Custom Rx Formula for Acne Drug Facts

Custom Rx Formula for Acne Drug Facts

Your Medication May Contain One or More of the Following:

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

Clindamycin Phosphate Clindamycin is a topical antibiotic which carries bacteriostatic activity against C. acnes. Clindamycin exerts Anti-inflammatory effect by inhibiting lipase production of C. acnes and leukocyte chemotaxis.(3-4)Clinical effectiveness of clindamycin does not decrease over time.(5)

Retinoic Acid (Tretinoin) Derived from Vitamin A, retinoic acid has been shown to reduce the number of acne comedones and prevent new ones. It 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.(6) It can cause loosening and exfoliation of the follicular and epithelial cells in the stratum corneum.

Do not use these medications 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. ∙ If the skin irritation worsens or does not go away. ∙ If you have asthma and it worsens.

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. ∙ Always wear sunscreen/SPF, skin coverings/clothing, and sunglasses 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.

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. ∙ Diarrhea, bloody diarrhea, colitis (including pseudomembranous colitis), stomach pains or cramps. ∙ Severe diarrhea called antibiotic-associated colitis, Clostridium difficile colitis (C. Diff, or CDAD, Clostridium difficile infections (CDI) or pseudomembranous colitis), regional enteritis, ulcerative colitis or Crohn’s disease. ∙ You experience unexpected or prolonged irritation or if you have concerns about the listed side effects. In most cases, side effects will subside over time, or your provider may change how often or how much medication you are applying.

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. ∙ Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis).

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. ∙ Inform your physician that you are taking 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. Dreno B. Topical antibacterial therapy for acne vulgaris. Drugs 2004: 64: 2389–2397.

  4. Del Rosso J. Emerging topical antimicrobial options for mild-to-moderate acne: a review of the clinical evidence. JDrugs Dermatol 2008: 7: s2–s7.

  5. Simonart T, Dramaix M. Treatment of acne with topical antibiotics: lessons from clinical studies. Br J Dermatol 2005:153: 395–403.

  6. 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.