PROFENDER (2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4h-pyrazino- 2,1-aisoquinolin-4-one, emodepside solution PROFENDER (2

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457), EMODEPSIDE (UNII: YZ647Y5GC9) (EMODEPSIDE - UNII:YZ647Y5GC9)

Available from:

Elanco US Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

PROFENDER Topical Solution is indicated for the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults) in cats.

Product summary:

Applications per Package 8 - 0.35 mL tubes (2 blisters of 4 tubes) Variety Pack 20 - 0.7 mL tubes (5 blisters of 4 tubes) 8 - 1.12 mL tubes (2 blisters of 4 tubes)   20 - 0.35 mL tubes (5 blisters of 4 tubes) 40 - 0.35 mL tubes (10 blisters of 4 tubes) 20 - 0.7 mL tubes (5 blisters of 4 tubes) 40 - 0.7 mL tubes (10 blisters of 4 tubes) 20 - 1.12 mL tubes (5 blisters of 4 tubes) 40 - 1.12 mL tubes (10 blisters of 4 tubes) Made in Germany Approved by FDA under NADA # 141-275 Manufactured for: Elanco US Inc. Greenfield, IN 46140 U.S.A ©2022 Elanco or its affiliates. Profender, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Revised: May 2022 ElancoTM

Authorization status:

New Animal Drug Application

Summary of Product characteristics

PROFENDER- 2-(CYCLOHEXYLCARBONYL)-1,2,3,6,7,11B-HEXAHYDRO-4H-
PYRAZINO(2,1-A)ISOQUINOLIN-4-ONE, EMODEPSIDE SOLUTION
PROFENDER- 2-(CYCLOHEXYLCARBONYL)-1,2,3,6,7,11B-HEXAHYDRO-4H-
PYRAZINO(2,1-A)ISOQUINOLIN-4-ONE, EMODEPSIDE
ELANCO US INC.
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_ELANCO™_
TOPICAL SOLUTION
PROFENDER™
(EMODEPSIDE/PRAZIQUANTEL)
CAUTION: Federal law (U.S.A.) restricts this drug to use by or on the
order of a
licensed veterinarian.
Topical Solution for the treatment and control of hookworm, roundworm
and tapeworm
infections in cats and kittens that are at least 8 weeks of age and
weigh at least 2.2 lbs.
(1 kg).
DESCRIPTION:
PROFENDER [1.98% emodepside/7.94% praziquantel] Topical Solution is a
clear yellow
ready-to-use solution packaged in single unit dosing applicator tubes
for topical (dermal)
treatment of cats 8 weeks of age and older and weighing at least 2.2
lbs (1 kg). The
formulation and dosage schedule is designed to provide a minimum of
1.36 mg/lb (3
mg/kg) emodepside and 5.45 mg/lb (12 mg/kg) praziquantel based on body
weight.
Emodepside, a semi-synthetic molecule, is a cyclic depsipeptide. The
chemical name is
Cyclo
[D-2-hydroxypropanoyl-N-methyl-L-leucyl-3-[4-(4-morpholinyl)phenyl]-D-2-
hydroxypropanoyl-N-methyl-L-leucyl-D-2-hydroxypropanoyl-N-methyl-L-leucyl-3-[4-(4-
morpholinyl)phenyl]-D-2-hydroxypropanoyl-N-methyl-L-leucyl].
Praziquantel is an
isoquinoline cestocide. The chemical name is
2-Cyclohexylcarbonyl-1,2,3,6,7,11b-
hexahydro-4H-pyrazine-2,1-a-iso-quinoline-4-one.
INDICATIONS:
PROFENDER Topical Solution is indicated for the treatment and control
of hookworm
infections caused by _Ancylostoma tubaeforme_ (adults, immature
adults, and fourth
stage larvae), roundworm infections caused by _Toxocara cati_ (adults
and fourth stage
larvae), and tapeworm infections caused by _Dipylidium caninum_
(adults) and _Taenia_
_taeniaeformis_ (adults) in cats.
DOSAGE AND ADMINISTRATION:
The recommended minimum dose is 1.36 mg/lb (3 mg/kg) emodepside + 5.45
mg/lb (12
mg/kg) praziquantel as a single topical dose. A single treat