ELOCOM LOTION

Israel - English - Ministry of Health

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Active ingredient:
MOMETASONE FUROATE
Available from:
MERCK SHARP & DOHME ISRAEL LTD
ATC code:
D07AC13
Pharmaceutical form:
LOTION
Composition:
MOMETASONE FUROATE 1 MG/G
Administration route:
TOPICAL
Prescription type:
Required
Manufactured by:
SCHERING-PLOUGH S.P.A., ITALY
Therapeutic group:
MOMETASONE
Therapeutic area:
MOMETASONE
Therapeutic indications:
The relief of the inflammatory and pruritic manifestations of corticosteroid - responsive dermatoses, such as psoriasis and atopic dermatitis.
Authorization number:
137 48 28715 21
Authorization date:
2012-10-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

20-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

18-08-2019

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS

(PREPARATIONS) 1986

This medicine can be sold under doctor's prescription only

ELOCOM

®

LOTION

Mometasone furoate 0.1%

For a list of inactive ingredients please refer to sections 2.5 and 6.

Read all of this leaflet carefully before you start using this medicine.

This leaflet contains summary information about ELOCOM. If you have any further questions, ask

your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if

their ailment seems similar to yours.

This medicine is not intended for children under the age of 2 years.

1. WHAT IS ELOCOM AND WHAT IT IS USED FOR?

1.1 What is ELOCOM?

Therapeutic group: ELOCOM Lotion belongs to a group of medicines called topical corticosteroids.

Topical corticosteroids have anti-inflammatory activity. These medicines are put on the surface of the skin

to reduce the redness and itchiness caused by certain skin problems.

1.2 What is ELOCOM Lotion used for?

ELOCOM Lotion is used to reduce inflammation and itchiness caused by certain corticosteroid-responsive

skin and scalp problems, such as psoriasis or atopic dermatitis in adults and children.

What is psoriasis?

Psoriasis is a skin disease in which itchy, scaly, pink patches develop on the elbows, knees, scalp and

other parts of the body.

What is dermatitis?

Dermatitis is a condition brought on by the skin reacting to outside agents e.g. detergents, causing the skin

to become red and itchy.

2. BEFORE YOU USE ELOCOM

2.1 Do not use ELOCOM if you:

Are allergic (hypersensitive) to mometasone furoate, any of the other ingredients of ELOCOM

Lotion, or to similar medicines (refer to sections 2.5 and 6).

Have any other skin or scalp problems as it could make them worse especially: rosacea (a skin

condition affecting the face); acne; skin atrophy (thinning of the skin); dermatitis around the mouth;

perianal and genital itching; nappy rash; cold sores; chickenpox; shingles; warts; ulcerated skin;

wounds; skin tuberculosis; post-vaccination reactions; other skin infections.

If you think that one of these is relevant to you, do not use ELOCOM until you have consulted your

doctor.

2.2 Special warnings concerning use of ELOCOM

ELOCOM may not be suitable for you, or you may need to be monitored regularly while taking it if any of the

following apply to you:

If your skin or scalp becomes irritated or sensitive after using ELOCOM, you should stop using it and tell

your doctor.

If you think that you have developed an infection on your skin or scalp whilst using ELOCOM, you should

tell your doctor as he may need to give you another type of medicine to use.

Do not apply on large surface areas of the skin or on open wounds.

If you are being treated for psoriasis – you may need to be monitored regularly.

The use of ELOCOM for children under 2 years is not recommended.

Special caution is required when using this medicine in children and adolescents. Use in these age

groups must be carried out under medical surveillance.

If you are not sure if any of the above apply to you, talk to your doctor before taking ELOCOM to see if

this medicine is suitable for you.

Do not light a cigarette or be exposed to fire until complete drying of the product.

2.3 Taking other medicines

If you are taking or have recently taken other medicines, including non-prescription medicines and

nutritional supplements, you should inform the attending doctor or pharmacist.

