Vitacid plus

Indication

Vitacid plus Cream is a combination of Fluocinolone Acetonide (Vitacid plus) (a corticosteroid), Hydroquinone (Vitacid plus) (a melanin synthesis inhibitor), and Tretinoin (Vitacid plus) (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.

Limitations of Use

Vitacid plus Cream is NOT indicated for the maintenance treatment of melasma. After achieving control with Vitacid plus Cream, some patients may be managed with other treatments instead of triple therapy with Vitacid plus Cream. Melasma usually recurs upon discontinuation of Vitacid plus Cream.

The safety and efficacy of Vitacid plus Cream in patients of Fitzpatrick Skin Types V and VI have not been studied. Excessive bleaching resulting in undesirable cosmetic effect in patients with darker skin cannot be excluded.

The safety and efficacy of Vitacid plus Cream in the treatment of hyperpigmentation conditions other than melasma of the face have not been studied.

Because pregnant and lactating women were excluded from, and women of childbearing potential had to use birth control measures in the clinical trials, the safety and efficacy of Vitacid plus Cream in pregnant women and nursing mothers have not been established.

Short-term treatment of moderate to severe melasma (darkening) of the face. It is used in combination with sun avoidance measures, including sunscreen use. It may also be used for other conditions as determined by your doctor.

Vitacid plus is a combination topical corticosteroid, depigmentation agent, and keratolytic. Exactly how Vitacid plus works to treat melasma is unknown.

Apply a thin film of Vitacid plus Cream to the effected area once daily, at least 30 minutes before bedtime.

Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply Vitacid plus Cream to the hyperpigmented areas of melasma including about ½ inch of normal appearing skin surrounding each lesion. Rub lightly and uniformly into the skin.

Therapy should be discontinued when control is achieved.

During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day. Vitacid plus Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

How supplied

Dosage Forms And Strengths

Cream, 0.01%/4%/0.05%.

Each gram of Vitacid plus Cream contains 0.1 mg of Fluocinolone Acetonide (Vitacid plus), 40 mg of Hydroquinone (Vitacid plus), and 0.5 mg of Tretinoin (Vitacid plus) in a light yellow, hydrophilic cream base.

Storage And Handling

Vitacid plus Cream is light yellow in color, and supplied in 30 g aluminum tubes, NDC 0299-5950-30.

Storage

Keep tightly closed. Store in a refrigerator, 2°-8° C (36°-46° F). Protect from freezing.

Marketed by: Galderma Laboratories, L.P. Fort Worth, TX 76177 USA. Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 USA. Manufactured by: G Production Inc. Baie d'Urfé, QC, H9X 3S4 Canada. Made in Canada. Revised: March 2014

See also:
What is the most important information I should know about Vitacid plus?

Vitacid plus Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.

Use Vitacid plus as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Vitacid plus. Talk to your pharmacist if you have questions about this information.
• Vitacid plus is for external use only.
• Apply Vitacid plus at least 30 minutes before bedtime.
• Wash your hands before and after using Vitacid plus.
• Gently wash your face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of medicine to the areas of melasma, including about ½ inch of normal-appearing skin surrounding each lesion. Rub lightly until the medicine is evenly distributed.
• Do not cover or bandage the treated area unless otherwise directed by your doctor.
• You may apply moisturizers and cosmetics during the day.
• If you miss a dose of Vitacid plus, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Vitacid plus.

See also:
What other drugs will affect Vitacid plus?

Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated with RENOVA because they may increase irritation with RENOVA.

RENOVA should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.

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What are the possible side effects of Vitacid plus?

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In the controlled clinical trials, adverse events were monitored in the 161 subjects who used Vitacid plus Cream once daily during an 8-week treatment period. There were 102 (63%) subjects who experienced at least one treatment-related adverse event during these trials. The most frequently reported events were erythema, desquamation, burning, dryness, and pruritus at the site of application. The majority of these events were mild to moderate in severity. Adverse events reported by at least 1% of patients and judged by the investigators to be reasonably related to treatment with Vitacid plus Cream from the controlled clinical trials are summarized (in decreasing order of frequency) as follows:

Table 1: Incidence and Frequency of Treatment-related Adverse Events with Vitacid plus Cream in at Least 1% or More of Subjects (N=161)

In an open-label trial, subjects who had cumulative treatment of melasma with Vitacid plus Cream for 6 months showed a similar pattern of adverse events as in the 8-week studies.

The following local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Vitacid plus, also known as all-trans-retinoic acid (ATRA), is a naturally occurring derivative of vitamin A (retinol). Retinoids such as Tretinoin (Vitacid plus) are important regulators of cell reproduction, proliferation, and differentiation and are used to treat acne and photodamaged skin and to manage keratinization disorders such as ichthyosis and keratosis follicularis. Vitacid plus also represents the class of anticancer drugs called differentiating agents and is used in the treatment of acute promyelocytic leukemia (APL).