60 Practice Trends P EDIATRIC N EWS • May 2007 Simple Label Makers Sub for Electronic Records

BY BRUCE K. DIXON makers at a cost of about $150 apiece. an extra step to ensure that patients know tate mailing,” she added. The label mak- Chicago Bureau “I have all my prescriptions on the at- what their medications are for. For exam- er also prints individual postage stamps us- tached software, so all I have to do to print ple, in addition to printing “Statin 20 mg ing the Web site www.stamps.com. f you’re not ready to invest thousands a label is go to the list on my computer, #90,” the label also says “cholesterol med.” “In addition, the data management soft- of dollars in an electronic medical click on the prescription, and it comes out “Patients love it, and pharmacists appre- ware that comes with the machine contains Irecords system, a desktop label writer of the machine,” said Dr. Lucas, who puts ciate being able to read the prescriptions may be just what the doctor ordered. one label into the patient’s chart and gives without ever having to call and ask me what “This is a very cost-effective alternative a second, signed, copy to the patient to take I wrote,” said Dr. Lucas. Pharmacists for anyone who doesn’t have an EMR sys- to the pharmacy. “Or I stick the label or la- The desktop labeling system also inte- appreciate not tem,” said Dr. Stephanie Lucas, who bels on a sheet of paper and fax it to the grates with software programs to pro- having to call and equipped her two-physician Detroit prac- pharmacy.” duce individual labels. “It’s nice because it ask me what I tice with several Dymo Twin Turbo label The internist and endocrinologist take has an optional mailing bar code to facili- wrote for a prescription.

DIFFERIN ® () Cream, 0.1% Other reported local cutaneous adverse events in patients who used OVERDOSAGE: DIFFERIN® Gel is intended for cutaneous use only. If the DIFFERIN® Cream once daily included: sunburn (2%), skin discomfort- medication is applied excessively, no more rapid or better results will be DR. LUCAS Rx Only BRIEF SUMMARY burning and stinging (1%) and skin irritation (1%). Events occurring in less obtained and marked redness, peeling, or discomfort may occur. The acute ® oral toxicity of DIFFERIN® Gel in mice and rats is greater than 10 mL/kg. For topical use only. Not for ophthalmic, oral, or intravaginal use. than 1% of patients treated with DIFFERIN Cream included: flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, Chronic ingestion of the drug may lead to the same side effects as those our entire Rolodex file of physicians, so that INDICATIONS AND USAGE: DIFFERIN® Cream is indicated for the topical pruritus, skin discoloration, rash, and eczema. associated with excessive oral intake of Vitamin A. treatment of acne vulgaris. patients referred to another facility get a OVERDOSAGE: DIFFERIN® Cream is intended for cutaneous use only. If CONTRAINDICATIONS: DIFFERIN® Cream should not be administered to the medication is applied excessively, no more rapid or better results will Marketed by: Manufactured by: legible copy of the name, address, and individuals who are hypersensitive to adapalene or any of the components be obtained and marked redness, scaling, or skin discomfort may occur. GALDERMA LABORATORIES, L.P. DPT Laboratories, Ltd. in the cream vehicle. The acute oral toxicity of DIFFERIN® Cream in mice and rats is greater than Fort Worth, Texas 76177 USA San Antonio, Texas 78215 USA phone number on a printed label that can PRECAUTIONS: General: If a reaction suggesting sensitivity or chemical 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects GALDERMA is a registered trademark. be affixed to the lab sheets or tickler file.” irritation occurs, use of the medication should be discontinued. Exposure to as those associated with excessive oral intake of Vitamin A. 325034-0903 sunlight, including sunlamps, should be minimized during use of adapalene. Revised: September 2003 Dr. Lucas also prints legible, customized Patients who normally experience high levels of sun exposure, and those with Marketed by: Manufactured by: inherent sensitivity to sun, should be warned to exercise caution. Use of instructions for each patient, and puts a GALDERMA LABORATORIES, L.P. DPT Laboratories, Ltd. sunscreen products and protective clothing over treated areas is recommended ■ Fort Worth, Texas 76177 USA San Antonio, Texas 78215 USA References: 1. Gollnick H, Cunliffe W, Berson D, et al. Management of second copy into each chart. when exposure cannot be avoided. Weather extremes, such as wind or cold, GALDERMA is a registered trademark. acne: a report from a global alliance to improve outcomes in acne. also may be irritating to patients under treatment with adapalene. www.differin.com J Am Acad Dermatol. 2003;49:S1-S37. 2. Shalita A, Weiss JS, Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. 325069-0805 Chalker DK, et al. A comparison of the efficacy and safety of adapalene The product should not be applied to cuts, abrasions, eczematous or sunburned Revised: August 2005 gel 0.1% and gel 0.025% in the treatment of acne vulgaris: skin. As with other , use of “waxing” as a depilatory method should a multicenter trial. J Am Acad Dermatol. 1996;34:482-485. I NDEX OF be avoided on skin treated with adapalene. 