Cerenia

Antiemetic

For oral use in dogs only

Cerenia Tablets are recommended for use in dogs 16 weeks and older.

For Prevention of Acute Vomiting

Administer Cerenia Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days.

Cerenia Tablets may be used interchangeably with Cerenia Injectable Solution for once daily dosing for the prevention of acute vomiting.

For Prevention of Vomiting Due to Motion Sickness

Administer Cerenia Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days. Dogs should be fasted 1 hour prior to administration of Cerenia Tablets. Administer Cerenia Tablets 2 hours prior to travel.

Laboratory and field studies have demonstrated that Cerenia Tablets are well tolerated in dogs after oral administration.

Target Animal Safety Study for Acute Vomiting

Fifty six Beagle dogs (28 males and 28 females) approximately 16 weeks of age were administered Cerenia Tablets orally once daily for 15 days at 0, 2, 6, and 10 mg/kg. There were 8 dogs (4 males and 4 females) in the 2 mg/kg group and 16 dogs (8 males and 8 females) in all other groups. Cerenia Tablets caused decreases in food consumption and body weight that were not dose-dependent and did not persist after cessation of treatment.

Beagle dogs approximately 8 weeks of age were administered Cerenia Tablets orally once daily for 15 days at 0, 2, 6, and 10 mg/kg using a protocol similar to the previous study. A dose dependent increase in severity of bone marrow hypoplasia was observed histologically. Interpretation of these study results is complicated by the health status of study animals. Dogs used in the study were weaned early, minimally acclimated to the test facility, many of the dogs in the study tested positive for coccidia and some tested positive for canine parvovirus.

Target Animal Safety Study for Motion Sickness

Forty Beagle dogs (20 males and 20 females) between 16 – 18 weeks of age were administered Cerenia Tablets orally once daily for 6 days at 0, 8 and 24 mg/kg. There were 16 dogs (8 males and 8 females) in the 0 and 24 mg/kg groups and 8 dogs (4 males and 4 females) in the 8 mg/kg group. At 24 mg/kg, Cerenia Tablets caused decreases in food consumption, with decreases in body weight, liver and testis weight; and an increase in RBC count indicating hemoconcentration, but the effects on feed consumption, body weight, and RBCs did not persist in the post-treatment recovery period (beyond Day 5).

Beagle dogs approximately 8 weeks of age were administered Cerenia Tablets orally once daily for 6 days at 0, 8, and 24 mg/kg using a protocol similar to the previous study. One dog in the 24 mg/kg/day group died of unknown causes on study day 2 and a dose dependent increase in occurrence and severity of bone marrow hypoplasia and lymphoid depletion was observed histologically. Interpretation of these study results is complicated by the health status of study animals. Dogs used in the study were weaned early, minimally acclimated to the test facility, and many of the dogs in the study tested positive for coccidia. Additionally, some dogs in the study tested positive for canine parvovirus, however, clinical parvoviral disease was not definitively diagnosed.

Tolerance Study

Twenty four Beagle dogs (14 males and 10 females) between 11 and 25 weeks of age were administered Cerenia Tablets in 2 phases with 8 dogs per group. In the first phase the dogs were administered 0, 20 or 30 mg/kg orally once daily for 7 days and in the second phase 0, 40, or 50 mg/kg once daily for 7 days. Cerenia Tablets administered at 20 and 30 mg/kg caused occasional vomiting. Cerenia Tablets administered at 40 mg/kg and 50 mg/kg caused clinically relevant signs of weight loss, vomiting, soft stools, weakness, lethargy, salivation and hypokalemia. Additionally, leukopenia characterized by a neutropenia and a trend toward decreasing plasma phosphorus values was seen. Decreased heart rate and prolonged corrected QT intervals were seen in all treatment groups in a dose dependent manner.

In US field studies in veterinary patients, Cerenia Tablets and Injectable Solution were well tolerated in dogs presenting with various conditions including parvovirus, gastroenteritis, and renal disease. There were no notable differences in mean laboratory values between Cerenia-treated and placebo-treated patients.

Cerenia Tablets were used safely in dogs receiving other frequently used veterinary products such as fluid and electrolyte replacement solutions, antimicrobial agents, vaccines, antacids, and antiparasitic agents.

Cerenia peach-colored tablets are scored with a break line, and contain 16, 24, 60 or 160 mg of maropitant as maropitant citrate per tablet. Each tablet is marked with "MPT" and the tablet strength on one side and the Pfizer logo on the other. Each tablet size is packaged in blister packs containing 4 tablets per perforated sheet.

US Patents: See US 6,222,038; US 6,255,320

NADA #141-262, Approved by FDA

75-1001-01
March 2007

Cerenia®
(maropitant citrate)
Tablets

Antiemetic

For oral use in dogs only

CAUTION: Federal (USA) law restricts this drug to use
by or on the order of a licensed veterinarian.

60 mg
4 Tablets Per Blister Card

NADA #141-262, Approved by FDA

Pfizer