Product Monograph - Solugel
ADVERSE REACTIONS
Clinical Trial Data
Skin and subcutaneous tissue disorders:
Very common (≥ 10%): peeling, application site erythema
Common (≥ 1% to < 10%): dryness, pruritus and contact sensitisation reactions
Uncommon (≥ 0.1% to < 1%): burning sensation
Post-Market Adverse Drug Reactions
General disorders and administrative site conditions: application site discoloration and application site reactions such as irritation and pain, dry lips, cheilitis.
Immune system disorders: allergic reactions, including application site hypersensitivity and anaphylaxis, lip swelling, urticaria and swelling of the face.
Skin and subcutaneous tissue disorders: application site rash, dermatitis, skin exfoliation and photosensitivity.
DRUG INTERACTIONS
Concomitant application of benzoyl peroxide with tretinoin, isotretinoin,and tazarotene should be avoided since it may reduce their efficacy and increase irritation. If combination treatment is required, the products should be applied at different times of the day (e.g., one in the morning and the other in the evening.)
Using topical benzoyl peroxide at the same time as topical sulfonamide-containing products may cause skin and facial hair to temporarily change colour (yellow/orange).
DOSAGE AND ADMINISTRATION
Adults and children 12 years of age and older:
Wash hands and affected area thoroughly with a non-medicated soap (contains no benzoyl peroxide) and water before use.
Benzoyl peroxide should be applied in a thin film over the entire affected area once or twice daily, or as directed by a health care practitioner, preferably after washing and drying the skin. Because excessive drying of the skin may occur, the patient should start with one application daily, and then gradually increase to two times daily if needed.
If excessive dryness or peeling occurs, frequency of application should be reduced or application temporarily interrupted, per physician instruction or patient tolerability.
Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continued use is normally required to maintain a clinical response.
SYMPTOMS AND TREATMENT OF OVERDOSAGE
Topically applied benzoyl peroxide is not generally absorbed in sufficient amounts to produce systemic effects.
Excessive application may result in severe irritation. In this event, discontinue use and wait until the skin has recovered.
Cold compresses can provide relief from irritation due to excessive application.
Accidental ingestion of topical benzoyl peroxide should be managed clinically.
DESCRIPTION AND COMPOSITION
SOLUGEL® (benzoyl peroxide gel USP, 8% w/w) and SOLUGEL® (benzoyl peroxide gel USP, 4% w/w) are white smooth gels.
Composition:
Each gram of SOLUGEL® Gel 4% (benzoyl peroxide gel USP, 4% w/w) contains 58.71 mg benzoyl peroxide. Each gram of SOLUGEL® Gel 8% (benzoyl peroxide gel USP, 8% w/w) contains 117.34 mg benzoyl peroxide. SOLUGEL® Gel 4% and SOLUGEL® Gel 8% also contain cetyl alcohol, promulgen G, simethicone, dimethyl isosorbide, fragrance, sodium hydroxide and purified water.
AVAILABILITY
SOLUGEL® Gel 8% (benzoyl peroxide gel USP, 8% w/w), 45 g tube.
SOLUGEL® Gel 4% (benzoyl peroxide gel USP, 4% w/w), 45 g tube.
STORAGE
Store at controlled room temperature, 15º – 30ºC.
For management of a suspected drug overdose, contact your regional Poison Control Centre.