FIROCOXIB FOR DOGS- firocoxib tablet, chewable
Firocoxib for Dogs by
Drug Labeling and Warnings
Firocoxib for Dogs by is a Animal medication manufactured, distributed, or labeled by Pegasus Laboratories, Inc., Excella. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Firocoxib Chewable Tablets for Dogs
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Description:
Firocoxib Chewable Tablets for
Dogs belongs to the coxib class of non-narcotic,
non-steroidal anti-inflammatory drugs. Firocoxib is a
white crystalline compound described chemically as
3-(cyclopropylmethoxy)-4-(4-(methylsulfonyl)phenyl)-
5,5-dimethylfuranone. The empirical formula is
C17H20O5S, and the molecular weight is 336.4. The
structural formula is shown below:
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Pharmacokinetics:
The absolute bioavailability of Firocoxib Chewable Tablets for Dogs is approximately 38% when administered as a 5 mg/kg oral dose to fasted adult dogs. Firocoxib is rapidly cleared from the blood via hepatic metabolism and fecal excretion (CLsystemic = ~0.4 L/hr/kg). Despite
a high level of plasma protein binding (96%), firocoxib exhibits a large volume of distribution (Vdλ of total drug = ~4.6 L/kg) and a terminal elimination half life of 7.8 hours (%CV = 30%). The oral drug absorption process is highly variable among subjects. Co-administration of firocoxib with food delays drug absorption (Tmax from 1 to 5 hours) and decreases peak concentrations (Cmax from 1.3 to 0.9 mcg/mL). However, food does not affect the overall oral bioavailability at the recommended dose. - Indications:
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Dosage and Administration:
Always provide the Client Information Sheet with prescription. Carefully consider the potential benefits and risks of Firocoxib Chewable Tablets for Dogs and other treatment options before deciding to use Firocoxib Chewable Tablets for Dogs. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage of Firocoxib Chewable Tablets for Dogs for oral administration in dogs is 2.27 mg/lb (5.0 mg/kg) body weight once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation
associated with soft-tissue and orthopedic surgery. The dogs can be treated with Firocoxib Chewable Tablets for Dogs approximately two hours prior to surgery. The tablets are scored and dosage should be calculated in half tablet increments. Firocoxib Chewable Tablets for Dogs can be administered with or without food. - Contraindications:
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Warnings:
Not for use in humans. Keep this and all medications out of the reach of children. Consult a physician in case of accidental ingestion by humans.
Keep Firocoxib Chewable Tablets for Dogs in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.For oral use in dogs only. Use of this product at doses above the recommended 2.27 mg/lb (5.0 mg/ kg) in puppies less than seven months of age has been associated with serious adverse reactions, including death (see Animal Safety). Due to tablet sizes and scoring, dogs weighing less than 12.5 lb (5.7 kg) cannot be accurately dosed.
All dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory testing to establish hematological and serum baseline data is recommended prior to and periodically during administration of any NSAID.
Owners should be advised to observe for signs of potential drug toxicity (see Adverse Reactions and Animal Safety) and be given a Client Information Sheet about Firocoxib Chewable Tablets for Dogs.
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Contact Information:
To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Pegasus Laboratories, Inc. at 1-800-874-9764 or www.prnpharmacal.com.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/
reportanimalae. -
Precautions:
This product cannot be accurately dosed in dogs less than 12.5 pounds in body weight.
Consider appropriate washout times when switching
from one NSAID to another or when switching from corticosteroid use to NSAID use.As a class, cyclooxygenase inhibitory NSAIDs
may be associated with renal, gastrointestinal and
hepatic toxicity. Sensitivity to drug-associated
adverse events varies with the individual patient.
Dogs that have experienced adverse reactions from
one NSAID may experience adverse reactions from
another NSAID. Patients at greatest risk for adverse
events are those that are dehydrated, on concomitant
diuretic therapy, or those with existing renal, cardiovascular,
and/or hepatic dysfunction. Concurrent
administration of potentially nephrotoxic drugs
should be carefully approached and monitored.
NSAIDs may inhibit the prostaglandins that maintain
normal homeostatic function. Such anti-prostaglandin
effects may result in clinially significant disease in
patients with underlying or pre-existing disease that
has not been previously diagnosed. Since NSAIDs
possess the potential to produce gastrointestinal
ulceration and/or gastrointestinal perforation,
concomitant use of Firocoxib Chewable Tablets for
Dogs with other anti-inflammatory drugs, such as
NSAIDs or corticosteroids, should be avoided.
