Medication Guide for
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines called Non-Steroidal AntiInflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: · with longer use of NSAID medicines · in people who have heart disease
NSAID medicines should never be used right before or after a heart surgery called a ìcoronary artery bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment.
Ulcers and bleeding:
· can happen without warning symptoms · may cause death
The chance of a person getting an ulcer or bleeding increases with:
· taking medicines called ìcorticosteroidsî and ìanticoagulantsî · longer use · smoking · drinking alcohol · older age · having poor health
NSAID medicines should only be used:
· exactly as prescribed
· at the lowest dose possible for your treatment · for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are use to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: · different types of arthritis · menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:
· if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine · for pain right before or after heart bypass surgery Tell your healthcare provider:
· about all of your medical conditions.
· about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. · if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
· if you are breastfeeding. Talk to your doctor.
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
|Serious side effects include:||Other side effects include:|
|· heart attack||· stomach pain|
|· stroke||· constipation|
|· high blood pressure||· diarrhea|
|· heart failure from body swelling (fluid retention)||· gas|
|· kidney problems including kidney failure||· heartburn|
|· bleeding and ulcers in the stomach and intestine||· nausea|
|· low red blood cells (anemia)||· vomiting|
|· life-threatening skin reactions||· dizziness|
|· life-threatening allergic reactions|
|· liver problems including liver failure|
|· asthma attacks in people who have asthma|
Get emergency help right away if you have any of the following symptoms:
· shortnes s of breath or trouble breathing body
· chest pain
· slurred speech
· weakness in one part or side of your
· swelling of the face or throat
Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:
· vomit blood
· more tired or weaker than usual
· there is blood in your bowel
· itching movement or it is black and
· your skin or eyes look yellow sticky like tar
· stomach pain
· skin rash or blisters with fever
· flu-like symptoms
· unusual weight gain
· swelling of the arms and legs, hands and feet
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
· Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
· Some of these NSAID medicines are sold in lower doses without a prescription (over ñthe ñcounter). Talk to your healthcare provider before using over ñthe ñcounter NSAIDs for more than 10 days.
NSAID medicines that need a prescription
|Diclofenac||Cataflam, Voltaren, Arthrotec (combined with misoprostol)|
|Etodolac||Lodine, Lodine XL|
|Fenoprofen||Nalfon, Nalfon 200|
|Ibuprofen||Motrin, Tab-Profen, Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone)|
|Indomethacin||Indocin, Indocin SR, Indo-Lemmon, Indomethagan|
|Naproxen||Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)|
|Tolmetin||Tolectin, Tolectin DS, Tolectin 600|
This Medication Guide has been approved by the U.S. Food and Drug Administration.
General: Significant interactions may occur when celecoxib is administered together with drugs that inhibit P450 2C9. Celecoxib metabolism is predominantly mediated via cytochrome P450 2C9 in the liver. Co-administration of celecoxib with drugs that are known to inhibit 2C9 should be done with caution. In vitro studies indicate that celecoxib is not an inhibitor of cytochrome P450 2C9, 2C19 or 3A4. In vitro studies also 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 metabolized by P450 2D6.
Clinical studies with celecoxib have identified potentially significant interactions with fluconazole and lithium. Experience with nonsteroidal anti-inflammatory drugs (NSAIDs) suggests the potential for interactions with furosemide and ACE inhibitors. The effects celecoxib on the pharmacokinetics and/or pharmacodynamics of glyburide, ketoconazole, methotrexate, phenytoin, tolbutamide, and warfarin have been studied in vivo and clinically important interactions have not been found.
ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of Angiotensin Converting Enzyme (ACE) inhibitors. This interaction should be given consideration in patients taking CELEBREX concomitantly with ACE-inhibitors.
Furosemide: Clinical studies, as well as post marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.
Aspirin: CELEBREX can be used with low dose aspirin. However, concomitant administration of aspirin with CELEBREX may result in an increased rate of GI ulceration or other complications, compared to use of CELEBREX alone. Because of its lack of platelet effects, CELEBREX is not a substitute for aspirin for cardiovascular prophylaxis.
Fluconazole: Concomitant administration of fluconazole at 200 mg QD resulted in a two-fold increase in celecoxib plasma concentration. This increase is due to the inhibition of celecoxib metabolism via P450 2C9 by fluconazole (see CLINICAL PHARMACOLOGY - Pharmacokinetics: Metabolism). CELEBREX should be introduced at the lowest recommended dose in patients receiving fluconazole.
Lithium: In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg BID with CELEBREX 200 mg BID as compared to subjects receiving lithium alone. Patients on lithium treatment should be closely monitored when CELEBREX is introduced or withdrawn.
Methotrexate: In an interaction study of rheumatoid arthritis patients taking methotrexate, CELEBREX did not have a significant effect on the pharmacokinetics of methotrexate.
Warfarin: The effect of celecoxib on the anti-coagulant effect of warfarin was studied in a group of healthy subjects receiving daily doses of 2-5 mg of warfarin. In these subjects, celecoxib did not alter the anticoagulant effect of warfarin as determined by prothrombin time. However, caution should be used when administering CELEBREX with warfarin since these patients are at increased risk of bleeding complications.
CELEBREX is contraindicated in patients with known hypersensitivity to celecoxib.
CELEBREX should not be given to patients who have demonstrated allergic-type reactions to sulfonamides.
CELEBREX should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients .
CELEBREX is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery