Label: DRONCIT FELINE CESTOCIDE- praziquantel tablet
- NDC Code(s): 58198-0032-1, 58198-0032-2
- Packager: Elanco US Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated October 24, 2022
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- SPL UNCLASSIFIED SECTION
- DESCRIPTION:
- INDICATIONS:
- CONTRAINDICATIONS:
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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.
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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:
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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.
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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:
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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:
- STORAGE:
- HOW SUPPLIED:
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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 ChinaDroncit, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2022 Elanco or its affiliates.
Approved by FDA under NADA # 111-79890207939_PA600229X
Revised: March 2022Elanco™
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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 ChinaDroncitTM
(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 tabletProduct 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