Product Monograph - Panoxyl 10 Gel
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
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.
Adults and children 12 years of age and older:
Gel
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 the physician, 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.
Due to the flammable nature of PANOXYL® Gel, patients should avoid smoking or being near an open flame during application and immediately after use.
Wash
Shake well before using. Wet face and wash thoroughly, massaging gently for one or two minutes with PANOXYL® Wash 5%. Rinse well with warm water, then rinse with cold water. Pat dry with a clean towel. Use once or twice daily, or as directed by the physician. 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.
Soap Bar
Using warm water, wash the affected area with lather from the soap bar for one to two minutes, rinse well and pat dry with a clean towel.
Use once or twice daily, or as directed by the physician. 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.
Missed Dose
If an application is missed, the next application of PANOXYL® should occur at the usual time.
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
Description:
PANOXYL® 10 Gel (benzoyl peroxide gel USP, 10% w/w) and PANOXYL® 20 Gel (benzoyl peroxide gel USP, 20% w/w) are white smooth gels.
PANOXYL® Wash 5% (benzoyl peroxide lotion 5% w/w) is a white to beige, viscous liquid.
PANOXYL® 5 Bar (benzoyl peroxide soap 5% w/w) and PANOXYL®10 Bar (benzoyl peroxide soap 10% w/w) are pure white oval biconvex bars.
Composition:
Each gram of PANOXYL® 10 Gel (benzoyl peroxide gel USP 10% w/w) contains 141.34 mg benzoyl peroxide. Each gram of PANOXYL® 20 Gel (benzoyl peroxide gel USP 20% w/w) contains 282.67 mg benzoyl peroxide. PANOXYL® 10 Gel and PANOXYL® 20 Gel also contain magnesium aluminum silicate, ethoxylated lauryl alcohol, hydroxypropyl methylcellulose, ethyl alcohol, citric acid anhydrous and purified water.
Each gram of PANOXYL® Wash 5% (benzoyl peroxide lotion 5% w/w) contains 68.59 mg benzoyl peroxide. PANOXYL® Wash 5% also contains imidazolidinyl urea, magnesium aluminium silicate, ethoxylated lauryl alcohol, hydroxypropyl methylcellulose, citric acid anhydrous, sodium alkyl aryl polyethylene sulfate, sodium dialkyl octyl sulfate succinate, sodium lauryl sulfoacetate and purified water.
Each gram of PANOXYL® 5 Bar (benzoyl peroxide soap 5% w/w) contains 66.03 mg benzoyl peroxide. PANOXYL® Bar 5% also contains cab-o-sil, purified water and tensianol base ks-1.
Each gram of PANOXYL® 10 Bar (benzoyl peroxide soap 10% w/w) contains 137.30 mg benzoyl peroxide. PANOXYL® Bar 10% also contains cab-o-sil, purified water and tensianol soap base ks-1.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
AVAILABILITY
PANOXYL® 10 Gel (benzoyl peroxide gel USP, 10% w/w) and PANOXYL® 20 Gel (benzoyl peroxide gel USP, 20% w/w), 60 g tube.
PANOXYL® Wash 5% (benzoyl peroxide lotion 5% w/w), 175 mL bottle.
PANOXYL® 5 Bar (benzoyl peroxide soap 5% w/w) and PANOXYL® 10 Bar (benzoyl peroxide soap 10% w/w), 100 g bar.
STORAGE
Keep out of the sight and reach of children.
PANOXYL® Wash and Bar
Store at controlled room temperature, 15º – 30ºC.
PANOXYL® Gel
Store at controlled room temperature, 15º – 30ºC. Keep container tightly closed when not in use. Contents are flammable. Keep away from fire, flame or heat. Do not leave PANOXYL® Gel in direct sunlight.