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Description:
Novox Caplets
(carprofen),
25 mg, 75 mg and 100
mg
For oral use in dogs only
Non-steroidal anti-inflammatory drug
|
Dog Owner Information about Novox Caplets for
Osteoarthritis Pain
This summary contains important information about Novox
Caplets.
You should read this information before you start giving your dog
Novox Caplets and review it each time the 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 if you want to know more
about Novox Caplets.
What is Novox Caplets?
Novox Caplets are a
nonsteroidal anti-inflammatory drug (NSAID) that
is used to reduce pain and inflammation (soreness) due to osteoarthritis
in dogs. A licensed veterinarian must prescribe carprofen for your
dog. It is available as a caplet and is given to dogs by mouth.
Osteoarthritis (OA) 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 in performing these activities)
• Stiffness or decreased movement of joints
What kind of results can I expect when my dog is on
Novox
Caplets for OA?
While Novox Caplets are not a cure for osteoarthritis,
it can relieve the
pain and inflammation of OA and improve your dog’s mobility.
• Response varies from dog to dog but can be quite dramatic.
• In most dogs, improvement can be seen in a matter of days.
• If Novox Caplets are discontinued or not given as directed, your
dog’s pain and inflammation may come back.
Who should not take Novox Caplets?
Your dog should not be given Novox Caplets if he/she:
• Has had an allergic reaction to the active ingredient, carprofen.
• Has had an allergic reaction to aspirin or other NSAIDs (for example
etodolac or phenylbutazone) such as hives, facial swelling,
or red or
itchy skin.
Novox Caplets should be given to dogs only.
Cats should not be given
Novox Caplets. Call your veterinarian immediately if
your cat receives
Novox Caplets. People should not take Novox Caplets. Keep Novox
Caplets and all medicines out of reach of children. Call your physician
immediately if you accidentally take Novox Caplets.
How to give Novox Caplets to your dog.
Novox Caplets should be given according to your veterinarian’s
instructions.
Your veterinarian will tell you what amount of Novox Caplets is
right for your dog and for how long it should be given. Novox Caplets
should be given by mouth and may be given with or without food.
What to tell/ask your veterinarian before giving Novox
Caplets.
Talk to your veterinarian about:
• The signs of OA you have observed (for example limping, stiffness).
• The importance of weight control and exercise in the management
of OA.
• What tests might be done before Novox Caplets is prescribed.
• How often your dog may need to be examined by your veterinarian.
• The risks and benefits of using Novox Caplets.
Tell your veterinarian if your dog has ever had the following
medical
problems:
• Experienced side effects from Novox Caplets or other NSAIDs,
such as aspirin
• Digestive upset (vomiting and/or diarrhea)
• Liver disease
• Kidney disease
• A bleeding disorder (for example, Von Willebrand’s disease)
Tell your veterinarian about:
• Any other medical problems or allergies that your dog has now or
has had.
• All medicines that you are giving your dog or plan to give your
dog, including those you can get without a prescription.
Tell your veterinarian if your dog is:
• Pregnant, nursing or if you plan to breed your dog.
Novox Caplets
(carprofen),
25 mg, 75 mg and 100 mg
For oral use in dogs only
Non-steroidal anti-inflammatory drug
CAUTION
Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
DESCRIPTION
Carprofen is a non-steroidal anti-inflammatory drug (NSAID)
of the propionic acid
class that includes ibuprofen, naproxen, and ketoprofen. The chemical
name for
carprofen, a substituted carbazole, is
6-chloro-alpha-methyl-9H-carbazole-2-acetic
acid. The empirical formula is C15H12ClNO2 and the molecular weight
273.72. The
chemical structure of carprofen is shown above. Carprofen is a white,
crystalline
compound. It is freely soluble in ethanol, but practically insoluble in
water at 25°C.
INDICATIONS
Novox Caplets are indicated for the relief of pain and
inflammation associated with
osteoarthritis in dogs.
DOSAGE AND ADMINISTRATION
Always provide Client Information Sheet with
prescription. The recommended
dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body
weight daily.
The total daily dose may be administered as 2 mg/lb of body weight once
daily or
divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. Novox
Caplets are
scored and dosage should be calculated in half-tablet increments.
Tablets can be
halved by placing the tablet on a hard surface and pressing down on both
sides of
the score. Novox Caplets should be given by mouth and may be given with
or without
food. Care should be taken to ensure that the dog consumes the complete
dose.
EFFECTIVENESS
Confirmation of the
effectiveness of carprofen for the relief of pain and inflammation
associated with osteoarthritis was demonstrated in 7 placebo-controlled,
masked studies examining the anti-inflammatory and analgesic
effectiveness of
carprofen in various breeds of dogs.
