Celebrex

Generic name: celecoxib
Drug class: Cox-2 inhibitors

Medically reviewed by A Ras MD.

What is Celebrex?

Celebrex is a nonsteroidal anti-inflammatory drug (NSAID) that is used for the management of the signs and symptoms of Osteoarthritis, Rheumatoid arthritis, Juvenile rheumatoid arthritis, Ankylosing Spondylitis

Celebrex is also used for the management of Acute pain in adults, Primary dysmenorrhea

Celebrex helps to treat the pain, redness, swelling, and heat (inflammation) associated with the above conditions.

Description

CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure:

Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.

The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.

Mechanism of Action

Celecoxib has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of CELEBREX is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2.

Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro. Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

What is the most important information I should know about Celebrex?

Celebrex and other NSAIDs can cause serious side effects, including:

Increased risk of heart attack or stroke that can lead to death. This risk may happen early in treatment and many increase:
- with increasing doses of Celebrex
- with long use of Celebrex

Do not take Celebrex or other NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)”. Avoid taking Celebrex after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take Celebrex after a recent heart attack.

You may have an increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
- anytime during use
- without warning symptoms
- that may cause death

The risk of getting an ulcer or bleeding increases with:

past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
taking medicines called “corticosteroids”, “antiplatelet drugs”, “anticoagulants”, “SSRIs” or “SNRIs”
increasing doses of Celebrex
longer use of Celebrex
smoking
drinking alcohol
older age
poor health
advanced liver disease
bleeding problems

Celebrex should only be used:

exactly as prescribed
at the lowest dose possible for your treatment
for the shortest time needed

Who should not take Celebrex?

Do not take Celebrex:

if you have a known hypersensitivity to celecoxib or any of the other ingredients in Celebrex
if you have demonstrated allergic-type reactions to sulfonamides
if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs
right before or after heart bypass surgery
if you are more than 29 weeks pregnant

What should I tell my healthcare provider before taking Celebrex?

Before taking Celebrex and other NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:

have liver or kidney problems
have high blood pressure
have asthma
are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking Celebrex or other NSAIDs during pregnancy. You should not take Celebrex and other NSAIDs after 29 weeks of pregnancy
are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

How should I take Celebrex?

Take Celebrex exactly as prescribed. Your healthcare provider may need to change your dose of Celebrex until the dose us right for you.
Use the lowest possible dose for the shortest time needed.
Call your healthcare provider if the dose you are prescribed does not control your pain.
Celebrex can be taken with or without food.

What should I avoid while taking Celebrex?

Taking Celebrex with other NSAIDs or salicylates (e.g. diflunisal, salsalate) should be avoided due to the increased risk of gastrointestinal toxicity.
You should speak to your healthcare provided before taking Celebrex with low dose aspirin.

What are the possible side effects of Celebrex?

Celebrex and other NSAIDs can cause serious side effects, including:

see “What is the most important information I should know about Celebrex?”
new or worse high blood pressure
heart failure
liver problems including liver failure
kidney problems including kidney failure
low red blood cells (anaemia)
life-threatening skin reactions
life-threatening allergic reactions

Other side effects of Celebrex and other NSAIDs include:

stomach pain
constipation
diarrhea
gas
heartburn
nausea
vomiting
dizziness

Get emergency help right away if you get any of the following symptoms:

shortness of breath or trouble breathing
chest pain
weakness in one part or side of your body
slurred speech
swelling of the face or throat

Stop taking Celebrex and call your healthcare provider right away if you get any of the following symptoms:

nausea
more tired and weaker than usual
diarrhea
itching
your skin or eyes look yellow
indigestion or stomach pain
flu-like symptoms
vomit blood
there is blood in your bowel movement or it is black and sticky like tar
unusual weight gain
skin rash or blisters with fever
swelling of the arms, legs, hands and feet

If you take too much Celebrex call your healthcare provider or get medical help right away.

These are not all the possible side effect of Celebrex. For more information, ask your healthcare provider or pharmacist about Celebrex. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Celebrex

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Celebrex for a condition for which it was not prescribed. Do not give Celebrex to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about Celebrex, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Celebrex that is written for health professionals.

How should I store Celebrex?

Store at room temperature 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF)
Keep Celebrex and all medicines out of reach of children

What are the ingredients in Celebrex?

Active ingredient: celecoxib

Inactive ingredients: croscarmellose sodium, gelatin unspecified, lactose monohydrate, magnesium stearate, povidone unspecified, sodium lauryl sulfate

Label

PRINCIPAL DISPLAY PANEL – 50 MG BOTTLE LABEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0025-1515-01
Pfizer
Celebrex®
celecoxib capsules
50 mg
60 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 50 mg Bottle Label

PRINCIPAL DISPLAY PANEL – 100 MG BOTTLE LABEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0025-1520-31
Pfizer
Celebrex®
celecoxib capsules
100 mg
100 Capsules
Rx only

Principal Display Panel - 100 mg Bottle Label

PRINCIPAL DISPLAY PANEL – 200 MG CAPSULE SAMPLE BLISTER PACK CARTON

NDC 0025-1525-99
Rx only
PROFESSIONAL SAMPLE – NOT FOR SALE
ALWAYS DISPENSE WITH MEDICATION GUIDE
Contains: 1 blister x 3 capsules
CELEBREX®
(CELECOXIB) CAPSULES
200 mg per capsule
For patient information, please call 1-800-249-2692
or visit our web site at www.celebrex.com