Mometamed Cream is indicated for the relief of the inflammatory and pruritic manifestations of
corticosteroid responsive dermatoses such as: psoriasis, atopic dermatitis and eczema.

Use of topical corticosteroids in children or on the face should be limited to the least amount
compatible with an effective therapeutic regimen and duration of treatment should be no more
than 5 days.

A thin film of Mometamed Cream should be applied to affected skin areas once daily.

If irritation or sensitisation develops with the use of Mometamed, treatment should be
withdrawn and appropriate therapy instituted.
In case of an infection has been developed, 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.
Systemic absorption of topical corticosteriods can produce reversible hypothalamicpituitaryadrenal
(HPA) axis suppression with the potential for glucocorticosteroid insufficiency
after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and
glucosuria can also be produced in some patients by systemic absorption of topical
corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or
areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
Any of the side effects that are reported following systemic use of corticosteroids, including
adrenal suppression, may also occur with topical corticosteroids, especially in infants and
children.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to
their larger skin surface to body mass ratios. As the safety and efficacy of Mometamed in
paediatric patients below 2 years of age have not been established, its use in this age group is
not recommended.
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,
occlusion should not be used. If used 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.
As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When
long term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can
develop which takes the form of dermatitis with intense redness, stinging and burning. This can
be prevented by slow reduction of the treatment, for instance continues treatment on an
intermittent basis before discontinuing treatment.
Glucocorticoids can change the appearance of some lesions and make it difficult to establish an
adequate diagnosis and can also delay the healing.
Mometamed topical preparations are not for ophthalmic use, including the eyelids, because of
the very rare risk of glaucoma simplex or subcapsular cataract.

None known.

Pregnancy
Since safe use of Mometamed products in pregnant women has not been established, topical
corticosteroids should be used during pregnancy only if the potential benefit justifies potential
risk to the fetus. Drugs of this class should not be used on pregnant patients in large amounts
or for prolonged periods of time.
Breast feeding
It is not known whether topical administration of Mometamed Cream corticosteroids could
result in sufficient systemic absorption to produce detectable quantities in breast milk.
Systematically administered corticosteroids are secreted into breast milk in quantities not likely
to have a deleterious effect on the infant. Excessive, prolonged used of topical corticosteroids
can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency.
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.

No effects on the ability to drive or use machines have been seen with Mometamed Cream.

Treatment-related adverse reactions reported with Mometamed by body system and frequency
Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000,
<1/1,000); very rare (<1/10 000,); not known (cannot be estimated from available data).
Infections and infestations
Not known Infection, furuncle
Very rare Folliculitis
Nervous system disorders
Not known Paraesthesia,

Very rare burning sensation
Skin and subcutaneous tissue disorders
Not known Dermatitis contact, skin hypopigmentation,
hypertrichosis, skin striae, dermatitis acneiform, skin
atrophy.
Very rare Pruritus
General disorders and administration
site conditions
Not known Application site pain, application site reactions
Local adverse reactions reported infrequently with topical dermatalogic corticosteroids
include: skin dryness, irritation, dermatitis, perioral dermatitis, maceration of the skin, miliaria
and telangiectasiae.
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.

Excessive, prolonged use of topical corticosteroids can suppress hypothalamicpituitary-adrenal
function resulting in secondary adrenal insufficiency which is usually reversible.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce
the frequency of application or to substitute a less potent steroid.
The steroid content of each container is so low as to have little or no toxic effect in the unlikely
event of accidental oral ingestion.

Pharmacotherapeutic group: anti-inflammatory corticosteroid
ATC code: R01A D09

Mechanism of action
Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties.
It is likely that much of the mechanism for the anti-allergic and anti-inflammatory effects of
mometasone furoate may be due to its ability to inhibit the release of mediators of allergic
reactions.

Clinical efficacy and safety
Mometasone furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic
activity in standard animal predictive models.
In the croton oil assay in mice, mometasone was equipotent to betamethasone valerate after
single application and about 8 times as potent after five applications.
In guinea pigs, mometasone was approximately twice as potent as betamethasone valerate in
reducing m.ovalis-induced epidermal acanthosis (i.e. anti-psoriatic activity) after 14
applications.

Pharmacokinetic studies have indicated that systemic absorption following topical application
of mometasone furoate 0.1% is minimal, approximately 0.4% of the applied dose in man, the
majority of which is excreted within 72 hours following application. Characterization of
metabolites was not feasible owing to the small amounts present in plasma and excreta.

No additional data

 Methyl Paraben
 Propyl Paraben
 Liquid Paraffin
 Cetostearyl Alcohol
 Cetomacrogol 1000
 Propylene Glycol
 White Soft Paraffin
 Purified Water

None Known.

Store below 25°C, Do not refrigerate.
Keep out of sight and reach of children.
Do not use after the expiry date stated on the label.
Do not use if there is any physical change on the product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.

6.5. Nature and contents of container
White, homogenous, smooth cream, which is available in 30 gm collapsible aluminum tube
coated internally with epoxide resin, the tube is covered with white shrouded HDPE cap.

No special instructions