The concomitant use of protein bound drugs with
Firocoxib Chewable Tablets for Dogs has not been
studied in dogs. Commonly used protein-bound
drugs include cardiac, anticonvulsant, and behavioral
medications. The influence of concomitant drugs
that may inhibit the metabolism of Firocoxib
Chewable Tablets for Dogs has not been evaluated.
Drug compatibility should be monitored in patients requiring adjunctive therapy.If additional pain medication is needed after the
daily dose of Firocoxib Chewable Tablets for Dogs, a
non-NSAID class of analgesic may be necessary.Appropriate monitoring procedures should be
employed during all surgical procedures. Anesthetic
drugs may affect renal perfusion, approach concomitant
use of anesthetics and NSAIDs cautiously. The
use of parenteral fluids during surgery should be
considered to decrease potential renal complications
when using NSAIDs perioperatively.
The safe use of Firocoxib Chewable Tablets for Dogs
in pregnant, lactating or breeding dogs has not been
evaluated. -
Adverse Reactions:
Osteoarthritis: In controlled field studies, 128
dogs (ages 11 months to 15 years) were evaluated
for safety when given firocoxib chewable tablets at
a dose of 2.27 mg/lb (5.0 mg/kg) orally once daily
for 30 days. The following adverse reactions were
observed. Dogs may have experienced more than
one of the observed adverse reactions during the
study.Adverse Reactions Seen in U.S. Field Studies Adverse Reactions Firocoxib
n=128
Active
Control
n = 121
Vomiting 5 8 Diarrhea 1 10 Decreased Appetite or Anorexia 3 3 Lethargy 1 3 Pain 2 1 Somnolence 1 1 Hyperactivity 1 0 Firocoxib chewable tablets were safely used during
field studies concomitantly with other therapies
including vaccines, anthelmintics, and antibiotics.Soft-tissue Surgery: In controlled field studies
evaluating soft-tissue postoperative pain and inflam-
mation, 258 dogs (ages 10.5 weeks to 16 years)
were evaluated for safety when given firocoxib
chewable tablets at a dose of 2.27 mg/lb (5.0 mg/
kg) orally approximately 2 hours prior to surgery
and once daily thereafter for up to two days. The
following adverse reactions were observed. Dogs
may have experienced more than one of the observed reactions during the study.Adverse Reactions Seen in the Soft-tissue Surgery Postoperative Pain in Field Studies Adverse Reactions Firocoxib
Group
n=127
Control
Group*
n=131
Vomiting 5 6 Diarrhea 1 1 Bruising at Surgery Site
1 1 Respiratory Arrest
1 0 SQ Crepitusin Rear Leg and Flank 1 0 Swollen Paw 1 0 *Sham-dosed (pilled)
Orthopedic Surgery: In a controlled field study
evaluating orthopedic pain and inflam-
mation, 226 dogs of various breeds, ranging in age
from 1 to 11.9 years in the firocoxib-treated groups
and 0.7 to 17 years in the control group were evaluated
for safety. Of the 226 dogs, 118 were given
firocoxib chewable tablets at a dose of 2.27 mg/
lb (5.0 mg/kg) orally approximately 2 hours prior
to surgery and once daily thereafter for a total of
three days. The following adverse reactions were
observed. Dogs may have experienced more than
one of the observed reactions during the study.Adverse Reactions Seen in the Orthopedic Surgery Postoperative Pain Field Study Adverse Reactions Firocoxib
Group
n=118
Control
Group*
n=108
Vomiting 1 0 Diarrhea 2** 1 Brusing at Surgery Site 2 3 Inappetence/Decreased Appetite 1 2 Prexia 0 1 Incision Swelling, Redness 9 5 Oozing Incision 2 0 A case may be represented in more than one category
*Sham-dosed (pilled).
