- chlorhexidine dihydrochloride
POM: Prescription only medicine
This information is intended for use by health professionals
Nystatin/Chlorhexidine hydrochloride 100,000 units/g/1% Cream
The product contains nystatin 100,000 I.U./g, chlorhexidine hydrochloride 1.0% w/w in a water-miscible base.
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
A light yellow cream in a water-miscible base for topical application.
Nystaform cream is indicated for the treatment of infected skin conditions where fungal (particularly monilial) and/or bacterial infections are present.
Adults and Children:
Apply to infected areas 2-3 times daily. Continue application for 1 week after lesions have healed.
The patient should be advised that if the condition has not improved within seven days, to return to the surgery for further consultation. If the condition does not improve within 14 days of starting treatment, then an alternative treatment should be substituted.
Method of adminstration
For topical application only.
Known hypersensitivity to the active substance, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8), or to any of the excipients listed in section 6.1.
For external use only. Avoid contact with eyes. If sensitivity occurs, or if new infection appears, discontinue use and institute alternative therapy. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Nystaform Cream contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Nystaform Cream should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8).
As with all drugs, nystatin should be administered with caution during the early months of pregnancy and its use requires that the anticipated benefits outweigh the possible risks.
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Nystatin is poorly absorbed from the gastro-intestinal tract. In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed as soon as possible after ingestion.
Nystatin is a fungistatic and fungicidal antibiotic primarily effective against Candida albicans. Chlorhexidine has activity against a wide range of bacteria.
Nystatin is poorly absorbed from the gastro-intestinal tract. It is not absorbed through the skin or mucous membranes when applied topically.
Cetostearyl alcohol Ph. Eur
Octyldodecanol Ph. Eur
Polysorbate 60 Ph. Eur
Sorbitan stearate Ph. Eur
Cetyl esters wax Ph. Eur
Benzyl alcohol Ph. Eur
Purified water Ph. Eur
Do not store above 25°C.
30g resin-lined aluminium tubes with polyethylene caps contained in an outer cardboard carton.
For external use only. Avoid contact with eyes.
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