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ARTICOX (CELEBREX) INDICATIONS

Articox is indicated for relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in patients 2 years and older and ankylosing spondylitis. Articox is indicated for the management of acute pain in adults and for the treatment of primary dysmenorrhea. It is used in familial adenomatous polyposis (FAP) to decrease the number of polyps (growths) in the rectal area.

ARTICOX (CELEBREX) INSTRUCTIONS

Use Articox as directed by your doctor!

  • Take Articox by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
  • Some doses of Articox should be taken with food. Ask your doctor if you have questions about how to take Articox.
  • Take Articox with a full glass of water (8 oz/240 mL) as directed by your doctor.
  • Do not lie down for 30 minutes after taking Articox.
  • If you miss a dose of Articox and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Articox.

ARTICOX (CELEBREX) STORAGE

Store Articox at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Articox out of the reach of children and away from pets.

Do NOT use Articox if:

  • you are allergic to any ingredient in Articox
  • you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin, an NSAID (eg, ibuprofen), or a sulfonamide (eg, sulfamethoxazole)
  • you have recently had or will be having heart bypass surgery
  • you have severe liver or kidney problems
  • you are in the last 3 months of pregnancy
  • you are taking another nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen)

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Articox. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
  • if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
  • if you have a high fever, rash, high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart disease, heart failure), or blood vessel disease, or you are at risk for any of these diseases
  • if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you drink alcohol or smoke, or you have a history of alcohol abuse.

Some medicines may interact with Articox. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because risk of stomach bleeding may be increased
  • Fluconazole, another nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen), or probenecid because they may increase the risk of Articox's side effects
  • Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Articox
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin II receptor blockers (eg, valsartan), or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Articox.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Articox may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

  • Articox may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Articox with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Serious stomach ulcers or bleeding can occur with the use of Articox. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Articox with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you have severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor
  • Articox is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do not take aspirin while you are using Articox unless your doctor tells you to.
  • FAP patients - Articox has not been shown to reduce FAP-related cancers or the need for other procedures or surgeries. Continue your usual care while you use Articox.
  • Lab tests, including kidney and liver function, complete blood cell counts, blood clotting, and blood pressure, may be performed while you use Articox. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Articox with caution in the elderly; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
  • Caution is advised when using Articox in children who have juvenile rheumatoid arthritis; they may be more sensitive to its effects, especially blood clotting problems.
  • Pregnancy and breast-feeding: Articox may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Articox while you are pregnant. Articox is found in breast milk. If you are or will be breast-feeding while you use Articox, check with your doctor. Discuss any possible risks to your baby.

All medicines can cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; sore throat; stomach upset; stuffy nose.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hearing loss; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.



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