Duac

Duac Special Precautions

clindamycin + benzoyl peroxide

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Full Prescribing Info
Special Precautions
Contact with the mouth, eyes, lips, other mucous membranes or areas of irritated or broken skin should be avoided. In case of accidental contact, rinse well with water.
During the 1st week 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 moisturizer, temporarily reduce the frequency of application of Duac gel or temporarily discontinue use. However, efficacy has not been established for less than once daily dosing frequencies. Concomitant topical acne therapy should be use with caution because possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling desquamating, or abrasive agents.
If severe local irritancy (eg, severe erythema, severe dryness and itching, severe stinging/burning) occurs, Duac should be discontinued. As benzoyl peroxide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight should be avoided or minimized. When exposure to strong sunlight cannot be avoided, patients should be advised to use sunscreen product and wear protective clothing. If the patient has sunburn, this should be resolved before using Duac gel. The product may bleach hair and coloured or dyed fabrics. Avoid contact with hair, fabrics, furniture or carpeting.
Pseudomembranous colitis: Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life -threatening, with an onset of up to several weeks following cessation of therapy. Although this is unlikely to occur with topically applied Duac gel, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient should be investigated further, as the symptoms may indicate antibiotic-associated colitis.
Resistance to Clindamycin: Benzoyl peroxide reduces the potential for emergence of organisms resistant to clindamycin. However, patients with a recent history of systemic or topical clindamycin or erythromycin use are more likely to have preexisting antimicrobial resistant to Propionibacterium acnes and commensal flora.
Cross Resistance: Cross-resistance has been demonstrated between clindamycin and lincomycin. Resistance to clindamycin is often associated with inducible resistance to erythromycin (see Interactions).
Effects on the Ability to Drive or Operate Machinery: There have been no studies to investigate the effect of Duac on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of clindamycin/benzoyl peroxide.
Use in pregnancy: There are no well-controlled studies in pregnant women treated with topical Duac gel. There are limited data on the use of topical clindamycin or benzoyl peroxide alone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. No effects during pregnancy are anticipated since systemic exposure to clindamycin and benzoyl peroxide is low (see Pharmacology under Action). However, Duac should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
Use in lactation: Duac has not been studied during breastfeeding. Percutaneous absorption of this drug is low. However, it is not know whether clindamycin or benzoyl peroxide is excreted in human milk after topical application. Clindamycin is excreted in human milk following oral and parenteral administration. Duac 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 should not be applied to the breast area.
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