Custom Rx Formula for Rosacea Drug Facts

Custom Rx Formula for Rosacea 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)

Metronidazole Metronidazole, an antibacterial agent, is a mainstay of treatment for rosacea.(3) Metronidazole is a nitroimidazole with antibiotic action affected by rapid inhibition of DNA replication of anaerobic microbial cells. In addition, it has anti-inflammatory and potential immunosuppressive properties which are likely to be facilitated by its antioxidant action and suppression of cell-mediated immunity. Topical preparations of metronidazole are on the market and the exact mechanism of action is not fully known.(4) In vitro studies have shown that metronidazole exhibits antioxidant activity that may be the basis of its anti-inflammatory action in rosacea.(4)

Niacinamide Also known as nicotinamide, niacinamide is an amide derivative of niacin or vitamin B3. Niacinamide has UV absorptive, antioxidant, anti-inflammatory properties, and helps to prevent cell death. It is inferred that the niacin derivatives have photoprotective and anti-skin aging potential via the stimulation of collagen fibers and up-regulation of heat shock proteins, as well as direct antioxidant activity.(5) Niacinamide has shown to produce a significant reduction in sebum excretion rate. It also helps protect the natural barrier of the skin against infection and shown possible bacteriostatic effect on C. acnes.

Do not use this medication if: ∙ 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. ∙ You drink alcohol or take disulfiram, propylene glycol or other medications that may interfere with metronidazole, contact your provider first.

When using this product ∙ 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 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. ∙ Tell all your medical providers that you are taking this medication and what ingredients it includes. ∙ 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. ∙ If the skin irritation worsens or does not go away. ∙ Your asthma worsens.

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. Skin irritation is not uncommon, and this should subside within the first few weeks of using the medication. ∙ Contact your medical provider if 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. ∙ Because of the metronidazole component of this medication, it is important that you do not drink alcohol, take disulfiram or propylene glycol while on this medication – make sure to talk to your provider first before starting medication.

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. ∙ 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. ∙ Inform your providers that you are taking this medication.

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. Draelos ZD. Assessment of skin barrier function in rosacea patients with a novel 1% metronidazole gel. J Drugs Dermatol. 4(5):557-562.

  4. Zip C. An update on the role of topical metronidazole in rosacea. Skin Therapy Lett. 2006;11(2):1-4

  5. Philips N, Chalensouk-Khaosaat J, Gonzalez S. Stimulation of the Fibrillar Collagen and Heat Shock Proteins by Nicotinamide or Its Derivatives in Non-Irradiated or UVA Radiated Fibroblasts, and Direct Anti-Oxidant Activity of Nicotinamide Derivatives. Cosmetics 2015; 2. 146-161.

  6. Shalita AR, Smith JG, Parish LC et al. Topical nicotinamide compared with clindamycin gel in the treatment of inflammatory acne vulgaris. Int J Dermatol 1995; 34:434-437.