Centragard: Product Information

CENTRAGARD- eprinomectin and praziquantel solution
Boehringer Ingelheim Animal Health USA Inc.

CAUTION

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

DESCRIPTION

CENTRAGARD is a transdermal solution containing eprinomectin and praziquantel available in 0.3 mL and 0.9 mL unit applicators to treat cats from 1.8 lbs to 33 lbs. Each mL of CENTRAGARD contains 4 mg of eprinomectin and 83 mg of praziquantel, as well as the inactive ingredients (dimethyl isosorbide, glycerol formal, and butylated hydroxytoluene). Eprinomectin belongs to the avermectin class of anthelmintics and is a mixture of homologous components referred to as eprinomectin B1a and B1b. Praziquantel is a pyrazinoisoquinoline anthelmintic.

INDICATIONS

CENTRAGARD is indicated for the prevention of heartworm disease caused by Dirofilaria immitis , and for the treatment and control of roundworms (adult and fourth stage larval Toxocara cati), hookworms (adult and fourth stage larval Ancylostoma tubaeforme ; adult Ancylostoma braziliense), and tapeworms (adult Dipylidium caninum and Echinococcus multilocularis) in cats and kittens 7 weeks of age and older and 1.8 lbs or greater.

DOSAGE AND ADMINISTRATION

CENTRAGARD is dosed at a minimum of 0.055 mL/lb (0.12 mL/kg), which delivers a minimum dose of 0.23 mg/lb eprinomectin and 4.55 mg/lb praziquantel. Administer the entire contents of a CENTRAGARD unit applicator topically once a month as specified in the following table:

Cat Weight (lb)	Volume (mL)	Eprinomectin (mg)	Praziquantel (mg)
1.8-5.5	0.3	1.2	24.9
5.6-16.5	0.9	3.6	74.7
16.6-22.0	0.3 + 0.9	4.8	99.6
22.1-33.0	0.9 + 0.9	7.2	149.4

To apply CENTRAGARD pull back the plunger of the unit applicator slightly and remove the cap. Part the hair in one spot on the midline of the neck between the base of the skull and the shoulder blades, place the tip of the unit applicator on the skin and apply the contents directly on the skin. If the weight of the cat requires a second application, apply the contents in the same manner as described above in the same location. Discard applicator after use.

HEARTWORM PREVENTION
For prevention of heartworm disease, CENTRAGARD should be administered once a month. CENTRAGARD may be administered year round or at a minimum, should start 1 month before the cat’s first expected exposure to mosquitoes and continuing at monthly intervals until at least one month after the cat’s last exposure to mosquitoes. If a dose is missed and a 30-day interval between doses is exceeded, administer CENTRAGARD immediately and resume the monthly dosing schedule.

When replacing another monthly heartworm preventive product in a heartworm prevention program, the first treatment with CENTRAGARD should be given within one month of the last dose of the former medication. At the discretion of the veterinarian, cats older than 6 months of age may be tested to determine the presence of existing heartworm infection before treatment with CENTRAGARD.

TREATMENT AND CONTROL OF ROUNDWORMS, HOOKWORMS AND TAPEWORMS
CENTRAGARD treats and controls roundworms (adult and fourth stage larval Toxocara cati), hookworms (adult and fourth stage larval Ancylostoma tubaeformae , adult Ancylostoma braziliense), and tapeworms (adult Dipylidium caninum and Echinococcus multilocularis) after a single administration or when given monthly as part of a heartworm prevention program. Cats may be exposed to and can become infected with roundworms, hookworms, and tapeworms throughout the year, regardless of season or climate. Clients should be advised of appropriate measures to prevent reinfection of their cat with intestinal parasites. Because the prepatent period for E. multilocularis may be as short as 26 days, cats treated at the labeled monthly intervals may become reinfected and shed eggs between treatments.

HUMAN WARNING

Not for human use. Keep out of reach of children. Avoid contact with the application site for 5 hours following treatment. Wash hands after administering the product. If the product accidentally gets into the eyes, flush thoroughly with water. In case of accidental ingestion, or if skin or eye irritation occurs, contact a poison control center or physician for treatment advice.

PRECAUTIONS

Do not administer orally. Cats may salivate excessively and vomit if CENTRAGARD is accidentally administered orally or is ingested through licking/grooming the application site (see ANIMAL SAFETY).

The safety of CENTRAGARD has not been tested in breeding, pregnant or lactating cats.

The safety of CENTRAGARD has not been tested in kittens less than 7-9 weeks of age or weighing less than 1.8 lbs (0.8 kg).

ADVERSE REACTIONS

In a well-controlled field study, emesis, anorexia, lethargy, temporary clumping or spiking of the hair, or mild, transient skin reactions (itching, hair loss) were reported. When cats licked the application site after treatment, temporary excessive salivation was observed. Oral ingestion of CENTRAGARD may also result in hypersalivation, vomiting and/or lethargy. In margin of safety studies, transient neurological signs such as ataxia, disorientation, lethargy, and pupil dilation were observed in some cats. Correct application will minimize the occurrence of such events.

To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251.

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.

The Safety Data Sheet (SDS) provides additional occupational safety information. For customer service or to obtain product information, including the SDS, call 1-888-637-4251.

INFORMATION FOR OWNER OR PERSON TREATING ANIMAL

Echinococcus multilocularis is a tapeworm found in wild canids and domestic cats. E. multilocularis can infect humans and cause serious disease (alveolar hydatid disease). Owners of cats living in areas where E. multilocularis are endemic should be instructed on how to minimize their risk of exposure to this parasite, as well as their cat’s risk of exposure. Although ML-635 was 100% effective in laboratory studies in cats against E. multilocularis , no studies have been conducted to show that the use of this product will decrease the incidence of alveolar hydatid disease in humans. Because the prepatent period for E. multilocularis may be as short as 26 days, cats treated at the labeled monthly intervals may become reinfected and shed eggs between treatments.