Maropitant vs Metoclopramide in Dogs: Dosing, Safety & Key Differences

References

1. FREEDOM OF INFORMATION SUMMARYanimaldrugsatfda.fda.gov
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   An oral dosage of 0, 1, 2, or 3 mg/kg maropitant was administered to 40 Beagles with 10 dogs per group (5 males, 5 females) to select the dosage for the prevention of acute vomiting in dogs. Dogs were administered maropitant 19 hours before administration of 70 mg/m 2 cisplatin. The mean number of emetic events experienced by the placebo dogs was 20.3 compared to 2.7, 1.1 and 0.5 for maropitant dogs at 1, 2, and 3 mg/kg, respectively. Dogs administered 1 mg/kg of maropitant orally exhibited more emetic events than dogs receiving 2 and 3 mg/kg of maropitant. An oral dose of 2 mg/kg maropitant was selected for further evaluation. Oral Dose of 8 mg/kg for the prevention of…

   Least-squares mean VAS scores for nausea following syrup of ipecac administration ranged from 0.0 to 32.4 for the placebo-treated males compared to a range of 0.0 to 21.7 for the maropitant-treated males. No significant differences were observed in any VAS scores for males at any timepoints. g) Adverse Reactions: None reported. h) Conclusion: Maropitant at a minimum oral dose of 2 mg/kg was effective in the prevention of vomiting induced by syrup of ipecac. 2. Dose Confirmation Laboratory study at a minimum dose of 2 mg/kg orally a) Study Title and Number: Dose confirmation of the efficacy of CJ-11,972 for apomorphine-induced emesis in dogs. Study #1960C-60-03-672. b) Type of Study: Dose confirmation study conducted according to VICH GL9 GCP Guidance…

   (n=150) No. % No. % Vomiting 2 6 4.1 0 0 Salivation 10 6.8 8 5.3 Lethargy/Sedation 1 0.7 2 1.3 Retching 0 0 1 0.7 1 Animals may have experienced more than one adverse reaction 2 Not associated with motion sickness h) Conclusion: The data from this study demonstrate that maropitant at a minimum oral dosage of 8 mg/kg given two hours prior to transportation is effective for the prevention of vomiting due to motion sickness in dogs. 5. Field study at a minimum dosage of 8 mg/kg given 10 hours prior to travel a) Study Title and Number: Field effectiveness and safety of orally administered CJ-11,972 at 8 mg/kg, 10 hours before the journey, in the prevention of…

   (n=28) No. % No. % Hypersalivation 7 25.9 5 17.9 Retching 0 0 1 3.6 Agitation 0 0 1 3.6 1 Animals may have experienced more than one adverse reaction h) Conclusion(s): The results of this study support the conclusion that maropitant at a minimum dosage of 8 mg/kg is effective in preventing vomiting due to motion sickness in dogs. III.TARGET ANIMAL SAFETY: A. Tolerance Study 1. Oral safety study for 7 days in young dogs a. Study Title and Number: Safety of maropitant (CJ-11,972) administered as oral tablets for seven days to young dogs at dosages of 20 mg/kg and above. Study #5462E-36-02-265. b. Type of Study: Laboratory safety study. c. Study Dates: October 16 – November 28, 2002…

2. Maropitant citrateanimaldrugsatfda.fda.gov
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   II. EFFECTIVENESS: The terms maropitant, maropitant citrate, CJ-11,972, and CERENIA are used interchangeably throughout this document. These terms all refer to the same drug product. A. Dosage Characterization: Injectable Subcutaneous Dose of 1 mg/kg: A subcutaneous dosage of 1 mg/kg was selected as the dosage for the prevention and treatment of acute vomiting in dogs using data generated in a comparative pharmacokinetic study. Twelve Beagle dogs in a crossover design study with 6 dogs per group (3 males and 3 females) were administered either 2 mg/kg maropitant orally or 1 mg/kg maropitant subcutaneously. Blood samples were collected at 0.5, 1, 2, 3, 4, 8, 12, and 24 hours after drug administration and the plasma was analyzed to determine maropitant concentration.

