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Feldene

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING


Cardiovascular Risk
WARNINGS).
WARNINGS).

Gastrointestinal Risk
WARNINGS).

FELDENE DESCRIPTION


Feldene


CLINICAL PHARMACOLOGY

Pharmacodynamics


Pharmacokinetics









Pharmacogenetics, andSpecial Populations, Poor Metabolizers of CYP2C9 Substrates). The biotransformation products of piroxicam metabolism are reported to not have any anti-inflammatory activity.
Pharmacogenetics, andSpecial Populations, Poor Metabolizers of CYP2C9 Substrates).







Special Populations
















Other Information




INDICATIONS & USAGE

WARNINGS).



FELDENE CONTRAINDICATIONS



WARNINGS: Anaphylactoid ReactionsandPRECAUTIONS: Preexisting Asthma).
WARNINGS).


WARNINGS

CARDIOVASCULAR EFFECTS



WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation).
CONTRAINDICATIONS).







Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation




Renal Effects


Advanced Renal Disease


Anaphylactoid Reactions
CONTRAINDICATIONSandPRECAUTIONS: Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions


Other Hypersensitivity Reactions


Pregnancy

PRECAUTIONS

General



Hepatic Effects

ADVERSE REACTIONS).

Hematological Effects



Ophthalmologic Effects


Preexisting Asthma


Information for Patients
Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.
WARNINGS, CARDIOVASCULAR EFFECTS).
WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation).



WARNINGS).


Laboratory Tests


Drug Interactions














WARNINGS: Renal Effects), as well as to assure diuretic efficacy.







Carcinogenesis, Mutagenesis, Impairment of Fertility
PRECAUTIONS) and gastrointestinal lesions.


Pregnancy









Labor and Delivery


Nursing Mothers


Pediatric Use


Geriatric Use
WARNINGS, Gastrointestinal EffectsRisk of Ulceration, Bleeding, and Perforation).
Warnings: Renal Effects).

FELDENE ADVERSE REACTIONS


     Cardiovascular System:Edema.
     Digestive System:Anorexia, abdominal pain, constipation, diarrhea, dyspepsia, elevated liver enzymes, flatulence, gross bleeding/perforation, heartburn, nausea, ulcers (gastric/duodenal), vomiting.
     Hemic and Lymphatic System:Anemia, increased bleeding time.
     Nervous System:Dizziness, headache.
     Skin and Appendages:Pruritus, rash.
     Special Senses:Tinnitus.
     Urogenital System:Abnormal renal function.

     Body As a Whole:Fever, infection, sepsis.
     Cardiovascular System:Congestive heart failure, hypertension, tachycardia, syncope.
     Digestive System:Dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, stomatitis.
     Hemic and Lymphatic System:Ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia.
     Metabolic and Nutritional:Weight changes.
     Nervous System:Anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo.
     Respiratory System:Asthma, dyspnea.
     Skin and Appendages:Alopecia, bruising, desquamation, erythema, photosensitivity, sweat.
     Special Senses:Blurred vision.
     Urogenital System:Cystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, oliguria/polyuria, proteinuria, renal failure.

     Body As a Whole:Anaphylactic reactions, appetite changes, death, flu-like syndrome, pain (colic), serum sickness.
     Cardiovascular System:Arrhythmia, exacerbation of angina, hypotension, myocardial infarction, palpitations, vasculitis.
     Digestive System:Eructation, liver failure, pancreatitis.
     Hemic and Lymphatic System:Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia.
     Hypersensitivity:Positive ANA.
     Metabolic and Nutritional:Hyperglycemia, hypoglycemia.
     Nervous System:Akathisia, convulsions, coma, hallucinations, meningitis, mood alterations.
     Respiratory:Respiratory depression, pneumonia.
     Skin and Appendages:Angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens-Johnson Syndrome, urticaria, vesiculobullous reaction.
     Special Senses:Conjunctivitis, hearing impairment, swollen eyes.

OVERDOSAGE



DOSAGE & ADMINISTRATION

WARNINGS).


HOW SUPPLIED




Medication Guide

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)
What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:


NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:


The chance of a person getting an ulcer or bleeding increases with:






NSAID medicines should only be used:



What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:


Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:


Tell your healthcare provider:

Keep a list of your medicines to show to your healthcare provider and pharmacist.
NSAID medicines should not be used by pregnant women late in their pregnancy.
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:








Get emergency help right away if you have any of the following symptoms:





Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:












Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)


NSAID medicines that need a prescription
Generic Name Tradename *
*(combined with hydrocodone), Combunox (combined with oxycodone)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Feldene


Feldene

Feldene

piroxicam CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52125-084(NDC:0069-3230)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
piroxicam PIROXICAM 20 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
FD&C RED NO. 3
LACTOSE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
red 18 mm FELDENE;PFIZER;323 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52125-084-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018147 2012-09-26


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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