Dr. Reddy's Laboratories Announces the Launch of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) in the U.S. ...
November 12 2020 - 10:47AM
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 $74.8 million MAT for the most recent twelve months
ending in September 2020 according to IQVIA Health*.
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
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on
the management’s current views and assumptions and involve known or
unknown risks and uncertainties that could cause actual results,
performance or events to differ materially from those expressed or
implied in such statements. In addition to statements which are
forward-looking by reason of context, the words "may", "will",
"should", "expects", "plans", "intends", "anticipates", "believes",
"estimates", "predicts", "potential", or "continue" and similar
expressions identify forward-looking statements. Actual results,
performance or events may differ materially from those in such
statements due to without limitation, (i) general economic
conditions such as performance of financial markets, credit
defaults , currency exchange rates, interest rates, persistency
levels and frequency / severity of insured loss events, (ii)
mortality and morbidity levels and trends, (iii) changing levels of
competition and general competitive factors, (iv) changes in laws
and regulations and in the policies of central banks and/or
governments, (v) the impact of acquisitions or reorganization,
including related integration issues, and (vi) the susceptibility of our industry
and the markets addressed by our, and our customers’, products and
services to economic downturns as a result of natural disasters,
epidemics, pandemics or other widespread illness, including
coronavirus (or COVID-19), and (vii) other risks and uncertainties
identified in our public filings with the Securities and Exchange
Commission, including those listed under the "Risk Factors" and
"Forward-Looking Statements" sections of our Annual Report on Form
20-F for the year ended March 31, 2020. The company assumes no
obligation to update any information contained herein.”
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INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com (PH: +91-40-49002135)
MEDIA RELATIONS APARNA TEKURI aparnatekuri@drreddys.com (PH: +91-40-
49002446)
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