Droncit Feline Cestocide: Product Information

DRONCIT FELINE CESTOCIDE- praziquantel tablet
Elanco US Inc.

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

Principal Display Panel -- 50 Tablets Bottle Label
(click image for full-size original)

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

Principal Display Panel -- 150 Tablets Bottle Label
(click image for full-size original)
DRONCIT FELINE CESTOCIDE
praziquantel tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-0032
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAZIQUANTEL (PRAZIQUANTEL) 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 Multilevel Packaging
1 NDC:58198-0032-1 50 TABLET in 1 BOTTLE None
2 NDC:58198-0032-2 150 TABLET in 1 BOTTLE None
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 Operations
TriRx Shawnee LLC 118187894 MANUFACTURE, ANALYSIS, PACK, LABEL
Establishment
Name Address ID/FEI Operations
Merck KG auf Aktien 342249299 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Hisun Pharmaceutical (Nantong) Co., Ltd. 421314476 API MANUFACTURE

Revised: 10/2022 Elanco US Inc.

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