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Zyprexa (Olanzapine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

SCHIZOPHRENIA

Oral ZYPREXA is indicated for the treatment of schizophrenia.

The efficacy of ZYPREXA was established in short-term (6-week) controlled trials of schizophrenic inpatients (see CLINICAL PHARMACOLOGY).

The effectiveness of oral ZYPREXA at maintaining a treatment response in schizophrenic patients who had been stable on ZYPREXA for approximately 8 weeks and were then followed for a period of up to 8 months has been demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use ZYPREXA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

BIPOLAR DISORDER

Acute Monotherapy -- Oral ZYPREXA is indicated for the treatment of acute mixed or manic episodes associated with Bipolar I Disorder.

The efficacy of ZYPREXA was established in two placebo-controlled trials (one 3-week and one 4-week) with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features (see CLINICAL PHARMACOLOGY).

Maintenance Monotherapy -- The benefit of maintaining bipolar patients on monotherapy with oral ZYPREXA after achieving a responder status for an average duration of two weeks was demonstrated in a controlled trial (see Clinical Efficacy Data under CLINICAL PHARMACOLOGY). The physician who elects to use ZYPREXA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Combination Therapy -- The combination of oral ZYPREXA with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.

The efficacy of ZYPREXA in combination with lithium or valproate was established in two placebo-controlled (6-week) trials with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features (see CLINICAL PHARMACOLOGY).

AGITATION ASSOCIATED WITH SCHIZOPHRENIA AND BIPOLAR I MANIA

ZYPREXA IntraMuscular is indicated for the treatment of agitation associated with schizophrenia and bipolar I mania. "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.

The efficacy of ZYPREXA IntraMuscular for the treatment of agitation associated with schizophrenia and bipolar I mania was established in 3 short-term (24 hours) placebo-controlled trials in agitated inpatients with schizophrenia or Bipolar I Disorder (manic or mixed episodes) (see CLINICAL PHARMACOLOGY).

DOSAGE AND ADMINISTRATION

SCHIZOPHRENIA

Usual Dose -- Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

Efficacy in schizophrenia was demonstrated in a dose range of 10 to 15 mg/day in clinical trials. However, doses above 10 mg/day were not demonstrated to be more efficacious than the 10 mg/day dose. An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment. The safety of doses above 20 mg/day has not been evaluated in clinical trials.

Dosing in Special Populations -- The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients >/=65 years of age), or who may be more pharmacodynamically sensitive to olanzapine (see CLINICAL PHARMACOLOGY ; also see Use in Patients with Concomitant Illness and Drug Interactions under PRECAUTIONS). When indicated, dose escalation should be performed with caution in these patients.

Maintenance Treatment -- While there is no body of evidence available to answer the question of how long the patient treated with olanzapine should remain on it, the effectiveness of oral olanzapine, 10 mg/day to 20 mg/day, in maintaining treatment response in schizophrenic patients who had been stable on ZYPREXA for approximately 8 weeks and were then followed for a period of up to 8 months has been demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Patients should be periodically reassessed to determine the need for maintenance treatment with appropriate dose.

BIPOLAR DISORDER

Usual Monotherapy Dose -- Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

Short-term (3-4 weeks) antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials.

Maintenance Monotherapy -- The benefit of maintaining bipolar patients on monotherapy with oral ZYPREXA at a dose of 5 to 20 mg/day, after achieving a responder status for an average duration of two weeks, was demonstrated in a controlled trial (see Clinical Efficacy Data under CLINICAL PHARMACOLOGY). The physician who elects to use ZYPREXA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Bipolar Mania Usual Dose in Combination with Lithium or Valproate -- When administered in combination with lithium or valproate, oral olanzapine dosing should generally begin with 10 mg once-a-day without regard to meals.

Short-term (6 weeks) antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials.

Dosing in Special Populations -- See Dosing in Special Populations under DOSAGE AND ADMINISTRATION, Schizophrenia.

Administration of ZYPREXA ZYDIS (olanzapine orally disintegrating tablets)

After opening sachet, peel back foil on blister. Do not push tablet through foil. Immediately upon opening the blister, using dry hands, remove tablet and place entire ZYPREXA ZYDIS in the mouth. Tablet disintegration occurs rapidly in saliva so it can be easily swallowed with or without liquid.