   3) VAS Scores for Nausea: Least-squares mean VAS scores for nausea following syrup of ipecac administration ranged from 5.7 to 52.2 for the placebo-treated dogs compared to a range of 6.2 to 26.2 for the maropitant- treated dogs. Although no significant differences were noted in VAS scores between treatments for the first 33 minutes after syrup of ipecac administration, from 36 to 60 minutes, maropitant-treated dogs were lower than those of placebo-treated dogs at all time points except 54 minutes. g) Adverse Reactions: None reported. h) Conclusion: Maropitant at a dosage of 1 mg/kg administered subcutaneously was effective in the prevention of vomiting induced by syrup of ipecac.

   3) VAS Scores for Nausea Least-squares mean VAS scores for nausea following apomorphine administration ranged from 5.8 to 53.8 for the placebo-treated dogs compared to a range of 1.4 to 26.3 for the maropitant-treated dogs. VAS scores for maropitant-treated dogs were significantly lower (P < 0.047) than those of placebo-treated dogs at time points from 3 to 12 minutes and then at the 27 minute time point after receiving apomorphine. No significant differences in VAS scores were found at any other time points. g) Adverse Reactions: None reported. h) Conclusions: Maropitant at a dose of 1 mg/kg administered subcutaneously was effective in the prevention of vomiting induced by apomorphine.

   2) Prevention of acute vomiting indication [T01 (saline/saline) versus T03 (maropitant/saline)]: All dogs in Groups T01 (41) and T03 (39) and all emetic events following cisplatin therapy were included in the analysis for prevention of cisplatin-induced vomiting. Thirty-seven of 39 dogs (94.9%) in Group T03 experienced no emetic events compared to 2 of 41 dogs (4.9%) in Group T01. Significantly fewer (P < 0.0001) emetic events were observed in the maropitant-treated dogs than the saline-treated dogs.

3. Cerenia Tablets for Dogswww.drugs.com
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   Beagle dogs approximately 10 weeks of age were administered either placebo tablets for 2 days, CERENIA Tablets at 8 mg/kg for 2 days, placebo (saline) subcutaneously (SC) for 5 days, CERENIA Injectable Solution at 1 mg/kg SC for 5 days, or CERENIA Tablets at 2 mg/kg for 5 days (8 dogs in each dose group). Mild pain associated with injection was noted in more dogs and lasted longer in dogs that received maropitant injections compared to saline. Males administered CERENIA at 8 mg/kg orally for 2 days had a decrease in food consumption. Body weight and food consumption were variable throughout the 4 week acclimation period. Two dogs that received 8 mg/kg maropitant orally for 2 days were below the…

4. Emavert for Animal Use (Canada)www.drugs.com · May 28, 2026
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   The concurrent use of maropitant with other antiemetic agents has not been assessed in dogs and cats. Food consumption and weight gain of puppies being treated with Emavert should be closely monitored. Anorexia and weight loss may occur. Emavert causes dose related decreases in appetite and body weight. 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 maropitant compared to control puppies. In puppies, 16 weeks and older, bone marrow hypocellularity was not observed (see ANIMAL SAFETY section).

   Beagle dogs approximately 10 weeks of age were administered either placebo tablets for 2 days, maropitant citrate tablets at 8 mg/kg for 2 days, placebo (saline) subcutaneously (SC) for 5 days, maropitant citrate injection at 1 mg/kg SC for 5 days, or maropitant citrate tablets at 2 mg/kg for 5 days (8 dogs in each dose group). Mild pain associated with injection was noted in more dogs and lasted longer in dogs that received maropitant citrate injections compared to saline. Males administered maropitant at 8 mg/kg orally for 2 days had a decrease in food consumption. Two dogs that received 8 mg/kg maropitant orally for 2 days were below the reference range for reticulocyte counts. Decreases in reticulocyte counts were…

