Adult Dosing

Acute pain

• Flector: 1 patch bid to the most painful area

Osteoarthritis of knees

• Pennsaid solution: Apply 40 drops/knee qid
• Do not apply external heat or occlusive dressing to the treated knees

Osteoarthritis (Knees and Hands)

• Upper extremities joint: Gently massage 2 g/joint qid, [Max: 8 g/day/joint]
• Lower extremities joint: Gently massage 4 g/joint qid, [Max: 16 g/day/joint]
• Max: 32 g/ day over all affected joints
• Do not apply external heat or occlusive dressing to the treated knees

Actinic keratoses

• Solaraze Gel: Apply to the lesion bid x 60-90 days

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Flector
• Acute pain due to minor strains, sprains, and contusions

• Pennsaid
• Osteoarthritis of knees

• Voltaren Gel
• Osteoarthritis of the joints (knees & hands)

• Solaraze
• Topical treatment of actinic keratoses

• Hypersensitivity to any of the ingredients of the product
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
• Peri-operative pain in the setting of coronary artery bypass graft surgery
• Non-intact or damaged skin (exudative dermatitis, eczema, infected lesion, burns or wounds)
• Hypersensitivity to benzyl alcohol, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium [Solaraze gel]

• NSAIDs may increase risk of serious and potentially fatal cardiovascular thrombotic events, MI, and stroke. Risk further increases with duration of use, presence of cardiovascular disease/risk factors for CV disease
• Diclofenac is contraindicated in the treatment of peri-operative pain in the setting of CABG surgery
• NSAIDs may increase risk of serious GI events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events occur at any time and without warning symptoms. Elderly patients are at greater risk for serious GI events

Renal Dose Adjustment

• Renal impairment: Use cautiously, monitor renal function. Dose adjustments not defined
• Advanced renal disease: contraindicated

Hepatic Dose Adjustment

• Hepatic impairment: Use cautiously, monitor LFTs. Dose adjustments not defined

• Use the lowest effective dose for the shortest duration possible in patients with known CV disease or risk factors for CV disease as it may cause serious cardiovascular thrombotic events, myocardial infarction, and stroke
• Diclofenac leads to onset of new hypertension or worsening of pre-existing hypertension, closely monitor blood pressure before initiating and during treatment
• Concomitant use of NSAIDs with ACE-inhibitors, thiazides or loop diuretics, may impair the therapeutic response of these therapies
• Diclofenac causes inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine. Restrict use in patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding. If a serious GI adverse event is suspected, discontinue and promptly institute an alternative therapy
• Avoid long term therapy with the drug, concomitant use of oral corticosteroids or anticoagulants, smoking, and use of alcohol, as these may increase the risk of GI bleeding
• Long term use causes renal papillary necrosis and other renal injury. Patients with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly are at greater risk. Patients generally recover to pretreatment state after discontinuation of therapy
• Diclofenac therapy is contraindicated in advanced renal disease
• Severe hepatotoxicity can occur any time during treatment, closely monitor (ALT and AST) levels periodically in patients receiving continued therapy. Use the lowest effective dose for the shortest duration possible to minimize the potential risk of hepatotoxicity and avoid concomitant use of drugs known to be potentially hepatotoxic
• Do not use in patients with the aspirin triad
• Serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN) can occur with NSAIDs, discontinue the therapy at the first appearance of skin rash or any other sign of hypersensitivity
• Do not administer in pregnant female after 30 weeks as it causes premature closure of the ductus arteriosus in the fetus
• Check hematologic profile including hemoglobin or hematocrit at regular intervals in patients on long-term treatment with NSAIDs as it may cause anemia due to fluid retention, occult or gross GI blood loss
• Diclofenac inhibits platelet aggregation and prolongs bleeding time in some patients, closely monitor patients those with coagulation disorders or receiving anticoagulants
• Use cautiously in patients with pre-existing asthma/aspirin-sensitive asthma as it may exacerbate the symptoms
• Use cautiously in patients with fluid retention or heart failure, as it may cause fluid retention and edema
• Instruct patients to avoid exposure of treated area to the sunlight, as it results in an earlier onset of ultraviolet light induced skin tumors
• Avoid concomitant use with oral NSAIDs as it results in a higher rate of rectal hemorrhage, more frequent abnormal creatinine, urea and hemoglobin

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Asthma
• Cardiovascular disease
• Presence of cardiac risk factors
• Hypertension
• CHF
• Fluid retention
• History of PUD/GI bleed
• Hematological disorders
• Dehydration
• Long term use
• Diuretic use
• Pregnancy
• Coagulation disorder
• Anti coagulant use
• Corticosteroid use
• Alcohol use
• Smokers
• Elderly patients
• Concomitant use of ACE-inhibitors

Flector, Pennsaid, Solaraze, Voltaren Gel interacts with :

