Avocom 0.1% w/w Ointment is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.

Adults, including elderly patients and children: A thin film of Avocom 0.1% w/w Ointment should be applied to
the affected areas of skin once daily.
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.

Avocom 0.1% w/w is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster and chickenpox, verrucae vulgares, condylomata acuminata, molluscum contagiosum), parasitical and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions. Avocom 0.1% w/w should not be used on wounds or skin which is ulcerated. Avocom 0.1% w/w should not be used in patients who are sensitive to mometasone furoate or to other corticosteroids or to any of the excipients listed in section 6.1.

If irritation or sensitisation develop with the use of Avocom 0.1% w/w, treatment should be withdrawn, and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.
Systemic absorption of topical corticosteriods can produce reversible hypothalamic-pituitaryadrenal (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.
Paediatric 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 Avocom 0.1% w/w 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 a
dermatitis with intense redness, stinging and burning. This can be prevented by slow reduction of the treatment,
for instance continue 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.
Avocom 0.1% w/w Ointment contains propylene glycol which may cause skin irritation.
Avocom 0.1% w/w topical preparations are not for ophthalmic use, including the eyelids, because of the very rare
risk of glaucoma simplex or subcapsular cataract.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular)
corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the
patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual
disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy
(CSCR) which have been reported after use of systemic and topical corticosteroids.
Instruct patients not to smoke or go near naked flames - 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.

None stated.

Pregnancy
During pregnancy treatment with Avocom 0.1% w/w should be performed only on the physician's order. Then,
however, the application on large body surface areas or over a prolonged period should be avoided. There is
inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant
animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth
retardation. There are no adequate and well-controlled studies with Avocom 0.1% w/w in pregnant women and
therefore the risk of such effects to the human foetus is unknown. However as with all topically applied
glucocorticoids, the possibility that foetal growth may be affected by glucocorticoid passage through the
placental barrier should be considered. There may therefore be a very small risk of such effects in the human
foetus. Like other topically applied glucocorticoids, Avocom 0.1% w/w should be used in pregnant women only
if the potential benefit justifies the potential risk to the mother or the foetus.
Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to
produce detectable quantities in breast milk. Avocom 0.1% w/w should be administered to nursing mothers only
after careful consideration of the benefit/risk relationship. If treatment with higher doses or long-term application
is indicated, breast-feeding should be discontinued.

None stated.

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 hypothalamicpituitary-
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.

To reports any side effect(s):
- Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o SFDA call center: 19999
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: https://ade.sfda.gov.sa

• Other GCC States:

- Please contact the relevant competent authority

Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-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: Mometasone, ATC code: D07AC13
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.ovalisinduced
epidermal acanthosis (i.e. anti-psoriatic activity) after 14 applications.

Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone
furoate ointment 0.1% is minimal, approximately 0.7% 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.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in
other sections of the SPC.

Dexpanthenol
Stearic Acid
Cetostearyl Alcohol
Vaseline
Propylene Glycol
Purified Water

None known

•Shelf life of unopened tube is 24 months •Shelf life after first opening is 2 months

Store below 30°C.

Collapsible aluminum tube with HDPE screw cap. Pack size 30g and 50g

Not applicable.