DRONCIT FELINE CESTOCIDE- praziquantel tablet

Droncit by

Drug Labeling and Warnings

Droncit by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc., Merck KG auf Aktien. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 888-545-5973.

For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

WARNING:

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

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.

Manufactured for:
Elanco US Inc.
Greenfield, IN 46140 U.S.A.
Made in China

Droncit, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2022 Elanco or its affiliates.
Approved by FDA under NADA # 111-798

90207939_PA600229X
Revised: March 2022

Elanco™

Principal Display Panel

DroncitTM

(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

Manufactured for: Elanco US Inc.
Greenfield, IN 46140 U.S.A.
Approved by FDA under NADA # 111-798
Made in China

DroncitTM

(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.

150 Tablets

Manufactured for:
Elanco US Inc.
Greenfield, IN 46140 U.S.A.
Approved by FDA under NADA # 111-798
Made in China

INGREDIENTS AND APPEARANCE

DRONCIT FELINE CESTOCIDE 
praziquantel tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 58198-0032
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 (ROUND)	Size	10mm
Flavor		Imprint Code	Droncit;23
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58198-0032-1	50 in 1 BOTTLE
2	NDC: 58198-0032-2	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 - Elanco US Inc. (966985624)

Establishment
Name	Address	ID/FEI	Business Operations
TriRx Shawnee LLC		118187894	MANUFACTURE, ANALYSIS, PACK, LABEL

Establishment
Name	Address	ID/FEI	Business Operations
Merck KG auf Aktien		342249299	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Hisun Pharmaceutical (Nantong) Co., Ltd.		421314476	API MANUFACTURE