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US Brand Names

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Description

Celecoxib is used to relieve some symptoms caused by arthritis (osteoarthritis, rheumatoid arthritis, or juvenile rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it .

Celecoxib may also be used for the following problems:

• Ankylosing spondylitis;
• Familial adenomatous polyposis (polyps in the intestines);
• Moderate or severe pain, such as after dental or orthopedic procedures;
• Pain during menstruation

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Capsule

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Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of celecoxib in children 2 years of age and older .

Geriatric

This medicine has been tested in a limited number of elderly patients 65 years of age and older and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, elderly patients may be more sensitive to the side effects of celecoxib.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Pemetrexed
• Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse or
• Bleeding problems or
• Stomach ulcer or other stomach or intestinal problems or
• Tobacco use (or recent history of)—The chance of side effects may be increased

• Anemia or
• Asthma or
• Dehydration or
• Fluid retention (swelling of feet or lower legs) or
• Heart disease or
• High blood pressure or
• Kidney disease or
• Liver disease—Celecoxib may make these conditions worse

• Cardiovascular disease—Celecoxib may make this condition worse.

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Proper Use

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your health care professional. Taking too much of this medicine may increase the chance of unwanted effects.

If you cannot swallow the capsule, you may open it and pour the medicine into a teaspoon of applesauce. Stir the mixture well and swallow right away. Drink enough water after to make sure you swallow any excess medicine in mouth .

Any medicine that has been mixed with applesauce may be stored in a refrigerator and used within 6 hours.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For ankylosing spondylitis:
    • Adults— 200 mg once a day or 100 mg twice a day. Dose may be increased to 400 mg a day after 6 weeks if no effect is observed.
    • Children—Use and dose must be determined by your doctor.
  • For familial adenomatous polyposis (polyps in the intestines):
    • Adults— 400 mg twice a day with food.
    • Children—Use and dose must be determined by your doctor.
  • For moderate or severe pain, such as after dental or orthopedic procedures:
    • Adults— On the first day take 400 mg for the first dose then 200 mg as needed as a second dose. After the first day take 200 mg twice a day.
    • Children—Use and dose must be determined by your doctor.
  • Pain during menstruation:
    • Adults— On the first day take 400 mg for the first dose then 200 mg as needed as a second dose. After the first day take 200 mg twice a day.
    • Children—Use and dose must be determined by your doctor.
  • For rheumatoid arthritis or juvenile rheumatoid arthritis:
    • Adults— 100 to 200 mg twice a day.
    • Children 2 to 17 years of age—Dose is based on body weight and must be determined by your doctor. The dose usually is 50 mg twice a day for children weighing 10 to 25 kilograms (kg). For children weighing more than 25 kg, the dose usually is 100 mg twice a day.
    • Children below 2 years of age—Use and dose must be determined by your doctor.
  • For osteoarthritis:
    • Adults— 200 mg a day as a single dose or 100 mg twice day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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Precautions

If you will be taking this medicine for a long time, your doctor should check your progress at regular visits.

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. Therefore, do not regularly drink alcoholic beverages while taking this medicine, unless otherwise directed by your doctor.

Taking two or more of the nonsteroidal anti-inflammatory drugs together on a regular basis may increase the chance of unwanted effects. Also, taking acetaminophen, aspirin or other salicylates, or ketorolac (e.g., Toradol) regularly while you are taking a nonsteroidal anti-inflammatory drug may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your health care professional directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with this medicine for more than a few days, and do not take any ketorolac (e.g., Toradol) while you are taking this medicine, unless your doctor has directed you to do so and is following your progress.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

Check with your doctor immediately if fever, drowsiness, itching of the skin, tiredness, nausea, or stomach pain occurs; these effects may be the first signs of liver toxicity.

Celecoxib may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin, other nonsteroidal anti-inflammatory drugs, or sulfonamide-type drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once. Ask someone to drive you to the nearest hospital emergency room. If this is not possible, do not try to drive yourself. Call an ambulance, lie down, cover yourself to keep warm, and prop your feet higher than your head. Stay in that position until help arrives.

