Celecoxib Pfizer

New Zealand - English - Medsafe (Medicines Safety Authority)

Buy It Now

Active ingredient:
Celecoxib 200 mg;  
Available from:
Upjohn New Zealand ULC
INN (International Name):
Celecoxib 200 mg
Dosage:
200 mg
Pharmaceutical form:
Capsule
Composition:
Active: Celecoxib 200 mg   Excipient: Croscarmellose sodium Gelatin Lactose monohydrate Magnesium stearate Povidone Sodium laurilsulfate
Units in package:
Blister pack, physican sample pack, 2 capsules
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Pfizer Pharmaceuticals LLC
Therapeutic indications:
Symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. For the management of acute pain and treatment of primary dysmenorrhoea in adults. The decision to prescribe a selective 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 patient, and · after assessment of the individual patient's overall risks. As the cardiovascular 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.
Product summary:
Package - Contents - Shelf Life: Blister pack, physican sample pack - 2 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, physican sample pack - 10 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Aluminium foil or PVC/Aclar-Aluminium foil - 30 capsules - 36 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-5892/1a
Authorization date:
1998-09-03

CELECOXIB PFIZER

Page 1 of 4

Celecoxib Pfizer

celecoxib

(sell-e-cox-ib)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Celecoxib Pfizer. It

does not contain all the available

information.

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

stiffness in:

osteoarthritis,

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)

following surgery

dental 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

condition.

Your doctor, however, may have

prescribed Celecoxib Pfizer for

another purpose.

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

Celecoxib Pfizer

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

limbs

you have severe liver problems

Your doctor will decide if your

condition is too severe to take this

medicine.

you have problems with your

kidney function

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

an NSAID.

If you are allergic to aspirin,

NSAIDs, or other Coxib

medicines and use Celecoxib

Pfizer, these symptoms may be

severe.

you have an allergy to:

celecoxib

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

Pharmacist).

Symptoms of an allergic reaction to

these medicines may include:

asthma, wheezing or shortness of

breath

swelling of the face, lips or

tongue which may cause

difficulty in swallowing or

breathing

hives, itching or skin rash

fainting.

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

NSAID

you have an ulcer or gastric

bleeding

you have Irritable Bowel

Disease

you have heart failure

the expiry date printed on the

packaging has passed, even

though the capsules may look

alright

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

doctor

.

Before you start to take it

You must tell your doctor if:

CELECOXIB PFIZER

Page 2 of 4

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

your limbs

you have any allergies to:

any other medicines

any other substances such as

foods, dyes or preservatives.

you are pregnant or intend to

become pregnant

Related medicines, NSAIDs, have

been associated with reversible

infertility in some women.

Use of NSAIDs in early

pregnancy can increase the risk of

spontaneous abortion.

There is no information on the

use of Celecoxib Pfizer during

pregnancy.

Celecoxib Pfizer may affect your

developing baby if taken during

pregnancy.

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

problems including:

liver or kidney problems

asthma, hives, itching, skin

rash or a runny nose

high blood pressure or fluid

retention

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

grounds

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

water tablets)

When taken together these

medicines can cause kidney

problems.

you drink large amounts of

alcohol

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

infection.

If you have not told your doctor or

pharmacist about these things, tell

them before you start taking

Celecoxib Pfizer.

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

water tablets)

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

indigestion

some medicines used to treat

diabetes

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

non-steroidal anti-

inflammatories (NSAIDs) or

(cortico) steroids.

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

Pfizer

Follow all directions given to you

by your doctor and pharmacist

carefully.

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

Osteoarthritis

200 mg once daily or 100 mg twice

daily, or as directed by your doctor.

Rheumatoid arthritis

100 mg twice daily or 200 mg twice

daily.

Ankylosing spondylitis

100 mg twice daily or 200 mg once

daily, or as directed by your doctor.

Management of short-term pain

and menstrual cramps (period

pain)

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.

CELECOXIB PFIZER

Page 3 of 4

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

disease.

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

would normally.

Do not take a double dose to make

up for the dose you missed.

If you take too much

(overdose)

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

doctor immediately.

If you are about to start any new

medicines, tell your doctor and

pharmacist that you are taking

Celecoxib Pfizer.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking Celecoxib

Pfizer.

If you develop any skin rash (e.g.

hives, spots) while being treated

with Celecoxib Pfizer, contact your

doctor immediately.

The onset of these events, if they

occur, can occur at any time, but

most often occur in the first month of

treatment.

Things you must not do

Do not give Celecoxib Pfizer to

anyone else, even if they have the

same symptoms or condition as

you.

Do not take Celecoxib Pfizer to

treat any other complaints unless

your doctor tells you to.

Side effects

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,

indigestion, wind

swollen hands, ankles and feet,

unexplained weight gain

dizziness

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

genitals

swelling, blistering or peeling of

the skin, which may be

accompanied by fever, chills,

headache, sore throat, diarrhoea,

aching joints and muscles

muscles weakness

other signs of allergic reaction

such as wheezing, swelling of

the face, lips, mouth, tongue or

throat which may cause

difficulty in swallowing or

breathing

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

bowel motions

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

confusion

redness, irritation or watering of

the eye(s)

experience sensations with any of

the senses (sight, sound, touch,

taste or feel) which may not be

real

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,

CELECOXIB PFIZER

Page 4 of 4

difficulty speaking,

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

medicines.

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

list.

After taking Celecoxib

Pfizer

Storage

Keep your capsules where young

children cannot reach them.

A locked cupboard at least 1½ metres

above the ground is a good place to

store medicines.

