FELDENE (piroxicam)

There are 6 contraindications. Absolute contraindication.

Contraindication List
Aspirin exacerbated respiratory disease
Cerebrovascular accident
History of roux-en-Y gastric bypass
Post-operative from CABG surgery
Pregnancy
Renal transplant

There are 20 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Acute myocardial infarction
Alcohol use disorder
Chronic heart failure
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
CYp2c9 poor metabolizer
Debilitation
Edema
Gastrointestinal hemorrhage
Gastrointestinal perforation
Gastrointestinal ulcer
History of kidney donation
Hypertension
Increased risk of bleeding
Increased risk of bleeding due to coagulation disorder
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Nephrectomy
Systemic mastocytosis
Thrombotic disorder
Tobacco smoker

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Anemia

There are 58 severe adverse reactions.

More Frequent	Less Frequent
Increased alanine transaminase Increased aspartate transaminase	Abnormal hepatic function tests Allergic dermatitis Anemia Eosinophilia Leukopenia

Rare/Very Rare

Abnormal desquamation Acute eruptions of skin Acute myocardial infarction Acute pancreatitis Agranulocytosis Anaphylaxis Angina Angioedema Aplastic anemia Asthma Bloody stools Bloody vomit Bronchospastic pulmonary disease Bullous dermatitis Cerebrovascular accident Chest tightness Chronic heart failure Dyspnea Erythema Erythema multiforme Esophagitis Exfoliative dermatitis Gastric ulcer Gastrointestinal hemorrhage Gastrointestinal perforation Gastrointestinal ulcer Glomerulonephritis Hematuria Hemolytic anemia Hemorrhage Hepatitis Hyperkalemia Hypertension Hypoglycemic disorder Infection Interstitial nephritis Jaundice Kidney disease with reduction in glomerular filtration rate (GFr) Laryngeal edema Nephrotic syndrome Pancytopenia Proteinuria Purpura Renal failure Renal papillary necrosis Stevens-johnson syndrome Syncope Thrombocytopenic disorder Toxic epidermal necrolysis Urticaria Vasculitis

There are 49 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Dyspepsia Nausea	Anorexia Body fluid retention Constipation Diarrhea Dizziness Drowsy Edema Eructation Flatulence Headache disorder Pruritus of skin Skin rash Tinnitus

Rare/Very Rare

Acute cognitive impairment Alopecia Blurred vision Bruising Cystitis Depression Dysuria Ecchymosis Epistaxis Fatigue Female infertility Fever Flu-like symptoms General weakness Hallucinations Hearing loss Hyperglycemia Hyperhidrosis Insomnia Mood changes Nail disorders Nervousness Onycholysis Palpitations Paresthesia Petechiae Skin photosensitivity Stomatitis Symptoms of anxiety Tachycardia Visual changes Vomiting Xerostomia

There are no adequate and well-controlled studies of piroxicam in pregnant women. Use of NSAIAs during pregnancy at about 30 weeks of gestation or later can cause premature closure of the fetal ductus arteriosus, and use at about 20 weeks of gestation or later has been associated with fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, use of NSAIAs should be avoided in pregnant women at about 30 weeks of gestation or later; if NSAIA therapy is necessary between about 20 and 30 weeks of gestation, the lowest effective dosage and shortest possible duration of treatment should be used.

Monitoring of amniotic fluid volume via ultrasound examination should be considered if the duration of NSAIA treatment exceeds 48 hours; if oligohydramnios occurs, the drug should be discontinued and follow-up instituted according to clinical practice. Pregnant women should be advised to avoid use of NSAIAs beginning at 20 weeks' gestation unless otherwise advised by a clinician; they should be informed that NSAIAs should be avoided beginning at 30 weeks' gestation because of the risk of premature closure of the fetal ductus arteriosus and that monitoring for oligohydramnios may be necessary if NSAIA therapy is required for longer than 48 hours' duration between about 20 and 30 weeks of gestation. Known effects of NSAIAs on the human fetus during the third trimester of pregnancy include prenatal constriction of the ductus arteriosus, tricuspid incompetence, and pulmonary hypertension; nonclosure of the ductus arteriosus during the postnatal period (which may be resistant to medical management); and myocardial degenerative changes, platelet dysfunction with resultant bleeding, intracranial bleeding, renal dysfunction or renal failure, renal injury or dysgenesis potentially resulting in prolonged or permanent renal failure, oligohydramnios, GI bleeding or perforation, and increased risk of necrotizing enterocolitis.

Fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment has been observed, on average, following days to weeks of maternal NSAIA use, although oligohydramnios has been observed infrequently as early as 48 hours after initiation of NSAIA therapy. Oligohydramnios is often, but not always, reversible (generally within 3-6 days) following discontinuance of NSAIA therapy. Complications of prolonged oligohydramnios may include limb contracture and delayed lung maturation.

A limited number of case reports have described maternal NSAIA use and neonatal renal dysfunction, in some cases irreversible, without oligohydramnios. Some cases of neonatal renal dysfunction have required treatment with invasive procedures such as exchange transfusion or dialysis. Deaths associated with neonatal renal failure have been reported.

Methodologic limitations of these postmarketing studies and case reports include lack of a control group; limited information regarding dosage, duration, and timing of drug exposure; and concomitant use of other drugs. These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAIA use. Available data on neonatal outcomes generally involved preterm infants, and the extent to which certain reported risks can be generalized to full-term infants is uncertain.

Animal data indicate that prostaglandins have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, inhibitors of prostaglandin synthesis, such as piroxicam, were associated with increased pre- and post-implantation losses. Prostaglandins also have an important role in fetal kidney development.

In animal studies, inhibitors of prostaglandin synthesis impaired kidney development at clinically relevant doses. Animal reproduction studies in rats and rabbits receiving piroxicam revealed no evidence of teratogenicity at exposures up to 5 and 10 times, respectively, the maximum recommended human dose (MRHD). In rats, fetotoxicity (postimplantation loss) was observed at exposure levels of twice the MRHD, and delayed parturition and an increased incidence of stillbirth were observed at doses equivalent to the MRHD.

Data are lacking on the effects of piroxicam during labor or delivery. In animal studies, NSAIAs, including piroxicam, inhibited prostaglandin synthesis, delay parturition, and increased the incidence of stillbirth.

Limited data indicate that piroxicam is distributed into milk at concentrations of approximately 1-3% of the maternal concentration. No accumulation of the drug in milk relative to maternal plasma was observed. The manufacturer states that the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for piroxicam and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

No enhanced Geriatric Use information available for this drug.