2.4 Pregnancy and breast-feeding

Do not use this medicine without consulting your doctor before starting treatment if you are pregnant or

breast-feeding.

2.5 Important information about some of the ingredients of ELOCOM

ELOCOM Lotion contains propylene glycol, which can cause skin irritation.

3. HOW DO YOU USE ELOCOM?

Always use ELOCOM exactly as your doctor has told you. You should check with your doctor or pharmacist

if you are not sure.

ELOCOM is not intended for use in children under the age of 2 years.

Do not use this medicine frequently, or for a long period, without consulting a doctor. Your doctor will

determine the dosage and duration of the treatment.

A few drops of ELOCOM Lotion should be gently massaged into the affected area of the skin or scalp once

a day. Massage gently and thoroughly until absorption of the medication. Apply with the aid of your finger

and then wash your finger thoroughly.

Do not exceed the recommended dose. Do not swallow, for external use only.

You should always follow these instructions when using ELOCOM:

Do not use ELOCOM on your face or in children for more than 5 days.

Do not put ELOCOM under your child’s diaper, as this makes it easier for the active drug to pass through

the skin and possibly cause some unwanted effects.

You should check with your doctor before covering the treated areas with a bandage or plaster. Treated

areas on the face or in children should not be covered with a bandage or plaster.

You should not use a large amount of ELOCOM Lotion on large areas of the body for a long time (for

example every day for many weeks or months).

Do not use in or around the eyes, including eye-lids, because of the very rare risk of glaucoma or cataract.

Avoid contact with mucous membranes (e.g. in mouth and nose). In case of contact wash thoroughly.

If you use more ELOCOM than you should

If you (or somebody else) accidentally swallows ELOCOM Lotion, it should not produce any problems.

However, if you are worried, you should see your doctor.

If you use ELOCOM Lotion more often than you should, or on large areas of the body, it can affect some of

your hormones levels. In children, this may affect their growth and development.

If you have not used ELOCOM Lotion as you were told to do, and have used it too often and/or for a long

time, you should tell your doctor.

If you forget to use ELOCOM

It is important to use ELOCOM as the doctor has prescribed. If you forget to use ELOCOM Lotion at the

right time, use it as soon as you remember, then carry on as before.

If you stop using ELOCOM

If you have been using ELOCOM Lotion for a long time and your skin or scalp problem seems to have got

better, you should not suddenly stop using ELOCOM Lotion. If you do, you may find that your skin and

scalp becomes red and you may notice stinging and burning. To avoid this, you should speak to your doctor

as he will gradually reduce how often you need to use ELOCOM Lotion until you stop treatment altogether.

Even if there is an improvement in your health, do not discontinue use of this medicine before consulting

your doctor. If you have additional questions regarding the use of this medicine, consult the doctor or

pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, ELOCOM can cause side effects, in some of the users.

Do not be alarmed by reading the list of side effects, you may experience none of them.

A few people may find that they suffer from some of the following side effects after using ELOCOM:

allergic skin reactions, bacterial and secondary skin infections, acne, inflammation and/or infection of the

hair follicles, thinning of the skin, red marks with associated prickly heat, loss of skin colour, burning,

stinging, itching, tingling, excessive hair growth, softening of the skin and stretch marks.

Other side effects that may occur with topical corticosteroids are dry skin, skin irritation, dermatitis,

dermatitis around the mouth, and dilated capillary blood vessels.

If a side effect appears, if one of the side effects gets serious or if you suffer from a side effect not

mentioned in this leaflet, consult your doctor.

Side effects can be reported to the Ministry of Health by using the link "Adverse Drug Reactions Report" at

the home page of the Ministry of Health's web site (www.health.gov.il) which refers to the online side effects

reporting form,

or by using the link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il

5. HOW TO STORE ELOCOM?

Avoid Poisoning! This medicine, as all other medicines, must be stored in a safe place out of the reach

and sight of children and/or infants, in order to avoid poisoning. Do not induce vomiting unless explicitly

instructed to do so by a doctor!