	ACE Inhibitors
	Acenocoumarol
	Anafranil
	Angiotensin Receptor Blockers (ARBs)
	Anticancer Doses
	Brisdelle
	Celexa
	Citalopram
	Clomipramine
	Coumadin
	Cymbalta
	Desvenlafaxine
	Duloxetine
	Effexor
	Effexor XR
	Escitalopram
	Eskalith
	Fluoxetine
	Fluvoxamine
	Folotyn
	Imipramine
	Jantoven
	Khedezla
	Lexapro
	Lithium
	Lithobid
	Luvox
	Luvox CR
	Methotrexate
	Milnacipran
	Nefazodone
	Otrexup
	Paroxetine
	Paxil
	Paxil CR
	Pexeva
	Phenprocoumon
	Pralatrexate
	Pristiq
	Prozac
	Prozac Weekly
	Rheumatrex Dose Pack
	Sarafem
	Savella
	Selfemra
	Sertraline
	Tofranil
	Tofranil-PM
	Trexall
	Venlafaxine
	Warfarin
	Zoloft

Pregnancy Category: Flector patch, Voltaren Gel: Category C; Pennsaid: Category C prior to 30 weeks; Category D starting 30 weeks gestation; Solaraze: Category B

Breastfeeding: Safety unknown; Limited data on excretion of diclofenac into milk; drug has a short half-life and little glucuronide metabolite formation. Mostly considered to be acceptable during breastfeeding. More published information is required. Use caution especially while nursing a newborn or preterm infant based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 30 December 2010). However as per manufacturer data, because of the potential for possible serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

• GI: GI bleeding, GI ulcers, GI perforation, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, heartburn, elevated liver enzymes, nausea, vomiting, dyspepsia, dysgeusia, dry mouth, hematemesis, hepatitis, jaundice, appetite changes, hepatotoxicity
• CNS: Dizziness, headache, anxiety, hypokinesia, paresthesia, somnolence
• CV: Hypertension, CHF, tachycardia, syncope, arrhythmia, myocardial infarction, hypotension, vasculitis, palpitations, thromboembolism, fluid retention, peripheral edema, chest pain
• RESP: Dysnea, asthma, pneumonia, respiratory depression, bronchospasm, pharyngitis, sinusitis
• GU: Acute renal failure, rectal bleeding, dysuria, renal papillary necrosis, nephrotoxicity, hematuria
• DERM: Pruritis, dermatitis, burning, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pruritis, rashes, eczema, photosensitivity, angioedema, erythema multiforme, urticaria, acne, alopecia, hyperesthesia, skin carcinoma, skin nodule, skin ulcer
• HEMA: Anemia, increased bleeding time, thrombocytopenia, ecchymosis, eosinophilia, hyperglycemia, blood dyscrasias
• LOCAL: Application site dryness, irritation, erythema, atrophy, discoloration, hyperhidrosis, and vesicles
• MUSC: Arthralgia, arthrosis, myalgia
• MISC: Allergic reactions including anaphylaxis, fever, infections, asthenia

• NSAID; precise mechanism of action unknown, inhibits cyclooxygenase and reduces prostaglandin synthesis
• Minimal systemic absorption following topical application
• Metabolized by liver; CYP450: 2C8, 2C9 and 3A4 and UGT 2B7 substrate
• Renally excreted primarily (65%); bile (35%)
• Half life: 2 hrs
• Flector Patch: 12 hrs

US Trade Name(s)

• Flector
• Solaraze
• Voltaren Gel
• Pennsaid

US Availability

diclofenac (generic)

• GEL: 1%

Flector (diclofenac epolamine)

• TDP: 1.3%

Solaraze (diclofenac sodium)

• GEL: 3%

Voltaren Gel (diclofenac sodium)

• GEL: 1%

Pennsaid (diclofenac sodium)

• SOLN: 1.5% w/w

Canadian Trade Name(s)

• Voltaren Emulgel
• Voltaren Emulgel-Joint pain
• Pennsaid

Canadian Availability

Voltaren Emulgel, Voltaren Emulgel joint pain (diclofenac diethylamine)

• GEL: 1.16%

Pennsaid (diclofenac sodium)

• SOLN: 1.5%

UK Trade Name(s)

• Mobigel spray
• Solaraze
• Voltarol Emulgel
• Voltarol Gel Patch
• Voltarol Pain-eze Emugel

UK Availability

Mobigel spray (diclofenac sodium)

• SPRAY: 4%

Solaraze (diclofenac sodium)

• GEL: 3%

Voltarol Emulgel, Voltarol Pain-eze Emugel (diclofenac diethylammonium)

• GEL: 1.16%

Voltarol Gel Patch (diclofenac epolamine)

• TDP: 1%

Australian Trade Name(s)

• Voltaren Emulgel
• Dencorub
• Solaraze

Australian Availability

diclofenac sodium(generic)

• GEL: 10 mg/g

Voltaren Emulgel (diclofenac sodium)

• GEL: 1 %

Dencorub (diclofenac sodium)

• GEL: 1 %

Solaraze (diclofenac sodium)

• GEL: 3 %

[Outline]

Analgesics

Topical Analgesics

NSAIDs

Pricing data from www.DrugStore.com in U.S.A.

• Solaraze 3 % GEL [Tube] (PHARMADERM)
  100 % = $579.98
  300 % = $1699.98
• Pennsaid 1.5 % SOLN [Bottle] (MALLINCKRODT BRAND PHARMA)
  150 % = $180
  450 % = $499.95
• Flector 1.3 % PTCH [Box] (KING PHARMA)
  30 % = $193
  90 % = $547.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.