Pennsaid (diclofenac sodium)

WARNING

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• Pennsaid is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

• NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Pennsaid may cause serious side effects including:

• hives,
• sneezing,
• runny or stuffy nose,
• wheezing,
• trouble breathing,
• swelling in your face or throat,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• chest pain spreading to your jaw or shoulder,
• sudden numbness or weakness on one side of the body,
• slurred speech,
• shortness of breath,
• first sign of any skin rash (no matter how mild),
• swelling,
• rapid weight gain,
• severe headache,
• blurred vision,
• pounding in your neck or ears,
• little or no urination,
• nausea,
• diarrhea,
• stomach pain (upper right side),
• tiredness,
• itching,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• pale skin,
• unusual tiredness,
• lightheadedness,
• cold hands and feet,
• bloody or tarry stools,
• coughing up blood, and
• vomit that looks like coffee grounds

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Pennsaid include:

• heartburn,
• gas,
• stomach pain,
• nausea,
• vomiting,
• diarrhea,
• constipation,
• headache,
• dizziness,
• drowsiness,
• stuffy nose,
• itching,
• increased sweating,
• increased blood pressure, and
• skin redness, itching, dryness, scaling, or peeling where the medicine was applied

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Pennsaid. For more information, ask your doctor or pharmacist.

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

General Dosing Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

For relief of the pain of osteoarthritis (OA) of the knee(s), the recommended dose is 40 mg of diclofenac sodium (2 pump actuations) on each painful knee, 2 times a day.

Apply Pennsaid to clean, dry skin.

The pump must be primed before first use. Instruct patients to fully depress the pump mechanism (actuation) 4 times while holding the bottle in an upright position. This portion should be discarded to ensure proper priming of the pump. No further priming of the bottle should be required.

After the priming procedure, Pennsaid is properly dispensed by completely depressing the pump 2 times to achieve the prescribed dosage for one knee. Deliver the product directly into the palm of the hand and then apply evenly around front, back, and sides of the knee.

Application of Pennsaid in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.

Special Precautions

• Avoid showering/bathing for at least 30 minutes after the application of Pennsaid to the treated knee.
• Wash and dry hands after use.
• Do not apply Pennsaid to open wounds.
• Avoid contact of Pennsaid with eyes and mucous membranes.
• Do not apply external heat and/or occlusive dressings to treated knees.
• Avoid wearing clothing over the Pennsaid-treated knee(s) until the treated knee is dry.
• Protect the treated knee(s) from natural and artificial sunlight.
• Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with Pennsaid.
• Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s).
• Do not use combination therapy with Pennsaid and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

See Table 3 for clinically significant drug interactions with diclofenac.

Table 3: Clinically Significant Drug Interactions with Diclofenac

• Use of NSAIDs, including Pennsaid, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
• Avoid use of NSAIDs, including Pennsaid, in pregnant women starting at 30 weeks of gestation (third trimester).
• There are no adequate and well-controlled studies of Pennsaid in pregnant women.
• Based on available data, diclofenac may be present in human milk.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Pennsaid and any potential adverse effects on the breastfed infant from the Pennsaid or from the underlying maternal condition.