Brand and Other Names:Flector Transdermal Patch, Voltaren Gel, more...Pennsaid topical solution, Solaraze Gel
- Classes: Topical Skin Products
Dosing & Uses
Dosage Forms & Strengths
- 1% (Voltaren)
- 3% (Solaraze)
- 1.3% (180mg) (Flector)
topical solution (Pennsaid)
- 1.5% (16.05mg/mL; dropper bottle)
- 2% (20mg/pump actuation)
Solaraze gel: Apply thin layer to affected skin q12hr x60-90 days
- Apply 2 g (upper extremities)/4 g (lower extremities) q6hr
- Not to exceed 8 g/day to any single joint of (upper) extremities; 16 g/day to any single joint of (lower extremities)
- Administration: Use supplied dosing card to determine amount
Pennsaid topical solution
- Indicated for osteoarthritis of the knee
- 1.5%: Apply 40 gtt on each painful knee QID; dispense 10 gtts at a time either directly onto knee or first into hand and then spread evenly to front, sides, and back of knee; repeat procedure until 40 gtt have been applied
- 2%: Apply 40 mg (2 pump actuations) on each painful knee BID; dispense 40 mg at a time directly into palm of hand and then apply evenly to front, sides, and back of knee
Flector patch: 1 patch q12hr applied on most painful area
Solaraze gel: Apply to lesion area q12hr for 60-90 days
Pennsaid 2%: Prime pump before first use by fully depressing the pump mechanism (actuation) 4 times while holding the bottle in an upright position; this portion should be discarded to ensure proper priming
Apply to clean, dry skin
Avoid showering/bathing until gel/solution is dry for at least 30 min
Wash hands after use
Avoid clothing on knees until gel/solution is dry
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Dry skin (25-27%)
Contact dermatitis (19-33%)
Paresthesia (≤ 20%)
Pruritus (≤ 52%)
Black Box Warnings
- NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), & stroke, which can be fatal
- Risk may increase with duration of use
- Patients with risk factors for or existing cardiovascular disease may be at greater risk
- NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)
- Transdermal patch is contraindicated for use on non intact or damaged skin
- NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
- GI adverse events may occur at any time during use & without warning symptoms
- Elderly patients are at greater risk for serious GI events
Hypersensitivity to diclofenac, aspirin other NSAIDs or any ingredient
CABG perioperative period
Active GI ulceration or bleeding, severe renal/hepatic impairment, history of aspirin triad, elderly, history of heart failure
Risks of: cardiovascular thrombotic events; GI bleeding & ulceration; hepatotoxicity (with Na-salt)
Avoid sun exposure
Avoid using on open skin wounds, infected lesions, or exfoliative dermatitis
Concurrency with diuretics or ACE inhibitors
NSAIDs can lead to new onset or worsening of preexisting hypertension
Fluid retention and edema observed; monitor patients with conditions that may be aggravated (eg, CHF)
Avoid contact with eyes
Do not wear patch while showering
Elevations of 1 or more liver tests may occur during therapy with Flector Patch
Note: Not all Cautions/Contraindications apply to Solaraze/Flector
Pregnancy & Lactation
Pregnancy Category: 1st and 2nd trimesters - B (Solaraze), C (Voltaren gel, Pennsaid, Flector Patch); category D during 3rd trimester because of risk for premature closure of the ductus arteriosus
Lactation: Excretion in milk unknown/not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Decreases formation of prostaglandin by inhibiting cyclooxygenase enzymes 1 and 2; may have anti-inflammatory effects by inhibiting chemotaxis, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels
Half-Life: 12 hr (patch)
Absorption: 10% in epidermis (Solaraze gel); 6% systemic (Voltaren gel); 2-3% (topical solution)
Peak Plasma Time: 4.5±8 hr (Solaraze); 10-14 hr (Voltaren gel); 10-20 hr (Flector Patch)
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