Do not take medicines in the dark! Check the label and the dose each time you take your medicine.

Wear glasses if you need them.

Do not use ELOCOM after the expiry date (exp. date) which is stated on the pack. The expiry date refers

to the last day of the indicated month. In case of doubt, consult the pharmacist who dispensed the

medicine to you.

Store not above 25°C.

After first opening, use within 3 months.

Do not store different medications in the same package.

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. FURTHER INFORMATION

6.1 What ELOCOM Lotion contains

The active substance is mometasone furoate 0.1% (1mg/g).

The other ingredients are: isopropyl alcohol, propylene glycol, hydroxypropyl cellulose, sodium

dihydrogen phosphate dihydrate, purified water. May contain phosphoric acid.

6.2 What ELOCOM Lotion looks like and contents of the pack

ELOCOM Lotion is a colorless, to off-white lotion.

6.3 Manufacturer:

Merck Sharp & Dohme Corp., New-Jersey, USA.

6.4 License holder:

Merck Sharp & Dohme (Israel-1996) Company Ltd., P.O.Box 7121, Petah-Tikva 49170.

This Leaflet was checked and approved by the Ministry of Health on: March 2016.

Drug registration no. listed in the official registry of the Ministry of Health:

137-48-28715-22

Elocom

®

Cream, Ointment and Lotion

Physicians' Prescribing Information

1

DESCRIPTION OF THE PRODUCT

Elocom

Cream,

Ointment

Lotion

formulations

contain

mometasone furoate (SCH 32088; Figure 1.1), a synthetic 17-heterocyclic

corticosteroid

with

anti-inflammatory,

antipruritic

vasoconstrictive

properties, which is presently being therapeutically used for the treatment

of corticosteroid responsive dermatoses, such as psoriasis and atopic

dermatitis.

1.1

PHARMACEUTICAL PARTICULARS

1.1.1

Drug Substance

Mometasone furoate (see Figure

1.1), 9,21-dichloro-11β,17-dihydroxy-

-methylpregna-1,4-diene-3,20-dione 17-(2)-furoate, is a synthetic, anti-

inflammatory

corticosteroid

whose

steroid

nucleus

-methyl

analog of beclomethasone, but with a 21-chloro group and a novel (2)-

furoate

17-ester

function.

empirical

formula

Molecular Weight (MW) is 521.44.

1.1.2

Drug Product

1.1.2.1

Cream

Each

gram

Mometasone

furoate

cream

0.1%

contains:

mometasone furoate in a cream base of white soft paraffin, hexylene

glycol,

aluminium

starch

octenylsuccinate,

white

wax,

purified

water,

hydrogenated soybean lecithin, titanium dioxide, phosphoric acid.

1.1.2.2

Ointment

Each

gram

Mometasone

furoate

ointment

0.1%

contains:

mometasone furoate in an ointment base of hexylene glycol, propylene

glycol stearate, white wax, white petrolatum, purified water and phosphoric

acid to adjust the pH.

1.1.2.3

Lotion

Each gram of Elocom Lotion 0.1% contains: 1 mg of mometasone furoate

lotion

base

isopropyl

alcohol,

propylene

glycol,

hydroxypropylcellulose,

sodium

dihydrogen

phosphate

dehydrate

purified water. May also contain phosphoric acid to adjust the pH.

2

PRECLINICAL INFORMATION

PHARMACODYNAMIC PROPERTIES

The pharmacodynamic activity of mometasone furoate cream, ointment

and lotion is directly related to its active component, mometasone furoate,

and the vehicles.

