Pennsaid

What is Pennsaid?

• Pennsaid(Diclofenac) is a nonsteroidal anti-inflammatory drug used for the treatment of the pain of osteoarthritis of the knees.

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Diclofenac

Diclofenac 3D

What are the uses of this medicine?

• PENNSAID is indicated for the treatment of the pain of osteoarthritis of the knee(s).

How does this medicine work?

• Diclofenac (dye kloe' fen ak) is a phenylacetic acid derivative and belongs to the acetic acid class of NSAIDs that includes indomethacin, etodolac, ketorolac, nabumetone, tolmetin and sulindac.
• Like other NSAIDs, diclofenac acts as by inhibiting cellular cyclooxygenases (Cox-1 and Cox-2), which results in a decrease in production of pro-inflammatory prostaglandin, prostacyclin and thromboxane products, important mediators of inflammation and pain.
• Diclofenac has analgesic as well as antipyretic and anti inflammatory activities.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product.
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
• In the setting of coronary artery bypass graft (CABG) surgery.

What drug interactions can this medicine cause?

• Monitor patients for bleeding who are concomitantly using PENNSAID with drugs that interfere with hemostasis. Concomitant use of PENNSAID and analgesic doses of aspirin is not generally recommended.
• Concomitant use with PENNSAID may diminish the antihypertensive effect of these drugs. Monitor blood pressure.
• Concomitant use with PENNSAID 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.
• NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
• Concomitant use with PENNSAID can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.

Is this medicine FDA approved?

• Diclofenac was first approved in the United States in 1988 and currently over 5 million prescriptions are filled yearly.

How should this medicine be used?

Recommended dosage:

• The recommended dose is 2 pump actuations on each painful knee, 2 times a day.

Administration:

• Apply PENNSAID, to clean, dry skin.
• 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.
• Wash hands completely after administering the product.
• Wait until the area is completely dry before covering with clothing or applying sunscreen, insect repellent, cosmetics, topical medications, or other substances.
• Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s).
• Do not get PENNSAID in your eyes, nose, or mouth.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As PENNSAID (diclofenac sodium) topical solution 2% w/w

This medicine is available in fallowing brand namesː

• PENNSAID

What side effects can this medication cause?

The most common side effects of this medicine include:

• application site reactions

NSAIDs can cause serious side effects, including:

• Increased risk of a heart attack or stroke that can lead to death
• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines
• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions

What special precautions should I follow?

• 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.
• Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
• Avoid use of PENNSAID in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
• Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of PENNSAID in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
• Anaphylactic Reactions may occur with PENNSAID. Seek emergency help if an anaphylactic reaction occurs.
• PENNSAID is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
• NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome(SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue PENNSAID at first appearance of skin rash or other signs of hypersensitivity.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as PENNSAID. Discontinue and evaluate clinically.
• Limit use of NSAIDs, including PENNSAID, 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.
• Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
• Avoid exposure of treated knee(s) to natural or artificial sunlight.
• Avoid contact of PENNSAID with eyes and mucosa.
• Concomitant use of oral NSAIDs with PENNSAID 1.5% resulted in a higher rate of rectal hemorrhage. Avoid concurrent use with oral NSAIDs.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• lethargy
• drowsiness
• nausea
• vomiting
• epigastric pain
• Hypertension
• acute renal failure
• respiratory depression
• coma

Management of overdosage:

• Manage patients with symptomatic and supportive care following an NSAID overdosage.
• There are no specific antidotes.
• Emesis is not recommended due to a possibility of aspiration and subsequent respiratory irritation by DMSO contained in PENNSAID.
• Consider activated charcoal in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage).
• Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

Can this medicine be used in pregnancy?

• Use of NSAIDs, including PENNSAID, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• diclofenac sodium

Inactive Ingredients:

• ALCOHOL
• DIMETHYL SULFOXIDE
• HYDROXYPROPYL CELLULOSE
• PROPYLENE GLYCOL
• WATER

Who manufactures and distributes this medicine?

Distributed by:

• Horizon Medicines LLC
• Deerfield, IL USA

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Pennsaid
• FDA Pennsaid

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