SANDOZ ADAPALENE / BENZOYL PEROXIDE

General For external use only. Not for ophthalmic use. Avoid contact with the eyes, lips, angles of the nose, mucous membranes, abraded skin and open wounds. If contact occurs, rinse thoroughly with warm water. If a reaction suggesting allergic / hypersensitivity reactions to any component of the formula occurs, the use of the product should be discontinued.

Concomitant topical acne therapy is not recommended because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents (see DRUG INTERACTIONS, Drug-Drug Interactions). Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).

The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of electrolysis, “waxing” and chemical depilatories for hair removal should be avoided on skin treated with Sandoz Adapalene/Benzoyl peroxide (see DRUG INTERACTIONS, Drug-Lifestyle Interactions).

Sandoz Adapalene/Benzoyl peroxide may bleach hair and coloured fabric. Use caution when applying near hairline (see DRUG INTERACTIONS, Drug-Lifestyle Interactions). Patients should be advised to use non-comedogenic cosmetics (see DRUG INTERACTIONS, Drug-Lifestyle Interactions).

5%) Topical Gel. These treatment-related effects generally occur during the first four weeks of therapy, are mostly mild to moderate in intensity, and usually lessen as the skin adjusts with continued use. Depending on the degree of the side effects, patients can be directed to use a moisturizer, use the medication less frequently or temporarily discontinue use until the symptoms subside (see DOSAGE AND ADMINISTRATION).

SANDOZ ADAPALENE/BENZOYL PEROXIDE Product Monograph Page 5 of 41 As with any retinoid, exposure to excessive sunlight, including sunlamps, should be avoided while using the preparation, or a suitably effective sunscreen product and protective clothing over the treated areas is recommended when exposure cannot be avoided.

In case of sunburn, allow the skin to heal before using Sandoz Adapalene/Benzoyl peroxide. Weather extremes, such as wind or cold, may also be irritating to patients under treatment with adapalene. Carcinogenesis and Mutagenesis See TOXICOLOGY.

Special Populations Pregnant Women:

Orally administered retinoids have been associated with congenital abnormalities. g. damaged skin barrier, excessive use). 5% . Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, if the patient becomes pregnant while using these drugs, treatment should be discontinued.

There have been rare reports of birth defects among babies born to women exposed to topical retinoids during pregnancy. However, there are no well-controlled prospective studies of the use of topical retinoids, including adapalene, in pregnant women.

A retrospective study of mothers exposed to topical tretinoin during the first trimester of pregnancy found no increase in the incidence of birth defects. Adapalene administered orally at doses of ≥25 mg/kg/day has been shown to be teratogenic.

0 mg/kg/day. 0 mg adapalene/kg/day exhibited no foetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits (see TOXICOLOGY). 5% Topical Gel. 5% Topical Gel. Animal pharmacology studies indicate that adapalene is excreted in milk at levels lower than plasma levels.

Because many drugs are excreted in human milk, caution should be exercised when Sandoz Adapalene/Benzoyl peroxide is administered to a nursing mother. To avoid contact exposure of the infant, application of Sandoz Adapalene/Benzoyl peroxide to the chest should be avoided when used during breastfeeding.

5% in pediatric patients between the ages of 9 and 16 years. 5% in children below the age of 9 years have not been established. 5% in geriatric patients age 65 years and above have not been established. 5% topical gel include mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging.

These reactions […]