1.

Name of the medicinal product

Polyder cream

2. Qualitative and quantitative composition

Composition:
Each 100g contains
Beclomethasone dipropionate 0.025%
Miconazole nitrate 2.0%w/w
Neomycin sulphate 0.5%w/w
Chlorocresol 0.1%w/w
Cream base q.s

3. Pharmaceutical form

Cream in a collapsible tube

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications :

It is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tineapedis,
tineacuris and tineacoporis

4.2 Posology and Method of Administration

Polyderm cream is should not be used continuously for more than one week without reevaluation by
the physician. Adults and adolescents Apply thinly and gently rub in using only enough to cover the
entire affected area twice daily for up to seven days. Allow adequate time for absorption after each
application before applying an emollient. Treatment should not be continued for more than seven days
without medical supervision. If the condition worsens or does not improve within seven days, treatment
and diagnosis should be re-evaluated.

Children aged 2 years and over : Polyderm 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, polyderm cream
is contraindicated in children under 2 years of age. Children are more likely to develop local and
systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent
agents than adults. Care should be taken when using polyderm cream to ensure the amount applied is
the minimum that provides therapeutic benefit. Elderly, polyderm cream is suitable for use in the
elderly. However, the greater frequency of decreased hepatic and renal function in the elderly may
delay elimination if systemic absorption occurs. Therefore, the minimum quantity should be used for the
shortest duration to achieve the desired clinical benefit. Renal impairment Dosage should be reduced in
patients with reduced renal function.
4.3 Contraindications Polyderm cream is contraindicated in children under 2 years of age. Due to the
known ototoxic and nephrotoxic potential of neomycin sulphate, the use of polyderm cream in large
quantities or on large areas for prolonged periods of time is contraindicated in circumstances where
significant systemic absorption may occur.

4.4 Special Warnings and Precautions for Use Hypersensitivity

Polyderm cream should be used with caution in patients with a history of local hypersensitivity to
betamethasone, neomycin, miconazole or to any of the excipients in the preparation. Local
hypersensitivity reactions may resemble symptoms of the condition under treatment. Application to
open wounds should be avoided. Pseudomembranous colitis Pseudomembranous colitis has been
reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it
is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use.
Although this is less likely to occur with topically applied polyderm cream. If prolonged or significant
diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued
immediately and the patient investigated further. Reversible hypothalamic-pituitary-adrenal (HPA) axis
suppression manifestations of hypercortisolism (Cushing’s syndrome) and reversible
hypothalamicpituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of
increased systemic absorption of topical corticosteroids. If either of the above are observed, withdraw
the drug gradually by reducing the frequency of application, or by substituting a less potent
corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency. Risk
factors for increased corticosteroid systemic effects are: • Potency and formulation of topical
corticosteroid • Duration of exposure • Application to a large surface area • Use on occluded areas of
skin e.g. on intertriginous areas or under occlusive dressings (nappies may act as an occlusive dressing) •
Increasing hydration of the stratum corneum • Use on thin skin areas such as the face • Use on broken
skin or other conditions where the skin barrier may be impaired. Visual disturbance Visual disturbance
has been reported by patients using systemic and/or topical corticosteroids. If a patient has blurred
vision or other visual disturbances, consider evaluation of possible causes which may include cataract,
glaucoma or central serous chorioretinopathy. Use in children In comparison with adults, children may
absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to
systemic adverse effects. This is because children have an immature skin barrier and a greater surface
area to body weight ratio compared with adults. In children under 12 years of age, long-term continuous
topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.

Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.
Application to eyelids, if applied to the eyelids, care is needed to ensure that the preparation does not
enter the eye, as cataract and glaucoma might result from repeated exposure. In case of accidental
contact with the eyes or mucous membranes, rinse with water.

Extension of infection may occur due to the masking effect of the steroid. Any spread of infection
requires withdrawal of topical corticosteroid therapy and administration of appropriate systemic
antimicrobial therapy. Infection risk with occlusion Bacterial infection is encouraged by the warm, moist
conditions within skin folds and caused by occlusive dressings. When using occlusive dressings, the skin
should be cleansed before a fresh dressing is applied.

Chronic leg ulcers: Topical corticosteroids are sometimes used to treat the dermatitis around chronic
leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity
reactions and an increased risk of local infection. Flammability risk Product contains paraffin. Instruct
patients not to smoke or go near naked flames due to the 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.

4.5 Drug Interactions

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir and itraconazole) have been shown to
inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which
this interaction is clinically relevant depends on the dose and route of administration of the
corticosteroids and the potency of the CYP3A4 inhibitor. Following significant systemic absorption,
gentamicin sulphate can intensify and prolong the respiratory depressant effects of neuromuscular
blocking agents. Possibility of cumulative toxicity should be considered when neomycin sulphate is
applied topically in combination with systemic aminoglycoside therapy. It is known that systemically
administered miconazole nitrate inhibits CYP3A4/2C9. As there is limited percutaneous absorption of
miconazole, topical application is not expected to result in systemic exposure of clinical significance.
However, as there have been case reports of topical or intravaginal miconazole cream potentiating the
anticoagulant effects of coumarins in adults, caution should be exercised with concomitant use and
anticoagulant effect monitored.

