Label: CREDELIO QUATTRO- lotilaner, moxidectin, praziquantel, and pyrantel chewable tablet
- NDC Code(s): 58198-5825-1, 58198-5825-2, 58198-5825-3, 58198-5825-4, view more
- Packager: Elanco US Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated October 21, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
SPL UNCLASSIFIED SECTIONFlavored Chewable Tablets - For oral use in dogs only - CAUTION - Federal law restricts this drug to use by or on the order of a licensed veterinarian.
-
DESCRIPTION Credelio Quattro (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) are flavored chewable tablets available in five sizes for oral administration to dogs and puppies according to ...
-
INDICATIONS Credelio Quattro is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and ...
-
DOSAGE AND ADMINISTRATION Credelio Quattro is given orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 ...
-
CONTRAINDICATIONS There are no known contraindications for the use of Credelio Quattro.
-
WARNINGS Not for use in humans. Keep this and all drugs out of reach of children. Wash hands after handling. If accidentally ingested, seek medical attention immediately. Keep Credelio Quattro in a secure ...
-
PRECAUTIONS Lotilaner, one of the ingredients in Credelio Quattro, is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and ...
-
ADVERSE REACTIONS In a field safety and effectiveness study, Credelio Quattro was administered to dogs for the prevention of heartworm disease. The study included a total of 372 dogs treated once monthly for up to ...
-
CONTACT INFORMATION For a copy of the Safety Data Sheet (SDS) or to report suspected adverse drug events, contact Elanco US Inc. at 1-888-545-5973. For additional information about adverse drug experience reporting ...
-
INFORMATION FOR ANIMAL OWNER Echinococcus granulosus is a tapeworm found in wild canids and domestic dogs. E. granulosus can infect humans and cause serious disease (hydatid disease). Owners of dogs living in areas where E ...
-
CLINICAL PHARMACOLOGY Mechanism of Action - Credelio Quattro contains four active pharmaceutical ingredients, lotilaner, moxidectin, praziquantel, and pyrantel (as pamoate salt). Lotilaner is an ectoparasiticide ...
-
EFFECTIVENESS Heartworm Prevention - In two well-controlled laboratory studies, a single oral dose of Credelio Quattro was 100% effective in preventing the development of adult D. immitis in dogs inoculated ...
-
TARGET ANIMAL SAFETY Margin of Safety - Credelio Quattro was administered orally at 0X, 1X, 3X, and 5X the maximum labeled doses at 28-day intervals for nine treatments to 32 healthy, 8-week-old Beagle puppies. Dogs ...
-
HOW SUPPLIED Credelio Quattro (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) is available in five strengths of flavored chewable tablets formulated according to the weight of the dog (see ...
-
STORAGE INFORMATION Store at 15-25°C (59-77°F). Excursions permitted between 5 and 40°C (41 and 104°F). Approved by FDA under NADA # 141-581 - Manufactured for: Elanco US Inc, Greenfield, IN 46140 - Credelio Quattro ...
-
Principal Display Panel 3.3 - 6 lbs - Dogs & Puppies - 8 weeks of age and older - Credelio - Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable ...
-
Principal Display Panel 6.1 – 12 lbs - Dogs & Puppies - 8 weeks of age and older - Credelio - Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable ...
-
Principal Display Panel 12.1 – 25 lbs - Dogs & Puppies - 8 weeks of age and older - Credelio - Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable ...
-
Principal Display Panel 25.1 – 50 lbs - Dogs & Puppies - 8 weeks of age and older - Credelio - Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable ...
-
Principal Display Panel 50.1 – 100 lbs - Dogs & Puppies - 8 weeks of age and older - Credelio - Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable ...
-
INGREDIENTS AND APPEARANCEProduct Information