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Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Cough
• Fever
• Skin rash
• Sneezing
• Sore throat
• Swelling of face, fingers, feet, and/or lower legs

• Abnormal growth in breast
• Arm, back, or jaw pain
• Bloody or black tarry stools
• Blurred vision
• Burning feeling in chest or stomach
• Burning or stinging of skin
• Burning, tingling, numbness or pain in the hands, arms, feet, or legs
• Chest pain or discomfort
• Chest tightness or heaviness
• Chills
• Confusion
• Congestion in chest
• Cough
• Cramps
• Diarrhea
• Dry mouth
• Earache
• Fast or irregular heartbeat
• Fatigue
• Fever
• Heartburn
• Heavy bleeding
• Heavy nonmenstrual vaginal bleeding
• High blood pressure
• Increased hunger
• Increased thirst
• Increased urination
• Loss of appetite
• Loss of consciousness
• Muscle aches and pains
• Nausea
• Nerve pain
• Painful blisters on trunk of body
• Painful cold sores or blisters on lips, nose, eyes, or genitals
• Pale skin
• Redness or swelling in ear
• Sensation of pins and needles
• Shortness of breath
• Sore throat
• Soreness or redness around fingernails and toenails
• Stabbing pain
• Stiff neck
• Stomachache
• Stomach pain (severe)
• Sweating
• Tenderness in stomach area
• Troubled breathing with exertion
• Unexplained weight loss
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain
• Vomiting
• Vomiting of blood or material that looks like coffee grounds
• Weakness
• Wheezing

• Area rash
• Changes in skin color
• Clay-colored stools
• Dilated neck veins
• Light-colored stools
• Pale or a bluish color skin of the fingers or toes
• Seizures
• Slurred speech
• Sores, welting, or blisters
• Sudden and severe inability to speak
• Swelling of face, fingers, feet, or lower legs
• Unpleasant breath odor
• Weakness in arm and/or leg on one side of the body
• Yellow eyes and skin

• Bloody or black, tarry stools
• Continuing thirst
• Dizziness
• Drowsiness
• Headache, severe or continuing
• Nausea and/or vomiting
• Shortness of breath
• Stomach pain
• Sudden decrease in the amount of urine
• Swelling of face, fingers, and/or lower legs
• Tightness in chest and/or wheezing
• Troubled breathing
• Unusual tiredness or weakness
• Vomiting of blood or material that looks like coffee grounds
• Weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• Dizziness
• Gas
• Headache
• Heartburn
• Inability to sleep
• Nausea
• Pain or burning in throat
• Stomach pain
• Stuffy or runny nose

• Anxiety
• Bleeding after defecation
• Bloody or cloudy urine
• Blurred vision
• Breast pain
• Bone deformity
• Buzzing or ringing noise in ears
• Change in sense of taste
• Confusion
• Constipation
• Decrease in height
• Decreased appetite
• Degenerative disease of the joint
• Depression
• Difficult, burning, or painful urination
• Difficulty in moving or walking
• Difficulty swallowing
• Dry mouth
• Excessive muscle tone, muscle tension or tightness
• Excessive tearing
• Fast heartbeat
• Feeling of pressure
• Hair loss
• Hives
• Hoarseness
• Increased sweating
• Infection
• Inflammation
• Itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site
• Itching of the vagina or genital area
• Joint or muscle pain or stiffness
• Large amount of cholesterol in the blood
• Large, flat, blue or purplish patches in the skin
• Loss of energy or weakness
• Loss of hearing
• Muscle pain increased
• Muscle stiffness
• Nervousness
• Numbness or tingling in fingers and/or toes
• Pain during sexual intercourse
• Pain in back, ribs, arms, or legs
• Pain or burning in throat
• Pounding heartbeat
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Redness
• Redness or swelling in arms or legs
• Sensitivity of skin to sunlight
• Severe sunburn
• Sleepiness
• Straining while passing stool
• Sudden sweating and feelings of warmth
• Swelling
• Swelling or inflammation of the mouth
• Tenderness
• Thick, white vaginal discharge with no odor or with a mild odor
• Thinning of hair
• Trouble in swallowing
• Troubled breathing
• Uncomfortable swelling around anus
• Unexplained weight loss
• Unusual tiredness
• Voice changes
• Vomiting
• Warmth on skin
• Weakness or heaviness of legs

• Bleeding gums
• Blistering, peeling, loosening of skin
• Bloating
• Chills
• Fever and chills, blistering, peeling, loosening of skin
• Fever, redness, tenderness, itching, burning, or peeling of skin
• Joint or muscle pain
• Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• Loss of sense of smell
• Loss of sense of taste
• Pain
• Pinpoint red spots on skin
• Red or irritated eyes
• Red skin lesions, often with a purple center
• Shakiness and unsteady walk
• Sore throat
• Sores, ulcers, or white spots in mouth or on lips
• Stomach cramps
• Swelling of feet or lower legs
• Swelling of the neck
• Tenderness
• Trembling, or other problems with muscle control or coordination
• Ulcers, or white spots in mouth or on lips
• Unsteadiness
• Unusual bleeding or bruising
• Watery or bloody diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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