Label: DRONCIT CANINE CESTOCIDE- praziquantel tablet

  • NDC Code(s): 58198-0033-1, 58198-0033-2
  • Packager: Elanco US Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated November 26, 2021

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  • 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 34 mg praziquantel.

  • DESCRIPTION:

    Droncit® (praziquantel tablets) 34 Canine Cestocide are sized for easy oral administration to either adult dogs or puppies. The tablets may be crumbled and mixed with the feed.

  • INDICATIONS:

    Droncit® (praziquantel tablets) 34 Canine Cestocide are indicated for the removal of the following canine cestodes: Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus and for the removal and control of Echinococcus multilocularis.

  • CONTRAINDICATIONS:

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

  • 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 are digested and are not found in the feces.

  • USE DIRECTIONS:

    Droncit® (praziquantel tablets) 34 Canine 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:

    Dogs and Puppies*
    * Not intended for use in puppies less than 4 weeks of age.

    5 lbs. and under

    ½ tablet

    6-10 lbs.

    1 tablet

    11-15 lbs.

    1 ½ tablets

    16-30 lbs.

    2 tablets

    31-45 lbs.

    3 tablets

    46-60 lbs.

    4 tablets

    Over 60 lbs.

    5 tablets max

  • 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 living where reinfections are likely to occur, clients should be instructed in the steps to optimize prevention, otherwise, retreatment may be necessary. This is true in cases of Dipylidium caninum where reinfection is almost certain to occur if fleas are not removed from the animal and its environment. In addition, for control of Echinococcus multilocularis, a program of regular treatment every 21 to 26 days may be indicated (see E. multilocularis section below).

  • ECHINOCOCCUS MULTILOCULARIS:

    Echinococcus multilocularis is a tapeworm species ordinarily considered to be found in wild canids, including foxes, coyotes and wolves. The parasite has also been identified in domestic dogs and cats and potentially is a serious public health concern by involving humans as accidental intermediate hosts.

    The life cycle of the parasite is based on a predator-prey relationship, as depicted.

    Figure

    The adult tapeworm is small (1-4 mm) and resides in the intestinal tract of the definitive host (wild or domestic canids). Eggs from the adult tapeworm are shed in the feces of the infected canid. Rodents such as mice and voles serve as the intermediate host for E. multilocularis. Eggs ingested by rodents develop in the liver, lungs and other organs to form multilocular cysts. The life cycle is completed after a canid consumes a rodent infected with cysts. After ingestion of an infected rodent, larvae contained within the cyst develop into adult tapeworms in the intestinal tract of the canid. Eggs may begin to be passed in the feces of the canid approximately 28 days later.

    This parasite poses a serious public health problem because of the possibility for human involvement in the life cycle. If eggs shed by an infected canid are accidentally ingested, a highly pathogenic condition (Alveolar Hydatid Disease) results from development of the cyst stage in humans.

    The original geographic distribution of E. multilocularis was primarily confined to northern areas of North America. Current evidence indicates migration of the parasite well into the continental United States.2,3

    Domestic dogs living in E. multilocularis endemic areas that roam freely with the opportunity to catch wild rodents are at risk for infection. Pet owners should be advised on how to minimize this risk. Proper restraint of roaming dogs should be encouraged, along with regular treatment with Droncit® (praziquantel tablets) following the established dosage schedule (above) and the precautions indicated below.

    Additional information on the life cycle and epidemiology of this parasite is available in veterinary parasitology texts.4,5

  • DIAGNOSIS:

    Diagnosis of E. multilocularis in canids is difficult. The adult tapeworm produces no clinical signs of infection. Tapeworm segments (proglottids) are usually not observed in the feces. E. multilocularis eggs, observed using microscopic fecal examination procedures, are similar in appearance to the common taeniid species of canids such as Taenia pisiformis.

    Assistance in the diagnosis of E. multilocularis may be available from a state veterinary diagnostic laboratory. Additional information regarding areas where E. multilocularis is suspected or has been confirmed may be obtained from area veterinary schools or the Centers for Disease Control in Atlanta, GA.

  • TREATMENT:

    Dogs infected with E. multilocularis should be treated to prevent exposure of humans to infective eggs and to reduce perpetuation of the parasite's life cycle.

    The dosage of Droncit® (praziquantel tablets) for removal of E. multilocularis is the same as that indicated for the removal of the other tapeworm species listed on the label. Laboratory efficacy studies have demonstrated the recommended dosage is 100% efficacious for removal of this tapeworm.

    Under condition of continual exposure to wild rodents, retreatment of the dog at 21-26 day intervals is recommended to prevent the shedding of infectious eggs.

  • PRECAUTIONS:

    Strict hygienic precautions should be taken when handling dogs or feces suspected of harboring E. multilocularis. Infected dogs treated for the first time with Droncit® (praziquantel tablets) and dogs treated at intervals greater than 28 days may shed eggs in the feces after treatment. The animal should be held in the clinic during this interval and all feces should be incinerated or autoclaved. If these procedures are not possible, the eggs can be destroyed by soaking the feces in a sodium hypochlorite (bleach) solution of 3.75% or greater.6 All areas where the animal was maintained or in contact with should be thoroughly cleaned with sodium hypochlorite and allowed to dry completely before reuse.

  • 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 dogs as young as 4 weeks did not produce clinical signs of toxicity. No significant clinical chemistry, hematological, cholinesterase, 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 dogs. No adverse effects were noted.

  • ADVERSE REACTIONS:

    Seven instances (3.2%) of either vomiting, anorexia, lethargy or diarrhea were reported during the field trials in which 218 dogs were administered Droncit® (praziquantel tablets) 34 canine cestocide. The investigators rated these as non-significant.

    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 34 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.
    2.
    Hildreth, M.B., Johnson, M.D. and Kozacos, K.R. 1991. A Zoonosis of Increasing Concern in the United States. Compendium for Cont Ed 13(5): 727-740.
    3.
    Lieby, P.D., Carney, W.P., and Woods, C.E. 1970. Studies on Sylvatic Echinococcosis. Ill. Host Occurrence and Geographic Distribution of Echinococcus multilocularis in the North Central United States. J Parasit 56(6): 1141-1150.
    4.
    Georgi, J.R. and Georgi M.E. 1990. Parasitology for Veterinarians.W.B. Saunders Co. 118-138.
    5.
    Soulsby, E.J.L. 1982. Helminths, Arthropods and Protozoa of Domesticated Animals. 7th Edition. Lea & Febigir 118-138.
    6.
    Craig, P.S. and McPharson, C.N.L. 1988. Sodium Hypochlorite as an Ovicide for Echinococcus. Ann Trop Med and Parasit 82(2): 211-213.

    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

    87037134      LV2009

    September, 2020

    Elanco™

  • Principal Display Panel - 50 Tablet Bottle Label

    Droncit®

    (praziquantel tablets)

    34

    Canine Cestocide

    EACH TABLET CONTAINS: 34 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 CANINE CESTOCIDE 
    praziquantel tablet
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58198-0033
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL34 mg
    Product Characteristics
    Colorwhite (white to off white) Score2 pieces
    ShapeROUND (ROUND) Size13mm
    FlavorImprint Code Droncit;34
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-0033-150 in 1 BOTTLE
    2NDC:58198-0033-2150 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
    TriRx Shawnee LLC118187894MANUFACTURE, ANALYSIS, PACK, LABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Merck KG auf Aktien342249299API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Hisun Pharmaceutical (Nantong) Co., Ltd.421314476API MANUFACTURE