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HYDERABAD, India and PRINCETON, New Jersey, May 24, 2022–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, and its subsidiaries collectively referred to as “Dr. Reddy’s”) and Senores Pharmaceuticals, Inc. Today announced the launch of USP tablets of ketorolac bartetamine, 10 mg, a generic remedy of the reference drug Toradol Tablets, 10 mg in the U. S. market. U. S. Food and Drug Administration approved by the U. S. Food and Drug Administration. USFDA.
Ketorolac tromethamine USP tablets, 10 mg, are a nonsteroidal anti-inflammatory drug (“NSAID”) indicated for the short-term control (up to five days in adults) of moderately severe acute pain requiring opioid analgesia and only as a continuation of remedy after intravenous or intramuscular administration of ketorolac tromethamine, if desired.
“We are thrilled to partner with Dr. Reddy’s Labs to launch ketorolac tromethamine tablets in the U. S. market,” said Dhananjay Barot, Principal of Senores Pharmaceuticals, Inc.
“Our constant determination has helped expand our product portfolio, and we are a vital and reliable supplier of this product,” says Swapnil Shah, CEO of Senores Group.
“We are excited about this launch and excited to partner with Senores to create an affordable product and expand our portfolio in the U. S. market,” said Marc Kikuchi, CEO of North America Generics, Dr. Reddy’s Laboratories.
Toradol, the 10 mg logo, and generic tablets achieved U. S. sales of approximately MAT$16. 8 million over the past twelve months, through March 2022, according to IQVIA*.
Dr. Reddy’s Ketorolac Tromethamine USP tablets, 10 mg, are available in 100 vials.
Click here to view the complete prescribing data and approved indication, as well as the caution box for Dr. Reddy’s 10 mg cetolac tromethamine USP tablets.
FRAMED WARNING
Tablets of ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), are indicated short-term (up to five days in adults) for the control of severe acute pain requiring opioid analgesia and only as maintenance treatment following intravenous injection or IM dosing of ketorolac tromethamine, if necessary. The combined total duration of use of ketorolac bartetamine and ketorolac bartethamine tablets should not exceed five days.
Kerolac tromethamine tablets are not indicated for use in paediatric patients and are NOT indicated for chronic or minor painful conditions. to serious adverse events.
GASTROINTESTINAL RISK
Ketorolac tromethamine, by adding ketorolac bartetamine tablets, can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the abdomen or intestines, which can be fatal. These occasions can occur at any time of use and without precautionary symptoms. Therefore, kerolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer, in patients who recently experienced gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer or gastrointestinal bleeding. Elderly patients are at increased risk of serious gastrointestinal events (see WARNINGS).
CARDIOVASCULAR TOMBOTIC EVENTS
Nonsteroidal anti-inflammatory drugs (NSAIDs) lead to an increased risk of serious cardiovascular thrombotic events, in addition to myocardial infarction and stroke, which can be fatal. This risk could occur at the beginning of treatment and could accumulate with the duration of use. (see WARNINGS AND PRECAUTIONS).
Ketorolac tromethamine tablets are contraindicated from coronary artery bypass (CABG) surgery (see CONTRAINDICATIONS and WARNINGS).
RENAL RISK
Ketorolac tromethamine is CONTRAINDICATED in patients with complex renal impairment and in patients with renal impairment due to volume depletion (see WARNINGS).
RISK OF BLEEDING
Ketorolaco tromethamine acts as a platelet inhibitor and is CONTRAINDICATED in patients with suspected or demonstrated cerebrovascular hemorrhage, patients with hemorrhagic diathesis, incomplete hemostasis, and those at increased risk of bleeding (see WARNINGS AND PRECAUTIONS).
Ketorolac tromethamine is CONTRAINDICATED as a prophylactic analgesic before any primary surgical procedure.
RISK DURING LABOR AND DELIVERY
The use of ketorolac tromethamine during hard work and childbirth is contraindicated as it can adversely affect fetal flow and inhibit uterine contractions.