Like

other

topical

corticosteroids,

mometasone

furoate

anti-

inflammatory, antipruritic, and vasoconstrictive properties. The mechanism

of the anti-inflammatory activity of the topical steroids, in general, is

unclear. Corticosteroids, however, are thought to act by the induction of

phospholipase A2 inhibitory proteins, collectively called lipocortins. It is

postulated that these proteins control the biosynthesis of potent mediators

of inflammation, such as prostaglandins and leukotrienes, by inhibiting the

release of their common precursor arachidonic acid. Arachidonic acid is

released from membrane phospholipids by phospholipase A2.

Mometasone furoate is a potent inhibitor of the in vitro production of three

inflammatory cytokines that are involved in initiating and maintaining the

inflammatory state: interleukin 1 (IL-1), interleukin 6 (IL-6), and tumor

necrosis factor

(TNF-

PRECLINICAL PHARMACOKINETICS AND METABOLISM

Several studies were conducted to investigate for mometasone furoate the

absorption, distribution, metabolism and excretion following various routes

of administration and in different species. Mometasone furoate and/or its

metabolites are rapidly and extensively distributed in the rat. Mometasone

furoate undergoes extensive first-pass metabolism and is excreted as

metabolites mostly via the bile, and to a limited extent into the urine.

PRECLINICAL SAFETY DATA

No toxicological effects unique to mometasone furoate exposure were

demonstrated during the course of preclinical testing. All observed effects

are typical of this class of compounds and are related to exaggerated

pharmacologic effects of glucocorticoids.

Preclinical studies demonstrate that mometasone furoate is devoid of

androgenic, anti-androgenic, estrogenic or anti-estrogenic activity but, like

other glucocorticoids, it exhibits some anti-uterotrophic activity and delays

vaginal opening in animal models at high oral doses of 56 mg/kg/day and

280 mg/kg/day.

Mometasone furoate was non-mutagenic in the mouse-lymphoma assay

and the Salmonella/E. coli/mammalian microsome mutagenicity bioassay.

At cytotoxic doses only, mometasone furoate produced an increase in

chromosome aberrations in vitro in Chinese hamster ovary cell (CHO)

cultures in the non-activation phase, but not in the presence of rat liver S9

fraction.

However,

mometasone

furoate

induce

chromosomal

aberrations in vitro in a Chinese hamster lung cell (CHL) chromosomal-

aberrations assay or in vivo in the mouse bone-marrow erythrocyte-

micronucleus assay, in the rat bone-marrow clastogenicity assay, and the

mouse male germ-cell clastogenicity assay. Mometasone furoate also did

not induce unscheduled DNA synthesis in vivo in rat hepatocytes, The

finding of simple chromosomal aberrations in the non-activation phase of

the CHO assay is considered to be related to cytotoxicity and is not

considered to be of significance in the risk assessment of mometasone

furoate because of the negative results in the S9 phase of this assay, the

negative results in a second in vitro chromal aberrations assay (CHL

assay), and the negative results in three in vivo chromosomal aberrations

assays.

In studies of reproductive function, subcutaneous mometasone furoate

was well tolerated at doses up to 7.5 µg/kg. At 15 µg/kg, mometasone

furoate caused prolonged gestation and prolonged and difficult labor

occurred with a reduction in offspring survival and body weight or body

weight gain. There was no effect on fertility.

Like other glucocorticoids, mometasone furoate is a teratogen in rodents

and rabbits. Teratology studies were conducted in rats, mice and rabbits

oral,

topical and/or

subcutaneous

routes.

Effects

noted

were

umbilical hernia in rats, cleft palate in mice, and gall bladder agenesis,

umbilical

hernia,

flexed

front

paws

rabbits.

There

were

also

reductions in maternal body weight gains, effects on fetal growth (lower

fetal body weight and/or delayed ossification) in rats, rabbits and mice,

and reduced offspring survival in mice .

In an oral teratology study in rabbits, at 700 µg/kg, increased incidences of

resorption

malformations,

including

cleft

palate

and/or

head

malformations (hydrocephaly or domed head) were observed. Pregnancy

failure was observed in most rabbits at 2800 µg/kg.

