DUAC ONCE DAILY GEL
benzoyl peroxide / clindamycin
treatment for acne
DUAC ONCE DAILY GEL
Mild to moderate acne vulgaris If you require a prescription, please visit our online doctor
Mild to moderate acne vulgaris, particularly inflammatory lesions
For application to the skin. For external use only.
Adults and adolescents
Duac Once Daily Gel should be applied once daily in the evening, to affected areas after the skin has been thoroughly washed, rinsed with warm water and gently patted dry.
Use in Children
The safety and efficacy of Duac Once Daily Gel has not been established in prepubescent children (under 12 years of age), since acne vulgaris rarely presents in this age group.
Use in the Elderly
No specific recommendations.
Treatment with Duac Once Daily Gel should not exceed more than 12 weeks of continuous use.
Duac Once Daily Gel must not be administered to patients with known hypersensitivity to:
- benzoyl peroxide
- any of the excipients in the formulation.
Special warnings and precautions for use
Contact with the mouth, eyes and mucous membranes and with abraded or eczematous skin should be avoided. Application to sensitive areas of skin should be made with caution. In the event of accidental contact with the eyes, bathe with copious amounts of 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. It should also be used with caution in atopic patients, in whom further skin drying may occur.
The frequency of application should be reduced if excessive irritation or dryness develops.
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.
It is recommended that exposure to sun or sunlamps should be minimised.
Patients should be advised that, in some cases, 4-6 weeks of treatment may be required before the full therapeutic effect is observed.
Cross-resistance may occur with other antibiotics such as lincomycin and erythromycin when using antibiotic monotherapy.
Interaction with other medicinal products and other forms of interaction
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.
Simultaneous application of Duac Once Daily Gel and topical acne preparations containing vitamin A derivatives should be avoided.
Potential synergism exists between clindamycin and gentamycin.
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. 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.
Women of child-bearing potential
There are no contraindications in women of child-bearing potential who are practising adequate contraception. However, due to the lack of clinical studies in pregnant women, Duac Once Daily Gel should be used with caution when adequate contraception is not being practised.
Use during lactation
There is no restriction on the use of benzoyl peroxide during lactation.
It is not known whether clindamycin is excreted in human milk following the use of Duac Once Daily Gel, but oral and parenteral administration of clindamycin has been reported to result in the appearance of clindamycin in breast milk. For this reason, treatment of nursing mothers with Duac Once Daily is not recommended.
Duac Once Daily Gel may cause:
Skin and Subcutaneous Tissue Disorders; erythema, peeling, dryness, and pruritus at the site of application.
Nervous System Disorders; paraesthesia,
Skin and Subcutaneous Tissue Disorders; worsening of acne and contact dermatitis can occur.
These localised effects are typically mild to moderate. Reported frequencies in clinical trials are:
Very common (>1/10)
Skin and Subcutaneous Tissue Disorders; Erythema, Peeling, Dryness
Common (>1/100, <1/10)
Skin and Subcutaneous Tissue Disorders; Burning, Pruritus
Uncommon (>1/1000, <1/100)
Nervous System Disorder; Paraesthesia
Skin and Subcutaneous Tissue Disorders; Worsening of acne
Post marketing data have shown a much lower incidence of these localised effects.
In a few susceptible individuals there have been isolated reports of pseudomembraneous colitis or diarrhoea due to other topical treatments containing clindamycin. This is unlikely to occur with Duac Once Daily Gel, as plasma levels have been determined and the percutaneous absorption of clindamycin is clinically negligible.
With long term use of Duac Once Daily Gel resistance may occur.
Immune System Disorders
In the post-marketing environment there have been isolated instances of allergic reactions which
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