CONCOMITANT USE WITH NSAIDS
Ketorolac tromethamine is CONTRAINDICATED in patients who are recently receiving aspirin or NSAIDs due to the cumulative threat of serious NSAID-like effects.
SPECIAL POPULATIONS
The dose should be adjusted for patients 65 years of age or older, for patients with a body weight of less than 50 kg (110 lb) (see DOSAGE AND ADMINISTRATION) and for patients with increased serum creatinine (see WARNINGS).
Important Safety Information: Ketorolac Bartetamine Tablets, 10 mg
What facts do I want to know about ketorolac bartetamine tablets 10 mg?
GASTROINTESTINAL RISK: Ketorolac tromethamine, the addition of ketorolac tromethamine tablets, could cause peptic ulcers, gastrointestinal bleeding and/or perforation of the abdomen or intestines, which can be fatal. These occasions can occur at any time of use and without precautionary symptoms. Tromethamine is CONTRAINDICATED in patients with active peptic ulcer, in patients who have recently experienced gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer or gastrointestinal bleeding. Elderly patients have an increased threat of serious gastrointestinal events.
CARDIOVASCULAR TOMBOTIC EVENTS: Nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of serious cardiovascular thrombotic events, in addition to myocardial infarction and stroke, which can be fatal. duration of use. Kerolac tromethamine tablets are contraindicated as a component of coronary artery bypass surgery (CABG).
RENAL RISK: Ketorolac tromethamine is CONTRAINDICATED in patients with complex renal impairment and in patients with renal impairment due to volume depletion.
RISK OF BLEEDING: Ketorolac tromethamine inhibits platelet function and is CONTRAINDICATED in patients with suspected or demonstrated cerebrovascular hemorrhage, patients with hemorrhagic diathesis, incomplete hemostasis, and those at increased risk of bleeding. Ketorolac tromethamine is CONTRAINDICATED as a prophylactic analgesic before any primary surgery. procedure.
RISK DURING LABOR AND DELIVERY: The use of ketorolac tromethamine in labor and delivery is contraindicated as it may affect fetal flow and inhibit uterine contractions.
CONCOMITANT USE WITH NSAIDS: Ketorolac tromethamine is CONTRAINDICATED in patients who recently receive aspirin or NSAIDs due to the cumulative threat of serious NSAID-like effects.
SPECIAL POPULATIONS: The dose should be adjusted for patients 65 years of age or older, for patients with a body weight of less than 50 kg (110 lb).
Who does not use ketorolac tromethamine tablets, 10 mg?
Ketorolac tromethamine is contraindicated in patients who in the past have demonstrated a hypersensitivity reaction to ketorolac tromethamine.
Ketorolac tromethamine is contraindicated in patients with active peptic ulcer, in patients with gastrointestinal bleeding or perforation
Ketorolac tromethamine should not be given to patients who have experienced asthma, hives or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic reactions to NSAIDs have been reported in these patients.
just before or after a central bypass
Concomitant use of ketorolac tromethamine and probenecid is contraindicated.
Concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.
What do I say to my ketorolac bartetamine tablets, 10 mg?
Before taking ketorolac tromethamine tablets, tell him or her if you:
have liver or kidney problems
have high blood pressure
have asthma
are pregnant or pregnant. Taking NSAIDs around 20 weeks of pregnancy or later can harm your unborn baby. If you want to take NSAIDs for more than 2 days when you are 20 to 30 weeks pregnant, your health care provider may want to monitor the amount of fluid in your uterus around your baby. You deserve not to take NSAIDs after about 30 weeks of pregnancy.
breastfeed or breastfeed.
