatment (see section 4.4). A second injection, 5-10 mg, may be administered 2 hours after the first injection on the basis of individual clinical status. Not more than three injections should be given in any 24 hour period and the maximum daily dose of olanzapine of 20 mg (including all formulations) should not be exceeded.
Last Update: 6 Oct 15