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

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  • SPL UNCLASSIFIED SECTION
    Flavored 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 APPEARANCE
    Product Information