Separate placebo-controlled, masked, multicenter field studies confirmed
the antiinflammatory
and analgesic effectiveness of carprofen when dosed at
2 mg/lb once daily or when divided and administered at 1 mg/lb twice
daily. In
these 2 field studies, dogs diagnosed with osteoarthritis showed
statistically significant
overall improvement based on lameness evaluations by the veterinarian
and owner observations when administered carprofen at labeled doses.
CONTRAINDICATIONS
Novox Caplets should not be used in dogs exhibiting
previous hypersensitivity to
carprofen.
PRECAUTIONS
As a class, cyclooxygenase inhibitory NSAIDs may be
associated with gastrointestinal
and renal toxicity. Effects may result from decreased prostaglandin
production
and inhibition of the enzyme cyclooxygenase which is responsible for the
formation of prostaglandins from arachidonic acid.11-14 When NSAIDs
inhibit
prostaglandins that cause inflammation they may also inhibit those
prostaglandins
which maintain normal homeostatic function. These anti-prostaglandin
effects may
result in clinically significant disease in patients with underlying or
pre-existing|
disease more often than in healthy patients.12,14 NSAID therapy could
unmask
occult disease which has previously been undiagnosed due to the absence
of
apparent clinical signs. Patients with underlying renal disease for
example, may
experience exacerbation or decompensation of their renal disease while
on NSAID
therapy.11-14 The use of parenteral fluids during surgery should be
considered to
reduce the potential risk of renal complications when using NSAIDs
perioperatively.
Carprofen is an NSAID, and as with others in that class, adverse
reactions may
occur with its use. The most frequently reported effects have been
gastrointestinal
signs. Events involving suspected renal, hematologic, neurologic,
dermatologic,
and hepatic effects have also been reported. Patients at greatest risk
for renal toxicity
are those that are dehydrated, on concomitant diuretic therapy, or those
with
renal, cardiovascular, and/or hepatic dysfunction. Concurrent
administration of
potentially nephrotoxic drugs should be approached cautiously, with
appropriate
monitoring. Since many NSAIDs possess the potential to induce
gastrointestinal
ulceration, concomitant use of carprofen with other anti-inflammatory
drugs, suchas
corticosteroids and NSAIDs, should be avoided or very closely monitored.
Sensitivity to drug-associated adverse reactions varies with the
individual patient.
For example, carprofen treatment was not associated with renal toxicity
or gastrointestinal
ulceration in well-controlled safety studies of up to ten times the dose
in dogs.
Carprofen is not recommended for use in dogs with bleeding disorders
(e.g., Von
Willebrand’s disease), as safety has not been established in dogs with
these disorders.
The safe use of carprofen in animals less than 6 weeks of age, in
pregnant
dogs, dogs used for breeding purposes, or in lactating bitches has not
been established.
Safety has not been established for IV or IM administration. Studies to
determine the activity of caprofen when administered concomitantly with
other
protein-bound or similarly metabolized drugs have not been conducted.
Drug compatibility
should be monitored closely in patients requiring additional therapy.
Such
drugs commonly used include cardiac, anticonvulsant and behavioral
medications.
It has been suggested that treatment with carprofen may reduce the level
of
inhalant anesthetics needed.15 It is suggested to use different sites
for additional
injections. If additional pain medication is warranted after
administration of the
total daily dose of carprofen, alternative analgesia should be
considered. The use
of another NSAID is not recommended.
Novox Caplets should be stored out of reach of dogs in a secured
location. Severe
adverse reactions may occur if large quantities of caplets are ingested.
If you suspect
your dog has consumed Novox Caplets above the labeled dose, please call
your
veterinarian for immediate assistance and notify VEDCO, Inc. at
1-888-708-3326. |
INFORMATION FOR DOG OWNERS
Carprofen, 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
decreased
appetite, vomiting, diarrhea, 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 carprofen therapy 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.
WARNINGS
Keep out of reach of children. Not for human use.
Consult a physician in cases of
accidental ingestion by humans. For use in dogs only. Do not use in
cats.
All dogs should undergo a thorough history and physical examination
before initiation
of NSAID therapy. Appropriate laboratory tests to establish
hematological and
serum biochemical baseline data prior to, and periodically during,
administration of
any NSAID should be considered.
Owners should be advised to
observe for signs
of potential drug toxicity (see Information for Dog Owners and Adverse
Reactions).
ADVERSE REACTIONS
During investigational studies with an oral carprofen
formulation at twice daily
administration of 1 mg/lb, no clinically significant adverse reactions
were reported.
Some clinical signs were observed during field studies (n=297) which
were similar
for carprofen caplet- and placebo-treated dogs. Incidences of the
following were
observed in both groups: vomiting (4%), diarrhea (4%), changes in
appetite (3%),
lethargy (1.4%), behavioral changes (1%), and constipation (0.3%). The
product
vehicle served as control.
