Galliprant: Product Information
GALLIPRANT- grapiprant tablet
Elanco US Inc.
(grapiprant tablets)
For oral use in dogs only
20 mg, 60 mg and 100 mg flavored tablets
A prostaglandin E2 (PGE2 ) EP4 receptor antagonist; a non-cyclooxygenase inhibiting, non-steroidal anti-inflammatory drug
Caution:
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
Description:
GALLIPRANT (grapiprant tablets) is a prostaglandin E2 (PGE2 ) EP4 receptor antagonist; a non-cyclooxygenase (COX) inhibiting, non-steroidal anti-inflammatory drug (NSAID) in the piprant class. GALLIPRANT is a flavored, oval, biconvex, beige to brown in color, scored tablet debossed with a “G” that contains grapiprant and desiccated pork liver as the flavoring agent.
The molecular weight of grapiprant is 491.61 Daltons. The empirical formula is C26 H29 N5 O3 S. Grapiprant is N-[[[2-[4-(2-Ethyl-4,6-dimethyl-1H-imidazo[4,5-c] pyridin-1-yl)phenyl]ethyl]amino]carbonyl]-4 methylbenzenesulfonamide.
The structural formula is:
Structural Formula
Indication:
GALLIPRANT (grapiprant tablets) is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Dosage and Administration:
Always provide “Information for Dog Owners” Sheet with prescription. Use the lowest effective dose for the shortest duration consistent with individual response.
The dose of GALLIPRANT (grapiprant tablets) is 0.9 mg/lb (2 mg/kg) once daily. Only the 20 mg and 60 mg tablets of GALLIPRANT are scored.
The dosage should be calculated in half tablet increments. Dogs less than 8 lbs. (3.6 kgs) cannot be accurately dosed.
Dosing Chart
| Dose | Weight in pounds | Weight in kilograms | 20 mg tablet | 60 mg tablet | 100 mg tablet |
| 0.9 mg/lb (2 mg/kg) once daily | 8-15 | 3.6-6.8 | 0.5 | ||
| 15.1-30 | 6.9-13.6 | 1 | |||
| 30.1-45 | 13.7-20.4 | 0.5 | |||
| 45.1-75 | 20.5-34 | 1 | |||
| 75.1-150 | 34.1-68 | 1 |
The 100 mg tablet is not scored and should not be broken in half.
Breaking the 100 mg tablet in half will not guarantee that half of the active ingredient is contained within each half of the tablet. For dogs larger than 150 lbs (68 kgs), use a combination of tablet and half tablets to achieve the appropriate dose.
Contraindications:
GALLIPRANT should not be used in dogs that have a hypersensitivity to grapiprant.
Warnings:
Not for use in humans. Keep this and all medications out of reach of children and pets. Consult a physician in case of accidental ingestion by humans.
For use in dogs only. Store GALLIPRANT out of reach of dogs and other pets in a secured location in order to prevent accidental ingestion or overdose.
Precautions:
The safe use of GALLIPRANT has not been evaluated in dogs younger than 9 months of age and less than 8 lbs (3.6 kg), dogs used for breeding, or in pregnant or lactating dogs.
Adverse reactions in dogs receiving GALLIPRANT may include vomiting, diarrhea, decreased appetite, mucoid, watery or bloody stools, and decreases in serum albumin and total protein.
If GALLIPRANT is used long term appropriate monitoring is recommended.
Concurrent use with other anti-inflammatory drugs has not been studied. Concomitant use of GALLIPRANT with other anti-inflammatory drugs, such as COX-inhibiting NSAIDs or corticosteroids, should be avoided. If additional pain medication is needed after a daily dose of GALLIPRANT, a non-NSAID/non-corticosteroid class of analgesic may be necessary.
The concomitant use of protein-bound drugs with GALLIPRANT has not been studied. Commonly used protein-bound drugs include cardiac, anticonvulsant and behavioral medications.
Drug compatibility should be monitored in patients requiring adjunctive therapy. Consider appropriate washout times when switching from one anti-inflammatory to another or when switching from corticosteroids or COX-inhibiting NSAIDs to GALLIPRANT use.
The use of GALLIPRANT in dogs with cardiac disease has not been studied.
It is not known whether dogs with a history of hypersensitivity to sulfonamide drugs will exhibit hypersensitivity to GALLIPRANT. GALLIPRANT is a methylbenzenesulfonamide.
Adverse Reactions:
In a controlled field study, 285 dogs were evaluated for safety when given either GALLIPRANT or a vehicle control (tablet minus grapiprant) at a dose of 2 mg/kg (0.9 mg/lb) once daily for 28 days. GALLIPRANT-treated dogs ranged in age from 2 yrs to 16.75 years. The following adverse reactions were observed:
| *Dogs may have experienced more than one type or occurrence during the study. | ||
| Adverse reaction* | GALLIPRANT(grapiprant tablets) N = 141 | Vehicle control (tablets minus grapiprant)N = 144 |
| Vomiting | 24 | 9 |
| Diarrhea, soft stool | 17 | 13 |
| Anorexia, inappetence | 9 | 7 |
| Lethargy | 6 | 2 |
| Buccal ulcer | 1 | 0 |
| Immune mediated hemolytic anemia | 1 | 0 |
GALLIPRANT was used safely during the field studies with other concurrent therapies, including antibiotics, parasiticides and vaccinations.
To report suspected adverse drug events and/or to obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, call 1-888-545-5973.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth
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