ASPEN MOMETASONE CREAM
(and dosage form):
ASPEN MOMETASONE CREAM
Each 1 g cream contains: 1 mg Mometasone Furoate
A 13.4.1 Corticosteroids with or without anti-infective agents
Mometasone is a medium-potency synthetic topical steroid that has antiinflammatory, antipruritic and vasoconstrictive actions.
A minimal amount of mometasone is absorbed after topical application to normal skin.
That which is absorbed is metabolised in the liver and excreted in the urine.
ASPEN MOMETASONE CREAM is indicated for the relief of inflammatory manifestations of psoriasis and corticosteroid-responsive dermatoses.
Hypersensitivity to any of the ingredients.
Viral infections such as herpes simplex, vaccinia and varicella.
Untreated fungal infections.
ASPEN MOMETASONE CREAM is not for ophthalmic use. Safety and efficacy of ASPEN MOMETASONE CREAM in paediatric patients for more than three weeks of use have not been established. Use in paediatric patients under the age of two years is not recommended.
PREGNANCY AND LACTATION
Safety in pregnancy and lactation has not been established.
Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents may be absorbed percutaneously, teratogenicity following topical application cannot be excluded. ASPEN MOMETASONE CREAM should therefore not be used during pregnancy.
ASPEN MOMETASONE CREAM is not recommended for breast-feeding mothers.
DOSAGE AND DIRECTIONS FOR USE
A thin film of ASPEN MOMETASONE CREAM should be applied to completely cover the whole affected area once daily.
ASPEN MOMETASONE CREAM may be used with caution in paediatric patients from the age of two years and older.
Treatment should be discontinued once the condition is under control.
Duration of therapy is dependant on clinical response and may vary from a few days to a longer period of time. It should, however, not be continued for longer than three weeks without the patient being re-evaluated.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Skin and subcutaneous tissue disorders:
Long-term continuous therapy with ASPEN MOMETASONE CREAM may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilation of superficial blood vessels, telangiectasiae and ecchymoses, especially if applied to the face or if occlusive dressings are used.
Discontinue treatment if irritation or sensitisation occurs and treat appropriately.
In facial dermatoses, ASPEN MOMETASONE CREAM should be used cautiously and for short periods only, as a steroid rosacea-like facies may be produced.
Allergic contact dermatitis, burning, dryness, folliculitis, irritation, itching, secondary infection, skin atrophy.
Acneiform eruptions, perioral dermatitis, hypertrichosis, hypopigmentation, miliaria, maceration of the skin and striae, have been reported.
Systemic absorption may occur, especially when large quantities of the cream are used or applied to large areas of the body or to damaged skin and when an occlusive dressing technique is applied. This may result in benign intracranial hypertension, a Cushingoid state, depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland and growth retardation. These effects are most likely to be severe in children.
Safety of use for more than three weeks has not been established and ASPEN MOMETASONE CREAM should therefore be used for short
ASPEN MOMETASONE CREAM should not be applied to any skin crease areas and especially not in the nappy area of infants. Its use in children under the age of two years is not recommended, (see DOSAGE AND DIRECTIONS FOR USE).
Use with caution near the eyes.
If ASPEN MOMETASONE CREAM is used for the treatment of psoriasis, the pustular form of the disease may be provoked.
If secondary bacterial infection is present, suitable concomitant antimicrobial therapy should be applied.
KNOWN SYMPTOMS OF OVER-DOSAGE AND PARTICULARS OF ITS TREATMENT
Refer to SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Excessive or prolonged use of ASPEN MOMETASONE CREAM can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, but may also produce manifestations of hypercorticism, including Cushings syndrome.
Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of ASPEN MOMETASONE CREAM is advised.
TREATMENT IS SYMPTOMATIC AND SUPPORTIVE.
A stiff white to off-white oleaginous cream.
20 g and 50 g aluminium tubes closed with white high density polyethylene caps.
Store below 25°C.
Keep well closed
KEEP OUT OF REACH OF CHILDREN
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
DATE OF PUBLICATION OF THE PACKAGE INSERT
23 August 2005
New addition to this site: September 2007
Source: Pharmaceutical Industry
SAEPI HOME PAGE
TRADE NAME INDEX
GENERIC NAME INDEX
Information presented by Malahyde Information Systems © Copyright 1996-2007