Ansaid

Name: Ansaid

Ansaid Drug Class

Ansaid is part of the drug class:

  • Propionic acid derivatives

What is the most important information I should know about Ansaid (flurbiprofen)?

Flurbiprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Flurbiprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using flurbiprofen, especially in older adults.

What should I discuss with my healthcare provider before taking Ansaid (flurbiprofen)?

Flurbiprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Flurbiprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using flurbiprofen, especially in older adults.

You should not use flurbiprofen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure flurbiprofen is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

  • a history of heart attack, stroke, or blood clot;

  • a history of stomach ulcers or bleeding;

  • asthma;

  • liver or kidney disease; or

  • fluid retention.

Taking flurbiprofen during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using flurbiprofen.

It is not known whether flurbiprofen passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Flurbiprofen is not approved for use by anyone younger than 18 years old.

Before Using Ansaid

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 have not been performed on the relationship of age to the effects of flurbiprofen in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of flurbiprofen in the elderly. However, elderly patients are more likely to have age-related kidney, stomach, or heart problems, which may require caution and an adjustment in the dose for patients receiving flurbiprofen.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Ketorolac

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.

  • Abciximab
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Amiloride
  • Amineptine
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amtolmetin Guacil
  • Anagrelide
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • Balsalazide
  • Bemiparin
  • Bendroflumethiazide
  • Benzthiazide
  • Betamethasone
  • Betrixaban
  • Bismuth Subsalicylate
  • Bivalirudin
  • Bromfenac
  • Budesonide
  • Bufexamac
  • Bumetanide
  • Cangrelor
  • Celecoxib
  • Certoparin
  • Chlorothiazide
  • Chlorthalidone
  • Choline Magnesium Trisalicylate
  • Choline Salicylate
  • Cilostazol
  • Citalopram
  • Clomipramine
  • Clonixin
  • Clopamide
  • Clopidogrel
  • Cortisone
  • Cyclopenthiazide
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Deflazacort
  • Desipramine
  • Desirudin
  • Desmopressin
  • Desvenlafaxine
  • Dexamethasone
  • Dexibuprofen
  • Dexketoprofen
  • Diazoxide
  • Dibenzepin
  • Diclofenac
  • Diflunisal
  • Digoxin
  • Dipyridamole
  • Dipyrone
  • Dothiepin
  • Doxepin
  • Droxicam
  • Duloxetine
  • Edoxaban
  • Enoxaparin
  • Eplerenone
  • Epoprostenol
  • Eptifibatide
  • Escitalopram
  • Ethacrynic Acid
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Feverfew
  • Floctafenine
  • Flufenamic Acid
  • Fluocortolone
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Furosemide
  • Ginkgo
  • Gossypol
  • Heparin
  • Hydrochlorothiazide
  • Hydrocortisone
  • Hydroflumethiazide
  • Ibuprofen
  • Iloprost
  • Imipramine
  • Indapamide
  • Indomethacin
  • Ketoprofen
  • Lepirudin
  • Levomilnacipran
  • Lithium
  • Lofepramine
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Magnesium Salicylate
  • Meadowsweet
  • Meclofenamate
  • Mefenamic Acid
  • Melitracen
  • Meloxicam
  • Mesalamine
  • Methotrexate
  • Methyclothiazide
  • Methylprednisolone
  • Metolazone
  • Milnacipran
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Nefazodone
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Nortriptyline
  • Olsalazine
  • Opipramol
  • Oxaprozin
  • Oxyphenbutazone
  • Paramethasone
  • Parecoxib
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Phenyl Salicylate
  • Piketoprofen
  • Piroxicam
  • Polythiazide
  • Pralatrexate
  • Prasugrel
  • Prednisolone
  • Prednisone
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Protein C
  • Protriptyline
  • Reboxetine
  • Reviparin
  • Rivaroxaban
  • Rofecoxib
  • Salicylamide
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sibutramine
  • Sodium Salicylate
  • Spironolactone
  • Sulfasalazine
  • Sulindac
  • Tacrolimus
  • Tenoxicam
  • Tianeptine
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tolfenamic Acid
  • Tolmetin
  • Torsemide
  • Treprostinil
  • Triamterene
  • Trichlormethiazide
  • Trimipramine
  • Trolamine Salicylate
  • Valdecoxib
  • Venlafaxine
  • Vilazodone
  • Vorapaxar
  • Vortioxetine
  • Warfarin
  • Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Alacepril
  • Atenolol
  • Azilsartan
  • Azilsartan Medoxomil
  • Benazepril
  • Betaxolol
  • Bisoprolol
  • Candesartan
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Cilazapril
  • Delapril
  • Dicumarol
  • Enalapril
  • Enalaprilat
  • Eprosartan
  • Esmolol
  • Fosinopril
  • Imidapril
  • Irbesartan
  • Labetalol
  • Levobunolol
  • Lisinopril
  • Losartan
  • Metipranolol
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Olmesartan
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • Pindolol
  • Practolol
  • Propranolol
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Telmisartan
  • Temocapril
  • Timolol
  • Trandolapril
  • Valsartan
  • Zofenopril

