Dr. Reddy's Laboratories Announces the Launch of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) in the U.S. Market
Dr. Reddy’s Laboratories (NYSE: RDY) has launched Succinylcholine Chloride Injection USP, a generic equivalent of Quelicin®, approved by the USFDA. The new product comes in multiple-dose vials, with a concentration of 20 mg/mL. The Quelicin® market recorded U.S. sales of approximately $74.8 million over the last twelve months ending September 2020. The press release also includes a significant warning regarding the risk of cardiac arrest from hyperkalemic rhabdomyolysis in pediatric patients.
- Launch of Succinylcholine Chloride Injection, a generic version of Quelicin®.
- USFDA approval enhances product portfolio and market share.
- Quelicin® market recorded sales of approximately $74.8 million.
- Risk of cardiac arrest from hyperkalemic rhabdomyolysis associated with succinylcholine use in pediatric patients.
HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL), Multiple-Dose Vials a therapeutic equivalent generic version of Quelicin® (Succinylcholine Chloride) Injection, 20 mg/mL, approved by the U.S. Food and Drug Administration (USFDA).
The Quelicin® brand and generic market had U.S. sales of approximately
Dr. Reddy’s Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL), is available in multi-dose vials.
Please see full prescribing information including boxed warning.
https://www.drreddys.com/pi/succinylcholine-chloride.pdf
WARNING RISK OF CARDIAC ARREST FROM HYPERKALEMIC RHABDOMYOLYSIS There have been rare reports of acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest and death after the administration of succinylcholine to apparently healthy pediatric patients who were subsequently found to have undiagnosed skeletal muscle myopathy, most frequently Duchenne's muscular dystrophy.
This syndrome often presents as peaked T-waves and sudden cardiac arrest within minutes after the administration of the drug in healthy appearing pediatric patients (usually, but not exclusively, males, and most frequently 8 years of age or younger). There have also been reports in adolescents.
Therefore, when a healthy appearing infant or child develops cardiac arrest soon after administration of succinylcholine, not felt to be due to inadequate ventilation, oxygenation or anesthetic overdose, immediate treatment for hyperkalemia should be instituted. This should include administration of intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation. Due to the abrupt onset of this syndrome, routine resuscitative measures are likely to be unsuccessful. However, extraordinary and prolonged resuscitative efforts have resulted in successful resuscitation in some reported cases. In addition, in the presence of signs of malignant hyperthermia, appropriate treatment should be instituted concurrently.
Since there may be no signs or symptoms to alert the practitioner to which patients are at risk, it is recommended that the use of succinylcholine in pediatric patients should be reserved for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION). |
Quelicin® is a trademark of Hospira, Inc
*IQVIA Retail and Non-Retail MAT September 2020
RDY-0820-308
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com
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