3. Thiboutot D, Gold MH, Jarratt MT, et al. Randomized controlled ® ® trial of the tolerability, safety, and efficacy of adapalene gel 0.1% and Information for Patients: Patients using DIFFERIN Cream should receive DIFFERIN (adapalene gel) Gel, 0.1% tretinoin microsphere gel 0.1% for the treatment of acne vulgaris. Cutis. the following information and instructions: 2001;68:10-19. 4. Dosik JS, Homer K, Arsonnaud S. Cumulative A DVERTISERS 1. This medication is to be used only as directed by the physician. Rx Only BRIEF SUMMARY irritation potential of adapalene 0.1% cream and gel compared with ® 2. It is for external use only. INDICATIONS AND USAGE: DIFFERIN Gel is indicated for the topical cream 0.05% and 0.1%. Cutis. 2005;75:289-293. 5. Data Alcon Laboratories, Inc. treatment of acne vulgaris. on file. Galderma Laboratories, L.P. 6. NDC Health data, 2005. 3. Avoid contact with the eyes, lips, angles of the nose, and mucous Vigamox 37-38 membranes. CONTRAINDICATIONS: DIFFERIN® Gel should not be administered to 4. Cleanse area with a mild or soapless cleanser before applying this individuals who are hypersensitive to adapalene or any of the components Amerifit Brands Inc. medication. in the vehicle gel. Culturelle 20 ® 5. Moisturizers may be used if necessary; however, products containing WARNINGS: Use of DIFFERIN Gel should be discontinued if hypersensitivity alpha hydroxy or glycolic acids should be avoided. to any of the ingredients is noted. Patients with sunburn should be advised ArthroCare ENT not to use the product until fully recovered. 6. Exposure of the eye to this medication may result in reactions such as Corporate 18-19 swelling, conjunctivitis, and eye irritation. PRECAUTIONS: General: If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to 7. This medication should not be applied to cuts, abrasions, eczematous or AstraZeneca LP. sunlight, including sunlamps, should be minimized during the use of adapalene. sunburned skin. Pulmicort Flexhaler 13-14 Patients who normally experience high levels of sun exposure, and those with 8. Wax epilation should not be performed on treated skin due to the potential Tough inherent sensitivity to sun, should be warned to exercise caution. Use of for skin erosions. Barrier Therapeutics, Inc. sunscreen products and protective clothing over treated areas is recommended Vusion 28-29 9. During the early weeks of therapy, an apparent exacerbation of acne may when exposure cannot be avoided. Weather extremes, such as wind or cold, occur. This is due to the action of this medication on previously unseen also may be irritating to patients under treatment with adapalene. lesions and should not be considered a reason to discontinue therapy. Dermik Laboratories, Inc. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. BenzaClin 67-68 Overall clinical benefit may be noticed after two weeks of therapy, but at The product should not be applied to cuts, abrasions, eczematous skin, or least eight weeks are required to obtain consistent beneficial effects. sunburned skin. and Endo Pharmaceuticals Inc. Drug Interactions: As DIFFERIN® Cream has the potential to produce local Certain cutaneous signs and symptoms such as erythema, dryness, scaling, Synera 60a-60b irritation in some patients, concomitant use of other potentially irritating burning, or pruritus may be experienced during treatment. These are most topical products (medicated or abrasive soaps and cleansers, soaps and likely to occur during the first two to four weeks and will usually lessen with cosmetics that have a strong drying effect, and products with high concentra- Galderma Laboratories, L.P. continued use of the medication. Depending upon the severity of adverse Differin 59-60 tions of alcohol, astringents, spices or lime rind) should be approached with events, patients should be instructed to reduce the frequency of application or caution. Particular caution should be exercised in using preparations containing discontinue use. ® Tender. , resorcinol, or in combination with DIFFERIN Cream. If Graceway Pharmaceuticals, LLC Drug Interactions: As DIFFERIN® Gel has the potential to produce local irri- these preparations have been used, it is advisable not to start therapy with Atopiclair 23 tation in some patients, concomitant use of other potentially irritating topical DIFFERIN® Cream until the effects of such preparations in the skin have subsided. products (medicated or abrasive soaps and cleansers, soaps and cosmetics Janssen, L.P. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity that have a strong drying effect, and products with high concentrations of studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, In treating acne: Risperdal 53-56 alcohol, astringents, spices, or lime) should be approached with caution. and 4.0 mg/kg/day, and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day. Particular caution should be exercised in using preparations containing sulfur, 2 Johnson & Johnson Consumer Companies, Inc. These doses are up to 8 times (mice) and 6 times (rats) in terms of mg/m /day resorcinol, or salicylic acid in combination with DIFFERIN® Gel. If these prepa- Bedtime Bath and Lotion 47 the maximum potential exposure at the recommended topical human dose rations have been used, it is advisable not to start therapy with DIFFERIN® Gel the efficacy ® (MRHD), assumed to be 2.5 grams DIFFERIN Cream, which is approximately until the effects of such preparations in the skin have subsided. 1.5 mg/m2 adapalene. In the oral study, increased incidence of benign and malig- MedImmune Vaccines, inc. