GALLIPRANT- grapiprant tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Grapiprant (UNII: J9F5ZPH7NB) (Grapiprant - UNII:J9F5ZPH7NB)

Mevcut itibaren:

Elanco US Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION

Terapötik endikasyonlar:

GALLIPRANT should not be used in dogs that have a hypersensitivity to grapiprant.

Ürün özeti:

20 mg, 60 mg and 100 mg flavored tablets in 7, 30 and 90 count bottles Approved by FDA under NADA # 141-455 Manufactured for: Elanco US Inc. Greenfield, IN 46140

Yetkilendirme durumu:

New Animal Drug Application

Ürün özellikleri

GALLIPRANT- GRAPIPRANT TABLET
ELANCO US INC.
----------
GALLIPRANT
(grapiprant tablets)
FOR ORAL USE IN DOGS ONLY
20 MG, 60 MG AND 100 MG FLAVORED TABLETS
A PROSTAGLANDIN E (PGE ) 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 E (PGE ) 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
C
H
N O 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:
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.
®
2
2
2
2
26
29
5
3
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 do