**One dog had hemorrhagic gastroenteritis
Post-Approval Experience (Rev. 2009): The
following adverse reactions are based on postapproval
adverse drug event reporting. The
categories are listed in decreasing order of
frequency by body system:Gastrointestinal: vomiting, anorexia, diarrhea,
melena, gastrointestinal perforation, hematemesis,
hematachezia, weight loss, gastrointestinal ulceration,
peritonitis, abdominal pain, hypersalivation,
nauseaUrinary: elevated BUN, elevated creatinine, polydypsia,
polyuria, hematuria, urinary incontinence,
proteinuria, kidney failure, azotemia, urinary tract
infectionNeurological/Behavioral/Special Sense: depression/
lethargy, ataxia, seizures, nervousness, confusion,
weakness, hyperactivity, tremor, paresis, head tilt,
nystagmus, mydriasis, aggression, uveitisHepatic: elevated ALP, elevated ALT, elevated
bilirubin, decreased albumin, elevated AST, icterus,
decreased or increased total protein and globulin,
pancreatitis, ascites, liver failure, decreased BUNHematological: anemia, neutrophilia, thrombocytopenia,
neutropeniaCardiovascular/Respiratory: tachypnea, dyspnea,
tachycardiaDermatologic/Immunologic: pruritis, fever, alopecia,
moist dermatitis, autoimmune hemolytic anemia,
facial/muzzle edema, urticariaIn some cases, death has been reported as an
outcome of the adverse events listed above. -
Contact Information:
To report suspected adverse
drug events, for technical assistance or to obtain
a copy of the Safety Data Sheet (SDS), contact
Pegasus Laboratories, Inc. at 1-800-874-9764 or
www.prnpharmacal.com.For additional information about adverse drug
experience reporting for animal drugs, contact
FDA at 1-888-FDA-VETS or online at www.fda.gov/
reportanimalae. -
Information for Dog Owners:
Firocoxib Chewable
Tablets for Dogs, like other drugs of its class, is
not free from adverse reactions. Owners should be
advised of the potential for adverse reactions and be
informed of the clinical signs associated with drug
intolerance. Adverse reactions may include vomiting,
diarrhea, decreased appetite, dark or tarry stools,
increased water consumption, increased urination,
pale gums due to anemia, yellowing of gums,
skin or white of the eye due to jaundice, lethargy,
incoordination, seizure, or behavioral changes.Serious adverse reactions associated with this
drug class can occur without warning and in rare
situations result in death (see Adverse Reactions).
Owners should be advised to discontinue Firocoxib
Chewable Tablets for Dogs and contact their veterinarian
immediately if signs of intolerance are
observed. The vast majority of patients with drug
related adverse reactions have recovered when the
signs are recognized, the drug is withdrawn, and
veterinary care, if appropriate, is initiated. Owners
should be advised of the importance of periodic
follow up for all dogs during administration of
any NSAID. -
Clinical Pharmacology:
Mode of action: Firocoxib
Chewable Tablets for Dogs is a cyclooxygenaseinhibiting
(coxib) class, non-narcotic, non-ste-
roidal anti-inflammatory drug (NSAID) with anti-
inflammatory and analgesic properties. There are two
main cyclooxygenase enzymes, COX-1 and COX-2,
and a newly discovered third enzyme, COX-3, which
has yet to be fully characterized.1 Cyclooxygenase-1
(COX-1) is the enzyme responsible for facilitating
constitutive physiologic processes, e.g., platelet
aggregation, gastric mucosal protection, and renal
perfusion.2 It also is constitutively expressed in
the brain, spinal cord, and reproductive tract.3
Cyclooxygenase-2 (COX-2) is responsible for the
synthesis of inflammatory mediators, but it is also
constitutively expressed in the brain, spinal cord
and kidneys.4, 5, 6 Cyclooxygenase-3 (COX-3) is also
constitutively expressed in the canine and human
brain and also the human heart.7 Results from in vitrostudies showed firocoxib to be highly selective for
the COX-2 enzyme when canine blood was exposed
to drug concentrations comparable to those observed
following a once daily 5 mg/kg oral dose in dogs.8
However, the clinical significance of these findings
has not been established. -
Effectiveness:
Two hundred and forty-nine dogs of
various breeds, ranging in age from 11 months to
20 years, and weighing 13 to 175 lbs, were randomly
administered firocoxib or an active control drug in
two field studies. Dogs were assessed for lameness,
pain on manipulation, range of motion, joint swelling,
and overall improvement in a non-inferiority evalua-
tionof firocoxib compared with the active control. At
the study's end, 87% of the owners rated firoxib-
treated dogs as improved. Eighty-eight percent
of dogs treated with firocoxib were also judged
improved by the veterinarians. Dogs treated with
firocoxib showed a level of improvement in veteri-
narian-assessed lameness, pain on palpation, range
of motion, and owner-assessed improvement that
was comparable to the active control. The level of
improvement in firocoxib-treated dogs in limb weight
bearing on the force plate gait analysis assessment
was comparable to the active control.In a separate field study, two hundred fifty-eight
client-owned dogs of various breeds, ranging in
age from 10.5 weeks to 16 years and weighing from
7 to 168 lbs, were randomly administered firocoxib
or a control (sham-dosed-pilled) for the control of
postoperative pain and inflammation associated with
soft-tissue surgical procedures such as abdominal
surgery (e.g. ovariohysterectomy, abdominal
cryptorchidectomy, splenectomy, cystotomy) or
major external surgeries (e.g. mastectomy, skin
tumor removal ≥8 cm). The study demonstrated
that firocoxib-treated dogs had significantly lower
need for rescue medication than the control
(sham-dosed-pilled) in controlling postoperative
pain and inflammation associated with soft-surgery.A multi-center field study with 226 client-owned
dogs of various breeds, and ranging in age from 1
to 11.9 years in the firocoxib-treated groups and
0.7 to 17 years in the control group was conducted.
