Topical Tazarotene Therapy for Psoriasis, Acne Vulgaris, and ...

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Contraceptive counseling should be given to women ofchildbearing potential before topical tazarotene is used. Althoughabsorption is minimal, it should not be used by pregnant womensince systemic tazarotene is teratogenic.ConclusionsTopical tazarotene is very efficacious in the treatment ofpsoriasis, acne and photoaging. It is the most potent comedolytictopical retinoid currently available. Combination therapy withcorticosteroids or phototherapy in psoriasis, or antibiotics in acnevulgaris, can enhance efficacy and tolerance. Irritation can beminimized with patient education, and use of the 0.05% cream,on alternate day and short-contact regimens.References1. Chandraratna RA. Tazarotene—first of a new generation of receptor-selectiveretinoids. Br J Dermatol 135(Suppl 49):18-25 (1996 Oct).2. Bershad S, Poulin YP, Berson DS, et al. Topical retinoids in the treatment of acnevulgaris. Cutis 64(2 Suppl):8-20 (1999 Aug).3. Koo J. Population-based epidemiologic study of psoriasis with emphasis onquality of life assessment. Dermatol Clin 14(3):485-96 (1996 Jul).4. Weinstein GD, Krueger GG, Lowe NJ, et al. Tazarotene gel, a new retinoid fortopical therapy of psoriasis: vehicle-controlled study of safety, efficacy andduration of therapeutic effect. J Am Acad Dermatol 37(1):85-92 (1997 Jul).5. Guenther L. Tazarotene combination treatments in psoriasis. J Am AcadDermatol 43(2 Pt 3):S36-42 (2000 Aug).6. Guenther LC, Poulin YP, Pariser DM. A comparison of tazarotene 0.1% gel oncedaily plus mometasone furoate 0.1% cream once daily versus calcipotriene0.005% ointment twice daily in the treatment of plaque psoriasis. Clin Ther22(10):1225-38 (2000 Oct).7. Koo J, Martin D. Double-blind comparison of tazarotene gel q.d. plusmometasone furoate cream q.d. versus mometasone furoate cream b.i.d. Posterpresentation at: American Academy of Dermatology annual meeting, (1999 July28-August 1), New York, NY.8. Lebwohl M, Lombardi K, Tan MH. Duration of improvement in psoriasis aftertreatment with tazarotene 0.1% gel plus clobetasol propionate 0.05% ointment:comparison of maintenance treatments. Int J Dermatol 40(1):64-6 (2001 Jan).9. Ho V, Schacter D, Miller R, et al. Acne management for the 90s: currenttreatment guidelines. Can J Diagnosis 12(suppl):1-25 (1995).10. Lebwohl MG, Breneman DL, Goffe BS, et al. Tazarotene 0.1% gel pluscorticosteroid cream in the treatment of plaque psoriasis. J Am Acad Dermatol39(4 Pt 1):590-6 (1998 Oct).11. Green L, Sadoff W, and the Tazarotene Plus High-Potency or Mid-PotencySteroid Study Group. A clinical evaluation of tazarotene 0.1% gel, with andwithout a high- or mid-high-potency corticosteroid, in patients with stableplaque psoriasis. J Cut Med Surg. In Press 2002.12. Koo JY, Lowe NJ, Lew-Kaya DA, et al. Tazarotene plus UVB phototherapy inthe treatment of psoriasis. J Am Acad Dermatol 43(5 Pt 1):821-8 (2000 Nov).13. Behrens S, Grundmann-Kollmann M, Schiener R, Peter RU, Kerscher M.Combination phototherapy of psoriasis with narrow-band UVB irradiation andtopical tazarotene gel. J Am Acad Dermatol 42(3):493-5 (2000 Mar).14. Behrens S. Combination treatment of psoriasis with photochemotherapy andtazarotene gel, a receptor-selective topical retinoid. (Letter to Ed.) Br J Dermatol141:154-179 (1999).15. Webster GF, Berson D, Stein LF, Fivenson DP, Tanghetti EA, Ling M. Efficacyand tolerability of once-daily tazarotene 0.1% gel versus once-daily tretinoin0.025% gel in the treatment of facial acne vulgaris: a randomized trial. Cutis67(6 Suppl):4-9 (2001 Jun).16. Leyden JJ, Tanghetti EA, Miller B, et al. Once-daily tazarotene 0.1% gel versusonce-daily tretinoin 0.1% microsponge gel for the treatment of facial acnevulgaris: a double-blind randomized trial. Cutis 69(suppl 2):12-19 (2002).17. Webster GF, Guenther L, Poulin YP, et al. A multicenter, double-blind,randomized comparison study of the efficacy and tolerability of once-dailytazarotene 0.1% gel and adapalene 0.1% gel for the treatment of facial acnevulgaris. Cutis 69(suppl 2):4-11 (2002).18. Leyden J, Lowe N, Kakita L, Draelos Z. Comparison of treatment of acne vulgariswith alternate-day applications of tazarotene 0.1% gel and once-daily applicationsof adapalene 0.1% gel: a randomized