UPSHER-SMITH ADDS UNIT-DOSE TABLETS TO EXPAND HALOPERIDOL FAMILY OF PRODUCTS. | Tech Reddy

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MAPLE GROVE, Minn., November 7, 2022 /PRNewswire/ — Upsher-Smith Laboratories, LLC (Upsher-Smith) announced today that it has expanded its line of USP Haloperidol tablets and now offers 1 mg, 5 mg and 10 mg dosage packages. The new packaging aims to expand the dispensing capabilities of pharmacies using unit dose packaged products. Upsher-Smith’s Haloperidol tablets are also available in 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg doses in bottles of 100 tablets. Haloperidol tablets are the generic version of the brand name product, Haldol® Tablet*.

The haloperidol unit tablet market in the US sold approx 9 million dollars for the last 12 months July 2022 According to IQVIA.

Product information

Product

The force

NDC #

Package size

Haloperidol Tablets, USP

1 mg

0832-1520-01

Number 100 is UD

Haloperidol Tablets, USP

5 mg

0832-1540-01

Number 100 is UD

Haloperidol Tablets, USP

10 mg

0832-1550-01

Number 100 UD

If you have questions about ordering, please call Upsher-Smith at 1-800-654-2299.

TO WARN

INCREASED MORTALITY IN PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs have an increased risk of death. An analysis of seventeen placebo-controlled trials (modal duration 10 weeks), mainly in patients receiving atypical antipsychotic drugs, found that the risk of death in drug-treated patients was 1.6 to 1.7 times that of placebo-treated patients. During a typical 10-week controlled trial, the death rate in drug-treated patients was 4.5% compared to 2.6% in the placebo group. Although causes of death varied, most deaths were either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that treatment with conventional antipsychotics, as well as atypical antipsychotics, may increase mortality. It is unclear whether findings of increased mortality in observational studies may be due to antipsychotic medication as opposed to some patient characteristics. Haloperidol is not approved for the treatment of patients with psychosis associated with dementia (see WARNINGS).

Please see the full prescribing information, including the boxed note for Haloperidol Tablets, USP here. You may also call 1-888-650-3789 to obtain a copy of the complete prescription information.
You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA at http://www.fda.gov/medwatch.

About Upsher-Smith

Upsher-Smith Laboratories, LLC is a trusted US pharmaceutical company committed to improving the health and lives of patients through high quality products and a relentless commitment to sustainable growth. The company brings brands and generics to a wide range of customers, always backed by its meticulous service levels, strong industry relationships and commitment to continuous supply. For more information, visit www.upsher-smith.com.

*Haldol is a registered trademark of Johnson & Johnson Corp; Haldol tablets are discontinued.

SOURCE Upsher-Smith Laboratories, LLC

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