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Solaraze topical

Generic Name: Diclofenac Sodium topical
Class: Skin and Mucous Membrane Agents, Miscellaneous
VA Class: DE900
Chemical Name: 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid monosodium salt
Molecular Formula: C14H10Cl2NNaO2
CAS Number: 15307-79-6

Warning(s)

Special Alerts:

[Posted 12/04/2009] Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for diclofenac (topical) to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Prototypical NSAIA; phenylacetic acid derivative.1 2 3 4 5

Uses for Solaraze

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

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Actinic Keratoses

Treatment of actinic keratoses.1 2 3 4

Solaraze Dosage and Administration

General

Complete healing of the lesions or optimal therapeutic response may not occur until 30 days after cessation of therapy.1

Administration

Topical Administration

Apply to actinic keratosis lesions as a 3% gel.1

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adults

Actinic Keratoses
Topical

Apply a sufficient amount (usually 0.5 g for each 5 cm × 5 cm lesion) and rub gently onto the lesions twice daily for 60–90 days.1

Cautions for Solaraze

Contraindications

  • Known hypersensitivity to diclofenac or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Sensitivity Reactions

Sensitivity reactions, including anaphylaxis, possible in patients without prior exposure to diclofenac.1 Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps).1

General Precautions

GI Effects

Use with caution in patients with active GI ulceration or bleeding.1

Topical Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

For external use only; avoid contact with eyes.1 Do not apply to open skin wounds, infected lesions, or exfoliative dermatitis.1

Safety and efficacy of concomitant use with other topical products (e.g., sunscreens, cosmetics, other topical medications) unknown.1

Specific Populations

Pregnancy

Category B.1 Avoid use in third trimester (possible premature closure of ductus arteriosus) or in late pregnancy (possible delay in labor or parturition).1

Lactation

Discontinue nursing or the drug because of potential risk to nursing infants.1

Pediatric Use

Safety and efficacy not established in children.1 Actinic keratoses generally are not seen in the pediatric population; diclofenac sodium gel should not be used by children.1

Geriatric Use

Actinic keratoses occur frequently in an older patient population.1 No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1

Hepatic Impairment

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Use with caution in patients with severe hepatic impairment.1

Renal Impairment

Use with caution in patients with severe renal impairment.1

Common Adverse Effects

Contact dermatitis, rash, dry skin, exfoliation (scaling).1

Interactions for Solaraze

NSAIAs

Potential pharmacologic interaction with oral NSAIAs including analgesic/anti-inflammatory dosages of aspirin.1

Solaraze Pharmacokinetics

Absorption

Bioavailability

Absorbed into epidermis after topical application to the skin.1 2

Minimal systemic absorption following topical application (serum diclofenac concentrations averaged 20 ng/mL following topical application twice daily for up to 105 days versus 1417 ng/mL following a single 50-mg oral dose of diclofenac sodium).1 6

Distribution

Plasma Protein Binding

Bound to albumin.1

Elimination

Metabolism

Metabolized in the liver via hydroxylation and conjugation following oral administration; metabolism following topical administration is expected to be similar to that following oral administration.1

Elimination Route

Mainly excreted in urine following oral administration.1

Half-life

1–2 hours following oral administration.1

Stability

Storage

Topical

Gel

20–25°C (may be exposed to 15–30°C).a Protect from heat; do not freeze.a

Actions

  • Prototypical NSAIA.1 2 3 4 5

  • While the mechanism(s) of the topical effects has not been established,1 2 3 diclofenac has inhibited angiogenesis and induced neovascular regression in inflammatory tissue in animal models.2 3

  • NSAIAs, including diclofenac, may inhibit angiogenesis through inhibition of substance P or by blocking the angiogenic effects of prostaglandin E2 (PGE2).2

  • For topical use in the treatment of actinic keratoses, diclofenac sodium is commercially available as a 3% gel with benzyl alcohol, hyaluronate sodium, polyethylene glycol monomethyl ether, and purified water.1 The contribution of individual vehicle components to the efficacy of diclofenac sodium gel remains to be established.1

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Risk of adverse effects, including irritant or allergic contact dermatitis.1 Importance of reporting signs and symptoms of adverse dermal reactions.1 Necessity of interrupting therapy if severe dermal reactions occur.1

  • Avoid exposure to sunlight and use of sunlamps.1

  • Importance of monitoring and follow-up evaluation.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription, OTC, or herbal products, as well as any concomitant illness.1 Safety and efficacy of use with other topical products (e.g., sunscreens, cosmetics, other topical medications) is unknown.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Diclofenac

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Gel

3%

Solaraze (with benzyl alcohol)

Bioglan

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Flector 1.3% Patches (KING PHARMA): 30/$193.00 or 90/$547.96

Pennsaid 1.5% Solution (MALLINCKRODT BRAND PHARMA): 150/$180.00 or 450/$499.95

Solaraze 3% Gel (PHARMADERM): 100/$579.98 or 300/$1,699.98

Voltaren 1% Gel (ENDO PHARMACEUTICALS): 100/$42.99 or 300/$110.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Bioglan Pharma Inc. Solaraze (diclofenac sodium 3%) topical gel prescribing information. Malvern, PA: 2001 Jun 1.

2. Rivers JK, McLean DI. An open study to assess the efficacy and safety of topical 3% diclofenac in a 2.5% hyaluronic acid gel for the treatment of actinic keratoses. Arch Dermatol. 1997; 133:1239-42. [IDIS 392849] [PubMed 9382562]

3. Peters DC, Foster RH. Diclofenac/Hyaluronic acid. Drugs Aging. 1999; 14:313-9. [PubMed 10319244]

4. McEwan LE, Smith JG. Topical diclofenac/hyaluronic acid gel in the treatment of solar keratoses. Australas J Dermatol. 1997; 38:187-9. [PubMed 9431711]

5. Hamor GH. Nonsteroidal anti-inflammatory drugs. In: Foye WO, ed. Principles of medicinal chemistry. 3rd ed. Philadelphia: Lea & Febiger; 1989:503-30.

6. Novartis Pharmaceuticals. Cataflam diclofenac potassium (immediate- release tablets), Voltaren diclofenac sodium (delayed-release tablets), Voltaren-XR diclofenac sodium (extended-release tablets) prescribing information (dated 2000 May). In Physicians’ desk reference. 55th ed. Montvale, NJ: Medical Economics Company; 2001:2151-5.

7. Bioglan Pharma, Malvern, PA: Personal communication.

a. Bioglan Pharma Inc. Solaraze (diclofenac sodium 3%) topical gel prescribing information. Malvern, PA: 2003 May.

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