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Dyloject Generic Name & Formulations
Legal Class
Rx
General Description
Diclofenac sodium 37.5mg/mL; soln for IV inj.
Pharmacological Class
NSAID (benzeneacetic acid deriv.).
How Supplied
Single-dose vials—25
Manufacturer
Generic Availability
NO
Dyloject Indications
Indications
Mild-to-moderate pain. Moderate-to-severe pain alone or in combination with opioid analgesics.
Dyloject Dosage and Administration
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.
Dyloject Contraindications
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.
Dyloject Boxed Warnings
Not Applicable
Dyloject Warnings/Precautions
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 1st 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.
Dyloject Pharmacokinetics
See Literature
Dyloject Interactions
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).
Dyloject Adverse Reactions
Adverse Reactions
Nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, insomnia; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, anaphylactic reactions, anemia.
Dyloject Clinical Trials
See Literature
Dyloject Note
Not Applicable
Dyloject Patient Counseling
See Literature
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