Xenoderm Ointment 30gm

Product Information

XENODERM OINTMENT

Presentation

Xenoderm Ointment: Each gram ointment contains Clobetasol Propionate BP 0.5mg, Neomycin Sulfate USP 5mg and Nystatin USP 20mg.

Indications

Xenoderm is indicated in more resistant dermatoses such as recalcitrant eczemas and psoriasis (excluding widespread plaque

psoriasis) where secondary bacterial or candidal infection is present, suspected or likely to occur, as when using occlusive

dressings.

Dosage & administration

Adults and children over 2 years: Apply sparingly to the affected area once or twice daily until improvement occurs. As with other

highly-active topical steroid preparations therapy should be discontinued when control is achieved. In the more responsive

conditions this may be within a few days. In very resistant lesions, especially where there is hyperkeratosis, the

anti-inflammatory effects of Xenoderm can be enhanced, if necessary, by occluding the treatment area with polythene. Overnight

occlusion only is usually adequate to bring about a satisfactory response, thereafter improvement can be usually maintained by

application without occlusion. Treatment should not be continued for more than 7 days without medical supervision. If a longer

course is necessary, it is recommended that treatment should not be continued for more than 4 weeks without the patient’s

condition being reviewed. Repeat short courses of Xenoderm may be used to control exacerbations. If continuous steroid treatment

is necessary, a less potent preparation should be used. Dosage in Renal Impairment: Dosage should be reduced in patients with

reduced renal. Elderly: Xenoderm is suitable for use in the elderly. Caution should be exercised in cases where a decrease in

renal function exists and significant systemic absorption of neomycin sulphate may occur. Children: Xenoderm is suitable for use

in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children,

thus this cream is not recommended for use in neonates and infants (younger than 2 years). For topical administration only.

Contra-indications, warnings, etc.

Contra-indications: Rosacea, acne vulgaris and perioral dermatitis. Primary cutaneous viral infections (e.g. herpes simplex,

chickenpox). Hypersensitivity to the preparations. Use of Xenoderm is not indicated in the treatment of primary infected skin

lesions caused by infection with fungi (e.g. candidiasis, tinea), bacteria (e.g. impetigo), or yeast; secondary infections due to

Pseudomonas or Proteus species; perianal and genital pruritus, dermatoses in children under 2 years of age, including dermatitis

and napkin eruptions. Preparations containing neomycin should not be used for the treatment of otitis externa when the eardrum is

perforated, because of the risk of ototoxicity. Due to the known ototoxic and nephrotoxic potential of neomycin sulfate the use of

this medicinal product in large quantities or on large areas for prolonged periods is not recommended in circumstances where

significant systemic absorption may occur. A possibility of increased absorption exists in very young children, therefore Xenoderm

is not recommended for use in neonates and infants (up to 2 years). In neonates and infants, absorption by immature skin may be

enhanced, and renal function may be immature. Warnings and precautions: Long term continuous topical therapy should be avoided

where possible, particularly in infants and children, as adrenal suppression can occur readily even without occlusion. If used in

childhood, or on the face, courses should be limited to 5 days and occlusion should not be used. It should be noted that the

child’s napkin may act as an occlusive dressing. The face, more than other areas of the body, may exhibit atrophic changes after

prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis and

severe eczema. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might

result. If the cream does enter the eye, it should be bathed in copious amounts of water. Topical corticosteroids may be hazardous

in psoriasis for a number of reasons, including rebound relapses, development of tolerance, risk of generalized pustular psoriasis

and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient

supervision is important. Extension of the infection may occur due to the masking effect of the steroid. If infection persists,

systemic chemotherapy is required. Any spread of infection requires withdrawal of topical corticosteroid therapy. Bacterial

infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a

fresh dressing is applied. 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. Extended or

recurrent application may increase the risk of contact sensitization. Products which contain antimicrobial agents should not be

diluted. Clobetasol/Neomycin/Nystatin cream contains arachis oil (peanut oil) and should not be taken/applied by patients known to

be allergic to peanuts. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya

allergy should also avoid this medicinal product. Drug interactions: Neomycin sulfate can intensify and prolong the respiratory

depressant effects of neuromuscular blocking agents following significant systemic absorption. However, if used in accordance with

the recommendations systemic exposure to neomycin sulfate is expected to be minimal and drug interactions are unlikely to be

significant. No hazardous interactions have been reported with use of Clobetasol Propionate or Nystatin. Pregnancy and lactation:

There is little information to demonstrate the possible effect of topically applied Neomycin in pregnancy and lactation. However,

Neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity, thus the use

of Clobetasol/Neomycin/Nystatin is not recommended in pregnancy and lactation. The safe use of clobetasol propionate during

lactation has not been established. Side effects: Local hypersensitivity reactions such as erythema, rash, pruritus, urticaria,

local skin burning and allergic contact dermatitis may occur at the site of application and may resemble symptoms of the

conditions under treatment. As with other topical corticosteroids prolonged use of large amounts or treatment of extensive areas

can result in sufficient systemic absorption to produce the features of hypercortisolism. This effect is more likely to occur in

infants and children and if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing. Provided the

weekly dosage is less than 50g in adults, any suppression of the HPA axis is likely to be transient with a rapid return to normal

values once the short course of steroid therapy has ceased.The same applies to children given a proportionate dosage. Prolonged

and intensive treatment with a highly active corticosteroid preparation may cause local atrophic changes in the skin such as

thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or when skin

folds are involved. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked

the pustular form of the disease. There are reports of pigmentation changes and hypertrichosis with topical steroids. If signs of

hypersensitivity appear, application should be stopped immediately. Exacerbation of symptoms may occur. Overdose: Acute overdosage

is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may appear and in

this situation topical steroids should be reduced or discontinued gradually undermedical supervision because of the risk of

adrenal insufficiency. 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 sulphate should also be determined. Haemodialysis may reduce the serum

level of neomycin sulfate.

Pharmaceutical Precaution

Store in a cool and dry place, protected from light.

Packaging Quantity

Xenoderm Ointment: Carton containing 30g ointment in alu tube.

Manufactured by

UniMed & UniHealth Manufacturers Ltd.

Gazipur, Bangladesh

® Registered Trademark