New Zealand - English - Medsafe (Medicines Safety Authority)
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Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about Celecoxib Pfizer. It
does not contain all the available
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Celecoxib
Pfizer against the benefits it is
expected to have for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Read this leaflet carefully before
you start Celecoxib Pfizer and
keep it with the medicine.
You may need to read it again.
What Celecoxib Pfizer
is used for
Celecoxib Pfizer is used to treat joint
pain, tenderness, swelling and
rheumatoid arthritis and
ankylosing spondylitis, a chronic
inflammatory rheumatic disorder
that primarily affects, but is not
limited to, the spine.
Celecoxib Pfizer is also used to
relieve short-term pain, in cases such
menstrual cramps (period pain)
Celecoxib Pfizer contains celecoxib
and belongs to a group of medicines
called Coxibs which are used to
relieve pain and inflammation in a
number of conditions.
Although Celecoxib Pfizer can
relieve the symptoms of pain and
inflammation, it will not cure your
Your doctor, however, may have
prescribed Celecoxib Pfizer for
Ask your doctor if you have any
questions about why Celecoxib
Pfizer has been prescribed for you.
Celecoxib Pfizer is not approved for
use in children or adolescents under
18 years of age.
This medicine is only available with
a doctor's prescription.
Before you take
When you must not take it
Do not take Celecoxib Pfizer if:
your doctor has told you that
you have severe heart or blood
vessel disease affecting the
circulation in your brain or
you have severe liver problems
Your doctor will decide if your
condition is too severe to take this
you have problems with your
you have had an attack of
asthma, hives, itching, skin rash
or a runny nose after taking
aspirin or Non-steroidal Anti-
inflammatory Drugs (NSAIDs,
medicines used to treat pain
and inflammation), including
other Coxib medicines
Many medicines used to treat
headache, period pain and other
aches and pains contain aspirin or
If you are allergic to aspirin,
NSAIDs, or other Coxib
medicines and use Celecoxib
Pfizer, these symptoms may be
you have an allergy to:
any of the ingredients listed
at the end of this leaflet
sulfonamides, a group of
medicines which include,
for example, certain
antibiotics (if you are not
sure if you are taking one of
these medicines ask your
Symptoms of an allergic reaction to
these medicines may include:
asthma, wheezing or shortness of
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
hives, itching or skin rash
If you are allergic to sulfonamides or
any of the capsule ingredients and
take Celecoxib Pfizer, these
symptoms may be severe.
Ask your doctor or pharmacist if
any of this applies to you:
you are already taking an
you have an ulcer or gastric
you have Irritable Bowel
you have heart failure
the expiry date printed on the
packaging has passed, even
though the capsules may look
If you take this medicine after the
expiry date has passed, it may not
work as well.
the packaging is torn or shows
signs of tampering.
If you are not sure if you should be
taking Celecoxib Pfizer, talk to your
Before you start to take it
You must tell your doctor if:
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you currently have diabetes,
high blood pressure, high
cholesterol levels, heart failure
or have a history of heart
problems or stroke, or
problems with the circulation in
you have any allergies to:
any other medicines
any other substances such as
foods, dyes or preservatives.
you are pregnant or intend to
Related medicines, NSAIDs, have
been associated with reversible
infertility in some women.
Use of NSAIDs in early
pregnancy can increase the risk of
There is no information on the
use of Celecoxib Pfizer during
Celecoxib Pfizer may affect your
developing baby if taken during
Celecoxib Pfizer use is not
recommended in pregnancy
unless your doctor considers it
essential. If you are taking
Celecoxib Pfizer while pregnant,
you may need to be closely
monitored by your doctor.
Discuss any questions you may
have with your doctor.
you are breast-feeding or
intend to breast-feed
Small amounts of celecoxib
passes into breast milk, therefore,
taking Celecoxib Pfizer during
breast-feeding should be
discussed with your doctor.
you have any other health
liver or kidney problems
asthma, hives, itching, skin
rash or a runny nose
high blood pressure or fluid
peptic ulcer (i.e. stomach or
duodenal ulcer), a recent
history of one, or have had
peptic ulcers before
vomiting blood or material
that looks like coffee
bleeding from the rectum
(back passage), have black
sticky bowel motions
(stools) or bloody diarrhoea.
you are taking Celecoxib Pfizer
together with any medicines
used to treat high blood
pressure and some other heart
problems such as ACE
inhibitors, angiotensin receptor
antagonists, beta blockers and
diuretics (also called fluid or
When taken together these
medicines can cause kidney
you drink large amounts of
you are a smoker
you currently have an infection.
