Animal NDC 58198-0032-2 Droncit Feline Cestocide

Praziquantel

Animal Product Information

Field Name	Field Value
Animal NDC Code	58198-0032-2
Proprietary Name	Droncit Feline Cestocide What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name	Praziquantel What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name	Elanco Us Inc.
Product Type	Prescription Animal Drug
Usage Information	Droncit (praziquantel tablets) 23 Feline Cestocide are indicated for the removal of the following feline cestodes: Dipylidium caninum and Taenia taeniaeformis.
Active Ingredient(s)	Praziquantel
Marketing Category	NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number	NADA111798 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Droncit Feline Cestocide Images

Droncit Feline Cestocide Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Other
Description:
Indications:
Contraindications:
Action:
Use Directions:
Fasting:
Retreatment:
Animal Safety:
Pregnancy:
Adverse Reactions:
Warning:
Storage:
How Supplied:
References:
Principal Display Panel

Other

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 25°C (77°F)

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.

90207939_PA600229X
Revised: March 2022

Elanco™

Principal Display Panel

Droncit^TM

(praziquantel tablets)

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