The carcinogenicity and toxicological potential of inhaled Mometasone

Furoate (aerosol with CFC propellant and surfactant) at concentrations of

0.25 to 2.0 ug/I was investigated in studies in mice and rats of up to 24

months.

Typical

glucocorticoid-related

effects,

including

several

non-

neoplastic

lesions,

were

observed.

statistically

significant

dose-

response relationship was detected for any of the tumor types.

3

CLINICAL PHARMACOLOGY

PHARMACOKINETIC PROPERTIES

extent

percutaneous

absorption

topical

corticosteroids

determined by many factors including the vehicle and the integrity of the

epidermal

barrier

occlusive

dressings.

Topical

corticosteroids can be absorbed from normal intact skin. Inflammation

and/or

other

disease

processes

skin

increase

percutaneous

absorption. Occlusive dressings substantially increase the percutaneous

absorption of topical corticosteroids.

3.1.1

Absorption

The percutaneous absorption of

H-mometasone furoate was studied in

man following topical application of cream (0.1%) and ointment (0.1%)

formulations. Results showed that only about 0.4% and 0.7% of the

steroid, respectively, were systemically absorbed following 8 hours of

contact, without occlusion, through intact skin of normal volunteers .The

percutaneous absorption of

H-mometasone furoate also was studied in

psoriasis

patients

following

single

dose

topical

application

ointment 0.1% formulation over a 100cm

area. Results showed that only

1.3% of mometasone was absorbed systemically following 12 hours of

application

through

unoccluded

skin.

Minimal

absorption

would

anticipated with the lotion formulation.

In studies of the effects of mometasone furoate cream and ointment on

the hypothalamic-pituitary-adrenal axis (HPA), 15 grams were applied

twice daily for 7 days to 6 patients with psoriasis or atopic dermatitis. The

cream or ointment was applied without occlusion to at least 30% of the

body surface. The results suggest that the drug caused a slight lowering of

adrenal corticosteroid secretion, although in no case did plasma cortisol

levels go below the lower limit of the normal range.

Mometasone furoate lotion was applied at 15 ml twice daily (30 ml per

day) to diseased skin (patients with scalp and body psoriasis) of four

patients for seven days, to study its effects on the hypothalamic-pituitary-

adrenal (HPA) axis. Plasma cortisol levels for each of the four patients

remained well within the normal range and changed little from baseline

In a study involving 24 children (6 months to 13 years of age) with

moderate to severe atopic eczema, mometasone furoate cream was

applied once daily for three to six weeks. Occlusive dressings were not

used. The plasma cortisol levels for all patients remained within or above

the normal range during the course of treatment. Clinical laboratory values

of the children generally remained within the normal range. There were

some laboratory values that were outside the normal range during the

course of treatment; however, the investigator did not consider these

values to be of clinical significance or indicative of specific organ system

toxicity

Mometasone

furoate

ointment,

grams,

applied

daily

under

occlusion for three weeks in 24 psoriasis patients. Plasma cortisol levels

remained within normal limits for all patients.

3.1.2

Distribution

Due to the negligible absorption of mometasone furoate following topical

administration, the pharmacokinetics of the drug was evaluated following

intravenous administration of mometasone furoate. The apparent volume

of distribution was 917 liters, indicating that any absorbed mometasone

furoate would be extensively distributed in human plasma, mometasone

furoate is over 99% bound.

3.1.3

Metabolism

Absorbed

mometasone

furoate

undergoes

rapid

extensive

metabolism to multiple metabolites. The multiple metabolites are more

polar than mometasone furoate, and because of their polarity, are not

considered

have

pharmacological

activity.

major

metabolite

formed.

After

intravenous

administration,

total

body

clearance of

mometasone furoate was 976 ml/min, confirming extensive metabolism.

3.1.4

Excretion

Following

intravenous

administration

based

compartmental

modeling, the effective plasma elimination half-life is 5.8 hours. Any

absorbed drug is excreted as metabolites mostly via the bile, and to a

limited extent, into the urine.