Dogs were randomly assigned to either the firocoxib
or the control (sham-dosed-pilled) group for the
control of postoperative pain and inflammation asso-
ciated with orthopedic surgery. Surgery to repair
a ruptured cruciate ligament included the following
stabilization procedures: fabellar suture and/or
imbrication, fibular head transposition, tibial plateau
leveling osteotomy (TPLO), and ‘over the top’ technique.
The study (n = 220 for effectiveness) demon-
strated that foirocoxib-treated dogs had signifcantly
lower need for rescue medication than the control
(sham-dosed-pilled) in controlling postoperative
pain and inflammation associated with orthopedic
surgery. -
Animal Safety:
Animal Safety: In a target animal safety study,
firocoxib was administered orally to healthy adult
Beagle dogs (eight dogs per group) at 5, 15, and 25
mg/kg (1, 3, and 5 times the recommended total daily
dose) for 180 days. At the indicated dose of 5 mg/
kg, there were no treatment related adverse events.
Decreased appetite, vomiting, and diarrhea were
seen in dogs in all dose groups, including unmedicated
controls, although vomiting and diarrhea were
seen more often in dogs in the 5X dose group.
One dog in the 3X dose group was diagnosed with
juvenile polyarteritis of unknown etiology after
exhibiting recurrent episodes of vomiting and
diarrhea, lethargy, pain, anorexia, ataxia, propriocep-
tive deficits, decreased albumin lavels, decreased
and then elevated platelet counts, increased bleeding
times, and elevated liver enzymes. On histopathologic
examination, a mild ileal ulcer was found in one
5X dog. This dog also had a decreased serum albumin
which returned to normal by study completion. One
control and three 5X dogs had focal areas of inflam-
mation in the pylorus or small intestine. Vacuolization
without inflammatory cell infiltrates was noted in the
thalamic region of the brain in three control, one 3X,
and three 5X dogs. Mean ALP was within the normal
range for all groups but was greater in the 3X and
5X dose groups than in the control group. Transient
decreases in serum albumin were seen in multiple
animals in the 3X and 5X dose groups, and in one
control animal.
In a separate safety study, firocoxib was administered
orally to healthy juvenile (10-13 weeks of age)
Beagle dogs at 5, 15, and 25 mg/kg (1, 3, and 5 times
the recommended total daily dose) for 180 days. At
the indicated (1X) dose of 5 mg/kg, on histopathologic
examination, three out of six dogs had minimal
periportal hepatic fatty change. On histopathologic
examination, one control, one 1X, and two 5X dogs
had diffuse slight hepatic fatty change. These animals
showed no clinical signs and had no liver enzyme
elevations. In the 3X dose group, one dog was
euthanized because of poor clinical condition (Day
63). This dog also had a mildly decreased serum
albumin. At study completion, out of five surviving
and clinically normal 3X dogs, three had minimal periportal
hepatic fatty change. Of twelve dogs in the 5X
dose group, one died (Day 82) and three moribund
dogs were euthanized (Days 38, 78, and 79) because
of anorexia, poor weight gain, depression, and in
one dog, vomiting. One of the euthanized dogs had
ingested a rope toy. Two of these 5X dogs had mildly
elevated liver enzymes. At necropsy all five of the
dogs that died or were euthanized had moderate
periportal or severe panzonal hepatic fatty change;
two had duodenal ulceration; and two had pancreatic
edema. Of two other clinically normal 5X dogs (out
of four euthanized as comparators to the clinically
affected dogs), one had slight and one had moderate
periportal hepatic fatty change. Drug treatment was
discontinued for four dogs in the 5X group. These
dogs survived the remaining 14 weeks of the study.
