diclofenac topical (Flector Transdermal Patch, Voltaren Gel, Pennsaid topical solution, Solaraze Gel)

Dosing and uses of Flector Transdermal Patch, Voltaren Gel (diclofenac topical)

• Adult
• Pediatric

 

Adult dosage forms and strengths

geL

• 1% (Voltaren)
• 3% (Solaraze)

patch

• 1.3% (180mg) (Flector)

topical solution (Pennsaid)

• 1.5% (16.05mg/mL; dropper bottle)
• 2% (20mg/pump actuation)

 

Actinic Keratoses

Solaraze gel: Apply thin layer to affected skin q12hr x60-90 days

 

Osteoarthritis

Voltaren geL

• 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

 

Acute Pain

Flector patch: 1 patch q12hr applied on most painful area

 

Actinic keratoses

Solaraze gel: Apply to lesion area q12hr for 60-90 days

 

Administration

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

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Flector Transdermal Patch, Voltaren Gel (diclofenac topical) adverse (side) effects

>10%

Dry skin (25-27%)

Rash (20-35%)

Contact dermatitis (19-33%)

Pain (15-26%)

Paresthesia (≤ 20%)

Pruritus (≤ 52%)

Exfoliation (6-24%)

 

1-10%

Hypertension

Chest pain

Skin ulcer

Diarrhea

Dyspepsia

Alepesia

Photosensitivity

Edema

Conjunctivitis

Hematuria

Asthma

Pneumonia

 

Warnings

Black box warnings

Cardiovascular Risk

• 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

Gastrointestinal Risk

• 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

 

Contraindications

Hypersensitivity to diclofenac, aspirin other NSAIDs or any ingredient

CABG perioperative period

 

Cautions

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 and 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

 

Pregnancy categories

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.

 

Pharmacology of Flector Transdermal Patch, Voltaren Gel (diclofenac topical)

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

 

Pharmacokinetics

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)

Excretion: Urine