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

windowsills.

Heat and dampness can destroy some

medicines.

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.

Disposal

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.

Product description

What it looks like

Celecoxib Pfizer 100 mg -

opaque, white capsules with two

blue bands marked 7767 and

100.

The 100 mg capsules come in

blister packs of 60.

Celecoxib Pfizer 200 mg -

opaque, white capsules with two

gold bands marked 7767 and

200.

The 200 mg capsules come in

blister packs of 30.

Ingredients

Active Ingredient

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.

Other ingredients

lactose monohydrate

sodium lauryl sulphate

povidone

croscarmellose sodium

magnesium stearate

gelatin

titanium dioxide

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

capsule).

Celecoxib Pfizer does not contain

sucrose, gluten, tartrazine or other

azo dyes.

Supplier

Celecoxib Pfizer is supplied in New

Zealand by:

Pfizer New Zealand Limited

PO Box 3998

Auckland, New Zealand.

Toll Free number: 0800 736 363.

This document was prepared in

January 2020.

Registered Trademark

© Pfizer Australia Pty Ltd 2020

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NEW ZEALAND DATA SHEET

1. PRODUCT NAME

Celecoxib Pfizer

®

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

ankylosing spondylitis.

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

patient, and

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

Dose

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

possible period.

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).

Osteoarthritis

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.

Rheumatoid Arthritis

The recommended daily dose is 200 mg - 400 mg taken in two divided doses.

Ankylosing Spondylitis

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.

Special Population

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

dose.

Children and Adolescents

Celecoxib Pfizer is not approved for use in patients under 18 years of age.

Hepatic Impairment

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

recommended dose.

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

10) is

contraindicated (see section 4.3, 4.4 and 5.2).

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Renal Impairment

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

s

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

5.2).

Method of Administration

Oral use. Swallow the capsules whole with a glass of fluid.

4.3 Contraindications

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,

Anaphylactoid Reactions).

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

Effects).

Celecoxib Pfizer is contraindicated in:

Patients

with

unstable ischaemic

heart

disease

thrombus

aetiology,

documented

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

score

10). See section 4.2 and 5.2.

Child-Pugh is a classification of the severity of liver disease.

Parameter

Points Assigned

1

2

3

Ascites

Absent

Slight

Moderate

Bilirubin (mg/dL)

<2

>3

Albumin (g/dL)

>3.5

2.8-3.5

<2.8

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Parameter

Points Assigned

1

2

3

Prothrombin time (seconds over control)

<4

>6

<1.7

1.7-2.3

>2.3

Encephalopathy

None

Grade1-2

Grade3-4

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

disease);

grade

(significant

functional

compromise);

10-15

grade

(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

Cardiovascular Effects

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

significant

established

ischaemic

heart

disease,

peripheral

arterial

disease

and/or

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).

Prescribers

should

inform

individual

patient

possible

increased

risks

when

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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Gastrointestinal Effects

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

disease

(such

ulceration,

bleeding

inflammatory

conditions).

addition

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

be considered.

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.

Anaphylactoid Reactions

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.

Hypertension

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

increase

upon

termination

celecoxib

treatment

necessary

(see

section

4.5,

Dextromethorphan and Metoprolol).

Use with Other NSAIDs

The concomitant use of celecoxib and a non-aspirin NSAID should be avoided.

Hepatic Effects

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

AST.

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.

clinical

signs

symptoms

consistent

with

liver

disease

develop,

systemic

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.

Renal Effects

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

and 6-keto-PGF

(a prostacyclin metabolite) but leaves serum thromboxane B

(TXB

) and

urinary excretion of 11-dehydro-TXB

, a thromboxane metabolite (both COX-1 products)

unaffected.

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

Celecoxib Pfizer.

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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Haematological Effects

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).

Pre-existing Asthma

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

pre-existing asthma.

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,

heart

failure,

compromised

cardiac

function,

pre-existing

oedema

other

conditions

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

Abrupt

discontinuation

corticosteroids

lead

exacerbation

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

patients

receiving

celecoxib

compared

with

patients

placebo.

Other

laboratory

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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Detecting Infections

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

Oral Anticoagulants

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

therapy

with

warfarin

similar

agents,

serious

bleeding

events,

some

them

fatal,

predominantly in elderly have been reported. Because increases in prothrombin time (INR)

have

been

reported,

anticoagulation/INR

should

monitored,

patients

taking

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).

Aspirin

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.

Antihypertensives

including

Angiotensin

Converting

Enzyme

(ACE)

Inhibitors,

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

compromised

renal

function,

co-administration

NSAIDs,

including

selective

COX-2

inhibitors,

with

inhibitors,

angiotensin

antagonists

diuretics,

result

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

thereafter.

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.

Ciclosporin

Because

their

effect

renal

prostaglandins,

NSAIDs

increase

risk

nephrotoxicity with ciclosporin.

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Effects of Celecoxib on Other Drugs

CYP2D6 Inhibition

Clinical pharmacokinetics study and

in-vitro

studies indicate that celecoxib, although not a

substrate, is an inhibitor of cytochrome P450 2D6. Therefore, there is a potential for an

in-vivo

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).

Digoxin

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.

Methrotrexate

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

(e.g.,

neutropenia,

thrombocytopenia,

renal

dysfunction).

During

concomitant

Celecoxib Pfizer and methotrexate, patients should be monitored for methotrexate toxicity.

Lithium

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.

Oral Hypoglycaemics

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

CYP2C9 Inhibitors

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.

CYP2C9 Inducers

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.

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