4.6 Use in Special Population (such as pregnant women, lactating women, paediatric patients, geriatric
patients etc.)

Fertility: There are no data in humans to evaluate the effect of topical betamethasone dipropionate with
neomycin on fertility. No fertility studies in animals have been performed with topical miconazole.
Animal studies indicate no effects of oral miconazole on male or female fertility. As there is limited
percutaneous absorption of miconazole following topical application, impact on fertility is not expected.
Pregnancy :There are limited data from the use of topical betamethasone dipropionate with neomycin
in pregnant women. There are no adequate and well-controlled studies of topical miconazole in
pregnant women. Oral miconazole has been shown to be embryotoxic in the rat at high doses. No
reproductive studies in animals have been performed with topical miconazole. Topical administration of
corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of
this finding to humans has not been established. 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 polyderm
cream is not recommended in pregnancy.

Lactation: Percutaneous absorption of miconazole is limited, however, it is not known whether

miconazole is excreted in human milk after topical application. The safe use of betamethasone
dipropionate with neomycin and miconazole during lactation has not been established. It is not known
whether topical administration of corticosteroids could result in sufficient systemic absorption to
produce detectable amounts in breast milk. Thus, use of polyderm is not recommended in lactation.

4.7 Effects on Ability to Drive and Use Machines

There have been no studies to investigate the effect of betamethasone dipropionate with neomycin on
driving performance or the ability to operate machinery. Miconazole is not known to exert an effect on
the central nervous system following topical application. A detrimental effect on such activities would
not be anticipated from the adverse reaction profile of BETNOVATE-GM.

4.8 Undesirable effects

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and
<1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.
Post-marketing data

Infections and Infestations

Very rare Opportunistic infection
Immune System Disorders
Very rare Hypersensitivity, generalised rash
Endocrine Disorders
Very rare Hypothalamic-pituitary adrenal (HPA) axis suppression
Cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth
retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract,
hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia,
trichorrhexis
Skin and Subcutaneous Tissue Disorders
Common Pruritus, local skin burning /skin pain
Very rare Allergic contact dermatitis /dermatitis, erythema, rash, urticaria, pustular psoriasis, skin
thinning* / skin atrophy*, skin wrinkling*, skin dryness*, striae*, telangiectasias*, pigmentation
changes*, hypertrichosis, exacerbation of underlying symptoms
General Disorders and Administration Site Conditions
Very rare Application site irritation/pain
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.
Eye disorders
Not known Vision, blurred.
Reporting of suspected 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 to NAFDAC.
4.9 Overdose
Symptoms and signs
Topically applied betamethasone valerate may be absorbed in sufficient amounts to produce systemic effects.
Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features
of hypercortisolism may occur.
Treatment
In the event of overdose, betamethasone dipropionate should be withdrawn gradually by reducing the
frequency of application, or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid
insufficiency.

5. Pharmacological properties
5.1 Pharmacodynamic properties
Mechanism of action
Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit late phase allergic
reactions including decreasing the density of mast cells, decreasing chemotaxis and activation of eosinophils,
decreasing cytokine production by lymphocytes, monocytes, mast cells and eosinophils, and inhibiting the
metabolism of arachidonic acid.
Pharmacodynamic effects
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties.
5.2 Pharmacokinetic properties
Absorption
Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous
absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the
epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase
percutaneous absorption.
Distribution
The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is
necessary because circulating levels are well below the level of detection.
Metabolism
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar
to systemically administered corticosteroids. They are metabolised, primarily in the liver.
Elimination
Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their metabolites are
also excreted in the bile.
5.3 Preclinical safety data
Reproductive toxicity
Subcutaneous administration of betamethasone dipropionate to mice or rats at doses ≥0.1 mg/kg/day or rabbits
at doses ≥12 micrograms/kg/day during pregnancy produced foetal abnormalities including cleft palate and
intrauterine growth retardation.
The effect on fertility of betamethasone dipropionate has not been evaluated in animals.

6. Pharmaceutical particulars
6.1 List of excipients
Chlorocresol BP
White Soft Paraffin BP
Liquid Paraffin BP
Sodium Acid Phosphate BP
Phosphoric Acid BP
Sodium Hydroxide BP
Purified Water BP
6.2 Incompatibilities
Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Pack sizes:

A collapsible tube of 20g

6.6 Special precautions for disposal and other handling

NAME OF APPLICANT/MANUFACTURER

APTEKA PHARMA LTD

145, Club Road, Kano

Manufactured by

AMRIYA PHARMACEUTICALS

Kilo 25 Alexandria Cairo desert road,Egypt.