On average, the dogs in the 3X and 5X dose groups
did not gain as much weight as control dogs. Rate of
weight gain was measured (instead of weight loss)
because these were young growing dogs. Thalamic
vacuolation was seen in three of six dogs in the
3X dose group, five of twelve dogs in te 5X dose
group, and to a lesser degree in two unmedicated
controls. Diarrhea was seen in all dose groups,
including unmedicated controls.
In a separate dose tolerance safety study involving a
total of six dogs (two control dogs and four treated
dogs), firocoxib was administered to four healthy
adult Beagle dogs at 50 mg/kg (ten times the recommended
daily dose) for twenty-two days. All dogs
survived to the end of the study. Three of the four
treated dogs developed small intestinal erosion or
ulceration. Treated dogs that developed small intestinal
erosion or ulceration had a higher incidence of
vomiting, diarrhea, and decreased food consumption
than control dogs. One of these dogs had severe
duodenal ulceration, with hepatic fatty change and
associated vomiting, diarrhea, anorexia, weight
loss, ketonuria, and mild elevations in AST and
ALT. All four treated dogs exhibited progressively
decreasing serum albumin that, with the exception of
one dog that developed hypoalbuminemia, remained
within normal range. Mild weight loss also occurred
in the treated group. One of the two control dogs and
three of the four treated dogs exhibited transient
increases in ALP that remained within normal range. - Storage:
- How Supplied:
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REFERENCES
1 Willoughby DA, Moore AR and Colville-Nash PR.
COX-1, COX-2, and COX-3 and the future treat-
ment of chronic inflammatory disease. Lancet
2000;355:646-648.2 Smith, et al., Pharmacological Analysis of Cyclo-
oxygenase-1 in Inflammation. Proc. Natl. Acad. Sci.
USA, Pharmacology 1998;95:13313-13318.3 Jones CJ and Budsberg SC. Physiologic characteristics
and clinical importance of the cyclooxygenase
isoforms in dogs and cats. JAVMA
2000;217(5):721-729.4 Zhang, et al., Inhibition of Cyclo-oxygenase-2
Rapidly Reverses Inflammatory Hyperalgesia and
Prostaglandin E2 Production. JPET 1997;283:1069-
1075.5Jones and Budsberg, pp. 721-729.
6Zhang, et al., pp. 1069-1075.
7 Chandrasekharan NV, Dai H, et al. COX-3, a cyclooxygenase-
1 variant inhibited by acetaminophen and
other analgesic/antipyretic drugs: Cloning, structure
and expression. Proc. Natl. Acad. Sci. USA,
2002;99(21):13926-13931.8Data on file with the NADA 141-230.
- SPL UNCLASSIFIED SECTION
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Information for Dog Owners aboutFirocoxib Chewable Tablets for Dogs
Firocoxib Chewable Tablets for Dogs
Firocoxib Chewable Tablets for Dogs are used for the control of
pain and inflammation due to osteoarthritis or associated with soft-
tissue and orthopedic surgery in your dog.This summary contains important information about Firocoxib
Chewable Tablets for Dogs. You should read this information before
you start giving your dog Firocoxib Chewable Tablets for Dogs
and review it each time your prescription is refilled. This sheet is
provided only as a summary and does not take the place of instructions
from your veterinarian. Talk to your veterinarian if you do not
understand any of this information or you want to know more about
Firocoxib Chewable Tablets for Dogs.What is Firocoxib Chewable Tablets for Dogs?
Firocoxib Chewable Tablets for Dogs is a veterinary prescription
non-steroidal anti-inflammatory drug (NSAID) used to control pain
and inflammation due to osteoarthritis, or associated with soft-tissue
and orthopedic surgery in dogs.Osteoarthritis is a painful condition caused by “wear and tear” of
cartilage and other parts of the joints that may result in the following
changes or signs in your dog:
Limping or lameness.