trial. Cutis 67(6 suppl):10-6 (2001 Jun).19. Draelos ZD, Tanghetti EA, and the Tazarotene Combination Leads to EfficaciousAcne Results (CLEAR) Trial Study Group. Cutis 69(suppl 2):20-29 (2002).20. Sefton J, Kigman AM, Kopper SC, Lue JC, Gibson JR. Photodamage pilot study:a double-blind, vehicle-controlled study to assess the efficacy and safety oftazarotene 0.1% gel. J Am Acad Dermatol 43(4):656-63 (2000 Oct).21. Kang S, Leydon JJ, Lowe NJ, et al. Tazarotene cream for the treatment of facialphotodamage: a multicenter, investigator-masked, randomized, vehiclecontrolled,parallel comparison of 0.01%, 0.025%, 0.05%, and 0.1% tazarotenecreams with 0.05% tretinoin emollient cream applied once daily for 24 weeks.Arch Dermatol 137(12):1597-604 (2001 Dec).————— INDUSTRY NEWS —————Roche Initiates an Enhanced Pregnancy Prevention Programto Prevent Accutane- Exposed PregnanciesIn January 2002, Hoffmann-LaRoche, working closely with the US FDA distributed an enhanced version of their Pregnancy Prevention Program for Womenon Accutane ® to more than 375,000 dermatologists, primary care prescribers and pharmacists in the US. The program is called S.M.A.R.T. (System to ManageAccutane ® Related Teratogenicity). It involves the prescriber, pharmacist and patient to ensure that female patients are not pregnant when they begin takingAccutane ® and that they do not become pregnant while taking the medication and for one month after stopping treatment. An innovative component of theprogram is the use of yellow self-adhesive Accutane ® Qualifications Stickers, which prescribers will apply to all Accutane ® prescriptions.To receive the first Accutane ® prescription, the female patient will be required to meet four qualifications:1. Have two negative pregnancy tests – the first as a screening test and the second as a confirmation test that will be administered during the first 5 daysof her next menstrual period.2. Select and commit to using two effective forms of birth control simultaneously one month prior to treatment, during treatment and for one month afterstopping treatment.3. Read and sign an informed consent agreement explaining the risk of potential birth defects associated with Accutane ® .4. Learn about and be encouraged to enroll in the Accutane ® Survey, a system to track female Accutane ® patients, learn about their experiences withpregnancy prevention efforts and determine their pregnancy status.Each month the patient must have a negative pregnancy test and receive contraception counseling from the prescriber before receiving a new prescription.If the patient meets these qualifications, or is male, the prescriber will then write a prescription for a 1-month supply, affix one of the yellow Accutane ®Qualification Stickers and date it. Prescriptions must be filled within 7 days of the qualification date on the sticker.This program is being phased in and the deadline for compliance is April 10, 2002.The S.M.A.R.T. program is only applicable for treating patients in the US. For other countries, including Canada, Roche has created uniquely tailoredprograms to address their distinctive health care needs.4Skin Therapy Letter • Editor: Dr. Stuart Maddin • Vol. 7 No. 3 • March 2002
Common Sense Dermatological Drug SuggestionsFor Women Who Are Breast-feedingC. Zip, MD, FRCPCDepartment of Medicine, University of Calgary, Calgary, Alberta, CanadaABSTRACTUse of medications by breast-feeding mothers is not uncommon. When prescribing a medication to a nursing mother, the physicianmust weigh the potential risk of exposing the infant to the medication or the risks of not breast-feeding against the benefits of themedication to the mother. Information regarding the safety of common dermatological medications during lactation will bereviewed. Based on this information, treatment recommendations will be made.Key Words: breast-feeding, antimicrobials, antihistimines, immunomodulators, antipsoriatics, steriods, scabicides, anti-acne agentsBreast-feeding provides optimal nutrition in the first 6 months oflife. Well documented benefits of breast-feeding include adecreased incidence of infantile diarrhea 1 and infection. 2 Otherstudies show a possible protective affect against sudden infantdeath syndrome, 3 insulin dependent diabetes mellitus, 4 Crohn’sdisease, 5 ulcerative colitis, 5 lymphoma, 6 and allergic disorders. 