FDA APPROVES PENNSAID (DICLOFENAC SODIUM TOPICAL SOLUTION)

The U.S. Food and Drug Administration (FDA) has approved Pennsaid Topical Solution (diclofenac sodium topical solution) for the treatment of the signs and symptoms of osteoarthritis of the knee.

What is said about Pennsaid ?
Pennsaid Topical Solution is in a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.
Pennsaid is used to treat the signs and symptoms of osteoarthritis of the knee(s).

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have a history of stomach ulcer or bleeding, liver or kidney disease, high blood pressure, fluid retention or congestive heart failure.

While the risk of absorbing Pennsaid into your bloodstream is low, all non-steroidal anti-inflammatory drugs (NSAIDs) can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use Pennsaid just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance. This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are using an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to diclofenac (Cataflam, Voltaren), aspirin, or an other NSAID, have a liver or kidney disease. Do not use Pennsaid just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

While the risk of absorbing Pennsaid into your bloodstream is low, all NSAIDs can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are using an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Pennsaid can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Pennsaid application-
Apply Pennsaid to clean, dry skin. Dispense Pennsaid 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread Pennsaid Topical Solution evenly around front, back and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution. After you apply Pennsaid, wait at least 10 minutes before dressing. Do not bathe or shower for at least 30 minutes after applying Pennsaid. Wait until the area is completely dry before covering with clothing or applying sunscreen, insect repellent, cosmetics, topical medications, or other substances.

Do not cover the treated skin with a bandage or expose it to heat from a hot tub, heating pad, sauna, or heated water bed. Heat or bandaging can increase the amount of drug you absorb through your skin and may cause harmful effects. Do not use Pennsaid on an open skin wound, or on areas of eczema, infection, skin rash, or burn injury. Wait until the condition has fully healed before using Pennsaid.

Pennsaid side effects-
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medication and call your doctor at once if you have any of these serious side effects:
chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools;
coughing up blood or vomit that looks like coffee grounds;
swelling or rapid weight gain;
urinating less than usual or not at all;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
bruising, severe tingling, numbness, pain, muscle weakness; or
a severe skin reaction.

Less serious side effects may include:
dryness or itching of treated skin;
peeling or scaling of treated skin; or
fever, chills, sore throat, body aches or other flu symptoms.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Disclaimer : The above information has been cited from literature in public domain. This is for research purpose/ dissemination of knowledge only and should not be construed as medical advise.