Diclofenac sodium

DICLOFENAC SODIUM

Manufacturer: Medsource Pharmaceuticals

Score: 144.0

Quick Summary

Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). It works by inhibiting the enzyme cyclooxygenase (COX), reducing the formation of prostaglandins, thromboxanes, and prostacylin. The recommended dose is 40 drops on each painful knee, 4 times a day. Important safety information includes a boxed warning for cardiovascular and gastrointestinal risks, and contraindications for patients with known hypersensitivity to diclofenac sodium or any other component of the drug, history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, and use in the perioperative period of coronary artery bypass graft (CABG) surgery.

Key Clinical Findings and Indications

Treatment of signs and symptoms of osteoarthritis of the knee(s)
Inhibition of cyclooxygenase (COX) enzyme
Reduction of prostaglandins, thromboxanes, and prostacylin formation

Important Safety Information

Warning

Cardiovascular and gastrointestinal risks

Contraindications

Known hypersensitivity to diclofenac sodium or any other component of the drug
History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
Use in the perioperative period of coronary artery bypass graft (CABG) surgery

Adverse Reactions

Application site reactions (e.g. dryness, erythema, induration, vesicles, paresthesia, pruritus)
Gastrointestinal events (e.g. bleeding, ulceration, perforation)
Cardiovascular events (e.g. myocardial infarction, stroke)

Dosing Recommendations

General Guidance

No dose adjustments recommended

Osteoarthritis of the knee(s)

Adult Dose

40 drops on each painful knee, 4 times a day

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation
Avoid use starting at 30 weeks gestation due to risk of premature closure of the ductus arteriosus

Nursing Mothers

It is not known whether diclofenac is excreted in human milk
Caution advised when using in nursing mothers

Pediatric Use

Safety and effectiveness not established in pediatric patients

Geriatric Use

Use caution in treating elderly patients (65 years and older)
Monitor renal function in elderly patients

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