If you are given Celecoxib Pfizer
while you have an infection, it
may hide some of the signs of an
If you have not told your doctor or
pharmacist about these things, tell
them before you start taking
Taking other medicines
Tell your doctor or your
pharmacist if you are taking any
other medicines, including
medicines you buy without a
prescription from a pharmacy,
supermarket or health food shop.
Some medicines and Celecoxib
Pfizer may interfere with each
other. These include:
any medicines used to treat high
blood pressure and some other
heart problems such as ACE
inhibitors, angiotensin receptor
antagonists, beta blockers or
diuretics (also called fluid or
digoxin, a medicine used to treat
abnormal heart beats and some
other heart problems
fluconazole, an antifungal agent
lithium, a medicine used to treat
some types of depression
warfarin or similar medicines
including Eliquis (apixaban),
Xarelto (rivaroxaban) or Pradaxa
(dabigatran), medicines used to
stop blood clots
aspirin or salicylates, medicines
used to treat pain
antacids, medicines used to treat
some medicines used to treat
methotrexate, a medicine used to
treat arthritis and some cancers
cyclosporin, a medicine used to
suppress the immune system
certain medicines used to treat
pain and inflammation called
inflammatories (NSAIDs) or
Your doctor may need to adjust the
dosage of these medicines, or provide
additional advice if you are also
taking Celecoxib Pfizer.
How to take Celecoxib
Follow all directions given to you
by your doctor and pharmacist
They may differ from the
information in this leaflet.
If you do not understand the
instructions on the label, ask your
doctor or pharmacist for help.
How much to take
200 mg once daily or 100 mg twice
daily, or as directed by your doctor.
100 mg twice daily or 200 mg twice
100 mg twice daily or 200 mg once
daily, or as directed by your doctor.
Management of short-term pain
and menstrual cramps (period
400 mg as a single dose on the first
day and 200 mg once daily on
following days. You may take an
additional 200 mg on the following
days if needed. You may take
Celecoxib Pfizer for up to 5 days.
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How to take it
Swallow the capsules whole with a
glass of fluid. Celecoxib Pfizer can
be taken with or without food.
How long to take it
Depending on your condition, you
may need Celecoxib Pfizer for a few
days or for longer periods.
Celecoxib Pfizer will not cure your
condition but should help control
pain, swelling and stiffness.
Keep taking Celecoxib Pfizer for as
long as your doctor advises.
Do not exceed the dose
recommended by your doctor.
Your risk of developing heart or
blood vessel diseases (e.g., heart
attack) may increase with dose and
duration of use even if you don't have
a history of heart or blood vessel
If you need to take Celecoxib
Pfizer for a long time see your
doctor for regular check-ups so
your doctor can monitor your
condition and treatment.
If you forget to take it
If it is almost time for your next
dose, skip the dose you missed and
take your next dose when you are
meant to. Otherwise, take it as
soon as you remember, then go
back to taking your capsules as you
Do not take a double dose to make
up for the dose you missed.
If you take too much
Immediately telephone your doctor
or Poisons Information Centre
(telephone 0800 POISON or 0800
764 766) for advice, or go to
Accident and Emergency at your
nearest hospital if you think you or
anyone else may have taken too
much Celecoxib Pfizer. Do this
even if there are no signs of
discomfort or poisoning. You may
need urgent medical attention.
If you take too much Celecoxib
Pfizer, you may feel tired, drowsy,
sick, vomit, and have stomach pain.
You may also have difficulty
breathing and feel faint.
While you are taking it
Things you must do
If you become pregnant while
taking Celecoxib Pfizer, tell your
If you are about to start any new
medicines, tell your doctor and
pharmacist that you are taking
Tell all doctors, dentists and
pharmacists who are treating you
that you are taking Celecoxib
If you develop any skin rash (e.g.
hives, spots) while being treated
with Celecoxib Pfizer, contact your
The onset of these events, if they
occur, can occur at any time, but
most often occur in the first month of
Things you must not do
Do not give Celecoxib Pfizer to
anyone else, even if they have the
same symptoms or condition as
Do not take Celecoxib Pfizer to
treat any other complaints unless
your doctor tells you to.
