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Vizomet
0.1 % w/w Cream
COMPOSITION
Contains Mometasone Furoate 0.1% w/w. Methyl Hydroxybenzoate 0.2% w/w and
Propyl Hydroxybenzoate 0.1% w/w as preservatives.
PHARMACODYNAMICS
Mometasone furoate is a synthetic corticosteroid, exhibits
anti-inflammatory, antipruritic and vasoconstrictive properties.
PHARMACOKINETICS
Systemic absorption following topical application of mometasone furoate
cream 0.1% is minimal, approximately 0.4% of the applied dose in man, the
majority of which is excreted within 72 hours following application.
Characterisation of metabolites was not feasible owing to the small amounts
present in plasma and excreta.
INDICATIONS
Vizomet is indicated for the relief of inflammatory and pruritic
manifestations of corticosteroid responsive dermatoses.
DOSAGE AND ADMINISTRATION
A thin film of Vizomet should be applied to the affected skin areas once
daily until the lesion heals or for a duration of three weeks, whichever is
sooner.
CONTRAINDICATIONS
Vizomet is contraindicated in facial rosacea, acne vulgaris, perioral
dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g.
impetigo), viral (e.g. herpes simplex, herpes zoster and chickenpox) and
fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis,
syphilis or post-vaccine reactions. Vizomet should not be used in patients
who are sensitive to mometasone furoate, to other corticosteroids or to any
components of this preparation.
WARNINGS AND PRECAUTIONS
If irritation or sensitisation develops with the use of mometasone furoate,
treatment should be withdrawn and appropriate therapy instituted.
Should an infection develop, use of an appropriate antifungal or
antibacterial agent should be instituted. If a favourable response does not
occur promptly, the corticosteroid should be discontinued until the
infection is adequately controlled.
Local and systemic toxicity is common especially following long continued
use on large areas of damaged skin, in flexures and with polythene
occlusion. If used in childhood, or on the face, courses should be limited
to 5 days and occlusion should not be used. Long term continuous therapy
should be avoided in all patients irrespective of age.
Topical steroids may be hazardous in psoriasis for a number of reasons
including rebound relapses following development of tolerance, risk of
centralised 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.
Mometasone furoate topical preparations are not for ophthalmic use.
DRUG INTERACTIONS
No drug interactions have been identified.
PREGNANCY AND LACTATION
Use in pregnancy: Since safe use of mometasone furoate in pregnant women has
not been established, topical corticosteroids should only be used in
pregnancy when the potential benefits outweigh the possible risks to the
fetus. Drugs of this class should not be used on pregnant patients in large
amounts or for prolonged periods of time.
Use in lactation: It is not known whether topical administration of
corticosteroids could result in sufficient systemic absorption to produce
detectable quantities in breast milk. Mometasone furoate should be
administered to nursing mothers only after careful consideration of the
benefit/risk relationship.
SIDE EFFECTS
Local adverse reactions occasionally reported with mometasone furoate
include paresthesia, folliculitis, burning, pruritis, tingling, stinging,
allergic contact dermatitis, hypopigmentation, hypertrichosis, secondary
infection, striae, acneiform reactions and signs of skin atrophy.
Local adverse reactions reported infrequently with other topical
corticosteroids include: irritation, perioral dermatitis, maceration of the
skin and miliaria.
Paediatric patients may demonstrate greater susceptibility to topical
corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and
Cushing's syndrome than mature patients because of a larger skin surface
area to body weight ratio.
Chronic corticosteroids therapy may interfere with the growth and
development of children.
SYMPTOMS AND TREATMENT FOR OVERDOSAGE
Symptoms: Excessive, prolonged
use of topical corticosteroids can suppress pituitary-adrenal function
resulting in secondary adrenal insufficiency.
Treatment: Appropriate symptomatic treatment is indicated. Acute
hypercorticoid symptoms are virtually reversible. Treat electrolyte
imbalance, if necessary, in cases of chronic toxicity, slow withdrawal of
corticosteroids is advised.
STORAGE CONDITION
Store below 25°C.
SHELF LIFE
3 years from the date of manufacture.
PRODUCT DESCRIPTION
White, smooth, homogeneous and water-miscible cream in aluminium collapsible
tube of 15g and 5g.
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