FDA.reportPublic FDA data

Application 089703

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEINJECTABLE;INJECTIONEQ 5MG BASE/MLNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089703-001PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTION1988-04-07

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECaplin Steriles Limited29f0e68d-4653-472d-bd86-e87a8e2cb5292026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATESomerset Therapeutics, LLCd382e3d4-3175-42f2-b9eb-d9a7b97cbbfc2025-09-01Boxed warning, Warnings, Adverse reactionsName fallback
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECardinal Health 107, LLC6135944c-3ee2-4491-9704-33f56ad435f42025-06-23Boxed warning, Warnings, Adverse reactionsName fallback
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0dc48e66-6081-421b-952b-4867c9c4c7942025-03-11Boxed warning, Warnings, Adverse reactionsName fallback
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHikma Pharmaceuticals USA Inc.baf59816-7577-4652-b065-fb6de9e545692025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECivica, Inc.e3e0c6c5-6b92-40e0-a926-29c64846be932025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEFOSUN PHARMA USA INCf793cdb3-9fd8-79e1-e053-6394a90ae08b2024-12-21Boxed warning, Warnings, Adverse reactionsName fallback
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEGland Pharma Limiteda0fd3d58-7470-4d0f-9e6c-84e92c02a97f2024-12-12Boxed warning, Warnings, Adverse reactionsName fallback
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEAvenacy Inc.fd07a1a3-c0df-4926-9964-07348e45a5fd2024-12-09Boxed warning, Warnings, Adverse reactionsName fallback
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0338b221-db43-45c9-a829-d970fe6643ab2024-12-06Boxed warning, Warnings, Adverse reactionsName fallback
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECosette Pharmaceuticals, Inc.4687b9f5-2d67-4fe0-af4d-2415a42b52922024-12-02Boxed warning, Warnings, Adverse reactionsName fallback
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEAmneal Pharmaceuticals LLCe913d678-7a5d-4e74-9e9c-1b9a3affd2652024-11-16Boxed warning, Warnings, Adverse reactionsName fallback
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEEugia US LLC24358d03-d06d-4946-8ebd-a62bc15d33c02024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEMylan Institutional LLC185c1647-06ea-401e-ad1d-8727d77eb8272024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEHF Acquisition Co LLC, DBA HealthFirste181c18d-32a8-587e-e053-2995a90acc5b2024-01-30Boxed warning, Warnings, Adverse reactionsName fallback
PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATESagent Pharmaceuticalsfed5ed29-7091-4b3c-bf67-64f32cd189bb2022-11-29Boxed warning, Warnings, Adverse reactionsName fallback
PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEBaxter Healthcare Corporation11cb37c7-01b4-4223-b2ea-a3695639b80b2021-04-26Boxed warning, Warnings, Adverse reactionsName fallback

Boxed warning cross-check#

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boxed warning

BOXED WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Prochlorperazine Edisylate Injection, USP is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).

Warnings cross-check#

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warnings

WARNINGS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Prochlorperazine Edisylate Injection, USP is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). The extrapyramidal symptoms which can occur secondary to prochlorperazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye's syndrome or other encephalopathy. The use of prochlorperazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye's syndrome. Tardive Dyskinesia Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic drug treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic drug treatment is withdrawn. Antipsychotic drug treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Given these considerations, antipsychotic drugs should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond t...

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs (see WARNINGS ). Cholestatic jaundice has occurred. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. There have been a few observations of fatty changes in the livers of patients who have died while receiving the drug. No causal relationship has been established. Leukopenia and agranulocytosis have occurred. Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate leukocyte depression, stop treatment and start antibiotic and other suitable therapy. Neuromuscular (Extrapyramidal) Reactions These symptoms are seen in a significant number of hospitalized mental patients. They may be characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism. Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted. In most cases barbiturates by suitable route of administration will suffice, or injectable diphenhydramine may be useful. In more severe cases, the administration of an antiparkinsonism agent, except levodopa, usually produces rapid reversal of symptoms. Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed. Motor Restlessness Symptoms may include agitation or jitteriness and sometimes insomnia. These symptoms often disappear spontaneously. At times these symptoms may be similar to the original neurotic or psychotic symptoms. Dosage should not be increased until these side effects have subsided. If these symptoms become too troublesome, they can usually be controlled by a reduction of dosage or change of drug. Treatment with antiparkinsonian agents, benzodiazepines or propranolol may be helpful. Dystonia Class effect : Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck m...