Droncit ® (praziquantel tablets)

Manufacturer
Bayer HealthCare, LLC Animal Health Division
Effective date
2020-11-25
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:00:39

Label at a glance#

ProductDroncit Feline Cestocide
Active ingredientPRAZIQUANTEL
Label structure17 sections

Dosage and administration

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 ...

Label contents#

Full prescribing information#

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:

DESCRIPTION SECTION

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:

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

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

ACTION:

MECHANISM OF ACTION 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.

USE DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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*

4 pounds and under

     ½ tablet

5-11 pounds

      1 tablet

Over 11 pounds

1 ½ tablets

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

FASTING:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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:

ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION

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:

PREGNANCY SECTION

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

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

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:

WARNINGS SECTION

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:

SPL UNCLASSIFIED SECTION

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

HOW SUPPLIED:

HOW SUPPLIED SECTION

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

50 Tablets

150 Tablets

REFERENCES:

REFERENCES SECTION

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 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 Tablet Carton - Droncit Principal Display Panel
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PRAZIQUANTELACTIVE INGREDIENT6490C9U4572
PRAZIQUANTELACTIVE MOIETY6490C9U4572

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0859-21280859-2128-01, 0859-2128-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAZIQUANTEL6490C9U457ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAZIQUANTELPRAZIQUANTELPar Health USA, LLC16f2b9c4-a260-4a31-bd52-e5945913246c2026-08-12Warnings, Adverse reactionsName fallback
generic name: PRAZIQUANTEL
BiltricidePRAZIQUANTELBayer HealthCare Pharmaceuticals Inc.34ce1cdd-648e-4f1e-8512-bf3d4cc22eb92026-03-02Warnings, Adverse reactionsName fallback
generic name: PRAZIQUANTEL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.