Slayback Pharma announces approval and immediate launch of Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection in 200 mcg/ 50 mL and 400 mcg/ 100 mL (4 mcg/mL) vials, generic equivalent of Precedex™ 4 mcg/ mL

December 10, 2019 |

3 min read

Slayback Pharma LLC announced the final approval and launch in the United States of Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection.

PRINCETON, N.J., Dec. 10, 2019 /PRNewswire/ -- Slayback Pharma LLC announced today the final approval and launch in the United States of Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection. Slayback’s Dexmedetomidine product is available in 50 ml and 100 ml ready-to-infuse vials. Slayback has already commenced shipping the product to its customers.

Ajay Singh, CEO of Slayback Pharma, said: “Slayback’s launch of Dexmedetomidine 4 mcg/ml vials is a result of a smart intellectual property strategy coupled with our strong research and development capability. It is yet another milestone in our pursuit of difficult sterile products.”

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is available in 200 mcg/50 mL and 400 mcg/ 100 mL (4 mcg/mL) vials, and can be ordered through your wholesaler/distributor. Please contact our customer service team at 1-844-566-2505.

See the following important safety information and refer to the Package Insert for full prescribing information.

Indications and Usage
Dexmedetomidine hydrochloride in 0.9% Sodium Chloride injection is a relatively selective alpha2-adrenergic agonist indicated for:

Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours.
Sedation of non-intubated patients prior to and/or during surgical and other procedures.

Important Safety Information for Dexmedetomidine Hydrochloride
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of dexmedetomidine hydrochloride in 0.9% sodium chloride injection, patients should be continuously monitored while receiving dexmedetomidine hydrochloride in 0.9% sodium chloride injection.

Hypotension, Bradycardia, and Sinus Arrest:
Reports of hypotension and bradycardia have been associated with dexmedetomidine hydrochloride in 0.9% sodium chloride injection infusion.

Caution should be exercised when administering dexmedetomidine hydrochloride in 0.9% sodium chloride injection to patients with advanced heart block and/or severe ventricular dysfunction.

Transient Hypertension:
Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of dexmedetomidine hydrochloride in 0.9% sodium chloride injection.

Arousability:
Some patients receiving dexmedetomidine hydrochloride in 0.9% sodium chloride injection have been observed to be arousable and alert when stimulated.

Withdrawal:
Intensive Care Unit Sedation:
The most common events were nausea, vomiting, and agitation.

Procedural Sedation:
In adult subjects, withdrawal symptoms were not seen after discontinuation of short-term infusions of dexmedetomidine hydrochloride in 0.9% sodium chloride injection (<6 hours).

Tolerance and Tachyphylaxis:
Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions

Hepatic Impairment:
Since dexmedetomidine hydrochloride in 0.9% sodium chloride injection clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration].

Possible side effects:

Hypotension, bradycardia and sinus arrest
Transient hypertension

You may report an adverse event related to Dexmedetomidine Hydrochloride made by Slayback Pharma by calling 1-844-566-2505 or emailing medical@slayback-pharma.com. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for Dexmedetomidine Hydrochloride.

References:
Dexmedetomidine Hydrochloride prescribing information. Slayback Pharma, 12/2019.
Precedex™ is a trademark of Orion Corporation.

About Slayback Pharma

Slayback Pharma is a New Jersey-based pharmaceutical company focused on the development of complex and specialty generic products.

(PRNewsfoto/Slayback Pharma LLC)