Decreased activity or exercise (reluctance to stand, climb stairs,
jump or run, or difficulty performing these activities).
Stiffness or decreased movement of joints.Firocoxib Chewable Tablets for Dogs is indicated for the control
of postoperative pain and inflammation following soft-tissue and
orthopedic surgeries (e.g. spays, cruciate ligament repair). Your
veterinarian may administer Firocoxib Chewable Tablets for Dogs
before the procedure and recommend that the dog be treated for a
few days after going home.What kind of results can I expect when my dog is on
Firocoxib Chewable Tablets for Dogs for osteoarthritis?
While Firocoxib Chewable Tablets for Dogs is not a cure for
osteoarthritis, it can control the pain and inflammation and improve
your dog’s mobility.Response varies from dog to dog, but improvement can be quite
dramatic.
In most dogs, improvement can be seen within days.
If Firocoxib Chewable Tablets for Dogs is discontinued or not
given as directed, your dog's pain and inflammation may return.What kind of results can I expect when my dog is on
Firocoxib Chewable Tablets for Dogs for the control of pain and
inflammation following soft-tissue and orthopedic surgery?
Firocoxib Chewable Tablets for Dogs allow your dog to recover
more comfortably by controlling pain and inflammation following
soft-tissue and orthopedic surgery.
Control of pain and inflammation may vary from dog to dog.
If Firocoxib Chewable Tablets for Dogs are not given according to
your veterinarian’s directions, your dog’s pain may return.
Consult your veterinarian if your dog appears to be uncomfortable.Which dogs should not take Firocoxib Chewable Tablets for Dogs?
Your dog should not be given Firocoxib Chewable Tablets for Dogs
if he/she:
Has an allergic reaction to firocoxib, the active ingredient in
Firocoxib Chewable Tablets for Dogs.
Has had an allergic reaction (such as hives, facial swelling, or red
or itchy skin) to aspirin or other NSAIDs.
Is presently taking aspirin, other NSAIDs, or corticosteroids.
Is under 12.5 pounds in body weight.
Has pre-existing kidney or liver disease.
Has decreased appetite, vomiting or diarrhea.Firocoxib Chewable Tablets for Dogs should only be given to dogs.
People should not take Firocoxib Chewable Tablets for Dogs.
Keep Firocoxib Chewable Tablets for Dogs and all medications
out of the reach of children. Call your physician immediately if you
accidentally take Firocoxib Chewable Tablets for Dogs.What to tell/ask your veterinarian before giving Firocoxib Chewable
Tablets for Dogs.
Talk to your veterinarian about:
The signs of osteoarthritis you have observed in your dog, such
as limping or stiffness.
The importance of weight control in the management of
osteoarthritis.
What tests might be done before Firo coxib Chewable Tablets for
Dogs is prescribed.
How often your dog may need to be examined by your veterinarian.
The risks and benefits of using Firocoxib Chewable Tablets for
Dogs. Serious adverse reactions, including death, have been
associated with Firocoxib Chewable Tablets for Dogs administration
at doses above the recommended dose in puppies less than
seven months of age.Tell your veterinarian if your dog is currently experiencing or has ever
had the following medical problems:
Any side effects from taking Firocoxib Chewable Tablets for Dogs
or other NSAIDs, such as aspirin.
Any digestive upset (vomiting and/or diarrhea).
Any kidney disease.
Any liver disease.Tell your veterinarian about:
Any other medical problems or allergies that your dog has now,
or has had in the past.
All medicines that you are giving or plan to give to your dog,
including those you can get without a prescription and any dietary
supplements.Tell your veterinarian if your dog:
Is under 7 months of age.
Is pregnant, nursing or if you plan to breed your dog.How to give Firocoxib Chewable Tablets for Dogs to your dog.
Firocoxib Chewable Tablets for Dogs should be given according
to your veterinarian’s instructions. Do not change the way you give
Firocoxib Chewable Tablets for Dogs to your dog without first
speaking with your veterinarian. Your veterinarian will tell you what
amount of Firocoxib Chewable Tablets for Dogs is right for your dog
and for how long it should be given. Firocoxib Chewable Tablets for
Dogs may be offered to the dog by hand or you can place the tablet
in your dog’s mouth. Firocoxib Chewable Tablets for Dogs may be
given with or without food.What are the possible side effects that may occur in my dog during
Firocoxib Chewable Tablets for Dogs therapy?