Check with your doctor as soon as
possible if you have any problems
while taking Celecoxib Pfizer, even
if you do not think the problems
are connected with the medicine or
are not listed in this leaflet.
Like other medicines, Celecoxib
Pfizer can cause some side effects. If
they occur, most are likely to be
minor and temporary.
Ask your doctor or pharmacist any
questions you may have.
Tell your doctor if you notice any
of the following:
stomach pain, diarrhoea,
swollen hands, ankles and feet,
unexplained weight gain
sore throat, runny nose, sinusitis,
upper respiratory tract infection.
Tell your doctor immediately if
you notice any of the following:
skin rash, including hives, raised
red, itchy spots
blistering and bleeding in the
lips, eyes, mouth, nose and
swelling, blistering or peeling of
the skin, which may be
accompanied by fever, chills,
headache, sore throat, diarrhoea,
aching joints and muscles
other signs of allergic reaction
such as wheezing, swelling of
the face, lips, mouth, tongue or
throat which may cause
difficulty in swallowing or
collapse or fainting, shortness of
breath or tiredness, irregular
heartbeat, chest pain, swollen or
sore leg veins
severe stomach or throat pain,
vomiting blood or black sticky
bleeding or bruising more than
usual, reddish or purple blotches
under the skin
nausea, lethargy, itchiness, flu-
like symptoms or yellowing of
the skin or eyes (jaundice)
signs of anaemia such as
tiredness, being short of breath
and looking pale
loss or deterioration of hearing
redness, irritation or watering of
experience sensations with any of
the senses (sight, sound, touch,
taste or feel) which may not be
severe or persistent headache,
fever, stiff neck, sensitivity to
light and vomiting.
sudden severe headache, loss of
consciousness, sudden tingling,
numbness or paralysis on one side
the face, arm, leg or body,
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understanding, reading or writing,
loss of coordination or balance.
These are serious side effects. You
may need urgent medical attention.
Not all of these side effects have
been reported with Celecoxib Pfizer
but have been seen with similar
Other side effects not listed above
may occur in some people.
Do not be alarmed by this list of
possible side effects.
You may not get any of them.
Tell your doctor if you notice
anything else that is making you
feel unwell, even if it is not on this
After taking Celecoxib
Keep your capsules where young
children cannot reach them.
A locked cupboard at least 1½ metres
above the ground is a good place to
Keep Celecoxib Pfizer in a cool,
dry place where the temperature
stays at or below 25°C. Do not
store it, or any other medicine, in
the bathroom or near a sink. Do
not leave it in the car or on
Heat and dampness can destroy some
Keep your capsules in their blister
pack until it is time to take them.
If you take the capsules out of their
container they may not keep well.
If your doctor tells you to stop
taking Celecoxib Pfizer, or the
capsules have passed their expiry
date, ask your pharmacist what to
do with any left over.
What it looks like
Celecoxib Pfizer 100 mg -
opaque, white capsules with two
blue bands marked 7767 and
The 100 mg capsules come in
blister packs of 60.
Celecoxib Pfizer 200 mg -
opaque, white capsules with two
gold bands marked 7767 and
The 200 mg capsules come in
blister packs of 30.
The active ingredient in Celecoxib
Pfizer is celecoxib.
Celecoxib Pfizer 100 mg –
100 mg celecoxib/capsule
Celecoxib Pfizer 200 mg –
200 mg celecoxib/capsule
Celecoxib Pfizer 400 mg –
400 mg celecoxib/capsule.
sodium lauryl sulphate
iron oxide yellow CI 77492
(200 mg and 400 mg capsules)
indigo carmine CI 73015
(100 mg capsule)
brilliant blue FCF CI 42090
aluminium lake (400 mg
Celecoxib Pfizer does not contain
sucrose, gluten, tartrazine or other
Celecoxib Pfizer is supplied in New
Pfizer New Zealand Limited
PO Box 3998
Auckland, New Zealand.
Toll Free number: 0800 736 363.
This document was prepared in
© Pfizer Australia Pty Ltd 2020
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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
100 mg, 200 mg and 400 mg capsules.
2. QUALITATIVE AND QUANTITATIVE COMPOISTION
Celecoxib Pfizer 100 mg contains 100 mg celecoxib.
Celecoxib Pfizer 200 mg contains 200 mg celecoxib.
Celecoxib Pfizer 400 mg contains 400 mg celecoxib.
