DYLOJECT Rx

Indications for DYLOJECT:

Mild-to-moderate pain. Moderate-to-severe pain alone or in combination with opioid analgesics.

Adult:

Use lowest effective dose for shortest duration. Individualize. 37.5mg by IV bolus inj over 15 secs every 6hrs as needed; max 150mg/day.

Children:

Not established.

Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery. Moderate-to-severe renal impairment in the perioperative period and who are at risk for volume depletion.

Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term NSAID therapy. Pre-existing asthma. Discontinue at 1^st sign of skin rash or any other hypersensitivity. May mask signs of infection or fever. Moderate-to-severe hepatic or renal impairment: not recommended. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30 weeks gestation; Cat.D: ≥30 weeks gestation; avoid). Nursing mothers.

Pharmacological Class:

NSAID (benzeneacetic acid deriv.).

Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Potentiated by CYP2C9 inhibitors (eg, voriconazole) and antagonized by CYP2C9 inducers (eg, rifampin); may need dose adjustments. Caution with other hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics).

Adverse Reactions:

Nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, insomnia; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, anaphylactic reactions, anemia.

Generic Availability:

NO

How Supplied:

Single-dose vials—25