PENNSAID Topical solution Ref.[50794] Active ingredients: Diclofenac

4.1 Dosing Considerations

• For patients older than 65 years and frail or debilitated see 4.2 Recommended Dose and Dosage Adjustment.
• Because the long-term safety of PENNSAID is unknown, PENNSAID is indicated for a treatment regimen of not more than three months in duration, whether continuous or intermittent.
• PENNSAID therapy should be discontinued if the application site displays signs of significant skin reaction, including swelling, urticaria or vesiculobullous rash.

4.2 Recommended Dose and Dosage Adjustment

Table 1. Dosage and Administration of PENNSAID (1.5% w/w diclofenac sodium solution):

Pediatrics (<18 years of age)

No data are available to Health Canada, therefore PENNSAID is contraindicated for pediatric patients.

Geriatrics (≥65 years of age)

Patients older than 65 years and frail or debilitated patients are most susceptible to a variety of adverse reactions from non-steroidal anti-inflammatory drugs (NSAIDs); the incidence of these adverse reactions increases with dose and duration of treatment. In addition, these patients are less tolerant to ulceration and bleeding. Most reports of fatal GI events are in this population. Older patients are also at risk of lower esophageal ulceration and bleeding. For such patients, consideration should be given to a starting dose lower than the one usually recommended, with individual adjustment when necessary and under close supervision. See 7 WARNINGS AND PRECAUTIONS, Renal.

4.4 Administration

PENNSAID is intended for external use only. Contact with the eyes or mucous membranes should be avoided.

PENNSAID should be applied to clean, dry skin, and not used under bandages or dressings.

PENNSAID should be dispensed onto the hand, or directly onto the knee, and spread evenly around front, back and sides of the knee until completely covered.

PENNSAID treatment has no relationship to food intake. The treatment regiment for PENNSAID should not exceed three months in duration, whether continuous or intermittent.

4.5 Missed Dose

If one or more doses are missed, the next scheduled dose should be applied. Two doses of PENNSAID should not be applied to make up for a forgotten dose.

In the event of ingestion of PENNSAID (1.5% w/w diclofenac sodium in 45% dimethyl sulfoxide), there is no specific antidote. An entire 60 mL bottle of PENNSAID contains approximately 960 mg of diclofenac sodium. Systemic absorption should be prevented as soon as possible by the induction of vomiting, gastric lavage or treatment with activated charcoal. Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal irritation and respiratory depression. Measures to accelerate elimination (e.g., forced diuresis, hemoperfusion, and dialysis) may be considered, but may be of limited use because of the high protein binding and extensive metabolism of diclofenac.

A 60 mL bottle of PENNSAID contains approximately 29 g of dimethyl sulfoxide (DMSO), well below any toxic level (oral LD₅₀ of DMSO in monkeys is >4 g/kg, while dermal LD₅₀ in monkeys is >11 g/kg). Acute toxicity through inhalation of high vapor concentrations of DMSO, through the use or abuse of PENNSAID, is remote. In the event that exposure occurs, it may lead to irritation of the mucous membranes of the upper respiratory tract, wheezing, nausea or vomiting. Treatment includes administration of oxygen or other symptomatic measures as necessary.

In the event of topical application of an excessive dose, wash the area with soap and water as soon as possible. Local irritation may occur. Treatment includes symptomatic measures as necessary.

For management of a suspected drug overdose, contact your regional poison control centre.

Store at room temperature (15-25°C). Keep out of the reach of children. Any unused product or waste material should be disposed of in accordance with local requirements.