Excipient(s) with Known Effect
Each 100 mg, 200 mg and 400 mg capsule contains 149.7 mg, 49.8 mg and 99.6 mg lactose
monohydrate, respectively. For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
100 mg capsules: Opaque, white capsules with 2 blue bands marked 7767 and 100.
200 mg capsules: Opaque, white capsules with 2 gold bands marked 7767 and 200.
400 mg capsules: Opaque, white capsules with 2 green bands marked 7767 and 400.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and
For the management of acute pain and treatment of primary dysmenorrhoea in adults.
The decision to prescribe a selective cyclooxygenase 2 (COX-2) inhibitor should only be made:
if non-pharmacological interventions and simple analgesic therapies have been tried and
found to lack analgesic efficacy or to have unacceptable adverse effects in the individual
after assessment of the individual patient’s overall risks.
As the cardiovascular (CV) risks of the selective COX-2 inhibitors may increase with dose and
duration of exposure, the shortest duration possible and the lowest effective daily dose should
be used. Patients on long-term treatment should be reviewed regularly, such as every three
months, with regards to efficacy, risk factors and ongoing need for treatment.
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4.2 Dose and Method of Administration
All patients taking celecoxib should commence therapy at the lowest recommended dose, and
be titrated to the lowest dose compatible with effective control of symptoms for the shortest
Patients on long-term treatment should be reviewed regularly with regards to efficacy, risk
factors and ongoing need for treatment.
The following doses can be given without regard to timing of meals (also see section 5.2,
Absorption for full description of food effect).
The recommended daily dose is 200 mg taken once daily (OD) or in two divided doses. A dose
of 200 mg twice daily (BD) may be used if needed.
The recommended daily dose is 200 mg - 400 mg taken in two divided doses.
The recommended daily dose is 200 mg taken OD or in two divided doses. Some patients may
benefit from a total daily dose (TDD) of 400 mg.
Management of Acute Pain and Treatment of Primary Dysmenorrhoea
The recommended dose is 400 mg as a single dose on the first day, followed by 200 mg OD
on subsequent days. Patients may be instructed to take an additional dose of 200 mg on any
given day, if needed. The maximum recommended dose is 400 mg per day. Celecoxib Pfizer
can be administered up to 2 hours prior to surgery.
Elderly (>65 years old)
No dosage adjustment is generally necessary. However, for elderly patients with a lower than
average body weight (<50 kg), it is advisable to initiate therapy at the lowest recommended
Children and Adolescents
Celecoxib Pfizer is not approved for use in patients under 18 years of age.
No dosage adjustment is necessary in patients with mild hepatic impairment. In arthritis
patients with moderate hepatic impairment, Celecoxib Pfizer should be introduced at the lowest
There is no clinical experience in patients with severe hepatic impairment. Therefore, the use
of Celecoxib Pfizer in patients with severe hepatic impairment (Child-Pugh score
contraindicated (see section 4.3, 4.4 and 5.2).
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No dosage adjustment is necessary in patients with mild or moderate renal impairment. There
is no clinical experience in patients with severe renal impairment (see
ection 4.3 and 4.4).
CYP2C9 Poor Metabolisers
Patients who are known, or suspected to be CYP2C9 poor metabolisers based on previous
history/experience with other CYP2C9 substrates should be administered celecoxib with
caution. Consider starting treatment at half the lowest recommended dose (see section 4.5 and
Method of Administration
Oral use. Swallow the capsules whole with a glass of fluid.
Known hypersensitivity to Celecoxib Pfizer or any of the excipients contained in the Celecoxib
Pfizer capsules (see list in section 6.1).
Demonstrated allergic-type reactions to sulfonamides.
Celecoxib Pfizer should not be given to patients who have experienced asthma, urticaria, or
allergic-type reactions after taking acetylsalicylic acid (ASA) or other non-steroidal anti-
inflammatory drugs (NSAIDs), including other COX-2 specific inhibitors. Severe, rarely fatal,
anaphylactoid reactions to NSAIDs have been reported in such patients (see section 4.4,
Celecoxib Pfizer should not be used with other NSAIDs because of the absence of any evidence
demonstrating synergistic benefits and the potential for additive adverse reactions.
Celecoxib Pfizer is contraindicated for the peri-operative treatment of pain in patients
undergoing coronary artery bypass graft (CABG) surgery (see section 4.4, Cardiovascular
Celecoxib Pfizer is contraindicated in:
myocardial infarction (MI) or stroke within 3 months
Patients with active peptic ulceration or gastrointestinal (GI) bleeding
Patients with estimated
creatinine clearance <30 mL/min
Patients with congestive heart failure (NYHA II-IV).
