Diclofenac Sodium

DICLOFENAC

Manufacturer: Asclemed USA, Inc.

Score: 145.0

Quick Summary

Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) used for the treatment of signs and symptoms of osteoarthritis of the knee(s). The recommended dose is 40 drops per knee, 4 times a day. It has several safety considerations, including an increased risk of serious cardiovascular thrombotic events and gastrointestinal bleeding. The drug is contraindicated in patients with known hypersensitivity, asthma, urticaria, or other allergic-type reactions, and in the setting of coronary artery bypass graft (CABG) surgery.

Key Clinical Findings and Indications

Treatment of signs and symptoms of osteoarthritis of the knee(s)
Relief of pain and inflammation

Important Safety Information

Warning

Increased risk of serious cardiovascular thrombotic events and gastrointestinal bleeding

Contraindications

Known hypersensitivity to diclofenac or any components of the drug product
History of asthma, urticaria, or other allergic-type reactions
Setting of coronary artery bypass graft (CABG) surgery

Adverse Reactions

Application site skin reactions (dryness, erythema, induration, vesicles, paresthesia, pruritus, vasodilation, acne, urticaria)
Gastrointestinal events (nausea, dyspepsia, diarrhea, abdominal pain)
Cardiovascular events (palpitation, cardiovascular disorder)

Dosing Recommendations

General Guidance

No dose adjustments recommended

Osteoarthritis of the knee(s)

Adult Dose

40 drops per knee, 4 times a day

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Use during pregnancy only if potential benefit justifies potential risk to fetus
Avoid use starting at 30 weeks gestation

Nursing Mothers

Use with caution in nursing mothers

Pediatric Use

Safety and effectiveness not established in pediatric patients

Geriatric Use

Elderly patients at greater risk for NSAID-associated adverse reactions
Start dosing at low end of dosing range and monitor for adverse effects

Similar Drugs

Diclofenac sodium

DICLOFENAC SODIUM

Medsource Pharmaceuticals

Similarity: 92.7%