4

INDICATIONS AND USAGE

THERAPEUTIC INDICATIONS

Mometasone furoate cream, ointment and lotion are indicated for the relief

of the inflammatory and pruritic manifestations of corticosteroid-responsive

dermatoses, such as psoriasis, atopic dermatitis.

5

SAFETY INFORMATION

CONTRAINDICATIONS

Elocom 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

fungal

(e.g.

candida

dermatophyte)

infections,

varicella,

tuberculosis,

syphilis

post-vaccine

reactions.

Elocom should not be used on wounds or on skin which is ulcerated.

Elocom should not be used in patients who are sensitive to mometasone

furoate or to other corticosteroids or to any of the ingredients in this

medicine.

WARNINGS/PRECAUTIONS

If irritation develops, topical corticosteroids should be discontinued and

appropriate therapy instituted.

In the presence of a dermatological infection, use of an appropriate

antifungal

antibacterial

agent

should

instituted.

favorable

response

does

occur

promptly,

corticosteroid

should

discontinued until the infection is adequately controlled.

Systemic

absorption of

topical

corticosteroids

can produce

reversible

hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential

glucocorticosteroid

insufficiency

after

withdrawal

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

areas

under

occlusion

should

evaluated

periodically for evidence of HPA axis suppression.

side

effects

that

reported

following

systemic

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 Elocom in pediatric patients below 2 years of

have

been

established,

this

group

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

burning.

This

prevented

slow

reduction

treatment,

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.

Elocom ointment and lotion contains propylene glycol which may cause

skin irritation.

Elocom topical preparations are not for ophthalmic use, including the

eyelids, because of the very rare risk of glaucoma simplex or subcapsular

cataract.

Pregnancy and lactation:

During

pregnancy

lactation

treatment

with

Elocom

should

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

corticosteroids

pregnant

animals

cause

abnormalities of fetal development including cleft palate and intra-uterine

growth retardation. There are no adequate and well-controlled studies with

Elocom in pregnant women and therefore the risk of such effects to the

human

fetus

unknown.

However

with

topically

applied

glucocorticoids,

possibility

that

fetal

growth

affected

glucocorticoid

passage

through

placental

barrier

should

considered. There may therefore be a very small risk of such effects in the

human fetus. Like other topically applied glucocorticoids, Elocom should

be used in pregnant women only if the potential benefit justifies the

potential risk to the mother or the fetus.

It is not known whether topical administration of corticosteroids could

result in sufficient systemic absorption to produce detectable quantities in

breast milk. Elocom 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.

ADVERSE REACTIONS

Table 1: Treatment-related adverse reactions reported with Elocom 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

dermatologic

corticosteroids

include:

skin

dryness

irritation,

dermatitis,

perioral

dermatitis,

maceration of the skin, miliaria and telangiectasiae.

Pediatric 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.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Excessive,

prolonged

topical

corticosteroids

suppress

hypothalamic-pituitary-adrenal

function,

resulting

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.

DRUG INTERACTIONS

None known

INTERFERENCE WITH LABORATORY TESTS

None identified

6

DOSAGE AND ADMINISTRATION

Apply a thin film of mometasone furoate cream of ointment or a few drops

of mometasone furoate lotion to the affected skin areas once daily.

7 STORAGE

Store below 25

Elocom ointment: after first opening, use within 1 month.

Elocom lotion and cream: after first opening, use within 3 months.

8 MANUFACTURER

Elocom ointment and cream: Schering-Plough Labo N.V., Heist-op-den-

Berg, Belgium.

Elocom lotion: Merck Sharp & Dohme Corp., New-Jersey, USA.

9 REGISTRATION HOLDER

Merck Sharp & Dohme (Israel-1996) Company Ltd, P.O.B. 7121 Petach-

Tiqva 49170.

The format of this leaflet was determined by the Ministry of Health and its

content was checked and approved in December 2014.

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