What are the possible side effects of ketorolac tromethamine tablets, 10 mg?
new or worsened upper blood pressure
cardiac arrest
liver problems, liver failure
kidney problems, kidney failure
life-threatening reactions
low level of red blood cells (anemia)
life-threatening allergic reactions
shortness of breath or breathing
slurred speech
Chest pain
swelling of the face or throat
weakness in a component of your body
nausea
Vomiting blood
weaker or weaker than usual
blood in your stool or is black and sticky like tar
Diarrhoea
unusual weight gain
chop
rash or blisters with fever
your eyes are yellow
swelling of the arms, legs, and feet
indigestion or pain
flu-like symptoms
These are not all the imaginable side effects of ketorolac tromethamine tablets, 10 mg. Call your doctor for a medical recommendation about side effects. For more information, consult your doctor or pharmacist. Side effects, call the Medical Information Call Center of Dr. Reddy’s Laboratory at 1-888-DRL-DRUG (1-888-375-3784) or email medinfo@drreddys. com or contact the U. S. FDA. UU. al 1-800-FDA-1088 ( 1-800-332-1088) or online at http://www. fda. gov/safety/medwatch. Refer to the package leaflets for ketorolac tromethamine 10 mg tablets for full prescription information and instructions for use.
Indication and use of ketorolac tromethamine tablets, 10 mg
Tablets of ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), are indicated short-term (up to five days in adults) for the control of severe acute pain requiring opioid analgesia and only as maintenance treatment following intravenous injection or IM dosing of ketorolac tromethamine, if necessary. The combined total duration of use of ketorolac bartetamine and ketorolac bartethamine tablets should not exceed five days.
* IQVIA Retail and Non Retail MAT March 2022.
RDY-0522-410
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an incorporated pharmaceutical company, committed to providing affordable, cutting-edge medicines for a healthier life. Reddy’s provides a product portfolio and adds APIs, custom pharmaceutical array generics, biosimilars and differentiated formulations. Our main areas of interest for healing are gastrointestinal, cardiovascular, diabetology, oncology, pain control and dermatology. Reddy’s operates in markets around the world. Our main markets are the United States, India, Russia and the CIS countries and Europe. For more information, log in to: www. drreddys. com
About Señores Pharmaceuticals, Inc.
Senores Pharmaceuticals, founded in Atlanta, Georgia, is one of the fastest developing pharmaceutical corporations in the U. S. market. Currently, the company has more than 15 products advertised or registered with the USFDA. For more information, visit www. senorespharma. com
Disclaimer: This press release may include forward-looking statements and other forward-looking statements based on management’s existing ideals and assumptions and involve known and unknown hazards and uncertainties that may also cause actual results, functionality or occasions differ materially from those expressed. or implied by such statements. In addition to forward-looking statements due to context, the words “possibly”, “will”, “should”, “expect”, “plan”, “intend”, “anticipate”, “believes” Array “estimates”, “predict “, “potential” or “continuing” and similar expressions identify forward-looking statements. Actual results, functionality or events could differ materially from those indicated in such statements due to, among other things, (i) general economic conditions, such as money market functionality, credit defaults, exchange rates, interest rates, forbearance grades and insured loss frequency/severity, (ii) loss grades and mortality and morbidity trends, (iii) festival grade conversion and general competitive factors, (iv) adjustments in legislation and regulations and central bank policies and/or government, (v) have an effect on acquisitions or reorganizations, adding similar integration problems, and (vi) the sensitivity of our industry and the markets for which our products and facilities are destined and those of our consumers to which economic downturns resulting from natural disasters, epidemics, pandemics or other diseases, adding coronavirus (or COVID-19), and (vii) other known dangers and uncertainties in our public filings with the Securities and Exchange Commission, adding those indexed in the “Risk Factors” and “Forward-Looking Statements” of our Annual Report on Form 20-F for the fiscal year ended December 31 March 2021. The Company assumes no legal responsibility to update the data involved here.
See the businesswire. com edition: https://www. businesswire. com/news/home/20220524006009/en/
Contacts
INVESTOR RELATIONS AMIT AGARWALAMITA@DRREDDYS. COM
USHA IYERUSHAIYER@DRREDDYS. COM MEDIA RELATIONS