Interactions with Food/Tobacco/Alcohol

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:

  • Anemia or
  • Bleeding problems or
  • Congestive heart failure or
  • Dehydration or
  • Edema (fluid retention or body swelling) or
  • Heart attack, recent or
  • Hyperkalemia (high potassium in the blood) or
  • Hypertension (high blood pressure) or
  • Hypovolemia (low blood volume) or
  • Kidney disease or
  • Liver disease (eg, hepatitis) or
  • Stomach ulcers or bleeding, history of or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Aspirin-sensitive asthma or
  • Aspirin sensitivity, history of—Should not be used in patients with these conditions.
  • Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Ansaid® (flurbiprofen tablets, USP) 50 mg and 100 mg

Cardiovascular Risk

  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
  • Ansaid® is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle

NDC 0009-0305-03
6505-01-301-0804

Ansaid®
flurbiprofen
tablets, USP

100 mg

100 Tablets

Ansaid 
flurbiprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0009-0170
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
flurbiprofen (flurbiprofen) flurbiprofen 50 mg
Inactive Ingredients
Ingredient Name Strength
carnauba wax  
silicon dioxide  
croscarmellose sodium  
hypromellose  
lactose  
magnesium stearate  
cellulose, microcrystalline  
propylene glycol  
titanium dioxide  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code Ansaid;50;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:0009-0170-24 2000 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018766 10/31/1988 01/12/2009
Ansaid 
flurbiprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0009-0305
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
flurbiprofen (flurbiprofen) flurbiprofen 100 mg
Inactive Ingredients
Ingredient Name Strength
carnauba wax  
silicon dioxide  
croscarmellose sodium  
hypromellose  
lactose  
magnesium stearate  
cellulose, microcrystalline  
propylene glycol  
titanium dioxide  
FD&C BLUE NO. 2  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 14mm
Flavor Imprint Code Ansaid;100;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:0009-0305-03 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE
2 NDC:0009-0305-30 2000 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018766 10/31/1988 01/12/2009
Labeler - Pharmacia and Upjohn Company (829076566)
Establishment
Name Address ID/FEI Operations
Pharmacia and Upjohn Company 829076566 ANALYSIS, API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084545 ANALYSIS
Revised: 02/2010   Pharmacia and Upjohn Company

Where can i get more information?

Your pharmacist can provide more information about flurbiprofen.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 8.05. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Flurbiprofen Breastfeeding Warnings

Use should be avoided. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.

Concentrations in breast milk and plasma levels of nursing mothers suggest a breastfed infant could receive about 0.1 mg of this drug per day from a mother taking 200 mg/day. Due to the low levels in breast milk and its short half-life, this drug is unlikely to adversely affect the breastfed infant, especially if the infant is older than 2 months; however, according to some manufacturers, use should be avoided.

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