   Maropitant citrate injection was administered intravenously to 24 Beagle dogs approximately 16 weeks of age once daily for 5 days at 0, 1, and 3 mg/kg (4 females and 4 males in each dose group). The product was administered at room temperature over 1-2 minutes. Reaction to injection was not specifically recorded. One male dog in the 1 mg/kg group had low hematocrit and white blood cell count on study day 5. One female dog in the 3 mg/kg group had an increased fibrinogen on study day 5. There were no other clinically relevant findings during the study, at necropsy or histopathology. In a U.S. field study for the prevention and treatment of vomiting associated with administration of cisplatin for…

   | | | --- | | Frequency of adverse reactions by treatment | | Adverse reaction | Placebo (n=41) | Maropitant citrate injection (n=77) | | | # dogs | % occurrence | # dogs | % occurrence | | Diarrhea | 1 | 2.4 | 6 | 7.8 | | Anorexia | 0 | 0 | 4 | 5.2 | | Injection site reaction | 0 | 0 | 3 | 4 | | Lethargy | 1 | 2.4 | 2 | 2.6 | The following adverse reactions were reported during the course of a U.S. field study for the prevention and treatment of acute vomiting in dogs treated with 1.0 mg/kg maropitant citrate injection subcutaneously and/or maropitant citrate…

5. Cerenia Tablets (60 mg) for Dogs (Canada)www.drugs.com · May 28, 2026
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   ● Maropitant is metabolized in the liver and therefore should be used with caution in dogs with hepatic disease. As maropitant is accumulated in the body due to metabolic saturation, careful monitoring of liver function, in addition to any adverse events, should be implemented when treatment is extended beyond 14 days (see Pharmacokinetics section). ● Maropitant is a highly protein bound drug; use caution when administering other drugs that are highly protein bound. Drug interactions between maropitant and other drugs have not been thoroughly investigated in dogs. ● Hypoproteinemic dogs being treated with maropitant should be monitored closely; if adverse effects are seen, treatment should be discontinued. ● If maropitant therapy has not been effective after 3 days of use,…

   ● The concurrent use of maropitant with other antiemetic agents has not been assessed in dogs. ● Food consumption and weight gain of puppies being treated with CERENIA should be closely monitored. Anorexia and weight loss may occur. CERENIA causes dose related decreases in appetite and body weight. 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 section).

   Beagle dogs approximately 10 weeks of age were administered either placebo tablets for 2 days, CERENIA tablets at 8 mg/kg for 2 days, placebo (saline) subcutaneously (SC) for 5 days, CERENIA injection at 1 mg/kg SC for 5 days, or CERENIA tablets at 2 mg/kg for 5 days (8 dogs in each dose group). Mild pain associated with injection was noted in more dogs and lasted longer in dogs that received maropitant injections compared to saline. Males administered CERENIA at 8 mg/kg orally for 2 days had a decrease in food consumption. Body weight and food consumption were variable throughout the 4 week acclimatization period. Two dogs that received 8 mg/kg maropitant orally for 2 days were below the reference…

6. Clinical particulars - Cerenia tablets for dogs (NI)www.noahcompendium.co.uk · Nov 27, 2015
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   The safety of the veterinary medicinal product has not been established in dogs less than 16 weeks of age for the 8 mg/kg dose (motion sickness), and in dogs less than 8 weeks of age for the 2 mg/kg dose (vomiting) as well as in pregnant or lactating bitches. Use only according to the benefit-risk assessment by the responsible veterinarian. Maropitant is metabolised in the liver and therefore should be used with caution in patients with hepatic disease. As maropitant is accumulated in the body during a 14-day treatment period due to metabolic saturation, careful monitoring of liver function in addition to any adverse events should be implemented during long term treatment.

   As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily repeated administration, lower doses than recommended might be sufficient in some individuals and when repeating the dose. Symptoms of overdose (and where applicable, emergency procedures and antidotes) Cerenia tablets were well tolerated when administered for 15 days at dosages up to 10 mg/kg bodyweight per day. Clinical signs including vomiting on first administration, excess salivation and watery faeces have been observed when the product has been administered at doses in excess of 20 mg/kg. Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance…

7. Maropitant Citrate Tabletsdailymed.nlm.nih.gov
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   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) |

   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. 1Not associated with motion sickness. | Frequency of Adverse Reactions by Treatment | Adverse Reaction | Placebo (n=195) | maropitant citrate (n=208) |

   Beagle dogs approximately 10 weeks of age were administered either placebo tablets for 2 days, maropitant citrate tablets at 8 mg/kg for 2 days, placebo (saline) subcutaneously (SC) for 5 days, maropitant citrate injectable solution at 1 mg/kg SC for 5 days, or maropitant citrate tablets at 2 mg/kg for 5 days (8 dogs in each dose group). Mild pain associated with injection was noted in more dogs and lasted longer in dogs that received maropitant injections compared to saline. Males administered maropitant citrate at 8 mg/kg orally for 2 days had a decrease in food consumption. Body weight and food consumption were variable throughout the 4 week acclimation period. Two dogs that received 8 mg/kg maropitant orally for 2…

8. Cerenia® (maropitant citrate) Tabletsdailymed.nlm.nih.gov
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   Beagle dogs approximately 10 weeks of age were administered either placebo tablets for 2 days, CERENIA Tablets at 8 mg/kg for 2 days, placebo (saline) subcutaneously (SC) for 5 days, CERENIA Injectable Solution at 1 mg/kg SC for 5 days, or CERENIA Tablets at 2 mg/kg for 5 days (8 dogs in each dose group). Mild pain associated with injection was noted in more dogs and lasted longer in dogs that received maropitant injections compared to saline. Males administered CERENIA at 8 mg/kg orally for 2 days had a decrease in food consumption. Body weight and food consumption were variable throughout the 4 week acclimation period. Two dogs that received 8 mg/kg maropitant orally for 2 days were below the…

9. highlights of prescribing informationdailymed.nlm.nih.gov
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   - Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with metoclopramide dosages of 30 mg to 40 mg daily. Such reactions occurred more frequently in adults less than 30 years of age and at higher than recommended dosages. EPS occurred more frequently in pediatric patients compared to adults (metoclopramide is not approved for use in pediatric patients). Symptoms can occur in the first 24 to 48 hours after starting metoclopramide. Symptoms included involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions were present as stridor and dyspnea, possibly due to laryngospasm. Diphenhydramine hydrochloride or benztropine mesylate may be…

   The clearance of metoclopramide is decreased and the systemic exposure is increased in patients with moderate to severe renal impairment compared to patients with normal renal function, which may increase the risk of adverse reactions. Reduce the metoclopramide dosage in patients with moderate and severe renal impairment (creatinine clearance less than or equal to 60 mL/minute), including those receiving hemodialysis and continuous ambulatory peritoneal dialysis [see Dosage and Administration (2.2, 2.3), Clinical Pharmacology (12.3)].

   Patients with severe hepatic impairment (Child-Pugh C) have reduced systemic metoclopramide clearance (by approximately 50%) compared to patients with normal hepatic function. The resulting increase in metoclopramide blood concentrations increases the risk of adverse reactions. There is no pharmacokinetic data in patients with moderate hepatic impairment (Child-Pugh B). Reduce metoclopramide dosage in patients with moderate or severe (Child-Pugh B or C) hepatic impairment [see Dosage and Administration (2.2, 2.3)]. There is no dosage adjustment required for patients with mild hepatic impairment (Child-Pugh A). In addition, metoclopramide, by producing a transient increase in plasma aldosterone, may increase the risk of fluid retention in patients with hepatic impairment [see Warnings and Precautions (5.6)].

   Metoclopramide is a substrate of CYP2D6. The elimination of metoclopramide may be slowed in patients who are CYP2D6 poor metabolizers (compared to patients who are CYP2D6 intermediate, extensive, or ultra-rapid metabolizers); possibly increasing the risk of dystonic and other adverse reactions to metoclopramide [see Clinical Pharmacology (12.3)]. Reduce the metoclopramide dosage in patients who are poor CYP2D6 metabolizers [see Dosage and Administration (2.2, 2.3)].

