Feldene
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- FELDENE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- FELDENE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- FELDENE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- Medication Guide
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
FELDENE DESCRIPTION
CLINICAL PHARMACOLOGY
PharmacodynamicsPharmacokinetics
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 EFFECTSWARNINGS, 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
GeneralHepatic 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
Feldenepiroxicam CAPSULE
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