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity nant pheochromocytomas in the adrenal medullas of male rats was observed. you expect and FluMist 21 studies with adapalene have been conducted in mice at topical doses of 0.3, 0.9, No photocarcinogenicity studies were conducted. Animal studies have and 2.6 mg/kg/day and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day, Merck & Co., Inc. shown an increased risk of skin neoplasms with the use of pharmacologically approximately 4-75 times the maximal daily human topical dose. In the oral similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory the tolerability Gardasil 8a-8b study, positive linear trends were observed in the incidence of follicular cell or to sunlight. Although the significance of these studies to human use is not adenomas and carcinomas in the thyroid glands of female rats, and in the RotaTeq 44-46 clear, patients should be advised to avoid or minimize exposure to either incidence of benign and malignant pheochromocytomas in the adrenal sunlight or artificial UV irradiation sources. medullas of male rats. your patients Merz Pharmaceuticals Adapalene did not exhibit mutagenic or genotoxic effects in vivo (mouse No photocarcinogenicity studies were conducted. Animal studies have shown Mederma 24 micronucleus test) and in vitro (Ames test, Chinese hamster ovary cell an increased tumorigenic risk with the use of pharmacologically similar drugs assay, mouse lymphoma TK assay) studies. deserve. Nestle (e.g., retinoids) when exposed to UV irradiation in the laboratory or to sunlight. Reproductive function and fertility studies were conducted in rats administered Although the significance of these studies to human use is not clear, patients Good Start 27 oral doses of adapalene in amounts up to 20 mg/kg/day (up to 80 times the should be advised to avoid or minimize exposure to either sunlight or artificial MRHD based on mg/m2 comparisons). No effects of adapalene were found on UV irradiation sources. Novartis Pharmaceuticals Corporation the reproductive performance or fertility of the F males or females. There O In a series of in vivo and in vitro studies, adapalene did not exhibit mutagenic Zaditor 3 were also no detectable effects on the growth, development and subsequent or genotoxic activities. reproductive function of the F1 generation. PharmaDerm Pregnancy: Teratogenic effects. Pregnancy Category C. No teratogenic effects Nursing Mothers: It is not known whether this drug is excreted in human were seen in rats at oral doses of adapalene 0.15 to 5.0 mg/kg/day, up to Cutivate 5-6 milk. Because many drugs are excreted in human milk, caution should be ® 120 times the maximal daily human topical dose. Cutaneous route teratology exercised when DIFFERIN Cream is administered to a nursing woman. studies conducted in rats and rabbits at doses of 0.6, 2.0, and 6.0 mg/kg/day, Sanofi-Aventis U.S. LLC Pediatric Use: Safety and effectiveness in pediatric patients below the age up to 150 times the maximal daily human topical dose exhibited no fetotoxicity Allegra-D 10-12 of 12 have not been established. and only minimal increases in supernumerary ribs in rats. There are no adequate Tough on acne. ADVERSE REACTIONS: In controlled clinical trials, local cutaneous irritation and well-controlled studies in pregnant women. Adapalene should be used dur- Sanofi Pasteur Inc. was monitored in 285 acne patients who used DIFFERIN® Cream once ing pregnancy only if the potential benefit justifies the potential risk to the fetus. Gentle on patients. Pentacel 31, 33, 35 daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, Nursing Mothers: It is not known whether this drug is excreted in human Menactra 41-42 pruritus and burning were assessed during these studies. The incidence of milk. Because many drugs are excreted in human milk, caution should be ActHIB 57-58 ® local cutaneous irritation with DIFFERIN Cream from the controlled clinical exercised when DIFFERIN® Gel is administered to a nursing woman. studies is provided in the following table: Pediatric Use: Safety and effectiveness in pediatric patients below the age Differin and Galderma are registered trademarks. Sepracor Inc. Incidence of Local Cutaneous Irritation with of 12 have not been established. ©2006 Galderma Laboratories, L.P. XopenexHFA 25-26 DIF-656 Printed in USA 01/06 DIFFERIN® Cream from Controlled Clinical Studies (N=285) ADVERSE REACTIONS: Some adverse effects such as erythema, scaling, dryness, pruritus, and burning will occur in 10-40% of patients. Pruritus or Shire USA Inc. None Mild Moderate Severe burning immediately after application also occurs in approximately 20% of www.differin.com Next Generation 7-8 Erythema 52% (148) 38% (108) 10% (28) <1% (1) patients. The following additional adverse experiences were reported in www.galdermausa.com Corporate 51 Scaling 58% (166) 35% (100) 6% (18) <1% (1) approximately 1% or less of patients: skin irritation, burning/stinging, erythema, Dryness 48% (136) 42% (121) 9% (26) <1% (2) sunburn, and acne flares. These are most commonly seen during the first TAP Pharmaceutical Products Inc. Pruritus (persistent) 74% (211) 21% (61) 4% (12) <1% (1) month of therapy and decrease in frequency and severity thereafter. All Prevacid 15-16 Burning/Stinging 71% (202) 24% (69) 4% (12) <1% (2) adverse effects with use of DIFFERIN® Gel during clinical trials were (persistent) reversible upon discontinuation of therapy. Teva Specialty Pharmaceuticals LLC ProAir 39-40