Polycutan

/ Perrigo

Apply a thin layer of the cream twice daily (morning and evening) on the affected area and massage into the skin.
See prescribing information for full details.

For the treatment of dermatitis involving also a bacterial and/or fungal infection.

• Hypersensitivity to the active substances, to other aminoglycoside antibiotics or to any of the excipients.
• Skin lesions, caused by infection with viruses (e.g. herpes simplex, chicken pox), or bacteria (e.g. impetigo).
• Use is not indicated in treatment of secondary infections due to Pseudomonas or
  Proteus species.
• Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of this medicine in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.
• The cream should not be applied in the external auditory canal of patients with perforated eardrum.
• Do not use the cream to treat nail or scalp infections

This medicinal product is not intended for ophthalmic use.

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.

Visual disturbance

Visual disturbance may be reported with systemic topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of

possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use if systemic and topical corticosteroids.

Paediatric population

A possibility of increased absorption exists in very young children: in neonates and infants, absorption by immature skin may be enhanced, and renal function may be immature. In infants and children, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur even without occlusion. In infants, the napkin may act as an occlusive dressing, and increase absorption.

Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.

As with all corticosteroids prolonged application to the face is undesirable.

Extended or recurrent application may increase the risk of contact sensitisation.

Extension of infection may occur due to the masking effect of the steroid.

Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity; and neomycin has nephrotoxic potential.

In renal impairment the plasma clearance of neomycin is reduced.

Products which contain antimicrobial agents should not be diluted.

Excipient with known effect

This product contains Cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). The cream also contains Benzyl alcohol which may cause allergic reactions and mild local irritation.

Instruct patients not to smoke or go near flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Burning sensation, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, maceration of the skin, secondary infection, striae and skin atrophy, ototoxicity, nephrotoxicity.
As the listed undesirable effects are based on spontaneous reports, assigning an accurate frequency of occurrence for each is not possible.
See prescribing information for full details.

– Following significant systemic absorption, neomycin can intensify and prolong
the respiratory depressant effects of neuromuscular blocking agents.
– Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently, the effectiveness of such contraceptives may be reduced.
Patients should be advised to use alternative precautions for at least five days after using this product.

Pregnancy:
Clotrimazole: There is a limited amount of data from the use of clotrimazole in pregnant women. At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, but only under the supervision of a physician.
Dexamethasone acetate: Topical application of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may, therefore, be a very small risk of such effects in the human fetus. There is inadequate evidence of safety with topical corticosteroids in human pregnancy.
Neomycin sulfate: There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy. However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity, thus use of this medicinal product is not recommended in pregnancy.
Lactation:
Clotrimazole: There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects. Clotrimazole may be used during lactation.
Neomycin sulfate: There is little information to demonstrate the possible effect of topically applied neomycin in lactation. This medicinal product is not recommended in breastfeeding.

Clotrimazole
No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.
However, in the event of accidental oral ingestion, gastric lavage is rarely required and should be considered only if a life-threatening amount of Clotrimazole has been ingested within the preceding hour or if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or
vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.
Neomycin sulfate and Dexamethasone acetate
Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.
Also, consideration should be given to significant systemic absorption of neomycin sulfate. If this is suspected, use of the product should be stopped and the patient’s general status, hearing acuity, renal and neuromuscular functions should be monitored.
Blood levels of neomycin sulfate should also be determined. Haemodialysis may reduce the serum level of neomycin sulfate.