Today's Veterinary Practice provides comprehensive information to keep every small animal practitioner up to date on companion animal medicine and surgery as well as practice building and management.
Issue link: http://todaysveterinarypractice.epubxp.com/i/715668
Antiemetic For subcutaneous or intravenous injection in dogs and cats C aution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. i ndiCations: Dogs: CERENIA (maropitant citrate) Injectable Solution is indicated for the prevention and treatment of acute vomiting in dogs. Cats: CERENIA (maropitant citrate) Injectable Solution is indicated for the treatment of vomiting in cats. d osage and administration: Use of refrigerated product may reduce the pain response associated with subcutaneous injection. Dogs: For Prevention and Treatment of Acute Vomiting in Dogs: Dogs 2-4 Months of Age: Administer CERENIA Injectable Solution subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/kg (0.1 mL/2.2 lb) of body weight once daily for up to 5 consecutive days. Dogs 4 months of Age and Older: Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/1 kg (1 mL/22 lb) of body weight once daily for up to 5 consecutive days. In dogs that are actively vomiting, it is recommended to initiate treatment with CERENIA Injectable Solution. Thereafter, CERENIA Tablets may be used for the prevention of acute vomiting at 2 mg/kg once daily. (See CERENIA Tablets package insert for complete prescribing information). For Prevention of Vomiting in Dogs 4 months of Age and Older Caused by Emetogenic Medications or Chemotherapeutic Agents: Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) of body weight one time, 45-60 minutes prior to use of emetogenic medications or chemotherapeutic agents. Cats: For Treatment of Vomiting in Cats 4 Months of Age and Older: Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/kg (0.1 mL/2.2 lb) of body weight once daily for up to 5 consecutive days. The underlying cause of acute vomiting should be identified and addressed in dogs and cats that receive CERENIA Injectable Solution. If vomiting persists despite treatment, the case should be re-evaluated. W arnings: Not for use in humans. Keep out of reach of children. In case of accidental injection or exposure, seek medical advice. Topical exposure may elicit localized allergic skin reactions in some individuals. Repeated or prolonged exposure may lead to skin sensitization. In case of accidental skin exposure, wash with soap and water. CERENIA is also an ocular irritant. In case of accidental eye exposure, flush with water for 15 minutes and seek medical attention. In puppies younger than 11 weeks of age, histological evidence of bone marrow hypocellularity was observed at higher frequency and greater severity in puppies treated with CERENIA compared to control puppies. In puppies 16 weeks and older, bone marrow hypocellularity was not observed (see ANIMAL SAFETY ). P reCautions: The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins. Use with caution in patients with hepatic dysfunction because CERENIA Injectable Solution is metabolized by CYP3A, CYP2D15 (dogs) and CYP1A (cats) enzymes (see Pharmacokinetics). The influence of concomitant drugs that may inhibit the metabolism of CERENIA Injectable Solution has not been evaluated. CERENIA Injectable Solution is highly protein bound. Use with caution with other medications that are highly protein bound. The concomitant use of CERENIA Injectable Solution with other protein bound drugs has not been studied in dogs or cats. Commonly used protein bound drugs include NSAIDs, cardiac, anticonvulsant, and behavioral medications. Drug compatibility should be monitored in patients requiring adjunctive therapy. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens. Adverse Reactions: DOGS: In a US field study for the prevention and treatment of vomiting associated with administration of cisplatin for cancer chemotherapy, the following adverse reactions were reported in 77 dogs treated with CERENIA Injectable Solution at 1 mg/kg subcutaneously or 41 dogs treated with placebo: Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=41) CERENIA (n=77) # dogs % occur # dogs % occur Diarrhea 1 2.4 6 7.8 Anorexia 0 0 4 5.2 Injection site reaction (swelling, pain upon injection) 0 0 3 4 Lethargy 1 2.4 2 2.6 The following adverse reactions were reported during the course of a US field study for the prevention and treatment of acute vomiting in dogs treated with 1 mg/kg CERENIA Injectable Solution subcutaneously and/or CERENIA Tablets at a minimum of 2 mg/kg orally once daily for up to 5 consecutive days: Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=69) CERENIA (n=206) # dogs % occur # dogs % occur Death during study 4 5.8 10 4.9 Euthanized during study 0 0 2 1 Diarrhea 6 8.7 8 3.9 Hematochezia/bloody stool 5 7.2 4 1.9 Anorexia 2 2.9 3 1.5 Otitis/Otorrhea 0 0 3 1.5 Endotoxic Shock 1 1.4 2 1 Hematuria 0 0 2 1 Excoriation 0 0 2 1 Other clinical signs were reported but were <0.5% of dogs. Adverse reactions seen in a European field study included ataxia, lethargy and injection site soreness in one dog treated with CERENIA Injectable Solution. Post-Approval Experience (Rev. 2015) The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events reported for dogs are listed in decreasing order of reporting frequency for CERENIA Injectable Solution: Pain/vocalization upon injection, depression/lethargy, anorexia, anaphylaxis/anaphylactoid reactions (including swelling of the head/face), ataxia, convulsions, hyper- salivation, tremors, fever, dyspnea, collapse/loss of consciousness, recumbency, injection site reactions (swelling, inflammation) and sedation. Cases of death (including euthanasia) have been reported. CATS: The following adverse reactions were reported during the course of a US field study for the treatment of vomiting in cats treated with 1 mg/kg CERENIA Injectable Solution subcutaneously once daily for up to five consecutive days: Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=62) CERENIA (n=133) # cats % occur # cats % occur Moderate Response to Injection 1,2 1 1.6 30 22.6 Significant Response to Injection 1,3 1 1.6 15 11.3 Fever/Pyrexia 2 3.2 2 1.5 Dehydration 0 0 3 2.3 Lethargy 0 0 2 1.5 Anorexia 0 0 1 0.8 Hematuria 0 0 1 0.8 Hypersalivation 0 0 1 0.8 Injection site swelling 1 1.6 0 0 1 The clinician observed and graded each cat's response to injection. 2 Cat objected to the injection by retreating and vocalizing 3 Cat objected to the injection by retreating, hissing, scratching, and vocalization Post-Approval Experience (Rev. 2015) The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events reported for cats are listed in decreasing order of reporting frequency for CERENIA Injectable Solution: Depression/lethargy, anorexia, hypersalivation, pain/vocalization upon injection, dyspnea, ataxia, fever, recumbency, vomiting, panting, convulsion, and muscle tremor. Cases of death (including euthanasia) have been reported. To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth. s torage Conditions: CERENIA Injectable Solution should be stored at controlled room temperature 20-25°C (68-77°F) with excursions between 15-30°C (59-86°F). After first vial puncture, CERENIA Injectable Solution should be stored at refrigerated temperature 2-8°C (36-46°F). Use within 90 days of first vial puncture. Stopper may be punctured a maximum of 25 times. H oW suPPlied: CERENIA Injectable Solution is supplied in 20 mL amber glass vials. Each mL contains 10 mg of maropitant as maropitant citrate. NADA #141-263, Approved by FDA Distributed by: Zoetis Inc. Kalamazoo, MI 49007 Revised: October 2015 Made in France 8811855A&P; Brief Summary of Prescribing Information