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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 see sections 4. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 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 see section 4.
An effect on inflammatory and non-inflammatory lesions may be seen as early as week of treatment see section 5. 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. 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. Contact with the mouth, eyes, lips, other Duac acne cream 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 moisturiser, 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 Duac acne cream may be severe, Duac acne cream with the use of peeling, desquamating, or abrasive agents.
If severe local irritancy e.
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 prolonged or ificant diarrhoea occurs or the patient suffers from abdominal cramps, treatment with Duac acne cream 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.
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 see section 5. Cross-resistance may occur with other antibiotics such as lincomycin and erythromycin when using antibiotic monotherapy see section 4. 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.
There are no adequate data Duac acne cream the use of Duac Once Daily Gel in pregnant women. There are limited data on the use of clindamycin and benzoyl peroxide alone in pregnant women. 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 Duac acne cream of Duac Once Daily Gel in human pregnancy is not established. 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. 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 Duac acne cream listed by MedDRA system organ class and by frequency. Allergic reactions including hypersensitivity and anaphylaxis. Gastrointestinal disorders. Colitis including pseudomembranous colitishaemorrhagic diarrhoea, diarrhoea, abdominal pain.
Application site reactions including skin discoloration. 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. Also in addition to the ADRs reported above, in studies conducted with topical clindamycin alone, headache and application site pain were reported commonly.
The percentage of patients that had symptoms present before treatment at baseline and during treatment were as follows:. Before Treatment Baseline. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www. Excessive application of Duac Once Daily Gel may result in severe irritation. In this event, discontinue use and wait until the skin has Duac acne cream. 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 Duac acne cream 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.
Clindamycin is a lincosamide antibiotic with bacteriostatic action against Gram-positive aerobes and Duac acne cream wide range of anaerobic bacteria. Lincosamides such as clindamycin bind to the 23S subunit of the bacterial ribosome and inhibit the early stages of protein synthesis. The action of clindamycin is predominantly bacteriostatic although high concentrations may be slowly bactericidal against sensitive strains.
Although clindamycin phosphate is inactive in-vitrorapid in-vivo hydrolysis converts this compound to the antibacterial active clindamycin. Clindamycin activity has been demonstrated clinically in comedones from acne patients at sufficient levels to be active against most strains of Propionibacterium acnes.
Clindamycin in-vitro inhibits all Propionibacterium acnes cultures tested MIC 0. Benzoyl Duac acne cream is mildly keratolytic acting against comedones at all stages of their development. It is an oxidising agent with bactericidal activity against Propionibacterium acnesthe organism implicated in acne vulgaris. Furthermore it is sebostatic, counteracting the excessive sebum production associated with acne. Duac Once Daily Gel has a combination of mild keratolytic and antibacterial properties providing activity particularly against inflamed lesions of mild to moderate acne vulgaris.
The prevalence of acquired resistance may vary geographically and with time for selected species. Local information of resistance is desirable, particularly when treating severe infections. The inclusion of benzoyl peroxide reduces the potential for the emergence of organisms resistant to clindamycin.
The presentation of both active ingredients in one product is more convenient and ensures patient compliance. In five randomised double-blind clinical studies of patients with facial acne vulgaris with both inflammatory and non-inflammatory lesions, used Duac, used benzoyl peroxide, used clindamycin and used vehicle.
Treatment was applied once daily for 11 weeks and patients were evaluated and lesions counted at 2, 5, 8 and 11 weeks. The mean percentage reduction in the of lesions after Duac acne cream weeks is shown in the table. Mean percent reduction in of lesions from baseline after 11 weeks.
Statistically ificant differences highlighted in bold. The reduction in total lesions was ificantly greater with Duac Once Daily Gel than clindamycin or vehicle in all five studies. The improvement was consistently greater with Duac Once Daily Gel than benzoyl peroxide, but the difference did not achieve statistical ificance in individual studies.
Against inflammatory lesions, Duac Once Daily Gel was ificantly superior to clindamycin alone in four of five studies and to benzoyl peroxide alone in three of five studies. Against non-inflammatory lesions, Duac Once Daily Gel was ificantly better than clindamycin in four of five studies, and tended to be better than benzoyl peroxide alone. Overall improvement in acne was assessed by the physician and was ificantly better with Duac Once Daily Gel than with either benzoyl peroxide or clindamycin alone in three of five studies.
An effect on inflammatory lesions was apparent from week 2 of treatment. The effect on non-inflammatory lesions was more variable, with efficacy generally apparent after weeks of treatment. In a maximised percutaneous absorption study the mean plasma clindamycin levels during a four-week dosing period for Duac Once Daily Gel were negligible 0.
The presence of benzoyl peroxide in the formulation did not have an effect on the percutaneous absorption of clindamycin. Radio-label studies have shown that absorption of benzoyl peroxide through the skin can only occur following its conversion to benzoic acid. Benzoic acid is mostly conjugated to form hippuric acid, which is excreted via the kidneys.
In a Duac acne cream year carcinogenicity study in mice, topical administration of Duac Once Daily Gel showed no evidence of increased carcinogenic risk, compared with controls. In a photococarcinogenicity study in mice, a slight reduction in the median time to tumour formation was observed relative to controls following concurrent exposure to Duac Once Daily Gel and simulated sunlight. The clinical relevance of the findings in this study is unknown.
Repeat-dose dermal toxicity studies conducted Duac acne cream Duac Once Daily Gel, in two species, for up to 90 days, revealed no toxic effects, apart from minor local irritation. Although high doses of benzoyl peroxide have been shown to induce DNA strand breaks, the available data from other mutagenicity studies, carcinogenicity studies and a photo co-carcinogenicity study indicate that Duac acne cream peroxide is not a carcinogen or a photocarcinogen.
In-vitro and in-vivo studies did not reveal any mutagenic potential of clindamycin.
No long-term animal studies investigating the tumorigenic potential of clindamycin have been conducted. Otherwise, preclinical data reveal no special hazard for humans based on conventional studies of single and repeat-dose toxicity and toxicity to reproduction. Internally lacquered membrane-sealed aluminium tubes fitted with a polyethylene screw-cap, packed into a carton. Help us improve emc by letting us know which of the following best describes you.Duac acne cream
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DUAC Once Daily