Differin

Differin Special Precautions

adapalene

Manufacturer:

Galderma

Distributor:

Zuellig
Full Prescribing Info
Special Precautions
Gel 0.1% and Cream: General: If a reaction suggesting sensitivity or severe irritation occurs, use of the medication should be discontinued. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, to discontinue use temporarily, or to discontinue use altogether. Differin Gel and Differin Cream should not come into contact with the eyes, mouth, angles of the nose or mucous membranes. If product enters the eye, wash immediately with warm water. The product should not be applied to either broken (cuts and abrasions) or eczematous skin, nor should it be used in patients with severe acne.
Effects on The Ability to Drive and Use Machines: Based upon the pharmacodynamic profile and clinical experience, performance related to driving and using machines should not be affected.
Gel 0.3%: General: For external use only.
Avoid contact with the eyes, lips, angles of the nose, mucous membranes and open wounds. Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning or pruritus are associated with the topical application of retinoids and can also be expected with the use of Adapalene (Differin) 0.3% gel. These treatment-related effects generally occur during the first two to four weeks of therapy and usually resolve as the skin undergoes adjustment with continued use. Depending on the degree of the side effects, patients can be directed to use the medication less frequently or temporarily discontinue use until the symptoms subside (see DOSAGE & ADMINISTRATION).
Patients should be advised to use non-comedogenic cosmetics. Colour cosmetics such as blushers and powders are acceptable, however, make-up cosmetics should be water based only. Cosmetics must be removed by thorough cleansing before the area is treated.
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. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene. As with other retinoids, use of waxing as a depilatory method should be avoided on skin treated with adapalene.
Special Populations: Use in Pregnancy: It is recommended that topical adapalene should not be used by pregnant women. Topical adapalene should be used by women of childbearing years only after contraceptive counselling.
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 (38 times the Maximum Recommended Human Dose [MRHD] based on mg/m2 comparisons for rats or 65 times MRHD for rabbits) has been shown to be teratogenic. No teratogenic effects were seen in rats at oral doses of up to 5.0 mg/kg/day adapalene (7.6 times the MRHD). Cutaneous teratology studies in rats and rabbits at doses of 0.6 (0.03 %), 2.0 (0.1 %) and 6.0 (0.3 %) mg/kg/day (17 times the MRHD for rats or 32 times the MRHD for rabbits) exhibited no teratogenicity. At 2 mg/kg/day (0.1% adapalene gel), no adverse events were observed in rabbits and only a marginal increase in the incidence of additional lumbar ribs was observed in rats. However, at 6 mg/kg/day (0.3% adapalene gel), in addition to the recorded increase in foetal rib numbers in the rat and rabbit, there were also other skeletal anomalies in both species. There are no adequate and well-controlled studies in pregnant women.
Use in Lactation: It is not known whether this drug is excreted in human milk. 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 Adapalene (Differin) 0.3% gel is administered to a nursing mother.
Use in Children (12-16 years of age): No specific monitoring or hazards are associated with the use of the product in pediatric patients between the ages of 12 and 16 years. Safety and effectiveness in children below the age of 12 have not been established.
Use in Elderly (> 65 years of age): Safety and effectiveness in geriatric patients age 65 and above have not been established.
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