Firocoxib Chewable Tablets for Dogs, like other NSAIDs, may cause
some side effects. Serious side effects associated with NSAID
therapy in dogs can occur with or without warning, and, in rare
situations, result in death. The most common side effects associated
with Firocoxib Chewable Tablets for Dogs therapy involve the digestive
tract (vomiting and decreased food consumption). Liver and
kidney problems have also been reported with NSAIDs. Look for the
following side effects that may indicate your dog is having a problem
with Firocoxib Chewable Tablets for Dogs:
Decrease or increase in appetite.
Vomiting.
Change in bowel movements (such as diarrhea, or black, tarry or
bloody stools).
Change in behavior (such as decreased or increased activity level,
incoordination, seizure, or aggression).
Yellowing of gums, skin, or whites of the eyes (jaundice).
Change in drinking habits (frequency or amount consumed).
Change in urination habits (frequency, color, or smell).
Change in skin (redness, scabs, or scratching).
Unexpected weight loss.It is important to stop the medication and contact your
veterinarian immediately if you think your dog has a medical
problem or side effect while taking Firocoxib Chewable Tablets
for Dogs. If you have additional questions about possible
side effects, talk with your veterinarian or call 1-800-874-9764.Can Firocoxib Chewable Tablets for Dogs be given with other
medications?
Firocoxib Chewable Tablets for Dogs should not be given with
other NSAIDs (for example, aspirin, carprofen, etodolac, deracoxib,
meloxicam, or tepoxalin) or corticosteroids (for example, prednisone,
cortisone, dexamethasone, or triamcinolone).Tell your veterinarian about all medications that you have given your
dog in the past, and any medications you are planning to give with
Firocoxib Chewable Tablets for Dogs. This should include other
medicines that you can get without a prescription or any dietary
supplements. Your veterinarian may want to check that all of your
dog’s medicines can be given together.What do I do in case my dog eats more than the prescribed amount
of Firocoxib Chewable Tablets for Dogs?
Consult your veterinarian immediately if your dog eats more than the
prescribed amount of Firocoxib Chewable Tablets for Dogs.What else should I know about Firocoxib Chewable Tablets
for Dogs?
This sheet provides a summary of information about Firocoxib
Chewable Tablets for Dogs. If you have any questions or concerns
about Firocoxib Chewable Tablets for Dogs, osteoarthritis pain, or
post operative pain following soft-tissue and orthopedic surgery,
talk with your veterinarian.
As with all prescribed medicines, Firocoxib Chewable Tablets
for Dogs should only be given to the dog for which they were
prescribed. They should be given to your dog only for the condition
for which they were prescribed, at the prescribed dose.
It is important to periodically discuss your dog’s response to
Firocoxib Chewable Tablets for Dogs tablets. Your veterinarian will
determine if your dog is responding as expected and if your dog
should continue receiving Firocoxib Chewable Tablets for Dogs.Contact Information: To report suspected adverse drug events, for
technical assistance or to obtain a copy of the Safety Data Sheet
(SDS), contact Pegasus Laboratories, Inc. at 1-800-874-9764 or
www.prnpharmacal.com.For additional information about adverse drug experience reporting
for animal drugs, contact FDA at 1-888-FDA-VETS or online at
www.fda.gov/reportanimalae.Approved by FDA under ANADA # 200-751
Rev. 08-2022
Sē●Qual™ Products by PRN™ Pharmacal
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INGREDIENTS AND APPEARANCE
FIROCOXIB FOR DOGS
firocoxib tablet, chewableProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC: 49427-356 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FIROCOXIB (UNII: Y6V2W4S4WT) (FIROCOXIB - UNII:Y6V2W4S4WT) FIROCOXIB 57 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) 58.14 kg MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) 42.14 kg SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 2.00 kg HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) 11.54 kg CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 6.08 kg MAGNESIUM STEARATE (UNII: 70097M6I30) 2.00 kg Product Characteristics Color brown (speckled tan to light brown) Score no score Shape ROUND Size 10mm Flavor Imprint Code 57;FX Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49427-356-48 60 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200751 07/31/2023 Labeler - Pegasus Laboratories, Inc. (108454760) Establishment Name Address ID/FEI Business Operations Pegasus Laboratories, Inc. 108454760 manufacture, analysis, label Establishment Name Address ID/FEI Business Operations Excella 329809800 api manufacture
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