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Diclofenac Sodium Topical solution

It is used to treat osteoarthritis of the knees

Generic Name: Pennsaid

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 12/04/2009] Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for diclofenac (topical) to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). It is used to treat osteoarthritis of the knees.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • asthma
  • bleeding problems
  • coronary artery bypass graft (CABG) surgery within the past 2 weeks
  • heart disease
  • high blood pressure
  • if you frequently drink alcohol containing drinks
  • kidney disease
  • liver disease
  • open or infected skin
  • stomach problems
  • an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the directions on the prescription label. Wash hands before and after use. Apply drops to the clean, dry skin of the knee. Or, apply drops to the hand then to knee. Rub around front, back, and sides of the knee. Do not apply to open wounds, infections, swelling, or areas of exfoliative dermatitis. Allow medicine to dry before using any other lotion or medicine on the same place. Do not get this medicine in your mouth or eyes. If this medicine gets in your eye, rinse out with plenty of cool tap water. Protect treatment area from sunlight and sun lamps. Use your doses at regular intervals. Do not use it more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • cidofovir
  • ketorolac
  • methotrexate

This medicine may also interact with the following medications:

  • aspirin
  • cyclosporine
  • lithium
  • medicines for blood pressure
  • medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
  • NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
  • other products used on the skin
  • steroid medicines like prednisone or cortisone


Last Updated: July 20, 2010
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