ZYPREXA Zydis 5 mg/1
Olanzapine · TABLET, ORALLY DISINTEGRATING · Eli Lilly and Company
ZYPREXA Zydis is a tablet, orally disintegrating containing olanzapine at 5 mg/1, taken oral. Manufactured by Eli Lilly and Company.
Key Facts
- Brand Name
- ZYPREXA Zydis
- Generic Name
- Olanzapine
- NDC Code (Product)
0002-4453- Manufacturer
- Eli Lilly and Company
- Strength
- 5 mg/1
- Dosage Form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Marketing Status
- Application #
- NDA021086
- Drug Class
- Atypical Antipsychotic [EPC]
- Marketing Start
- 06/01/2000
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZYPREXA ® (olanzapine) is an atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. ( 1.1 ) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1 ). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2 ) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2 ) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2 ). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribin…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Schizophrenia in adults ( 2.1 ) Oral: Start at 5-10 mg once daily; Target: 10 mg/day within several days Schizophrenia in adolescents ( 2.1 ) Oral: Start at 2.5-5 mg once daily; Target: 10 mg/day Bipolar I Disorder (manic or mixed episodes) in adults ( 2.2 ) Oral: Start at 10 or 15 mg once daily Bipolar I Disorder (manic or mixed episodes) in adolescents ( 2.2 ) Oral: Start at 2.5-5 mg once daily; Target: 10 mg/day Bipolar I Disorder (manic or mixed episodes) with lithium or valproate in adults ( 2.2 ) Oral: Start at 10 mg once daily Agitation associated with Schizophrenia and Bipolar I Mania in adults ( 2.4 ) IM: 10 mg (5 mg or 7.5 mg when clinically warranted) Assess for orthostatic hypotension prior to subsequent dosing (max. 3 doses 2-4 hrs apart) Depressive Episodes associated with Bipolar I Disorder in adults ( 2.5 ) 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 ( 2.5 ) Oral in combination with fluoxetine: Start at 2.5 mg of oral olanzapine and 20 mg of fluoxetine once daily Treatment Resistant Depression in …
Contraindications
4 CONTRAINDICATIONS None with ZYPREXA monotherapy. When using ZYPREXA and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax. For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products. None with ZYPREXA monotherapy. ( 4 ) When using ZYPREXA and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax ® . ( 4 ) When using ZYPREXA in combination with lithium or valproate, refer to the Contraindications section of the package inserts for those products. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The risks of using olanzapine in combination with other drugs have not been extensively evaluated in systematic studies. Diazepam: May potentiate orthostatic hypotension. ( 7.1 , 7.2 ) Alcohol: May potentiate orthostatic hypotension. ( 7.1 ) Carbamazepine: Increased clearance of olanzapine. ( 7.1 ) Fluvoxamine: May increase olanzapine levels. ( 7.1 ) ZYPREXA and Fluoxetine in Combination: Also refer to the Drug Interactions section of the package insert for Symbyax. ( 7.1 ) CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs and alcohol. ( 7.2 ) Antihypertensive Agents: Enhanced antihypertensive effect. ( 7.2 ) Levodopa and Dopamine Agonists: May antagonize levodopa/dopamine agonists. ( 7.2 ) Lorazepam (IM): Increased somnolence with IM olanzapine. ( 7.2 ) Other Concomitant Drug Therapy: When using olanzapine in combination with lithium or valproate, refer to the Drug Interactions sections of the package insert for those products. ( 7.2 ) 7.1 Potential for Other Drugs to Affect Olanzapine Diazepam — The co-administration of diazepam with olanzapine potentiated the orthostatic hypotension observed with olanzapine […
Adverse Reactions
6 ADVERSE REACTIONS When using ZYPREXA and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax. Most common adverse reactions (≥5% and at least twice that for placebo) associated with: Oral Olanzapine Monotherapy: Schizophrenia (Adults) – postural hypotension, constipation, weight gain, dizziness, personality disorder, akathisia. ( 6.1 ) Schizophrenia (Adolescents) – sedation, weight increased, headache, increased appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry mouth. ( 6.1 ) Manic or Mixed Episodes, Bipolar I Disorder (Adults) – asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor. ( 6.1 ) Manic or Mixed Episodes, Bipolar I Disorder (Adolescents) – sedation, weight increased, increased appetite, headache, fatigue, dizziness, dry mouth, abdominal pain, pain in extremity. ( 6.1 ) Combination of ZYPREXA and Lithium or Valproate: Manic or Mixed Episodes, Bipolar I Disorder (Adults) – dry mouth, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia. ( 6.1 ) ZYPREXA and Fluoxetine in Combination: Also refer t…
Frequently Asked Questions
What is ZYPREXA Zydis used for?
ZYPREXA Zydis contains Olanzapine. It is a tablet, orally disintegrating taken oral. Consult your doctor for specific uses.
Is ZYPREXA Zydis a controlled substance?
ZYPREXA Zydis is not classified as a controlled substance by the DEA.
What is the generic name for ZYPREXA Zydis?
The generic name for ZYPREXA Zydis is Olanzapine. There are 12 other brand versions of Olanzapine.
What is the NDC code for ZYPREXA Zydis 5 mg/1?
The NDC (National Drug Code) for ZYPREXA Zydis 5 mg/1 is 0002-4453, listed by Eli Lilly and Company.