What Celebrex is used for and how to use it
Россия
  • Россия
  • Украина

Celebrex - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Ankylosing Spondylitis, Familial Adenomatous Polyposis, Juvenile Rheumatoid Arthritis, Osteoarthritis, Pain, Period Pain (Dysmenorrhea), Rheumatoid Arthritis, Spondyloarthritis
Class: Cox-2 inhibitors, Nonsteroidal anti-inflammatory agents
Form: Capsules
Ingredients: celecoxib, croscarmellose sodium, ferric oxide edible ink (e172),gelatin, indigotine edible ink (e132), lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulphate, titanium dioxide (e171)

CELEBREX (Celecoxib)

About This Medication

What the Medication is Used For

Your health care provider has prescribed CELEBREX for you for one or more of the following medical conditions:

  • Osteoarthritis – relieve pain
  • Rheumatoid Arthritis – relieve joint pain and swelling
  • Ankylosing Spondylitis – relieve pain
  • Sprains, After orthopaedic (bone and joint) surgery (NOT open heart surgery), dental extraction – to relieve short-term pain (maximum use of 7 days)

What It Does

CELEBREX (celecoxib), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the type of prostaglandins (chemicals), produced by your body which cause joint swelling, redness and pain. At prescribed doses, CELEBREX does not affect the type of prostaglandins that helps maintain the protective layer of the stomach, and reduces the chances of bleeding from the stomach.

CELEBREX, as a nonsteroidal anti-inflammatory drug (NSAID), does NOT cure your illness or prevent it from getting worse. CELEBREX can only relieve pain and reduce swelling as long as you continue to take it.

When It Should not be Used

Do not take CELEBREX if you have any of the following medical conditions:

  • Heart bypass surgery (planning to have or recently had)
  • Severe, uncontrolled heart failure
  • Allergy to celecoxib or any of the other ingredients in Celebrex
  • Allergy to Sulfonamide drugs
  • Allergy to ASA (Acetylsalicylic Acid) or other NSAIDs (Nonsteroidal Anti-Inflammatory Drugs)
  • Current Pregnancy (after 28 weeks of pregnancy)
  • Currently Breastfeeding (or planning to breastfeed)
  • Ulcer (active)
  • Bleeding from the stomach or gut (active)
  • Bleeding in the brain
  • Inflammatory Bowel Disease (Crohn’s Disease or Ulcerative Colitis)
  • Liver Disease (active or severe)
  • Kidney Disease (severe or worsening)
  • High potassium in the blood

Safety and effectiveness of CELEBREX have NOT been established in children under 18 years of age.

Patients who took a drug in the same class as CELEBREX after a type of heart surgery (coronary artery bypass grafting (CABG) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lung(s), and infections or other complications than those who did NOT take that drug.

What the Medicinal Ingredient Is

Celecoxib

What the Important Nonmedicinal Ingredients Are

  • Croscarmellose sodium
  • Ferric oxide edible ink (E172) (200 mg capsules)
  • Gelatin
  • Indigotine edible ink (E132) (100 mg capsules)
  • Lactose monohydrate
  • Magnesium stearate
  • Povidone
  • Sodium lauryl sulphate
  • Titanium dioxide (E171)

What Dosage Forms It Comes In

Capsules, 100 mg and 200 mg

Warnings and Precautions

Serious Warnings and Precautions

If you have, or previously had, any of the following medical conditions, see your health care provider to discuss treatment options other than CELEBREX:

  • Heart Attack or Angina
  • Stroke or Mini-stroke
  • Loss of Vision
  • Current Pregnancy (less than 28 weeks)
  • Congestive Heart Failure

Before taking this medication tell your health care provider if you have any of the following:

  • High Blood Pressure
  • High Cholesterol
  • Diabetes Mellitus or on a low sugar diet
  • Atherosclerosis
  • Poor circulation to your extremities
  • Smoker or Ex-smoker
  • Kidney Disease or urine problems
  • Previous ulcer or bleeding from the stomach or gut
  • Previous bleeding in the brain
  • Bleeding problems
  • Family history of allergy to sulfonamide drugs
  • Family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)
  • Family history of asthma, nasal polyp, long-term swelling of the sinus (chronic sinusitis) or hives
  • Gastrointestinal problems (problems with your stomach and/or intestine)
  • Any other medical problem

Fertility may be decreased. The use of CELEBREX is not recommended in women who have difficulty conceiving.

Also, before taking this medication, tell your health care provider if you are planning to get pregnant.