There were no serious adverse events reported during clinical field
studies with
once daily administration of 2 mg/lb. The following categories of
abnormal health
observations were reported. The product vehicle served as control.
Post-Approval Experience
Although not all adverse reactions are reported, the
following adverse reactions are
based on voluntary post-approval adverse drug experience reporting. The
categories
of adverse reactions are listed in decreasing order of frequency by body
system.
Gastointestinal:
Vomiting, diarrhea,
constipation, inappetence, melena,
hematemesis, gastrointestinal ulceration, gastrointestinal bleeding,
pancreatitis.
Hepatic:
Inappetence, vomiting,
jaundice, acute hepatic toxicity, hepatic enzyme
elevation, abnormal liver function test(s), hyperbilirubinemia,
bilirubinuria,
hypoalbuminemia. Approximately one-fourth of hepatic reports were in
Labrador
Retrievers.
Neurologic:
Ataxia, paresis, paralysis,
seizures, vestibular signs, disorientation.
Urinary:
Hematuria, polyuria, polydipsia,
urinary incontinence, urinary tract infection,
azotemia, acute renal failure, tubular abnormalities including acute
tubular
necrosis, renal tubular acidosis, glucosuria.
Behavorial:
Sedation, lethargy,
hyperactivity, restlessness, aggressiveness.
Hematologic:
Immune-mediated hemolytic
anemia, immune-mediated thrombocytopenia,
blood loss anemia, epistaxis.
Dermatologic:
Pruritus, increased shedding,
alopecia, pyotraumatic moist dermatitis
(hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis.
Immunologic or
hypersensitivity:
Facial swelling, hives, erythema.
In rare situations, death
has been associated with some of the adverse reactions
listed above.
To report a suspected adverse reaction call 1-888-708-3326.
What are the possible side effects that may occur in my
dog
during Novox Caplets therapy?
Carprofen, like other drugs,
may cause some side effects. Serious but
rare side effects have been reported in dogs taking NSAIDs, including
Novox Caplets. Serious side effects can occur with or without warning
and in rare situations result in death.
The most common NSAID-related side effects generally
involve the
stomach (such as bleeding ulcers), and liver or kidney problems. Look
for the following side effects that can indicate your dog may be having
a problem with Novox Caplets or may have another medical problem:
• 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, amount consumed)
• Change in urination habits (frequency, color, or smell)
• Change in skin (redness, scabs, or scratching)
It is important to stop therapy and contact your veterinarian
immediately
if you think your dog has a medical problem or side effect from Novox
Caplets therapy. If you have additional questions about possible side
effects, talk to your veterinarian.
Can Novox Caplets be given with other medicines?
Novox Caplets should not be
given with other NSAIDs (for example,
aspirin, etodolac) or steroids (for example, cortisone, prednisone,
dexamethasone, triamcinolone).
Tell your veterinarian about all medicines you have given your dog in
the past, and any medicines that you are planning to give with Novox
Caplets. This should include other medicines that you can get without
a prescription. 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 Novox Caplets?
Contact your veterinarian
immediately if your dog eats more than the
prescribed amount of Novox Caplets.
What else should I know
about Novox Caplets?
This page provides a summary
of information about Novox Caplets. If
you have any questions or concerns about Novox Caplets or
osteoarthritis pain, talk to your veterinarian.
As with all prescribed medicines, Novox Caplets should only be given
to the dog for which it was prescribed. It should be given to your dog
only for the condition for which it was prescribed.
It is important to periodically discuss your dog’s response to Novox
Caplets at regular check ups. Your veterinarian will best determine if
your dog is responding as expected and if your dog should continue
receiving Novox Caplets.
STORAGE
Store tablets at controlled
room temperature 15°-30°C (59°-86°F).
HOW SUPPLIED
Novox Caplets 25 mg-Each light orange, convex tablet
debossed with “G” on one
side and bisected on the other side with “33” on the
left and “11” on the right of
the bisect.
Bottles of 60 . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . .NDC 50989-740-50
Bottles of 100 . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . .NDC 50989-740-51
Bottles of 180 . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . .NDC 50989-740-84
Novox Caplets 75 mg-Each light orange, convex tablet
debossed with “G” on one
side and bisected on the other side with “33” on the
left and “22” on the right of
the bisect.
Bottles of 60 . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . .NDC 50989-741-50
Bottles of 180 . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . .NDC 50989-741-84
Novox Caplets 100 mg-Each light orange, convex tablet
debossed with “G” on one
side and bisected on the other side with “33” on the
left and “33” on the right of
the bisect.
Bottles of 60 . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . .NDC 50989-742-50
Bottles of 180 . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . .NDC 50989-742-84
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