DICLOFENAC SODIUM TOPICAL GEL

NSAID

Brand names: Diclofenac Sodium

Pregnancy: Category CTopical

Mechanism of Action

12.1 Mechanism of Action Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium topical gel, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Indications

1 INDICATIONS AND USAGE Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment

such as the knees and those of the hands. Diclofenac sodium topical gel has not been evaluated for use on the spine

hip

or shoulder. Diclofenac sodium topical gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment

such as the knees and those of the hands. Diclofenac sodium topical gel was not evaluated for use on joints of the spine

hip

Contraindications

• 4 CONTRAINDICATIONS Diclofenac sodium topical gel is contraindicated in the following patients: Known hypersensitivity (e.g.
• anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see Warnings and Precautions ( 5.7
• 5.9 )] History of asthma
• urticaria
• or other allergic-type reactions after taking aspirin or other NSAIDs. Severe

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity
4 , 7) Heart Failure and Edema : Avoid use of diclofenac sodium topical gel in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5
Avoid use of diclofenac sodium topical gel in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function ( 5
7 ) Exacerbation of Asthma Related to Aspirin Sensitivity : Diclofenac sodium topical gel is contraindicated in patients with aspirin-sensitive asthma

Known Side Effects

7 documented side effects by frequency

Drug Not Working

>10%

Fatigue

1-10%

Joint Pain

1-10%

Rash

1-10%

Nausea

1-10%

Headache

0.1-1%

Hair Loss

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Topical