Maropitant

Indications

Ceritant (maropitant citrate) Tablets are indicated for the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs.

Dosage and Administration

For Prevention of Acute Vomiting For Prevention of Acute Vomiting in dogs 2 -7 months of age: Administer Ceritant (maropitant citrate) Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days (see WARNINGS and Animal Safety). For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer Ceritant (maropitant citrate) Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting. If vomiting persists despite treatment, the case should be re-evaluated. Ceritant (maropitant citrate) Tablets is most effective in preventing acute vomiting associated with chemotherapy if administered prior to the chemotherapeutic agent. For prevention of acute vomiting, dispense whole or half tablets in strength(s) that most closely result in a 2 mg/kg dose: Dog body weight Number of Tablets Pounds Kilograms 16 mg 24 mg 60 mg 8 4 ½ 15 8 1 25 12 1 50 24 2 65 30 1 130 60 2 Interchangeable use with Maropitant Citrate injectable solution for Prevention of Acute Vomiting: In dogs that are actively vomiting, to ensure that the full initial dose is administered, Maropitant Citrate injectable solution is recommended at a dose of 1 mg/kg once daily . (See package insert for Maropitant Citrate injectable solution.) Thereafter, for the prevention of acute vomiting, Ceritant (maropitant citrate) Tablets at a dose of 2 mg/kg once daily may be used interchangeably with Maropitant Citrate injectable solution for up to 5 days. For Prevention of Vomiting Due to Motion Sickness in dogs 4 months and older For Prevention of Vomiting due to motion sickness in dogs 4 months of age and older: Administer Ceritant (maropitant citrate) Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days (see WARNINGS and Animal Safety). Administer Ceritant (maropitant citrate) Tablets a minimum of two hours prior to travel with a small amount of food to mitigate vomiting associated with administration of the dose on an empty stomach; however, refrain from feeding a full meal prior to travel. Prevention of Vomiting Due to Motion Sickness in Dogs 4 months of age and older: Dispense whole or half tablets in strengths that most closely result in an 8 mg/kg dose once daily for up to 2 consecutive days: Dog body weight Number of Tablets Pounds Kilograms 16 mg 24 mg 60 mg 160 mg 2 1 ½ 3 1.5 ½ 4 2 1 6 3 1 8 4 2 13 6 2 16 7.5 1 22 10 ½ 33 15 2 44 20 1 66 30 1 ½ 88 40 2 132 60 3 Maropitant Citrate injectable solution should not be used interchangeably with Ceritant (maropitant citrate) Tablets for the prevention of vomiting due to motion sickness (8mg/kg).

Warnings

Not for use in humans. Keep out of the reach of children. In case of accidental ingestion, seek medical advice. Topical exposure may elicit localized allergic skin reactions in some individuals. Repeated or prolonged exposure may lead to skin sensitization. Wash hands with soap and water after administering drug. Ceritant (maropitant citrate) Tablets is also an ocular irritant. In case of accidental eye exposure, flush with water for 15 minutes and seek medical attention. Keep Ceritant (maropitant citrate) Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. 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 Ceritant (maropitant citrate) Tablets compared to control puppies. In puppies 16 weeks and older, bone marrow hypocellularity was not observed (see ANIMAL SAFETY ).

Precautions

The safe use of Ceritant (maropitant citrate) Tablets has not been evaluated in dogs used for breeding, or in pregnant or lactating bitches. The safe use of Ceritant (maropitant citrate) Tablets has not been evaluated in dogs with gastrointestinal obstruction, or dogs that have ingested toxins. Use with caution in dogs with hepatic dysfunction because Ceritant (maropitant citrate) Tablets is metabolized by CYP3A enzymes (see Pharmacokinetics ).Use with caution with other medications that are highly protein bound. The concomitant use of Ceritant (maropitant citrate) Tablets with other protein bound drugs has not been studied in dogs. Commonly used protein bound drugs include NSAIDs, cardiac, anticonvulsant, and behavioral medications. The influence of concomitant drugs that may inhibit the metabolism of Ceritant (maropitant citrate) Tablets has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. Ceritant (maropitant citrate) Tablets causes dose related decreases in appetite and body weight (see ANIMAL SAFETY ). To maximize therapeutic potential of Ceritant (maropitant citrate) Tablets, the underlying cause of vomiting should be identified and addressed in dogs receiving Ceritant (maropitant citrate) Tablets.