AGITATION ASSOCIATED WITH SCHIZOPHRENIA AND BIPOLAR I MANIA

Usual Dose for Agitated Patients with Schizophrenia or Bipolar Mania -- The efficacy of intramuscular olanzapine for injection in controlling agitation in these disorders was demonstrated in a dose range of 2.5 mg to 10 mg. The recommended dose in these patients is 10 mg. A lower dose of 5 or 7.5 mg may be considered when clinical factors warrant (see CLINICAL PHARMACOLOGY). If agitation warranting additional intramuscular doses persists following the initial dose, subsequent doses up to 10 mg may be given. However, the efficacy of repeated doses of intramuscular olanzapine for injection in agitated patients has not been systematically evaluated in controlled clinical trials. Also, the safety of total daily doses greater than 30 mg, or 10 mg injections given more frequently than 2 hours after the initial dose, and 4 hours after the second dose have not been evaluated in clinical trials. Maximal dosing of intramuscular olanzapine (e.g., three doses of 10 mg administered 2-4 hours apart) may be associated with a substantial occurrence of significant orthostatic hypotension (see PRECAUTIONS, Hemodynamic Effects). Thus, it is recommended that patients requiring subsequent intramuscular injections be assessed for orthostatic hypotension prior to the administration of any subsequent doses of intramuscular olanzapine for injection. The administration of an additional dose to a patient with a clinically significant postural change in systolic blood pressure is not recommended.

If ongoing olanzapine therapy is clinically indicated, oral olanzapine may be initiated in a range of 5-20 mg/day as soon as clinically appropriate (see Schizophrenia or Bipolar Disorder under DOSAGE AND ADMINISTRATION).

Intramuscular Dosing in Special Populations -- A dose of 5 mg per injection should be considered for geriatric patients or when other clinical factors warrant. A lower dose of 2.5 mg per injection should be considered for patients who otherwise might be debilitated, be predisposed to hypotensive reactions, or be more pharmacodynamically sensitive to olanzapine see CLINICAL PHARMACOLOGY ; also see Use in Patients with Concomitant Illness and Drug Interactions under PRECAUTIONS).

Administration of ZYPREXA IntraMuscular

ZYPREXA IntraMuscular is intended for intramuscular use only. Do not administer intravenously or subcutaneously. Inject slowly, deep into the muscle mass.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Directions for preparation of ZYPREXA IntraMuscular with Sterile Water for Injection

Dissolve the contents of the vial using 2.1 mL of Sterile Water for Injection to provide a solution containing approximately 5 mg/mL of olanzapine. The resulting solution should appear clear and yellow. ZYPREXA IntraMuscular reconstituted with Sterile Water for Injection should be used immediately (within 1 hour) after reconstitution. Discard any unused portion.

The following table provides injection volumes for delivering various doses of intramuscular olanzapine for injection reconstituted with Sterile Water for Injection.

Dose, mg Olanzapine Volume of Injection, mL
10.0 Withdraw total contents of vial
7.5 1.5
5.0 1.0
2.5 0.5

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.

HOW SUPPLIED

The ZYPREXA 2.5 mg, 5 mg, 7.5 mg, and 10 mg tablets are white, round, and imprinted in blue ink with LILLY and tablet number. The 15 mg tablets are elliptical, blue, and debossed with LILLY and tablet number. The 20 mg tablets are elliptical, pink, and debossed with LILLY and tablet number. The tablets are available as follows:

TABLET STRENGTH
2.5 mg 5 mg 7.5 mg 10 mg 15 mg 20 mg
Tablet No. 4112 4115 4116 4117 4415 4420
Identification LILLY
4112
LILLY
4115
LILLY
4116
LILLY
4117
LILLY
4415
LILLY
4420
NDC Codes:
Bottles 60 NDC 0002-
4112-60
NDC 0002-
4115-60
NDC 0002-
4116-60
NDC 0002-
4117-60
NDC 0002-
4415-60
NDC 0002-
4420-60
Blisters - ID * 100 NDC 0002-
4112-33
NDC 0002-
4115-33
NDC 0002-
4116-33
NDC 0002-
4117-33
NDC 0002-
4415-33
NDC 0002-
4420-33
Bottles 1000 NDC 0002-
4112-04
NDC 0002-
4115-04
NDC 0002-
4116-04
NDC 0002-
4117-04
NDC 0002-
4415-04
NDC 0002-
4420-04
*Identi-Dose® (unit dose medication, Lilly)

ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) are yellow, round, and debossed with the tablet strength. The tablets are available as follows:

ZYPREXA ZYDIS TABLET STRENGTH
Tablets * 5 mg 10 mg 15 mg 20 mg
Tablet No. 4453 4454 4455 4456
Debossed 5 10 15 20
NDC Codes:
Dose Pack 30
(Child-Resistant)

NDC 0002-
4453-85

NDC 0002-
4454-85

NDC 0002-
4455-85

NDC 0002-
4456-85
ZYPREXA is a registered trademark of Eli Lilly and Company.
ZYDIS is a registered trademark of R. P. Scherer Corporation.
*ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is manufactured for Eli Lilly and Company by Scherer DDS Limited, United Kingdom, SN5 8RU.

ZYPREXA IntraMuscular is available in:

NDC 0002-7597-01 (No. VL7597) - 10 mg vial (1s)

Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ see USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ see USP] for up to 1 hour if necessary. Discard any unused portion of reconstituted ZYPREXA IntraMuscular. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.

Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze.

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