Duac Once Daily 10mg/g + 50mg/g Gel (5%)
1g of gel contains:
- 10mg clindamycin as clindamycin phosphate
- 50mg anhydrous benzoyl peroxide as hydrous benzoyl peroxide.
White to slightly yellow homogeneous gel
Duac Once Daily Gel is indicated for the topical treatment of mild-to-moderate acne vulgaris, particularly inflammatory lesions, in adults and adolescents aged 12 years and above.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Adults and adolescents (aged 12 years and above)
Duac Once Daily Gel should be applied once daily in the evening, to the entire affected area.
Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation. If excessive dryness or peeling occurs, frequency of application should be reduced or application temporarily interrupted
An effect on inflammatory and non-inflammatory lesions may be seen as early as week 2–5 of treatment
The safety and efficacy of Duac Once Daily Gel has not been studied beyond 12 weeks in acne vulgaris clinical trials. Treatment with Duac Once Daily Gel should not exceed more than 12 weeks of continuous use.
The safety and efficacy of Duac Once Daily Gel has not been established in children under 12 years of age, therefore Duac Once Daily Gel is not recommended for use in this population.
No specific recommendations.
Method of administration:
Duac Once Daily Gel should be applied in a thin film after washing gently with a mild cleanser and fully drying. If the gel does not rub into the skin easily, too much is being applied.
Hands should be washed after application.
Duac Once Daily Gel must not be administered to patients with known hypersensitivity to:
- benzoyl peroxide
- any of the excipients in the formulation (see Summary of Product Characteristics) for full list of excipients).
Special warnings and precautions for use
- Contact with the mouth, eyes, lips, other mucous membranes or areas of irritated or broken skin should be avoided. Application to sensitive areas of skin should be made with caution. In case of accidental contact, rinse well with water
- Duac Once Daily Gel should be used with caution in patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis
- Duac Once Daily Gel should be used with caution in atopic patients, in whom further skin drying may occur
- During the first weeks of treatment, an increase in peeling and reddening will occur in most patients. Depending upon the severity of these side effects, patients can use a non-comedogenic moisturizer, temporarily reduce the frequency of application of Duac Once Daily Gel or temporarily discontinue use; however, efficacy has not been established for less than once daily dosing frequencies
- Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents
- If severe local irritancy (e.g. severe erythema, severe dryness and itching, severe stinging/burning) occurs, Duac Once Daily Gel should be discontinued
- As benzoyl peroxide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sun should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing
- If a patient has sunburn, this should be resolved before using Duac Once Daily Gel
- If prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment with Duac Once Daily Gel should be discontinued immediately, as the symptoms may indicate antibiotic-associated colitis. Suitable diagnostic methods, such as the determination of Clostridium difficile and toxin and, if necessary, colonoscopy should be employed and treatment options for colitis considered
- The product may bleach hair or coloured fabrics. Avoid contact with hair, fabrics, furniture or carpeting
Resistance to clindamycin
Patients with a recent history of systemic or topical clindamycin or erythromycin use are more likely to have pre-existing anti-microbial resistant Propionibacterium acnes and commensal flora.
Cross-resistance may occur with other antibiotics such as lincomycin and erythromycin when using antibiotic monotherapy.
Interactions (with other medicinal products)
No formal drug-drug interaction studies have been performed with Duac Once Daily Gel.
Concomitant topical antibiotics, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol and/or astringents, should be used with caution as a cumulative irritant effect may occur.
Duac Once Daily Gel should not be used in combination with erythromycin-containing products due to possible antagonism to the clindamycin component.
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore caution should be exercised with concomitant use.
Concomitant application of Duac Once Daily Gel with tretinoin, isotretinoin and tazarotene should be avoided since benzoyl peroxide 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-containing preparations at the same time as topical sulphonamide-containing products may cause skin and facial hair to temporarily change colour (yellow/orange).
Fertility, pregnancy and lactation
There are no adequate data from the use of Duac Once Daily Gel in pregnant women. Animal reproductive/developmental studies have not been conducted with Duac Once Daily Gel or benzoyl peroxide. There are limited data on the use of clindamycin and benzoyl peroxide alone in pregnant women. Data from a limited number of pregnancies exposed in the first trimester to clindamycin indicate no adverse effects of clindamycin on pregnancy or on the health of the foetus/new-born child.
Reproduction studies in rats and mice, using subcutaneous and oral doses of clindamycin, revealed no evidence of impaired fertility or harm to the foetus due to clindamycin.
The safety of Duac Once Daily Gel in human pregnancy is not established. Therefore, Duac Once Daily Gel should only be prescribed to pregnant women after careful risk/benefit assessment by the physician in charge.
Use of Duac Once Daily Gel has not been studied during breastfeeding. Percutaneous absorption of clindamycin and benzoyl peroxide is low however; it is not known whether clindamycin or benzoyl peroxide is excreted in human milk following the use of Duac Once Daily Gel. Oral and parenteral administration of clindamycin has been reported to result in the appearance of clindamycin in breast milk. For this reason, Duac Once Daily Gel should be used during lactation only if the expected benefit justifies the potential risk to the infant.
To avoid accidental ingestion by the infant if used during lactation, Duac Once Daily Gel should not be applied to the breast area.
There are no data on the effect of Duac Once Daily Gel on fertility in humans.
Adverse drug reactions (ADRs) are summarised below for Duac Once Daily Gel as a combination including any additional ADRs that have been reported for the single topical active ingredients, benzoyl peroxide or clindamycin. Adverse drug reactions are listed by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1,000 and <1/100); rare (≥1/10,000 and <1/1,000) and not known (cannot be estimated from the available data).
Nervous system disorders*
Gastrointestinal disorders Colitis (including pseudomembranous colitis), haemorrhagic diarrhoea, diarrhoea, abdominal pain Skin and
subcutaneous tissue disorders*
Erythema, peeling, dryness (Generally reported as 'mild' in severity)
Dermatitis, pruritus, erythematous rash, worsening of acne
General disorders and Administration site conditions Application site reactions including skin discolouration
*At site of application
†Based on postmarketing reports. Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency however, systemic reactions are rarely seen.
In addition to the ADRs reported in the table above, in the pivotal trial conducted with topical clindamycin 1%/benzoyl peroxide 3% gel, application site photosensitivity reaction was also reported commonly.
Also in addition to the ADRs reported above, in studies conducted with topical clindamycin alone, headache and application site pain were reported commonly.
During the five clinical trials with Duac Once Daily Gel, all patients were graded for facial erythema, peeling, burning, and dryness on the following scale: 0 = absent, 1 = mild, 2 = moderate and 3 = severe. The percentage of patients that had symptoms present before treatment (at baseline) and during treatment were as follows:
Local tolerability assessments for subjects (N=397) in the Duac Once Daily Gel group during the Phase 3 studies
Before treatment (Baseline)
Excessive application of Duac Once Daily Gel may result in severe irritation. In this event, discontinue use and wait until the skin has recovered.
Topically applied benzoyl peroxide is not generally absorbed in sufficient amounts to produce systemic effects.
Excessive application of topically applied clindamycin may result in absorption of sufficient amounts to produce systemic effects.
In the event of accidental ingestion of Duac Once Daily Gel, gastrointestinal adverse reactions similar to those seen with systemically administered clindamycin may be seen.
Appropriate symptomatic measures should be taken to provide relief from irritation due to excessive application.
Accidental ingestion should be managed clinically or as recommended by the National Poisons Centre, where available.
For full information, see the Duac Once Daily 5% Gel Summary of Product Characteristics.