FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Not for human use. Keep out of reach of children.
To prevent accidental ingestion of the product, children should not come in contact with the application site for twenty-four (24) hours while the product is being absorbed. Pregnant women, or women who may become pregnant, should avoid direct contact with, or wear disposable gloves when applying, this product. Studies performed in rats and rabbits suggest that emodepside may interfere with fetal development in those species.
PROFENDER Topical Solution may be irritating to skin and eyes. Reactions such as facial, tongue and hand swelling have been reported in humans in rare instances. Avoid contact with the application area while it is wet and wash hands thoroughly with soap and warm water after handling. People with known hypersensitivity to butylhydroxyanisole, emodepside or praziquantel should administer the product with caution. If the product accidentally gets into eyes, flush thoroughly with water. May be harmful if swallowed. In case of accidental ingestion or if skin or eye irritation occurs, call a poison control center or physician for treatment advice.
The Material Safety Data Sheet (MSDS) provides additional occupational safety information. For customer service or to obtain product information, including the MSDS, call 1-800-633-3796. For medical emergencies or to report an adverse reaction, call 1-800-422-9874.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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-isoquinoline- 4-one.
Sources
Profender Manufacturers
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Bayer Healthcare Llc Animal Health Division
Profender | Bayer Healthcare Llc Animal Health Division
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 treatment is effective and a second treatment should not be necessary. If re-infection occurs, the product can be re-applied after 30 days.
1. Select the package that correctly corresponds with the body weight of the cat. (See Table below.)
Cat
Weight*
Profender
Topical Solution
Volume
(mL)
Emodepside
(mg)
Praziquantel
(mg)
2.2-5.5 lbs.
Small
0.35
7.5
30.0
>5.5-11 lbs.
Medium
0.70
15.0
60.1
>11-17.6 lbs.
Large
1.12
24.0
96.1
* Cats over 17.6 lbs should be treated with the appropriate combination of tubes.
2. Remove one unit dose tube from the package.
3. While holding the tube in an upright position, remove the cap from the tube.
4. Turn the cap over and place the other end of cap onto the tip of the tube.
5. Twist the cap to break the seal and then remove cap from the tube.
6. Part the hair on the back of the cat’s neck at the base of the head, until the skin is visible.
7. To ensure the entire contents of the tube are administered, place the tip of the tube on the skin and squeeze the entire contents directly onto the skin. Lift tube away from the skin before releasing pressure on the tube.
Do not apply to broken skin or if hair coat is wet.
Do not get this product in the cat’s mouth or eyes or allow the cat to lick the application site for one hour. Oral exposure can cause salivation and vomiting. Treatment at the base of the head will minimize the opportunity for ingestion while grooming. In households with multiple pets, keep animals separated to prevent licking of the application site.
Stiff hair, a damp appearance of the hair, or a slight powdery residue may be observed at the treatment site. These effects are temporary and do not affect the safety or effectiveness of the product.
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