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
Updated November 25, 2020
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- SPL UNCLASSIFIED SECTION
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.
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:
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.
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.
- ADVERSE REACTIONS:
- HOW SUPPLIED:
- SPL UNCLASSIFIED SECTION
Principal Display Panel – 50 Tablets
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
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0859-2128 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL 23 mg Product Characteristics Color WHITE (White to off white) Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code Droncit;23 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0859-2128-01 50 in 1 BOTTLE 2 NDC:0859-2128-02 150 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA111798 12/11/1981 Labeler - Bayer HealthCare, LLC Animal Health Division (152266193)