These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION.
DICLOFENAC SODIUM topical solution 2% w/w, for topical use
Initial U.S. Approval: 1988
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
See full prescribing information for complete boxed 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 occur early in treatment and may increase with duration of use (5.1)
Diclofenac sodium is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (4, 5.1)
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (5.10)
04/2021
Warnings and Precautions, Fetal Toxicity (5.11)
04/2021
INDICATIONS AND USAGE
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s). (1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
The recommended dose is 2 pump actuations on each painful knee, 2 times a day. (2)
Apply diclofenac sodium topical solution to clean, dry skin. (2.1)
Dispense 40 mg (2 pump actuations) directly onto the knee or first into the hand and then onto the knee. Spread evenly around front, back and sides of the knee. (2.1)
Wash hands completely after administering the product. (2.2)
Wait until the area is completely dry before covering with clothing or applying sunscreen, insect repellent, cosmetics, topical medications, or other substances. (2.2)
Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s). (2.2)
Do not get diclofenac sodium topical solution in your eyes, nose, or mouth (2.2).
DOSAGE FORMS AND STRENGTHS
Diclofenac sodium topical solution 2% w/w (3)
CONTRAINDICATIONS
Known hypersensitivity to diclofenac or any components of the drug product. (4)
History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. (4)
In the setting of coronary artery bypass graft (CABG) surgery. (4)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop (5.3)
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (5.4, 7)
Heart Failure and Edema: Avoid use of diclofenac sodium in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5)
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of diclofenac sodium in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function (5.6)
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs (5.7)
Exacerbation of Asthma Related to Aspirin Sensitivity: Diclofenac sodium topical solution is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) (5.8)
Serious Skin Reactions: Discontinue diclofenac sodium at first appearance of skin rash or other signs of hypersensitivity. (5.9, 5.15)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically (5.10)
Fetal Toxicity: Limit use of NSAIDs, including diclofenac sodium topical solution, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus (5.11, 8.1).
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia (5.12, 7).
Exposure to light: Avoid exposure of treated knee(s) to natural or artificial sunlight. (5.15)
Eye Contact: Avoid contact of diclofenac sodium with eyes and mucosa. (5.16)
Oral Nonsteroidal Anti-inflammatory Drugs: Avoid concurrent use with oral NSAIDs. (5.17)
ADVERSE REACTIONS
The most common adverse reactions with diclofenac sodium topical solution are application site reactions. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly using diclofenac sodium with drugs that interfere with hemostasis. Concomitant use of diclofenac sodium and analgesic doses of aspirin is not generally recommended (7)
ACE Inhibitors, Angiotensin Receptor Blockers (ARB) or Beta-Blockers: Concomitant use with diclofenac sodium may diminish the antihypertensive effect of these drugs. Monitor blood pressure (7)
ACE Inhibitors and ARBs: Concomitant use with diclofenac sodium in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function (7)
Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects (7)
Digoxin: Concomitant use with diclofenac sodium can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels (7)
USE IN SPECIFIC POPULATIONS
Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of diclofenac sodium in women who have difficulties conceiving. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
