Label: DRONCIT FELINE CESTOCIDE- praziquantel tablet

  • NDC Code(s): 0859-2128-01, 0859-2128-02
  • Packager: Bayer HealthCare, LLC Animal Health Division
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated November 25, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    23 Feline Cestocide

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

    Each Tablet Contains 23 mg Praziquantel

  • DESCRIPTION:

    Droncit® (praziquantel tablets) 23 Feline Cestocide are sized for easy oral administration to either adult cats or kittens. The tablets may be crumbled and mixed with the feed.

  • INDICATIONS:

    Droncit® (praziquantel tablets) 23 Feline Cestocide are indicated for the removal of the following feline cestodes: Dipylidium caninum and Taenia taeniaeformis.

  • CONTRAINDICATIONS:

    There are no known contraindications to the use of praziquantel in cats.

  • ACTION:

    Droncit® (praziquantel tablets) is absorbed, metabolized in the liver and excreted in the bile. Upon entering the digestive tract from the bile, cestocidal activity is exhibited.1

    Following exposure to praziquantel, the tapeworm loses its ability to resist digestion by the mammalian host. Because of this, whole tapeworms, including the scolex, are very rarely passed after administration of praziquantel. In many instances only disintegrated and partially digested pieces of tapeworms will be seen in the stool. The majority of tapeworms killed are digested and are not found in the feces.

  • USE DIRECTIONS:

    Droncit® (praziquantel tablets) 23 Feline Cestocide may be administered directly per os or crumbled and mixed with the feed. The recommended dosage of praziquantel varies according to body weight. Smaller animals require a relatively larger dosage because of their higher metabolic rate. The optimum dose for each individual animal will be achieved by utilizing the following dosage schedule:

    *
    Not intended for use in kittens less than 6 weeks of age.

    Cats and Kittens*

    4 pounds and under

         ½ tablet

    5-11 pounds

          1 tablet

    Over 11 pounds

    1 ½ tablets

  • FASTING:

    The recommended dosage of praziquantel is not affected by the presence or absence of food in the gastrointestinal tract, therefore, FASTING IS NEITHER NECESSARY NOR RECOMMENDED.

  • RETREATMENT:

    For those animals maintained on premises where reinfections are likely to occur, clients should be instructed in the steps necessary to prevent reinfection; otherwise, retreatment may be necessary. This is especially true in cases of Dipylidium caninum infections where reinfection is almost certain to occur if fleas are not removed from the animal and its environment.

  • ANIMAL SAFETY:

    The safety index has been derived from controlled safety evaluations, clinical trials and prior approved use in foreign countries.

    Dosages of 5 times the labeled rate at 14 day intervals to cats as young as 5 ½ weeks did not produce clinical signs of toxicity. No significant clinical chemistry, hematological, or histopathological changes occurred. Symptoms of gross overdosage include vomition, salivation, diarrhea and depression.

  • PREGNANCY:

    Droncit® (praziquantel tablets) has been tested in breeding and pregnant cats. No adverse effects were noted.

  • ADVERSE REACTIONS:

    One instance of diarrhea and one of salivation (1.5%) were reported during the field trials in which 135 cats were administered Droncit® (praziquantel tablets) 23 Feline Cestocide.

    For medical emergencies or to report adverse reactions, call 1-800-422-9874.

  • WARNING:

    Keep out of the reach of children. Not for human use.

    For customer service or to obtain product information, including Safety Data Sheet, call 1-800-633-3796.

  • STORAGE:

    Store at less than or equal to 25°C (77°F)

  • HOW SUPPLIED:

    Bottle of 50 and 150 scored tablets. Each scored tablet contains 23 mg praziquantel.

    50 Tablets

    150 Tablets

  • REFERENCES:

    1 Andrews, P. Pharmacokinetic Studies with Droncit in Animals Using a Biological Assay. Veterinary Medical Review 2/76: 154-165.

     

  • SPL UNCLASSIFIED SECTION

    Bayer Logo

    Bayer HealthCare LLC, Animal Health Division
    Shawnee Mission, Kansas 66201 U.S.A.
    NADA 111-798, Approved by FDA
    Made in Germany

    Bayer, the Bayer Cross, and Droncit are registered
    trademarks of Bayer.
                                                                                                                                                           
    © 2017 Bayer NADA 111-798, Approved by FDA

    85660667 LV1701

  • Principal Display Panel – 50 Tablets

    50 Tablet Carton - Droncit Principal Display Panel

    Droncit®
    (praziquantel tablets)
    23
    Feline Cestocide

    EACH TABLET CONTAINS: 23 mg praziquantel.

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

    WARNING: KEEP OUT OF REACH OF CHILDREN.

    BAYER                                                             50 Tablets
    Bayer HealthCare LLC, Animal Health Division Shawnee Mission,
    Kansas 66201, USA NADA 111-798, Approved by FDA
    Made in Germany

  • INGREDIENTS AND APPEARANCE
    DRONCIT FELINE CESTOCIDE 
    praziquantel tablet
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0859-2128
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL23 mg
    Product Characteristics
    ColorWHITE (White to off white) Score2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code Droncit;23
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0859-2128-0150 in 1 BOTTLE
    2NDC:0859-2128-02150 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA11179812/11/1981
    Labeler - Bayer HealthCare, LLC Animal Health Division (152266193)