CERENIA® (maropitant citrate) Tablets Label Now Allows for Use Until Resolution of Acute Vomiting in Dogs
New dosing and administration directions offer veterinarians flexibility to prescribe the medication for longer than five consecutive days
FLORHAM PARK, N.J. – June 29, 2015 – Zoetis Inc. today announced that the U. S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) has approved an update to the labeling for CERENIA® (maropitant citrate) Tablets. The revised label now allows for once-daily administration until resolution of acute vomiting for dogs 7 months of age and older.
Previously, the dosing and administration instructions limited use to five consecutive days for prevention of acute vomiting. The dosing limitation for use in dogs 2 to 7 months of age remains five consecutive days.
“In 2007, treatment of acute vomiting changed. For the first time, veterinarians had CERENIA® (maropitant citrate), an FDA-approved antiemetic for animals that was broad-spectrum, safe and highly effective with strong science to support it,” said Todd R. Tams, DVM, DACVIM, Chief Medical Officer of VCA (Veterinary Centers of America). “Now, with the removal of the five-day dosing restriction, veterinarians have greater latitude to treat each patient individually.”
Dr. Tams added, “If vomiting isn’t controlled, an animal can become dehydrated. Additionally, acute vomiting may result in consequences such as electrolyte abnormalities or aspiration, which can lead to pneumonia or esophageal injury.” He also noted that resolution of acute vomiting can help dogs return to feeding earlier, which also supports the healing process.
The newly approved CERENIA Tablets label supports the safe use of CERENIA Tablets at 2mg/kg/day until resolution of acute vomiting in dogs over 7 months of age. Safety of maropitant in dogs was demonstrated in a three-month oral toxicity study and a two-week pharmacokinetics study that demonstrated maropitant concentrations reached steady state after approximately four days following 2 mg/kg/day oral administration.1
CERENIA Tablets are indicated for the prevention of acute vomiting in dogs and the prevention of vomiting due to motion sickness in dogs. CERENIA is also available as an injectable formulation. CERENIA® (maropitant citrate) Injectable Solution is indicated for the prevention and treatment of acute vomiting in dogs and for the treatment of vomiting in cats. The label for the CERENIA Injectable formulation is unchanged at this time. Please click here for more information.2
IMPORTANT SAFETY INFORMATION:
Use CERENIA Injectable for vomiting in cats 4 months and older, and acute vomiting in dogs 2 months and older. CERENIA Tablets are indicated for acute vomiting in dogs 2 months and older, and for prevention of vomiting due to motion sickness in dogs 4 months and older. Safe use has not been evaluated in cats and dogs with gastrointestinal obstruction, or those that have ingested toxins. Use with caution in cats and dogs with hepatic dysfunction. Pain/vocalization upon injection is a common side effect. In people, topical exposure may elicit localized allergic skin reactions, and repeated or prolonged exposure may lead to skin sensitization. See full Prescribing Information or call 1-888-ZOETIS1 (963-8471) for more information.
Zoetis (zô-EH-tis) is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products and genetic tests and supported by a range of services. In 2014, the company generated annual revenues of $4.8 billion. With approximately 10,000 employees worldwide at the beginning of 2015, Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in 120 countries. For more information, visit www.zoetisUS.com.
For Further Information, Contact:
1CERENIA® (maropitant citrate): Package Insert. Tablets U.S. Prescribing Information. NADA #141-262. Zoetis Inc, 2015.
2CERENIA® (maropitant citrate): Package Insert. Injectable U.S. Prescribing Information. NADA #141-263. Zoetis Inc, 2014.
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