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PENNSAID

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PENNSAID

PATIENT INFORMATION

Medication Guide For Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.

This chance increases:

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called “corticosteroids” and “anticoagulants”
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all of your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant. NSAID medicines should not be used past 30 weeks of pregnancy.
  • if you are breastfeeding. Talk to your healthcare provider.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include: Other side effects include:
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach
  • and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness

Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • slurred speech
  • weakness in one part or side of your body
  • swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over-thecounter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Generic Name Tradename
Celecoxib Celebrex®
Diclofenac Zorvolex, Zipsor, Flector, Cataflam®, Voltaren® , Voltaren gel, Arthrotec™ (combined with misoprostol), PENNSAID® 1.5%, PENNSAID
Diflunisal Dolobid®
Etodolac Lodine®, Lodine® XL
Fenoprofen Nalfon®, Nalfon® 200
Flurbirofen Ansaid®
Ibuprofen Motrin®, Tab-Profen®, Vicoprofen®* (combined with hydrocodone), Combunox™ (combined with oxycodone), Duexis (combined with famotidine)
Indomethacin Indocin®, Indocin® SR, Indo-Lemmon™ , Indomethagan™
Ketoprofen Oruvail, Nexcede®
Ketorolac Toradol, Sprix®
Mefenamic Acid Ponstel®
Meloxicam Mobic®
Nabumetone Relafen®
Naproxen Naprosyn®, Anaprox®, Anaprox® DS, EC-Naproxyn®, Naprelan®, Naprapac® (copackaged with lansoprazole), Treximet (combined with sumatriptan succinate) and Vimovo (combined with esomeprazole magnesium)
Oxaprozin Daypro®
Piroxicam Feldene®
Sulindac Clinoril®
Tolmetin Tolectin®, Tolectin DS®, Tolectin® 600
*Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Instructions for Use

PENNSAID®
(pen-sed)
(diclofenac sodium topical solution) 2%

Read the Medication Guide that comes with PENNSAID first. Be sure that you read, understand and follow these Instructions for Use before you use PENNSAID for the first time.

Important: For use on the skin only (topical). Do not get PENNSAID in your eyes, nose or mouth.

Before you use PENNSAID:

  • Apply PENNSAID exactly as your healthcare provider tells you. Talk with your healthcare provider or pharmacist if you are not sure.
  • Only use PENNSAID to treat pain from osteoarthritis in your knee or knees.
  • Apply PENNSAID on clean, dry skin that does not have any cuts, infections or rashes.
  • Use PENNSAID two times a day on your knee or knees as prescribed.
  • If you get PENNSAID in your eyes, rinse your eyes right away with water or saline. Call your healthcare provider if your eyes are irritated for more than one hour.

Before you use PENNSAID for the first time, you will need to prime the pump. To prime the pump, remove the cap (See Figure A) and fully press the top of the pump all the way down 4 times while holding the bottle in an upright position (See Figure B). Dispense this portion of the medicine into a tissue or paper towel and throw it away in a trash can. The pump is now ready to use. You should not need to prime the pump again.

Figure A

Remove the cap - Illustration

Figure B

Press the top of the pump - Illustration

Steps for using PENNSAID:

Step 1. Wash your hands with soap and water before applying PENNSAID.

Step 2. Remove the bottle cap and press the pump head down firmly and fully to dispense PENNSAID into the palm of your hand. Release the pump head and then press the pump head down firmly and fully a second time. When you use your PENNSAID, you can hold the bottle at an angle. Put 2 pumps of PENNSAID on your hand (See Figure C).

Figure C

Put 2 pumps of PENNSAID on your hand - Illustration

Step 3. Apply PENNSAID evenly around the front, back, and sides of your knee. PENNSAID should be applied without massaging the knee (See Figures D and E).

Figure D

Apply PENNSAID evenly - Illustration

Figure E

Apply PENNSAID evenly - Illustration

Step 4: Repeat Steps 2 and 3 for your other knee if your healthcare provider has prescribed PENNSAID for both knees.

Step 5: Wash your hands with soap and water right away after applying PENNSAID.

Step 6: Replace the cap on the bottle and store in an upright position.

After you use PENNSAID:

Do not:

  • cover your knee with clothing until your knee is completely dry.
  • put sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medicines on your knee until it is completely dry.
  • take a shower or a bath for at least 30 minutes after you put PENNSAID on your knee(s).
  • use heating pads or cover the treated area with bandages where you have applied PENNSAID.
  • exercise following application of PENNSAID.
  • use sunlamp and tanning beds. Protect your treated knee from sunlight. Wear clothes that cover your skin if you have to be in the sunlight.

How should I store PENNSAID?

  • Store PENNSAID at room temperature between 68°F to 77°F (20°C to 25°C).

Keep PENNSAID and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 1/30/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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