7The American Academy of Pediatrics (AAP) recommendsexclusive breastfeeding for the first six months of life, continuingto a year or beyond with the addition of solid food at 6 months ofage. 8 In Canada, approximately 80% of new mothers initiatebreast-feeding, 9 while 30-40% are still nursing 6 monthspostpartum. 10 Corresponding US figures are 64% and 29%,respectively. 11The use of prescription and over-the-counter (OTC) medicationsis common for nursing mothers. In one study of 14,000 pregnantor breastfeeding women, 79% of them took at least onemedication, while on average, 3.3 drugs were taken whilebreastfeeding. 12 Fortunately, severe adverse effects resultingfrom the presence of common medications in breast milk areuncommon. Of 838 infants exposed to medications throughbreast milk, 11% experienced minor reactions, and no seriousreactions requiring medical attention or cessation ofbreastfeeding occurred. 13 The adverse reactions that did occurwere consistent with the known pharmacological affects of thecausative agent.Transfer of Medications into Breast MilkA number of factors determine the passage of a drug into breastmilk. These include characteristics of the mother, the infant andthe drug itself. In general, drugs given to a nursing mother reachthe infant in much lower concentrations than those given to apregnant woman reach the fetus. 14AntimicrobialsPenicillins and cephalosporins are present only in trace amountsin breast milk, and are compatible with breast-feeding. 15 Theiruse is associated with a remote risk of alterations ingastrointestinal flora causing diarrhea and allergic sensitization ofthe infant. 16 Erythromycin is excreted into breast milk, but noadverse effects in infants exposed to this drug in breast milk havebeen reported, 16 and it is considered compatible withbreastfeeding by the AAP. Caution may be in order in whenprescribing erythromycin to lactating mothers of newbornshowever, because of recent reports of pyloric stenosis in neonatestreated with erythromycin. 17,18 It has been reported that thecalcium present in breast milk may inhibit absorption of the smallamount of tetracycline, however, use of tetracycline while breastfeedingis not advised, because the threshold for its affect on teethand bone is unknown. 14 Topical clindamycin is partially absorbedthrough the skin and small amounts may pass into breast milk. Noproblems have been reported in nursing infants with maternal useof topical clindamycin, 19 although bloody diarrhea was reportedin an infant of a mother on intravenous clindamycin. 20 Noadverse effects on the infant have been reported with use oftopical metronidazole during lactation, however the manufactureradvises against its use while breast-feeding. 21Acyclovir is considered safe during breast-feeding. 15,16Experience with the use of valacyclovir and famciclovir duringhuman lactation is lacking. 16Terbinafine and itraconazole are both excreted in breast milk, andthe safety of their use during lactation is unknown. Parenteralfluconazole has been safely used in neonates with candidiasis,and based on this, Briggs states that its use is probably safeduring breast-feeding. 16 The manufacturers of these threeantifungals do not recommend their use while breast-feeding andthe AAP has no rating. 22,23,24AntihistaminesSmall amounts of antihistamines are excreted in breast milk.Their use is not recommended during breast-feeding becauseinfants may be more susceptible to their adverse effects,particularly drowsiness and irritability. 19,25 Antihistamines mayalso reduce milk production in some women.ImmunomodulatorsBoth cyclosporine and methotrexate are excreted into breast milk,and considered contraindicated during breast-feeding by the AAPbecause of the possibility of immunosuppression, neutropenia,carcinogenesis and unknown affects on growth. 15Hydroxychloroquine is excreted in small amounts in breast milkand because of its slow elimination rate and potential toaccumulate to toxic levels in infants, caution is advised with dailySkin Therapy Letter • Editor: Dr. Stuart Maddin • Vol. 7 No. 3 • March 2002 5
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Page 3: ComparatorsResultsTazarotene 0.1% g
Page 7 and 8: lactation. 36,37 Spironolactone may

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