PetTrust Plus: Product Information

PETTRUST PLUS — ivermectin and pyrantel pamoate tablet, chewable
FidoPharmBrands,LLC

Package Insert Top

PetTrust Plus
(Ivermectin and Pyrantel)
Chewable Tablets

Caution: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

INDICATIONS:
For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of ascarids (Toxocara canis , Toxoscaris leonina) and hookworms (Ancylostoma caninum , Uncinaria stenocephala , Ancyclostoma braziliense).

DOSAGE:
PetTrust Plus ivermectin/pyrantel chewable tablets should be administered orally at monthly intervals at the
recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb) and 5 mg of pyrantel (as
pamoate salt) per kg (2.27 mg/Ib) of body weight. The recommended dosing schedule for prevention of canineheartworm disease and for the treatment and control of ascarids and hookworms is as follows:

Dog Weight

Chewable Tablets

Per Month

Ivermectin

Content

Pyrantel

Content

Color Coding on Blister

Card and Carton

Up to 25 lbs. 1 68 mcg 57 mg Blue
26 to 50 lbs. 1 136 mcg 114 mg Green
51 to 100 lbs. 1 272 mcg 227 mg Brown

PetTrust Plus ivermectin/pyrantel chewable tablets are recommended for dogs 6 weeks of
age and older. For dogs over 100 lbs, use the appropriate combination of these tablets.
ADMINISTRATION:
Remove only one chewable tablet at a time from the blister card.
Because most dogs find PetTrust Plus chewable tablets palatable, the product can be
offered to the dog by hand. Alternatively, it may be added intact to a small amount of dry food
or placed in the back of the dogs mouth for forced swallowing.
Care should be taken that the dog consumes the complete dose, and treated animals should
be observed for a few minutes after administration to ensure that part of the dose is not lost
or rejected. If it is suspected that any of the dose has been lost, redosing is recommended.
PetTrust Plus chewable tablets should be given at monthly intervals during the period of the
year when mosquitoes (vectors), potentially carrying infective heartworm larvae, are active.
The initial dose must be given within a month (30 days) after the dogs first exposure to mosquitoes.
The final dose must be given within a month (30 days) after the dogs last exposure
to mosquitoes.
When replacing another heartworm preventive product in a heartworm disease preventive
program, the first dose of PetTrust Plus chewable tablets must be given within a month (30
days) of the last dose of the former medication.
If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be
reduced. Therefore, for optimal performance, the chewable tablet must be given once a
month on or about the same day of the month. If treatment is delayed, whether by a few days
or many, immediate treatment with PetTrust Plus chewable tablets and resumption of the
recommended dosing regimen minimizes the opportunity for the development of adult
heartworms.
Monthly treatment with PetTrust Plus chewable tablets also provides effective treatment
and control of ascarids (T. canis, T. leonina) and hookworms (A. caninum, U. stenocephala,
A. braziliense). Clients should be advised of measures to be taken to prevent reinfection with
intestinal parasites.

EFFICACY:
PetTrust Plus chewable tablets given orally using the recommended dose and
regimen, are effective against the tissue larval stage of D. immitis for a month (30 days)
after infection and, as a result, prevent the development of the adult stage. PetTrust
Plus chewable tablets are also effective against canine ascarids (T. canis, T. leonina)
and hookworms (A. caninum, U. stenocephala, A. braziliense).
ACCEPTABILITY:
In acceptability trials, PetTrust Plus chewable tablets were shown to be
a palatable oral dosage form that was consumed at first offering by the majority of dogs

PRECAUTIONS:
All dogs should be tested for existing heartworm infection before starting
treatment with PetTrust Plus chewable tablets which are not effective against adult
D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae
before initiating a program with PetTrust Plus chewable tablets.
While some microfilariae may be killed by the ivermectin in PetTrust Plus chewable
tablets at the recommended dose level, PetTrust Plus chewable tablets are not effective
for microfilariae clearance. A mild hypersensitivity-type reaction, presumably due to
dead or dying microfilariae and particularly involving a transient diarrhea has been
observed in clinical trials with ivermectin alone after treatment of some dogs that have
circulating microfilariae.
Keep this and all drugs out of the reach of children. In case of ingestion by humans, clients
should be advised to consult a physician immediately. Physicians may contact a Poison Control Center for
advice concerning cases of ingestion by humans.

ADVERSE REACTIONS:
In clinical field trials with ivermectin/pyrantel, vomiting or diarrhea
within 24 hours of dosing was rarely observed (1.1% of administered doses). The following
adverse reactions have been reported following the use of ivermectin at the recommended
dose: depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering,
convulsions and hypersalivation.

