Custom Rx Formula for Melasma Drug Facts

Custom Rx Formula for Melasma Drug Facts

Your Medication May Contain One or More of the Following:

Azelaic Acid Comedolytic, antibacterial (against C. acnes and S. epidermidis) and anti-inflammatory agent. Inhibits the production of free radical oxygen by neutrophils. Reduces oxidative tissue injury at sites of inflammation and decreases melanin production. It can be used for post inflammatory hyperpigmentation in acne.(1-2)

Hydrocortisone Hydrocortisone is a type of topical synthetic corticosteroid which may accelerate healing and decrease side effects, such as inflammation, which may occur because of other medications in the combination. Anti-inflammatory, anti-proliferative, immunosuppressive, and vasoconstrictive actions. Effects on cutaneous T cells, macrophages, and dendritic cells. Decreases acute and chronic inflammation as well as associated itching. Long term daily use can result in unwanted side effects and HPA Axis suppression in some cases; therefore, using only for as long as condition permits is recommended.(3)

Hydroquinone A gold standard of depigmenting agents, hydroquinone is often the comparator in clinical trials of skin lightening agents. It bleaches or lightens the skin by slowing the production of melanin, so the dark spots gradually fade to match the normal skin coloration.(4) Hydroquinone has been used in several clinical studies for pigmentary disorders due to photodamage and in melasma.(3,5-6)

Kojic Acid Kojic Acid is a naturally occurring hydrophilic fungal derivative, evolved from certain species of Acetobacter Aspergillus and Penicillium, and used in the treatment of hyperpigmentation disorders. It is also obtained from either Japanese mushrooms or asafetida extracted.(7) It acts by inhibiting the production of free tyrosinase with efficacy like hydroquinone.

Retinoic Acid (Tretinoin) Derived from Vitamin A, the mainstay of topical therapy for intrinsically and extrinsically aged skin is topical retinoids, both natural and synthetic forms. Retinoic acid has been extensively investigated for their effects in aged skin.(8) Enhances the granulation that occurs during the proliferation stage of wound healing and aids in collagen synthesis. It can also decrease the MMP’s involved in collagen and elastin degradation.(9) It can cause loosening and exfoliation of the follicular and epithelial cells in the stratum corneum.

Do not use this medication if: ∙ You are pregnant, planning to become pregnant, or breastfeeding. ∙ You are allergic to any of the ingredients in your medication. Signs of an allergic reaction may include rash, hives, itching, shortness of breath, swelling of the face, lips tongue or throat, wheezing or cough. ∙ The area of skin where you are applying the medication is sunburned, cut, scraped, or damaged. ∙ You are sensitive to light or taking medications which cause photosensitivity.

When using these products: ∙ Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. ∙ Avoid tanning beds, sunlamps, skin waxing, and other manipulations to the skin as sensitivity is increased with using this medication. ∙ Inform your physician that you are taking this medication. ∙ Always wear sunscreen/SPF, skin coverings/clothing, and eyewear during the day as this medication can increase your risk of sunburn. ∙ Do not use other prescription or OTC anti-aging products with this medication without first consulting with your provider. ∙ Tell your provider of any changes to your medical history or medication list, including herbal and over-the-counter changes. ∙ If you miss an application, resume the next evening. Do not double applications at the same time. ∙ Skin irritation that may include burning or stinging is not uncommon with the use of azelaic acid, and this should subside within the first few weeks of using the medication.

Stop use and notify a clinician if you experience any of the following: ∙ Chest pain, rapid heartbeat, faintness, or dizziness. ∙ Sudden, unexplained weight gain. ∙ Your hands or feet swell. ∙ If the skin irritation worsens or does not go away. ∙ If your asthma worsens. ∙ You experience unexpected or prolonged irritation or if you have concerns about the listed side effects.

Side effects: ∙ May include warmth or stinging initially upon application. Skin reactions such as dry skin, stinging, change in skin color, redness, swelling, blisters and/or peeling may occur. ∙ May include burning, hypopigmentation, pruritus, skin atrophy. Application after bathing can reduce stinging effect (if present).4 ∙ In most cases, side effects will subside over time, or your provider may change how often or how much medication you are applying.

Warnings: ∙ For external use only. ∙ Wash hands before and after use of this medication. ∙ Avoid contact with eyes. Do not swallow. If swallowed, notify Poison Control. ∙ Do not use if you are pregnant, planning to become pregnant, or breastfeeding. ∙ Keep out of reach of children and pets. ∙ Women of child-bearing potential should not handle this medication. ∙ This medication is designed specifically for you and should not be shared with others. ∙ Using more medication than prescribed or for longer than indicated will not speed up results and may lead to increased risk of side effects.

Store at Controlled Room Temperature 68° to 77°F (20° to 25°C)

Information contained on this handout is provided as an informational aide and for reference use only. The content herein is not intended to be, act as, or replace medical advice or diagnosis for individual health conditions nor is it making evaluations as to the risks or benefits of compounded preparations. Please consult a licensed healthcare professional about diagnosis and treatment. Information and statements within this handout have not been evaluated by the Food and Drug Administration.

  1. Cunliffe WJ, Holland KT. Clinical and laboratory studies of treatment with 20% azelaic acid cream for acne. Acta Derm Venereol Suppl (Stockh). 1989; 143:31-34.2

  2. Katsambas A, Graupe K, Stratigos J. Clinical studies of 20% azelaic acid cream in the treatment of acne vulgaris. Comparison with vehicle and topical tretinoin. Acta Derm Venereol Suppl (Stockh). 1989; 143:35-39.

  3. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section.Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol 2014; 71:116–32.

  4. Draelos ZD. Skin lightening preparations and the hydroquinone controversy. Dermatol Ther 2007;20:308–13

  5. Haddad AL, Matos LF, Brunstein F, Ferreira LM, Silva A, Costa D. A clinical, prospective, randomized, double-blindtrial comparing skin whitening complex with hydroquinone vs. placebo in the treatment of melasma. Int J Dermatol2003;42:153–6.

  6. Ennes S, Paschoalick R, Alchorne MMDA. A double-blind, comparative, placebo-controlled study of the efficacy andtolerability of 4% hydroquinone as a depigmenting agent in melasma. J Dermatolog Treat 2000;11:173–9.

  7. O’Neil MJ Sr, ed. The Merck Index. 13th ed. Whithouse Station, NJ: Merck & Co., Inc.: 2001:158, 801, 951.

  8. Woodley DT, Zelickson AS, Briggaman RA, et al. Treatment of photoaged skin with topical tretinoin increases epidermal- dermal anchoring fibrils. A preliminary report. JAMA. 1990;263:3057.

  9. Fisher GJ, Datta SC, Talwar HS, et al. Molecular basis of sun-induced premature skin ageing and retinoid antagonism. Nature. 1996;379:335.