Patients with severe hepatic impairment (Child-Pugh
10). See section 4.2 and 5.2.
Child-Pugh is a classification of the severity of liver disease.
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Prothrombin time (seconds over control)
Modified Child-Pugh classification of the severity of liver disease according to the degree of
ascites, the plasma concentrations of bilirubin and albumin, the prothrombin time, and the
degree of encephalopathy. A total score of 5-6 is considered grade A (well-compensated
(decompensated disease). These grades correlate with one- and two-year patient survival:
grade A - 100 and 85 percent; grade B - 80 and 60 percent; and grade C - 45 and 35 percent.
4.4 Special Warnings and Precautions for Use
COX-2 inhibitors, including celecoxib, have been associated with an increased risk of serious
CV thrombotic adverse events, myocardial infarction and stroke, which can be fatal (see section
5.1, Clinical Efficacy and Safety, Cardiovascular Safety).
All NSAIDs, both COX-2 selective and non-selective, may cause an increased risk of serious
CV thrombotic events. This risk may increase with dose and duration of use. The relative
increase of this risk appears to be similar in those with or without known CV disease or CV
risk factors. However, patients with CV disease or CV risk factors may be at greater risk in
terms of absolute incidence, due to their increased rate at baseline.
Two large, controlled clinical trials of a different COX-2 selective inhibitor for the treatment
of pain in the first 10-14 days following CABG surgery found an increased incidence of
myocardial infarction and stroke. In the absence of comparable data with celecoxib, it may be
assumed that patients at high risk of CV disease (including patients with diabetes, ischaemic
heart disease, cardiac failure, hyperlipidaemia, hypertension, or smokers) who are undergoing
any major surgery may face an increased risk of developing a CV event. Patients with
cerebrovascular disease as well as patients at high risk for CV disease including those with
significant and multiple risk factors for CV events should only be treated with celecoxib after
careful consideration of the patient’s overall risk and the potential risks and benefits of
alternative analgesic therapies. See section 4.3.
To minimise the potential risk for an adverse CV event in patients treated with celecoxib, the
lowest effective dose should be used for the shortest duration possible (see section 4.2).
prescribing celecoxib for patients at high risk of CV adverse events. Physicians and patients
should remain alert for such events, even in the absence of previous CV symptoms. Patients
should be informed about the signs and symptoms of serious CV toxicity and the steps to take
if they occur. Celecoxib is not a substitute for CV prophylaxis because of its lack of effect on
platelets; therefore, concurrent anti-platelet therapies should not be discontinued. There is no
evidence that concurrent use of aspirin decreases the risk of CV adverse events associated with
COX-2 inhibitors, including celecoxib.
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Infrequently, serious gastrointestinal (GI) toxicity such as bleeding, ulceration, and upper and
lower GI perforation (including perforations of the stomach or intestine) has been observed in
patients treated with Celecoxib Pfizer.
Celecoxib Pfizer (celecoxib) exhibited a low incidence of gastroduodenal ulceration and
serious clinically significant GI events within clinical trials (see section 5.1, Clinical Efficacy
and Safety, Special Studies).
Serious GI toxicity, such as peptic ulceration, perforation and bleeding, sometimes severe and
occasionally fatal, can occur at any time, with or without warning symptoms, in patients treated
with NSAIDs. Minor upper GI problems, such as dyspepsia, are common, and may also occur
at any time during NSAID therapy. Therefore, physicians should remain alert for ulceration
and bleeding in patients treated with NSAIDs, even in the absence of previous GI tract
symptoms. Patients should be informed about the signs and/or symptoms of serious GI toxicity
and the steps to take if they occur.
Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is
symptomatic. It has been demonstrated that upper GI ulcers, gross bleeding or perforation,
caused by NSAIDs, appear to occur in approximately 1% of patients treated for 3-6 months,
and in about 2-4% of patients treated for one year. These trends continue thus, increasing the
likelihood of developing a serious GI event at some time during the course of therapy.
However, even short-term therapy is not without risk.
