CATAFLAM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CATAFLAM (CATAFLAM).
Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), decreasing prostaglandin synthesis, thereby reducing inflammation, pain, and fever.
| Metabolism | Hepatic metabolism primarily via CYP2C9; secondary pathways include CYP3A4 and glucuronidation. |
| Excretion | Approximately 50-60% of a single dose is excreted in urine as metabolites (primarily glucuronide conjugates and 4'-hydroxydiclofenac) with <1% unchanged. 30-40% is excreted in feces via bile. Renal clearance is 250-350 mL/min. |
| Half-life | Terminal elimination half-life of diclofenac is approximately 1-2 hours. However, for the enteric-coated formulation (Cataflam), the half-life may be slightly prolonged due to slower absorption; clinical relevance is minimal as analgesic duration is 4-8 hours. |
| Protein binding | >99% bound to albumin. Diclofenac is highly bound, primarily to albumin, with minor binding to alpha-1-acid glycoprotein. |
| Volume of Distribution | Approximately 0.1-0.2 L/kg (data from intravenous administration). Clinical meaning: Low Vd reflects extensive protein binding and limited tissue distribution; primarily stays in plasma and extracellular fluid. |
| Bioavailability | Oral: 50-60% due to first-pass metabolism. Rectal: 50-70%. Intramuscular: ~90%. |
| Onset of Action | Oral enteric-coated: 30-60 minutes. Oral immediate-release: 15-30 minutes. Rectal: 30-60 minutes. Intramuscular: 15-30 minutes. |
| Duration of Action | Analgesic/anti-inflammatory effect lasts 4-8 hours after oral or rectal administration. Clinical notes: Duration is dose-dependent; sustained-release forms may extend duration up to 12 hours, but Cataflam is immediate-release. |
50 mg orally three times daily; maximum 150 mg/day.
| Dosage form | TABLET |
| Renal impairment | GFR <30 mL/min: contraindicated; GFR 30-60 mL/min: use lowest effective dose, maximum 100 mg/day; GFR >60 mL/min: no adjustment needed. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated. |
| Pediatric use | Children ≥1 year: 0.5-1 mg/kg/dose orally every 8 hours; maximum 3 mg/kg/day or 150 mg/day, whichever is less. |
| Geriatric use | Start at 25 mg twice daily; maximum 100 mg/day; monitor renal function and gastrointestinal bleeding risk. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CATAFLAM (CATAFLAM).
| Breastfeeding | Present in breast milk in low concentrations; relative infant dose estimated at <1% of maternal weight-adjusted dose. M/P ratio approximately 0.02. Considered compatible with breastfeeding; use lowest effective dose for shortest duration. |
| Teratogenic Risk | Pregnancy Category C (1st and 2nd trimesters) and Category D (3rd trimester). Avoid in 3rd trimester due to risk of premature closure of ductus arteriosus and oligohydramnios. Associated with increased risk of miscarriage and congenital malformations, particularly cardiac defects, when used in 1st trimester. |
■ FDA Black Box Warning
Risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. Increased risk with duration of use and in patients with cardiovascular risk factors. Contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
| Serious Effects |
Absolute: Known hypersensitivity to diclofenac or any component of the formulation; history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; perioperative pain in the setting of CABG surgery. Relative: Advanced renal disease; active gastrointestinal bleeding or peptic ulcer disease; severe uncontrolled hypertension; pregnancy (especially third trimester).
| Precautions | Gastrointestinal effects: Risk of serious GI adverse events including bleeding, ulceration, and perforation. Cardiovascular effects: May cause hypertension, fluid retention, and exacerbation of heart failure. Renal effects: Risk of renal toxicity, especially in patients with pre-existing renal impairment. Hepatic effects: Elevated liver enzymes and potential hepatotoxicity. Hematologic effects: Inhibition of platelet aggregation and risk of bleeding. Anaphylactoid reactions: Possible in patients with aspirin sensitivity. Skin reactions: Severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome). |
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| Fetal Monitoring |
| Monitor maternal renal function, blood pressure, and signs of bleeding (especially in 3rd trimester). Fetal ultrasound for ductus arteriosus patency and amniotic fluid index if used beyond 32 weeks gestation. |
| Fertility Effects | Reversible inhibition of prostaglandin synthesis may impair follicle rupture and ovum release; use in women attempting conception is not recommended. May cause reversible delayed ovulation. |
| Food/Dietary | CATAFLAM may be taken with food or milk to minimize gastrointestinal irritation. Avoid concomitant use of alcohol, which increases the risk of gastrointestinal bleeding. Food does not significantly affect the absorption of diclofenac potassium. |
| Clinical Pearls | CATAFLAM (diclofenac potassium) is a nonsteroidal anti-inflammatory drug (NSAID) used for acute pain and dysmenorrhea. Its potassium salt formulation allows faster absorption than diclofenac sodium. Onset of analgesia occurs within 15-30 minutes. Use the lowest effective dose for the shortest duration. Contraindicated in patients with coronary artery bypass graft (CABG) surgery, active gastrointestinal bleeding, or severe renal impairment. Monitor renal function, blood pressure, and signs of gastrointestinal bleeding. Avoid concurrent use of other NSAIDs or anticoagulants. Not recommended in late pregnancy (may cause premature closure of ductus arteriosus). |
| Patient Advice | Take CATAFLAM with food or milk to reduce stomach upset. · Do not take more than the prescribed dose or for longer than recommended. · Avoid alcohol and other NSAIDs (e.g., ibuprofen, naproxen) while taking this medication. · Contact your doctor immediately if you experience chest pain, weakness, slurred speech, or signs of stomach bleeding (e.g., black/bloody stools, vomiting blood). · Store at room temperature away from moisture and heat. |