DYCLOPRO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DYCLOPRO (DYCLOPRO).
Diclofenac epolamine inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis and consequent inflammation, pain, and fever.
| Metabolism | Primarily hepatic via CYP2C9; minor pathways include CYP3A4 and glucuronidation. |
| Excretion | Primarily renal (approximately 70% as unchanged drug and metabolites); biliary/fecal excretion accounts for about 30%. |
| Half-life | Terminal elimination half-life is approximately 2-4 hours in adults with normal renal function; may be prolonged in renal impairment (up to 8-12 hours). |
| Protein binding | Approximately 99% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | 0.1-0.2 L/kg, indicating limited extravascular distribution, primarily confined to plasma and interstitial fluid. |
| Bioavailability | Oral: 70-90%; Topical: approximately 5-10% (highly variable); Intravenous: 100%. |
| Onset of Action | Oral: 30-60 minutes; Topical: 1-2 hours; Intravenous: immediate. |
| Duration of Action | Oral: 4-6 hours; Topical: 6-8 hours; Intravenous: 4-6 hours. Note: Analgesic effects may persist longer than anti-pyretic effects. |
50 mg intravenously every 8 hours
| Dosage form | SOLUTION |
| Renal impairment | GFR 30-60 mL/min: 50 mg every 12 hours; GFR <30 mL/min: 50 mg every 24 hours; hemodialysis: 50 mg after dialysis |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use |
| Pediatric use | 1 mg/kg intravenously every 8 hours; maximum 50 mg per dose |
| Geriatric use | Initiate at 25 mg every 8 hours, titrate based on renal function |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DYCLOPRO (DYCLOPRO).
| Breastfeeding | Excreted into breast milk in low amounts (M/P ratio not established). Considered compatible with breastfeeding by American Academy of Pediatrics; use lowest effective dose for shortest duration. Monitor infant for gastrointestinal effects or rash. |
| Teratogenic Risk | Pregnancy category C. First trimester: NSAIDs are associated with increased risk of spontaneous abortion and cardiac malformations. Second trimester: Use only if clearly needed; no specific malformation risk confirmed. Third trimester: Avoid due to risk of premature closure of ductus arteriosus, oligohydramnios, and fetal nephrotoxicity. |
■ FDA Black Box Warning
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Diclofenac is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
| Serious Effects |
["Known hypersensitivity to diclofenac or any component of the formulation","History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs","Treatment of peri-operative pain in CABG surgery"]
| Precautions | ["Cardiovascular thrombotic events","Gastrointestinal ulceration, bleeding, and perforation","Hypertension","Renal toxicity","Anaphylactoid reactions","Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)","Hematologic effects (anemia, inhibition of platelet aggregation)","Use with caution in patients with asthma, hepatic impairment, or fluid retention"] |
| Food/Dietary |
Loading safety data…
| Fetal Monitoring | Monitor maternal renal function, blood pressure, and signs of bleeding. In third trimester, perform fetal ultrasound to assess ductus arteriosus patency and amniotic fluid volume if used beyond 48 hours. |
| Fertility Effects | Reversible inhibition of ovulation due to interference with prostaglandin synthesis. May delay or prevent follicle rupture. Discontinue use if attempting conception. |
| Avoid alcohol; may increase risk of GI bleeding. Take with food or milk to reduce GI irritation. |
| Clinical Pearls | Dyclopro (diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) contraindicated in patients with coronary artery bypass graft surgery pain. Use lowest effective dose for shortest duration to reduce cardiovascular and GI risks. Can be used for acute migraine as a solution of 50 mg diclofenac potassium. For eye drops, avoid contact lenses during use and monitor for corneal healing. |
| Patient Advice | Take with food or milk to reduce stomach upset. · Avoid alcohol while taking this medication. · Do not take with other NSAIDs or aspirin without doctor approval. · Seek medical help if you experience signs of stomach bleeding (blood in vomit, black/tarry stools). · For eye drops, do not wear contact lenses during treatment. |