Patients most at risk of developing GI complications with NSAIDs are elderly patients; patients
with CV disease; patients using concomitant anti-platelet drugs (such as aspirin, even at low
doses) or corticosteroids; patients who consume alcohol; or patients with a prior history of GI
pharmacoepidemiological studies have identified several other co-therapies or co-morbid
conditions that may increase the risk for GI bleeding such as: treatment with anticoagulants,
longer duration of NSAID therapy, smoking and poor general health status. Celecoxib Pfizer
should be prescribed with extreme caution in these patients. Physicians and patients should
remain alert for ulceration and GI bleeding, even in the absence of symptoms.
Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore
special care should be taken in treating this population. To minimise the potential risk of an
ulcer complication, the lowest effective dose of Celecoxib Pfizer should be used for the shortest
possible duration. For high risk patients, alternate therapies that do not involve NSAIDs should
Studies have shown that patients with a history of peptic ulcer disease and/or GI bleeding and
who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed than
patients with neither of these risk factors. It is unclear how this finding applies to Celecoxib
Pfizer. There is no definitive evidence that the concomitant administration of histamine H2-
receptor antagonists and/or antacids will either prevent the occurrence of GI side effects or
allow the continuation of Celecoxib Pfizer if these adverse reactions appear.
As with NSAIDs in general, anaphylactoid reactions have occurred in patients without known
prior exposure to Celecoxib Pfizer. In post-marketing experience, rare cases of anaphylactoid
reactions and angioedema have been reported in patients receiving Celecoxib Pfizer. Celecoxib
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Pfizer should not be given to patients with the aspirin triad. This symptom complex typically
occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who
exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see section
4.3 and 4.4, Pre-existing Asthma). Emergency help should be sought in cases where an
anaphylactoid reaction occurs.
Serious Skin Reactions
Serious skin reactions, some of them fatal, including drug reaction with eosinophilia and
systemic symptoms (DRESS syndrome), exfoliative dermatitis, Stevens-Johnson syndrome,
and toxic epidermal necrolysis, have been reported very rarely in association with the use of
celecoxib. Patients appear to be at highest risk for these events early in the course of therapy;
the onset of the event occurring in the majority of cases within the first month of treatment.
Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any
other sign of hypersensitivity.
As with all NSAIDs, celecoxib can lead to the onset of new hypertension or worsening of pre-
existing hypertension, either of which may contribute to the increased incidence of CV events.
NSAIDs, including celecoxib, should be used with caution in patients with hypertension.
Blood pressure should be monitored closely during the initiation of therapy with celecoxib and
throughout the course of therapy.
Use with ACE Inhibitors, Angiotensin Receptor Antagonists, Anti-inflammatory Drugs
and Thiazide Diuretics
The use of an ACE inhibiting drug (ACE inhibitor or angiotensin receptor antagonist), and an
anti-inflammatory drug (NSAID or COX-2 inhibitor) and a thiazide diuretic at the same time,
increases the risk of renal impairment. This includes use in fixed-combination products
containing more than one class of drug. Concomitant use of all three classes of these
medications should be accompanied by increased monitoring of serum creatinine, particularly
at the initiation of the treatment. The concomitant use of drugs from these three classes should
be used with caution particularly in elderly patients or those with pre-existing renal impairment.
Use with Oral Anticoagulants
The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding and
should be given with caution (see section 4.5, Oral Anticoagulants).
Use with Drugs Metabolised by CYP2D6
Celecoxib has shown to be a moderately potent CYP2D6 inhibitor. For drugs that are
metabolised by CYP2D6, a dose reduction during initiation of celecoxib treatment or a dose
Dextromethorphan and Metoprolol).
Use with Other NSAIDs
The concomitant use of celecoxib and a non-aspirin NSAID should be avoided.
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking
NSAIDs, and notable elevations of ALT or AST (approximately three or more times the upper
limit of normal) have been reported in approximately 1% of patients in clinical trials with
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NSAIDs. These laboratory abnormalities may progress, may remain unchanged, or may be
transient with continuing therapy.
Rare cases of severe hepatic reactions, including jaundice, fatal fulminant hepatitis, liver
necrosis and hepatic failure (some with fatal outcome or requiring liver transplant), have been
reported with NSAIDs, including Celecoxib Pfizer (see section 4.8).
