- chlorhexidine dihydrochloride
POM: Prescription only medicine
This information is intended for use by health professionals
Nystaform HC Cream
Nystatin/Chlorhexidine hydrochloride/Hydrocortisone 100,000 units/g/1% /0.5% Cream
The product contains nystatin 100,000 I.U./g, chlorhexidine hydrochloride 1.0% w/w and hydrocortisone 0.5% 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 for topical application.
Nystaform HC cream is indicated for the treatment of infected dermatoses where fungal (particularly monilial) and/or bacterial infections are present.
Adults and Children:
Apply to infected areas 2-3 times daily.
Treatment should be for a maximum period of 7 days.
Method of adminstration
For topical application only.
Tuberculous lesions of the skin. Known hypersensitivity to the active substances, 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).
In infants, long-term continuous topical steriod therapy should be avoided. Adrenal suppression can occur even without occlusion. As with other topical corticosteroids, systemic absorption may occur when extensive areas are treated, particularly under occlusion.
Nystaform HC 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 HC 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).
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. The relevance of this finding to humans has not been established. However, topical steroids should not be used extensively in the first trimester of pregnancy and nystatin only with caution. The use of Nystaform HC Cream 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.
Hydrocortisone exercises a vasoconstrictive effect, thus reducing inflammation and oedema and also has an antipruritic effect.
Nystatin is poorly absorbed from the gastro-intestinal tract and is not absorbed through the skin or mucous membranes when applied topically.
Hydrocortisone is absorbed through the skin and is metabolised by the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.
Cetyl esters wax
Do not store above 25°C.
15g and 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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