SAFETY:
Studies with ivermectin indicate that certain dogs of the Collie breed are more
sensitive to the effects of ivermectin administered at elevated dose levels (more than 16
times the target use level of 6 mcg/kg) than dogs of other breeds. At elevated doses,
sensitive dogs showed adverse reactions which included mydriasis, depression, ataxia,
tremors, drooling, paresis, recumbency, excitability, stupor, coma and death. Ivermectin
demonstrated no signs of toxicity at 10 times the recommended dose (60 mcg/kg) in sensitive
Collies. Results of these trials and bioequivalency studies support the safety of
ivermectin products in dogs, including Collies, when used as recommended.
Ivermectin/pyrantel has shown a wide margin of safety at the recommended dose level in
dogs, including pregnant or breeding bitches, stud dogs and puppies aged 6 or more
weeks. In clinical trials, many commonly used flea collars, dips, shampoos,
anthelmintics, antibiotics, vaccines and steroid preparations have been administered
with ivermectin/pyrantel in a heartworm disease preventive program.
In one trial, where some pups had parvovirus, there was a marginal reduction in efficacy
against intestinal nematodes, possibly due to a change in intestinal transit time.

Store at controlled room temperature of 59·860 F (15·300 C). Protect product from light

HOW SUPPLIED:
PetTrust Plus chewable tablets are available in three dosage strengths
(See DOSAGE section) for dogs of different weights. Each strength comes in convenient
packs of 6 chewable tablets.
For technical assistance, call FidoPharmBrands, LLC 866-PETTRUST (or 866-738-8787)

Manufactured for: FidoPharmBrands, LLC, Yardley, PA 19067 USA
Manufactured by: Diamond Animal Health, Inc. Des Moines, IA 50327

PetTrust is a trademark of FidoPharmBrands, LLC
©2011 FidoPharmBrands,LLC All rights reserved.
ANADA 200-338, Approved by FDA. www.PetTrust.com

PetTrust up to 25 lbs. carton label

PetTrust up to 25 lbs. carton label
(click image for full-size original)

PetTrust 26 to 50 lbs. carton label

PetTrust 26 to 50 lbs. carton label
(click image for full-size original)

PetTrust 51 to 100 lbs. carton label

PetTrust 51 to 100 lbs. carton label
(click image for full-size original)

Small Blister Pack

Small Blister Pack
(click image for full-size original)

Medium Blister Pack

Medium Blister Pack
(click image for full-size original)

Large Blister Pack

Large Blister Pack
(click image for full-size original)
PETTRUST PLUS ivermectin and pyrantel pamoate tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:43369-300
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVERMECTIN (IVERMECTIN) IVERMECTIN 68 ug
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 57 mg
Product Characteristics
Color brown (Light to dark brown) Score no score
Shape RECTANGLE Size 14mm
Flavor MEAT (Artifical beeef) Imprint Code none
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43369-300-06 1 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 6 TABLET, CHEWABLE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (43369-300-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200338 11/15/2012
PETTRUST PLUS ivermectin and pyrantel pamoate tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:43369-301
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVERMECTIN (IVERMECTIN) IVERMECTIN 136 ug
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 114 mg
Product Characteristics
Color brown (Light to dark brown) Score no score
Shape RECTANGLE Size 19mm
Flavor MEAT (artifical beef) Imprint Code none
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43369-301-06 1 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 6 TABLET, CHEWABLE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (43369-301-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200338 11/15/2012
PETTRUST PLUS ivermectin and pyrantel pamoate tablet, chewable
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:43369-302
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVERMECTIN (IVERMECTIN) IVERMECTIN 272 ug
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 227 mg
Product Characteristics
Color brown (Light to dark brown) Score no score
Shape RECTANGLE Size 24mm
Flavor MEAT (artifical beef) Imprint Code none
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43369-302-06 1 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 6 TABLET, CHEWABLE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (43369-302-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200338 11/15/2012
Labeler — FidoPharmBrands,LLC (078346506)
Registrant — Heska Corp (603631326)
Establishment
Name Address ID/FEI Operations
Diamond Animal Health, Inc. 102913878 manufacture
Establishment
Name Address ID/FEI Operations
Moehs Catalana SL 460021629 api manufacture
Establishment
Name Address ID/FEI Operations
Zhejiang Hisun Pharmaceutical Co., Ltd. 654211754 api manufacture

Revised: 03/2013 FidoPharmBrands,LLC

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