Antifungals, Topical Therapeutic Class Review (TCR)

Antifungals, Topical Therapeutic Class Review (TCR)

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Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to PSTCREditor@.

November 2020 Proprietary Information. Restricted Access ? Do not disseminate or copy without approval. ? 2004-2020 Magellan Rx Management. All Rights Reserved.

FDA-APPROVED INDICATIONS

Drug

Tinea Tinea Tinea Tinea Cutaneous pedis cruris versicolor corporis candidiasis

Other

butenafine

(Lotrimin Ultra? [OTC])1

X

X

--

X

--

Relief of itching, burning, and cracking

butenafine

(Mentax?)2

X

X

X

X

--

--

ciclopirox 0.77%

(Ciclodan? cream,3

X

X

X

X

X

--

ciclopirox 0.77%

(Loprox?/cream/gel/

X

X

X

X

suspension) 4,5,6,7

Seborrheic scalp dermatitis X

(Loprox 1% shampoo only)

ciclopirox 8%

(Ciclodan solution; Ciclodan)8

--

--

--

--

Topical treatment in

immunocompetent patients with

--

mild to moderate onychomycosis

of fingernails and toenails due to

Trichophyton rubrum

ciclopirox 8% /

triamcinolone acetonide*

(TrilocicloTM)9

--

--

--

--

Topical treatment in

immunocompetent patients with

--

mild to moderate onychomycosis

of fingernails and toenails due to

Trichophyton rubrum

clotrimazole (Alevazol [OTC], solution)10

--

--

X (RX only)

X

For discomfort, scaly skin between

X

the toes or burning feet

Relief of itching, burning, and

cracking

clotrimazole

(Lotrimin? AF cream [OTC])11

X

X

--

X

--

Relief of itching, burning, and cracking

clotrimazole /

betamethasone cream (DermacinRx Therazole

X

X

--

X

Pak)12,13

Caused by the organism

--

Trichophyton rubrum, Trichophyton mentagrophytes, and

Epidermophyton floccosum

clotrimazole / betamethasone lotion14

X

X

--

X

--

--

econazole cream15

X

X

X

X

X

--

econazole foam (Ecoza?)16

X

--

--

--

--

--

econazole / triamcinolone

acetonide*

X

X

X

X

X

--

(TriamazoleTM)17

* Contains an antifungal agent co-packaged with topical corticosteroid triamcinolone 0.1% ointment, which is indicated for the relief of inflammatory and pruritic manifestations of corticosteroids responsive dermatosis.

Page 2

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FDA-Approved Indications (continued)

Drug

efinaconazole (Jublia?)18

ketoconazole19 ketoconazole (Extina?, Ketodan?)20,21 ketoconazole 2% shampoo22 ketoconazole (Nizoral? A-D 1% shampoo [OTC])23 ketoconazole (Xolegel?)24 luliconazole (LuzuTM)25

Tinea pedis

--

X ----X

Tinea cruris

--

X ----X

Tinea Tinea versicolor corporis

--

--

X

X

--

--

X

--

--

--

--

--

--

X

Cutaneous candidiasis

Other

Topical treatment of

--

onychomycosis of the toenails due to Trichophyton rubrum and

Trichophyton mentagrophytes

X

Seborrheic dermatitis

--

Seborrheic dermatitis

--

--

--

Seborrheic dermatitis

--

Seborrheic dermatitis

Caused by the organism

--

Trichophyton rubrum and

Epidermophyton floccosum

miconazole

(Desenex? [OTC])26

X

--

--

--

--

--

miconazole (AzolenTM [OTC])27

X

--

--

X

miconazole (Fungoid? [OTC])28

X

--

--

X

miconazole

(Lotrimin? AF spray [OTC])29

X

X

X

X

miconazole (Mycozyl APTM [OTC])30

X

X

--

X

miconazole (Zeasorb AF? [OTC])31

X

X

--

--

miconazole/zinc oxide/ white petrolatum (Vusion?)32

--

--

--

--

naftifine (Naftin?)33

X

X

--

X

nystatin34

--

--

--

--

nystatin/triamcinolone35

--

--

--

--

oxiconazole (Oxistat?)36

X

X

X (cream only)

X

sertaconazole (Ertaczo?)37

X

--

--

--

sulconazole (Exelderm?)38

X

X

X

X

tavaborole (Kerydin?)39

--

--

--

--

--

--

--

--

X

--

--

--

--

--

--

Diaper dermatitis (adjunctive treatment)

--

--

X

--

X

--

--

--

--

--

--

--

Topical treatment of

--

onychomycosis of the toenails due to Trichophyton rubrum or

Trichophyton mentagrophytes

Page 3

Antifungals, Topical Review ? November 2020 | Proprietary Information. Restricted Access ? Do not disseminate or copy without approval.