10. Vomend® 5 mg/ml Solution for Injection for Dogs and Catswww.noahcompendium.co.uk · Nov 27, 2015
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    Metoclopramide is rapidly and completely absorbed after parenteral administration. After subcutaneous administration to dogs and cats, maximum concentrations are obtained after 15-30 minutes. Metoclopramide is rapidly distributed into most tissues and fluids, crosses the blood-brain barrier and enters the central nervous system. Metoclopramide is metabolised by the liver. The elimination of metoclopramide is rapid, 65% of the dose being eliminated within 24 hours in the dog, primarily by the urinary route.

11. CLEVOR®dailymed.nlm.nih.gov · Dec 7, 2020
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    60.1 - 100 | 132.4 - 220.5 | 8 | An initial dose of 2 drops in each eye, followed 2 minutes later by 2 drops in each eye | Dose Administration: | - Wear gloves and protective eye wear when handling or administering this product to prevent accidental exposure. - Open the dropper by twisting off the tail. | | - Keep the dog's head steady in a slightly upright position. - Hold the dropper in an upright position without touching the eye. - Rest your finger on the forehead of your dog to maintain the distance between the dropper and the eye. - Squeeze the prescribed number of drops in to the eye(s). | | - CLEVOR is…

    Safety was evaluated during a field study that enrolled 132 dogs (100 in the CLEVOR group and 32 in the vehicle control group). CLEVOR was administered as drops into the eyes at the dose as directed by the dosing table (see DOSAGE AND ADMINISTRATION). The following table shows the number of dogs exhibiting ocular, systemic, and clinical pathology adverse reactions. Table 2: Adverse Reactions Reported During the Study (all dogs) Organ System | Adverse Reaction | CLEVOR (N=100) | Vehicle control (N=32) | * Assessment performed 30 minutes after dose administration † Tachycardia resolved for most dogs within 4 hours after dose administration ‡ Urinalysis results were reported for only 86 dogs (66 administered CLEVOR and 20 control) §

    Effectiveness was demonstrated in a multi-center, vehicle-controlled, randomized and masked field study in client-owned dogs of various breeds. Dogs enrolled in the study were 7 months to 15 years of age and weighed 1.9 to 66.3 kg. In this study, 132 dogs were enrolled and randomized to treatment with CLEVOR (n=100) or vehicle control (n=32). The effectiveness evaluation population included 99 CLEVOR treated dogs and 29 vehicle control dogs. Dogs received a dose administered as drops into the eye(s) approximately 1 hour after a meal. The dose was administered according to weight (see Dosage and Administration). If the dog did not vomit within 20 minutes of the first dose, a second dose was administered.

    The time to first vomition, the number of times the dog vomited, and the description of vomit were evaluated as secondary variables and support the effectiveness of CLEVOR for induction of vomiting in dogs. Eighty-five dogs (86%) in the CLEVOR group vomited within 20 minutes and therefore did not require a second dose. The time to first vomition ranged from 3 minutes to 37 minutes with a mean of 12 minutes. The duration between first and last vomiting episodes ranged from 0 to 108 minutes with a mean duration of 23 minutes. Eight dogs had vomiting episodes over a duration longer than an hour. Five of these eight dogs were administered an antiemetic (metoclopramide). The number of vomits ranged from…

12. Emeprid® 1 mg/ml oral solution for dogs and catswww.noahcompendium.co.uk · Nov 27, 2015
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    Concurrent use of metoclopramide with neuroleptics derivated from phenothiazine (acepromazine) and butyrophenones increases the risk of extrapyramidal effects (see Adverse reactions). Metoclopramide can potentiate the action of central nervous system depressants. If used concurrently, it is advised to use the lowest dosage of metoclopramide to avoid excessive sedation. Amounts to be administered and administration route Oral use. Administer the product directly into the mouth. 0.5 to 1 mg of metoclopramide hydrochloride per kg of body weight per day administered as either: 2.5 to 5.0 mg/10 kg (equivalent to 2.5 to 5 ml/10 kg), twice daily or 1.7 to 3.3 mg/10 kg (equivalent to 1.7 to 3.3 ml/10 kg), three times daily. Oral administrations can be repeated with interval of 6…