Inflacam 20mg /1ml

Piroxicam 20mg

Warnings

Black Box Warnings

Cardiovascular Risk

  • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), & stroke, which can be fatal
  • Risk may increase with duration of use
  • Patients with risk factors for or existing cardiovascular disease may be at greater risk
  • NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)

Gastrointestinal Risk

  • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
  • GI adverse events may occur at any time during use & without warning symptoms
  • Elderly patients are at greater risk for serious GI events

Contraindications

Absolute: ASA allergy

Relative: bleeding disorders, duodenal/gastric/peptic ulcer, stomatitis, SLE, ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of the ductus arteriosus)

Cautions

May increase risk of asthma (bronchial), cardiac disease, CHF, hepatic impairment, HTN, renal impairment

Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs

May cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine when used long term and can be fatal; administer lowest effective dose for short periods; use caution

NSAIDs including piroxicam can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal

Not for administration to patients that have experienced aspirin anaphylactoid reactions

Anemia reported in patients receiving NSAIDs, including piroxicam; may prolong bleeding time; monitor

NSAIDs may cause adverse eye reactions; consult ophthalmologist if symptoms occur

Based on mechanism of action, use of prostaglandin-mediated NSAIDs, including piroxicam, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women; women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including piroxicam, should be considered

Heart Failure(HF) risk

  • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
  • NSAIDS should be avoided or withdrawn whenever possible
  • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Inflacam 20mg /1ml only for the indication prescribed.

Resources
  • Drugs.com accessed Dec 14, 2017
  • Medscape accessed Dec 14, 2017
  • Mayo Clinic accessed Dec 14, 2017
  • Epocrates accessed Dec 14, 2017
  • Webmd accessed Dec 14, 2017