London - Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, has launched Fentanyl Citrate Injection, USP, in 25mcg/0.5mL and 50mcg/mL doses.

The product has been launched in the US and is indicated for: analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.

Use as a narcotic analgesic supplement in general or regional anesthesia.

Administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.

Use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

Hikma is introducing the first FDA approved 25mcg/0.5mL presentation to the US market and we are pleased to expand our portfolio with this launch, broadening the choice of medicines available to hospitals.

Hikma is a top three supplier of generic injectable medicines by volume in the US[1], with a growing portfolio of more than 150 products. We are continuously expanding our portfolio of essential medicines and introducing new dosage forms that enhance patient care.

This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States.

BOXED WARNING

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL CITRATE INJECTION

Addiction, Abuse, and Misuse

Because the use of Fentanyl Citrate Injection exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Fentanyl Citrate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Fentanyl Citrate Injection are essential.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Fentanyl Citrate Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

Cytochrome P450 3A4 Interaction

The concomitant use of Fentanyl Citrate Injection with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl Citrate Injection and any CYP3A4 inhibitor or inducer.

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