? 2004-2020 Magellan Rx Management. All Rights Reserved.

FDA-Approved Indications (continued)

Drug

Tinea Tinea Tinea Tinea Cutaneous pedis cruris versicolor corporis candidiasis

Other

terbinafine

(Lamisil? [OTC])40

X

X

X

X

--

--

terbinafine

(Lamisil? AT [OTC])41

X

X

-

X

-

--

tolnaftate

(Fungoid-DTM [OTC])42

X

--

--

--

--

--

tolnaftate

(Tinactin? [OTC])43

X

X

X

X

--

--

tolnaftate

(Lamisil AF Defense OTC])44 X

--

--

X

--

--

undecylenic acid

--

(Hongo Cura)45

X

X

--

X

--

undecylenic acid

(Sponix? Anti-Fungal

X

X

--

--

--

--

OTC])46

undecylenic acid/

chloroxylenol

X

--

--

X

(Gordochom [OTC])47

--

Relief of itching, burning, and

cracking

Treatment of tinea versicolor requires a legend topical product while the treatment of tinea pedis, tinea cruris, or tinea corporis may be treated with an over-the-counter (OTC) topical agent.

Manufacturer Listing

Drug

butenafine (Mentax) butenafine OTC (Lotrimin Ultra OTC) ciclopirox (Ciclodan) ciclopirox (Loprox) ciclopirox ciclopirox/triamcinolone acetonide (Trilociclo) clotrimazole OTC (Lotrimin AF) clotrimazole OTC (Alevazol) clotrimazole/betamethasone (Dermacinrx Therazole Pak) clotrimazole/betamethasone econazole econazole (Ecoza)

Manufacturer

Mylan generic, Schering-Plough/Bayer Medimetriks generic, Medimetriks/Valeant generic Puretek generic; Schering-Plough/Bayer generic, Capital Puretek generic generic Exeltis/Glenmark

Page 4

Antifungals, Topical Review ? November 2020 | Proprietary Information. Restricted Access ? Do not disseminate or copy without approval.

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Manufacturer Listing (continued)

Drug

Manufacturer

econazole /triamcinolone acetonide (Triamazole)

Puretek

efinaconazole (Jublia)

Valeant

ketoconazole

generic

ketoconazole (Extina, Ketodan)

Mylan, Medimetriks

ketoconazole 2% shampoo

generic

ketoconazole (Nizoral A-D 1% Shampoo [OTC])

Johnson & Johnson Consumer/Kramer

ketoconazole (Xolegel)

Aqua/Almirall

luliconazole (Luzu)

Oceanside, Valeant

miconazole OTC

generic

miconazole (Azolen) OTC

Stratus

miconazole (Desenex) OTC

GlaxoSmithKline Consumer

miconazole (Fungoid) OTC

Valeant/Pedinol

miconazole (Lotrimin AF) OTC

Schering-Plough/Bayer/MDS Consumer

miconazole (Mycozyl AP) OTC

Puretek

miconazole (Zeasorb AF) OTC

Crown

miconazole/zinc oxide/white petrolatum (Vusion)

Prestium/Mylan

naftifine

generic

naftifine (Naftin)

Sebela

nystatin

generic

nystatin/triamcinolone

generic

oxiconazole

generic

oxiconazole (Oxistat)

Sandoz

sertaconazole (Ertaczo)

Valeant

sulconazole (Exelderm)

generic; Sun/Journey

tavaborole (Kerydin)48

generic, Pharmaderm/Sandoz

terbinafine (Lamisil AT) OTC

generic; Novartis/GSK

tolnaftate (Fungoid-D) OTC

Valeant

tolnaftate (Tinactin) OTC

Schering-Plough/Bayer

tolnaftate (Lamisil AF) OTC

Novartis/GSK

tolnaftate OTC

generic

undecylenic acid (Hongo Cura) solution OTC

Kramer

undecylenic acid (Sponix Anti-Fungal) solution OTC

BioRx

undecylenic acid/chloroxylenol (Gordochom) solution OTC Gordon

Products that are available as convenience kits are not included in this Therapeutic Class Review.

Page 5

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? 2004-2020 Magellan Rx Management. All Rights Reserved.

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