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Precautions and Warnings With Diclofenac Sodium Topical Solution

If you are allergic to aspirin or any other NSAID, you should not use diclofenac sodium topical solution. Other warnings and precautions for this product relate to an increased risk of high blood pressure, stomach ulcers, and congestive heart failure. To reduce your risk of complications, talk to your healthcare provider about your medical history and current medications before starting treatment.

What Should I Tell My Healthcare Provider?

Prior to using diclofenac sodium topical solution (Pennsaid®), talk to your healthcare provider if you have:
 
Also, let your healthcare provider know if you:
 
  • Are pregnant or thinking of becoming pregnant
  • Are breastfeeding
  • Have had heart surgery recently.
     
You should also be sure to tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medications, vitamins, and herbal supplements.
 

Specific Diclofenac Sodium Topical Solution Warnings and Precautions

Some warnings and precautions to be aware of with diclofenac sodium topical solution include the following:
 
  • Even though this medication is a solution that is applied to the skin, some of the medication is absorbed into the bloodstream. Therefore, all of the standard warnings and precautions with other nonsteroidal anti-inflammatory drugs (NSAIDs) apply to diclofenac sodium topical solution as well.
     
  • There is a "Medication Guide" (a handout approved by the U.S. Food and Drug Administration) that should be dispensed along with diclofenac sodium topical solution. Be sure to read the guide before using this medication and periodically thereafter.
     
  • All NSAIDs, including diclofenac sodium, have been linked to cardiovascular events such as heart attack or stroke. People who have cardiovascular disease or cardiovascular risk factors appear to be at greater risk.
To decrease the chances of these problems occurring, you should take the smallest effective dose for the shortest period. Using diclofenac sodium topical solution is a good way to do this, since only 6 percent of the medication is absorbed into the rest of the body. Be sure to call 911 if you notice heart attack symptoms or stroke symptoms, such as:
    • Chest pain
    • Shortness of breath
    • Weakness
    • Slurring of speech.
 
  • All NSAIDs, including diclofenac sodium topical solution, may cause high blood pressure or make it worse in people who already have it. Therefore, this product should be used with caution in people with known high blood pressure.
     
  • All NSAIDs may cause congestive heart failure or fluid retention. Contact your healthcare provider if you notice unexplained weight gain or swelling while using this drug. Diclofenac sodium topical solution should be used with caution in people with heart failure.
     
  • All NSAIDs have been reported to cause problems in the stomach and intestines, including bleeding (known as gastrointestinal bleeding), stomach ulcers, or holes in the stomach or intestines (called perforations). These problems can lead to serious complications or even loss of life. Extreme caution should be used if diclofenac sodium topical solution is prescribed for people with a history of ulcers or gastrointestinal bleeding.
To decrease the risk of these problems, you should use the smallest effective dose for the shortest period. Contact your healthcare provider immediately if you experience any signs or symptoms of stomach ulcers or bleeding, including:
 
  • Stomach pain
  • Indigestion
  • Black, tarry stools
  • Vomiting blood.
 
It is important to understand that diclofenac sodium topical solution can cause this problem, even though it is not taken by mouth.
  • Diclofenac sodium topical solution can interact with certain medications (see Drug Interactions With Diclofenac Sodium Topical Solution).
     
  • Kidney damage can occur in people taking NSAIDs. This occurrence is more common in the elderly, as well as in people with kidney disease, heart failure, liver problems, and those taking a diuretic or angiotensin-converting enzyme (ACE) inhibitor.
     
  • Liver damage can occur in people taking diclofenac sodium topical solution. Contact your healthcare provider immediately if you notice things such as:
     
    • Nausea
    • Tiredness
    • Lethargy
    • Itchy or yellowing skin
    • Abdominal pain (stomach pain)
    • Flu-like symptoms.
 
  • NSAIDs have been reported to cause allergic reactions. Seek emergency medical attention immediately if you notice things such as difficulty breathing or swelling of the face and throat.
     
  • In rare cases, people using diclofenac sodium topical solution can develop a serious rash. If you notice an unexplained rash or develop blisters, fever, or itchy skin, stop using this product and call your healthcare provider right away.
     
  • There have been reports of anemia in people taking NSAIDs. Therefore, if you are using diclofenac sodium topical solution for an extended period and show signs of anemia, talk to your healthcare provider.
     
  • It is possible that diclofenac sodium topical solution could worsen asthma, especially in people with aspirin-sensitive asthma.
     
  • Avoid prolonged, unprotected sun exposure while using this medication, as animal studies indicate that it might increase the risk of skin cancers.
     
  • Diclofenac sodium topical solution is a pregnancy Category C or D medicine, depending on the particular trimester, which means it might not be safe during pregnancy. If you become pregnant while using this medicine, contact your healthcare provider immediately (see Pennsaid and Pregnancy).
     
  • It is unknown if diclofenac sodium topical solution passes through breast milk. Therefore, if you are breastfeeding a child, check with your healthcare provider (or your child's healthcare provider) before using this product (see Pennsaid and Breastfeeding).
     
The Dirty, Messy Part of BPH

Diclofenac Sodium Topical Solution Information

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