Adverse Reactions

Prevention of Acute Vomiting (minimum of 2 mg/kg) The following adverse reactions were reported during the course of a US field study for the prevention of acute vomiting in dogs treated with maropitant citrate tablets at a minimum of 2 mg/kg orally and/or injectable solution at 1 mg/kg subcutaneously once daily for up to 5 consecutive days: Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=69) maropitant citrate (n=206) # dogs % occurrence # dogs % occurrence 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. Prevention of Vomiting Due to Motion Sickness (minimum of 8 mg/kg) The following adverse reactions were reported during US studies for the prevention of vomiting due to motion sickness in dogs treated with maropitant citrate tablets at a minimum of 8 mg/kg orally one time. Dogs may have experienced more than one of the observed adverse reactions. Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=195) maropitant citrate (n=208) # dogs % occurrence # dogs % occurrence Hypersalivation 19 9.7 26 12.5 Vomiting 1 0 0 11 5.3 Muscle Tremors 1 0.5 2 1 Sedation/Depression 3 1.5 2 1 Retching 3 1.5 1 0.5 Flatulence 0 0 1 0.5 1 Not associated with motion sickness. The following adverse reactions were reported during a European field study for the prevention of vomiting due to motion sickness in dogs treated with maropitant citrate at a minimum of 8 mg/kg orally once daily for 2 consecutive days. Dogs may have experienced more than one of the observed adverse reactions. Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=106) maropitant citrate (n=107) # dogs % occurrence # dogs % occurrence Vomiting 4 4 10 9 Drowsiness/Lethargy/Apathy 1 1 8 8 Hypersalivation 2 2 5 5 Anxiety 0 0 2 2 Trembling/Tremors 0 0 2 2 Inappetence 0 0 2 2 Mucus in stool 0 0 1 1 The following Adverse Reactions were reported during the conduct of a US clinical field trial where maropitant citrate tablets were administered once daily for 28 consecutive days to 32 dogs: lethargy, vomiting, inappetence, corneal edema, and enlarged lymph nodes. Post-Approval Experience (Revised May 2019) 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 frequency: anorexia, depression/lethargy, hypersalivation, vomiting, diarrhea, trembling, ataxia, allergic reactions, weight loss, convulsion, hyperactivity, and panting. Cases of ineffectiveness have been reported. Cases of death (including euthanasia) have been reported. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact manufacturer. at 1-877-779-9838 For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Description

Maropitant is a neurokinin (NK1) receptor antagonist that blocks the pharmacological action of substance P in the central nervous system (CNS). Maropitant is the non-proprietary designation for a substituted quinuclidine. The empirical formula is C32H40N2O C6H8O7 H2O and the molecular weight 678.81. The chemical name is (2 S ,3 S )-2-benzhydryl- N -(5- tert -butyl-2-methoxybenzyl) quinuclidin-3-amine citrate monohydrate. Each peach-colored oval tablet is scored and contains 16, 24, 60 or 160 mg of maropitant as maropitant citrate per tablet. The chemical structure of maropitant citrate is: Image

Storage

Stored at controlled room temperature 20°-25°C (68°-77°F), excursions permitted to 40°C (104°F).

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• Maropitant Citrate Tablets Antiemetic For oral use in dogs only, FELIX PHARMACEUTICALS PRIVATE LIMITED. Set id f7ab442b-0350-40fa-8172-79777d7d2fbd.
• Maropitant Citrate Tablets Chewable Tablets Antiemetic For oral use in dogs only, FELIX PHARMACEUTICALS PRIVATE LIMITED. Set id 20c73923-9539-4d72-b4e3-5a868699e544.
• Maropitant Citrate Tablets Chewable Tablets Antiemetic For oral use in dogs only, BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA. Set id 221ef464-4fae-4165-861a-9ec36a0149b2.
• Maropitant Citrate Tablets Antiemetic For oral use in dogs only, BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA. Set id 889c6fcc-9130-4256-8550-7d515851e2f9.
• Maropitant Citrate Tablets, ZYVET ANIMAL HEALTH INC.. Set id 4df78641-53de-438f-bb12-54aa0d4ed192.
• ComforTrate TM (maropitant citrate) Tablets, MWI ( VetOne). Set id 24e68b73-b4d2-4e80-9b57-d2f53dfb8b45.
• ComforTrate™ (maropitant citrate) Tablets Antiemetic For oral use in dogs only, MWI/Vetone. Set id 362946e6-023f-42af-bb89-d3822a4e0b59.
• Cerenia ® (maropitant citrate) Tablets, Zoetis Inc.. Set id 3bc065ce-09d6-4131-a5a0-dca3909e0bc8.
• Emeprev™ (maropitant citrate) Injectable Solution, Dechra Veterinary Products, LLC. Set id dbe41248-7740-47f2-aa91-65310bfa3e66.
• Cerenia ® (maropitant citrate) Injectable Solution, Zoetis Inc.. Set id 6aeda328-97c9-4868-8ecb-b3a4dcdbc0a0.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming maropitant as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.