UZEDY 50 mg/.14mL
risperidone · INJECTION, SUSPENSION, EXTENDED RELEASE · Teva Pharmaceuticals USA, Inc.
UZEDY is a injection, suspension, extended release containing risperidone at 50 mg/.14mL, taken subcutaneous. Manufactured by Teva Pharmaceuticals USA, Inc..
Key Facts
- Brand Name
- UZEDY
- Generic Name
- risperidone
- NDC Code (Product)
51759-305- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Strength
- 50 mg/.14mL
- Dosage Form
- INJECTION, SUSPENSION, EXTENDED RELEASE
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA213586
- Drug Class
- Atypical Antipsychotic [EPC]
- Marketing Start
- 05/01/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE UZEDY is an atypical antipsychotic indicated: for the treatment of schizophrenia in adults. ( 1.1 ) as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. ( 1.2 ) 1.1 Schizophrenia UZEDY is indicated for the treatment of schizophrenia in adults . 1.2 Bipolar Disorder UZEDY is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder in adults.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Establish tolerability with oral risperidone prior to initiating UZEDY. ( 2.1 ) Administer UZEDY by subcutaneous injection in the abdomen or upper arm by a healthcare professional. Do not administer by any other route. ( 2.1 ) See Full Prescribing Information for important preparation and administration information. ( 2.7 ) Schizophrenia Initiate UZEDY at the clinically appropriate dose using the following table. ( 2.2 ) Comparable Daily Oral Risperidone Therapy UZEDY Dosage Once Monthly UZEDY Dosage Once Every 2 Months 2 mg 50 mg 100 mg 3 mg 75 mg 150 mg 4 mg 100 mg 200 mg 5 mg 125 mg 250 mg Bipolar I disorder Following establishment of tolerability with oral risperidone, initiate UZEDY at the clinically appropriate dose using the following table. ( 2.3 ) Comparable Daily Oral Risperidone Therapy UZEDY Dosage Once Monthly 2 mg 50 mg 3 mg 75 mg 4 mg 100 mg For patients currently receiving risperidone long acting intramuscular injectable given once every 2 weeks, switch to UZEDY as a once monthly injection, starting at least 5 weeks after the last dose of risperidone long acting injectable given once every 2 weeks. ( 2.3 ) Switch to UZEDY at the clinicall…
Contraindications
4 CONTRAINDICATIONS UZEDY is contraindicated in patients with a known hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its components. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone or paliperidone. Known hypersensitivity to risperidone, paliperidone, or to any of the components in UZEDY. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The interactions of UZEDY with co-administration of other drugs have not been studied. The drug interaction data provided in this section is based on studies with oral risperidone. Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): Increase risperidone plasma concentration. ( 2.6 , 7.1 ) Strong CYP3A4 inducers (e.g., carbamazepine): Decrease plasma concentrations of risperidone. ( 2.6 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions with UZEDY Table 13 includes clinically significant drug interactions with UZEDY. Table 13: Clinically Important Drug Interactions with UZEDY Strong CYP2D6 Inhibitors Clinical Impact: Concomitant use of UZEDY with strong CYP2D6 inhibitors may increase the plasma exposure of risperidone and lower the plasma exposure of a major active metabolite, 9-hydroxyrisperidone [see Clinical Pharmacology ( 12.3 )] . Intervention: When initiation of strong CYP2D6 inhibitors is considered, patients may be placed on the lowest dose (50 mg once monthly or 100 mg once every 2 months) of UZEDY prior to the planned start of strong CYP2D6 inhibitors to adjust for the expected increase in plasma concentrations of risperidone. When strong C…
Adverse Reactions
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 )] Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions ( 5.2 )] Neuroleptic malignant syndrome [see Warnings and Precautions ( 5.3 )] Tardive dyskinesia [see Warnings and Precautions ( 5.4 )] Metabolic changes [see Warnings and Precautions ( 5.5 )] Hyperprolactinemia [see Warnings and Precautions ( 5.6 )] Orthostatic hypotension and syncope [see Warnings and Precautions ( 5.7 )] Falls [see Warnings and Precautions ( 5.8 )] Leukopenia, neutropenia and agranulocytosis [see Warnings and Precautions ( 5.9 )] Potential for cognitive and motor impairment [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Dysphagia [see Warnings and Precautions ( 5.12 )] Priapism [see Warnings and Precautions ( 5.13 )] Body temperature regulation [see Warnings and Precautions ( 5.14 )] The most common adverse reactions with risperidone in patients with schizophrenia (≥5…
Frequently Asked Questions
What is UZEDY used for?
UZEDY contains risperidone. It is a injection, suspension, extended release taken subcutaneous. Consult your doctor for specific uses.
Is UZEDY a controlled substance?
UZEDY is not classified as a controlled substance by the DEA.
What is the generic name for UZEDY?
The generic name for UZEDY is risperidone. There are 12 other brand versions of risperidone.
What is the NDC code for UZEDY 50 mg/.14mL?
The NDC (National Drug Code) for UZEDY 50 mg/.14mL is 51759-305, listed by Teva Pharmaceuticals USA, Inc..