Label: DRONCIT FELINE CESTOCIDE- praziquantel tablet

  • NDC Code(s): 58198-0032-1, 58198-0032-2
  • Packager: Elanco US Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated June 9, 2021

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

  • SPL UNCLASSIFIED SECTION

    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:

    Cats and Kittens*

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

    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 51/2 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 25ºC (77ºF)

  • 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.

    Elanco US Inc.
    Shawnee, Kansas 66216 U.S.A
    Made in China
    Droncit, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

    © 2020 Elanco or its affiliates
    Approved by FDA under NADA # 111-798

    87037096  LV2009
    September, 2020

    Elanco™

  • Principal Display Panel - 50 Tablet Bottle Label

    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.

    50 Tablets

    Elanco US Inc. Shawnee, Kansas 66216 USA

    Approved by FDA under NADA # 111-798

    Made in China

    Principal Display Panel - 50 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    DRONCIT FELINE CESTOCIDE 
    praziquantel tablet
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58198-0032
    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
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code Droncit;23
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-0032-150 in 1 BOTTLE
    2NDC:58198-0032-2150 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA11179812/11/1981
    Labeler - Elanco US Inc. (966985624)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elanco US Inc.117617385MANUFACTURE, ANALYSIS, PACK, LABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Merck KG auf Aktien342249299API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Hisun Pharmaceutical (Nantong) Co., Ltd.421314476API MANUFACTURE