In controlled clinical trials of Celecoxib Pfizer, the incidence of borderline elevations of liver
tests was 6% for Celecoxib Pfizer and 5% for placebo, and approximately 0.2% of patients
taking Celecoxib Pfizer and 0.3% of patients taking placebo had notable elevations of ALT and
Physician and patients should remain alert for hepatotoxicity. Patients should be informed
about the signs and/or symptoms of hepatotoxicity. A patient with symptoms and/or signs
suggesting liver dysfunction (e.g., nausea, fatigue, lethargy, pruritis, jaundice, abdominal
tenderness in the right upper quadrant and “flu-like” symptoms), or in whom an abnormal liver
test has occurred, should be monitored carefully for evidence of the development of a more
severe hepatic reaction while on therapy with Celecoxib Pfizer.
manifestations occur (e.g., eosinophilia, rash, etc.), Celecoxib Pfizer should be discontinued.
The incidence of elevations in ALT and/or AST may be increased in patients treated with
celecoxib at doses greater than 400 mg daily.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal
injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a
compensatory role in the maintenance of renal perfusion. In these patients, administration of
a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily,
in renal blood flow, which may precipitate overt renal decompensation. Such patients should
be carefully monitored while receiving treatment with celecoxib. Patients at greatest risk of
this reaction are those with impaired renal function, heart failure, liver dysfunction, those
taking diuretics and ACE inhibitors (see section 4.4, Use with ACE Inhibitors, Angiotensin
Receptor Antagonists, Anti-inflammatory Drugs and Thiazide Diuretics), and the elderly.
Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Clinical trials with Celecoxib Pfizer have shown renal effects similar to those observed with
comparator NSAIDs. The relative roles of cyclooxygenase 1 (COX-1) and COX-2 in renal
physiology are not completely understood. Celecoxib reduces the urinary excretion of PGE
(a prostacyclin metabolite) but leaves serum thromboxane B
urinary excretion of 11-dehydro-TXB
, a thromboxane metabolite (both COX-1 products)
Caution should be used when initiating treatment with Celecoxib Pfizer in patients with
considerable dehydration. It is advisable to rehydrate patients first and then start therapy with
No information is available regarding the use of Celecoxib Pfizer in patients with advanced
kidney disease. Therefore, treatment with Celecoxib Pfizer is not recommended in these
patients. If Celecoxib Pfizer therapy must be initiated, close monitoring of the patient's kidney
function is advisable.
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Anaemia is sometimes seen in patients receiving Celecoxib Pfizer. In controlled clinical trials
the incidence of anaemia was 0.6% with Celecoxib Pfizer and 0.4% with placebo. Patients on
long-term treatment with Celecoxib Pfizer should have their haemoglobin or haematocrit
checked if they exhibit any signs or symptoms of anaemia or blood loss. Celecoxib Pfizer
does not generally affect platelet counts, prothrombin time (PT), or partial thromboplastin time
(PTT), and does not appear to inhibit platelet aggregation at indicated dosages (see section 5.1,
Special Studies, Platelet Function).
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with
aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal.
Since cross reactivity, including bronchospasm, between aspirin and other NSAIDs has been
reported in such aspirin-sensitive patients, Celecoxib Pfizer should not be administered to
patients with this form of aspirin sensitivity and should be used with caution in patients with
Fluid Retention and Oedema
Fluid retention and oedema have been observed in some patients taking Celecoxib Pfizer (see
section 4.8). As with all NSAIDs, celecoxib may exacerbate pre-existing hypertension, cardiac
failure or oedema, and the treatment of these conditions may be compromised. Therefore,
Celecoxib Pfizer should be used with caution in patients with fluid retention, hypertension,
predisposing to, or worsened by, fluid retention including those taking diuretic treatment or
otherwise at risk of hypovolaemia. Patients with pre-existing congestive heart failure or
hypertension should be closely monitored.
Use in Patients Being Treated with Corticosteroids
corticosteroid-responsive illness. Patients on prolonged corticosteroid therapy should have
their therapy tapered slowly if a decision is made to discontinue corticosteroids.
Use in Patients with Inflammatory Bowel Disease (IBD)
Short-term exposure of celecoxib to patients with ulcerative colitis (UC) in remission has not
shown an exacerbation of IBD in spondyloarthropathies, but the implications of longer term
exposure remain unknown. NSAIDs have been associated with an exacerbation of IBD
associated with spondyloarthropathies.
Effects on Laboratory Tests
Because serious GI tract ulcerations and bleeding can occur without warning symptoms,
physicians should monitor for signs or symptoms of GI bleeding.
During the controlled clinical trials, there was an increased incidence of hyperchloremia in
abnormalities that occurred more frequently in the patients receiving celecoxib included
hypophosphatemia, and elevated BUN. These laboratory abnormalities were also seen in
patients who received comparator NSAIDs in these studies. The clinical significance of these
abnormalities has not been established.