While Taking This Medication

  • tell any other doctor, dentist, pharmacist or other health care professional that you see, that you are taking this medication, especially if you are planning to have heart surgery;
  • do NOT drink alcoholic beverages while taking this medication because you would be more likely to develop stomach problems;

Interactions With This Medication

Talk to your health care provider and pharmacist if you are taking any other medication (prescription or non-prescription) such as any of the following (NOT a complete list):

  • Acetylsalicylic acid (ASA) or other NSAIDs (e.g.diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen)
  • Antacids or proton pump inhibitors (omeprazole)
  • Antidepressants [Selective serotonine receptor uptake inhibitor (SSRIs) (e.g. citalopram, paroxetine, fluoxetine, sertraline)]
  • Blood pressure medications, such as ACE (angiotensin converting enzyme) inhibitors (e.g. enalapril, lisinopril, perindopril, ramipril)], ARBs (angiotensin II receptor blockers) (e.g. candesartan, irbesartan, losartan, valsartan), beta blockers (e.g. metoprolol)
  • Blood thinners(to prevent blood clots), such as warfarin, apixaban, rivaroxaban, dabigatran, ASA, clopidogrel
  • Corticosteroids (including glucocorticoids) e.g. prednisone
  • Cyclosporin
  • Digoxin
  • Diuretics such as furosemide, hydrochlorothiazide
  • Fluconazole
  • Lithium
  • Dextromethorphan (found in some cough medications)
  • Tacrolimus

Using CELEBREX with a blood thinner increases the risk of bleeding.

Your health care provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner for the prevention of having a heart attack or stroke while you are taking CELEBREX. Take only the amount of ASA prescribed by your health care provider. You are more likely to upset or damage your stomach if you take both CELEBREX and ASA than if you take CELEBREX alone.

Proper Use of This Medication

Dose:18 years of age and older only

Medical
Condition
Starting
Dose
Maximum
Dose
(per day)
Maximum
Duration of
Treatment
(days)
Osteoarthritis
(18 years of
age and older)
200 mg once
a day or 100
mg twice a
day
200 mgnot
specified
Rheumatoid
Arthritis
(18 years of
age and older)
100 mg
twice a day
400 mgnot
specified
Ankylosing
Spondylitis
(18 years of
age and older)
200 mg once
a day or 100
mg twice a
day
200 mgnot
specified
Pain
(18 years of
age and older)
400 mg on
first day,
then 200 mg
once a day
400 mg7 days

Take CELEBREX only as directed by your health care provider. Do NOT take more of it, do NOT take it moreoften and do NOT take it for a longer period of time than your health care provider recommended. If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much CELEBREX may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.

If you will be using CELEBREX for more than 7 days, see your health care provider regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects.

This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.

CELEBREX is NOT recommended for patients under 18 year of age since safety and effectiveness have NOT been established.

CELEBREX can be taken with or without food.

Missed Dose

Take the dose you missed as soon as you remember, then take the next dose at the scheduled time.

Overdose

If you take more than the prescribed dose, contact your health care provider immediately.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Side Effects and What to Do About Them

CELEBREX may cause some side effects, especially if used for a long time or in large doses. When these side effects occur, you may require medical attention. Report all symptoms or side effects to your health care provider.

CELEBREX may cause you to become drowsy or tired. Be careful about driving or participating in activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking CELEBREX, do NOT drive or operate machinery.

CELEBREX may cause you to become more sensitive to sunlight. Any exposure to sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have a reaction from the sun, check with your health care provider.

Check with your health care provider IMMEDIATELY if you develop chills, fever, muscle aches or pains, or other flu-like symptoms occur, especially if they occur before or together with a skin rash. These symptoms may be the first signs of a SERIOUS ALLERGIC REACTION to this medication.

Serious Side Effects, how Often They Happen and What to Do About Them

Symptom / EffectSTOP Taking
Drug and Get
Emergency
Medical Attention
IMMEDIATELY
STOP Taking
Drug and Talk
to Your Health
Care Provider
Bloody or black tarry stools
Shortness of breath,
wheezing, any trouble
breathing or chest tightness
Skin rash, hives, swelling or
itching
Blurred vision or other visual
disturbance
Change in urine (amount or
colour) (dark red or brown)
Pain or difficulty urinating
Feet or lower leg swelling;
weight gain
Vomiting or persistent
indigestion, nausea, stomach
pain or diarrhea
Yellow discolouration of the
skin or eyes with or without
itchy skin
Malaise, fatigue, or loss of
appetite
Headaches, stiff neck
Mental confusion or
depression
Dizziness or light-headedness
Hearing problems
Pneumonitis (symptoms
include trouble breathing, dry
cough, tiredness)

This is NOT a complete list of side effects. If you develop any other symptoms while taking CELEBREX, see your health care provider.

Storage

Store at room temperature, between 15-30oC.

Do NOT keep outdated medicine or medicine no longer needed. Any outdated or unused medicine should be returned to your pharmacist.

Keep out of reach of children and pets.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found at: http://www.pfizer.ca