Mild to moderate pain and moderate to severe pain alone or in combination with opioid analgesics

Dyloject is indicated in adults for the management of mild to moderate pain and moderate to severe pain alone or in combination with opioid analgesics.

Dyloject is contraindicated in patients with:

Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke: Patients with known CV disease or risk factors for CV disease may be at greater risk. Use for the shortest possible duration.

Serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation, which can be fatal: Use for the shortest possible duration. Use with caution in patients with prior history of ulcer disease or GI bleeding.

Renal papillary necrosis and other renal injury with long-term administration of NSAIDs: Use caution when initiating treatment with Dyloject in patients with considerable dehydration. Dyloject is not recommended in patients with moderate to severe renal insufficiency. Use Dyloject with caution in patients at greatest risk for this reaction, including the elderly; those with impaired renal function, heart failure, or liver impairment; and those taking diuretics or ACE inhibitors.

Elevation of one or more liver tests and severe hepatic reactions: To minimize the potential risk for an adverse liver-related event in patients treated with diclofenac, use for the shortest duration possible. Exercise caution when prescribing Dyloject with concomitant drugs that are known to be potentially hepatotoxic (e.g., acetaminophen, certain antibiotics, anti-epileptics). Discontinue Dyloject immediately if abnormal liver tests persist or worsen.

New onset or worsening of hypertension: NSAIDs, including Dyloject, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Monitor blood pressure closely during treatment with Dyloject.

Fluid retention and edema: Use Dyloject with caution in patients with fluid retention or heart failure.

Anaphylactic reactions in patients with the aspirin triad or in patients without prior exposure to Dyloject: Discontinue Dyloject immediately if an anaphylactic reaction occurs.

Serious skin reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue Dyloject if rash or other signs of local skin reaction occur.

Starting at 30 weeks gestation, Dyloject and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. If this drug is used during this time period in pregnancy, the patient should be apprised of the potential hazard to a fetus.

Clinical studies and postmarketing observations have shown that Dyloject can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, observe patients closely for signs of renal failure, as well as to assure diuretic efficacy.

The most common adverse reactions (>5%) in controlled clinical trials include nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, and insomnia.