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By reducing inflammation, celecoxib may diminish the utility of diagnostic signs, such as
fever, in detecting infections.
4.5 Interaction with Other Medcines and Other Forms of Interaction
The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding and
should be given with caution. Oral anticoagulants include warfarin/coumarin-type and novel
oral anticoagulants (e.g., apixaban, dabigatran, and rivaroxaban). In patients on concurrent
predominantly in elderly have been reported. Because increases in prothrombin time (INR)
warfarin/coumarin-type anticoagulant after initiating treatment with celecoxib or changing the
dose. If INR increases, it may be sufficient to reduce the dose of the oral anticoagulant in order
to manage the interaction (see section 4.4, Gastrointestinal Effects).
Celecoxib Pfizer can be used with low dose aspirin. However, concomitant administration of
aspirin with Celecoxib Pfizer may result in an increased rate of GI ulceration or other
complications, compared to use of Celecoxib Pfizer alone (see section 5.1, Special Studies,
Upper Gastrointestinal Complications). Because of its lack of platelet effects, Celecoxib Pfizer
is not a substitute for aspirin for CV prophylaxis.
Angiotensin II Antagonists, Diuretics and Beta-blockers
Inhibition of prostaglandins may diminish the effect of antihypertensives including ACE
inhibitors, angiotensin II antagonists (also known as angiotensin receptor blockers or ARBs)
diuretics and beta-blockers. This interaction should be given consideration in patients taking
Celecoxib Pfizer concomitantly with these drugs.
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with
deterioration of renal function, including possible acute renal failure. These effects are usually
reversible. Therefore, the concomitant administration of these drugs should be done with
caution. Patients should be adequately hydrated and the clinical need to monitor the renal
function should be assessed at the beginning of the concomitant treatment and periodically
In a clinical study, approximately half of patients who received the ACE inhibitor, lisinopril,
in combination with celecoxib were unresponsive to lisinopril at the final clinic visit, compared
to under one third of patients who received lisinopril in combination with placebo; and this
difference was statistically significant.
nephrotoxicity with ciclosporin.
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Effects of Celecoxib on Other Drugs
Clinical pharmacokinetics study and
studies indicate that celecoxib, although not a
substrate, is an inhibitor of cytochrome P450 2D6. Therefore, there is a potential for an
drug interaction with drugs that are metabolised by P450 2D6.
Dextromethorphan and Metoprolol
Concomitant administration of celecoxib resulted in increases in plasma concentrations of
dextromethorphan and metoprolol (CYP2D6 substrates). These increases are due to celecoxib
inhibition to the CYP2D6 substrate metabolism via CYP2D6. Therefore, the dose of drugs
which are CYP2D6 substrate may need to be reduced when treatment with celecoxib is initiated
or increased when treatment with celecoxib is terminated (see section 4.4, Use with Drugs
Metabolised by CYP2D6).
Concomitant use of Celecoxib Pfizer with digoxin has been reported to increase serum
concentration and prolong half-life of digoxin. During concomitant use of Celecoxib Pfizer
and digoxin, serum digoxin levels should be monitored.
Celecoxib Pfizer did not have a significant effect on the pharmacokinetics of methotrexate.
Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity
Celecoxib Pfizer and methotrexate, patients should be monitored for methotrexate toxicity.
In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased
approximately 17% in subjects receiving lithium 450 mg BD with Celecoxib Pfizer 200 mg
BD as compared to subjects receiving lithium alone. Patients on lithium treatment should be
closely monitored when Celecoxib Pfizer is introduced or withdrawn.
The effect of celecoxib on the pharmacokinetics and/or pharmacodynamics of glibenclamide
and tolbutamide has been studied and clinically important interactions have not been found.
Effects of Other Drugs on Celecoxib
Concomitant administration of celecoxib with inhibitors of CYP2C9 can lead to increases in
plasma concentrations of celecoxib. Therefore, a dose reduction of celecoxib may be necessary
when celecoxib is co-administered with CYP2C9 inhibitors.
Concomitant administration of celecoxib with inducers of CYP2C9 (such as rifampicin,
carbamazepine and barbiturates) can lead to decreases in plasma concentrations of celecoxib.
Therefore, a dose increase of celecoxib may be necessary when celecoxib is co-administered
with CYP2C9 inducers.