Cream & Lipocream
Efficort Cream contains
hydrocortisone aceponate 0.127% w/w as the active ingredeint in an
oil-in-water cream base containing self-emulsifying wax, white petrolatum,
stearyl alcohol, benzyl alcohol and purified water.
Efficort Lipocream contains
hydrocortisone aceponate 0.127% w/w as the active ingredient in a
water-in-oil cream base containing white petrolatum, aluminium
di/tristearate, liquid paraffin, Protegin WX, DUB BW, magnesium sulphate
heptahydrate and purified water.
Efficort Cream and Lipocream are
for cutaneous use only.
Efficort is a potent
corticosteroid (class II) qaccording to the European classification.
It acts on certain inflammatory
and allergic processes occurring in the course f atopic and/or contact
dermatitis and on pruriginous effects linked to these processes. It has a
vasoconstrictor (anti-exudative) activity adn ti inhibits cellular
replication and the synthesis processes in the dermis and epidermis.
Systemic absorption measured in
terms f the effect on blood cortisol levels occurs after cutaneous
application of Efficort
The extent of absorption and of
systemic effects depends on the area treated and the condition of the
epidermis, the duration of the treatment: the more the treatment is
prolonged, the greater the likelihood of these effects is, the site of
application, the use of occlusive dressings.
Preclinical safety data
In animal studies, hydrocortisone
aceponate was well tolerated on cutaneous application for periods of up to
six months in rats and rabbits. The major symptoms of toxicity found in all
animal species by systemic routes of administration were related to
adrenocorticosteroid effects, and included alterations of the
pituitary-adrenal axis, and a slight anemia. Principal organs of toxicity
were the stomach, liver, adrenal, pituitary, lungs and spleen. In the
cutaneous route studies hydrocortisone aceponate the majority of these
findings were either absent or considerably reduced in magnitude.
INDICATIONS AND USAGE
Efficort is recommended for
steroid-responsive dermatoses (eczema, atopic dermatitis, psoriasis,
Efficort Cream is recommended for
the treatment of acute exudative lesions.
Efficort Lipocream is recommended
for the treatment of dry squamous inflammatory lesions.
Hypersensitivity to any
ingredient of the preparation, ulcerated lesions, acne and rosacea and
conditions for which cutaneous corticosteroid therapy is contra-indicated,
notably skin infections of bacterial, viral, fungal and parasitic origin,
even when these include an inflammatory response.
Cutaneous application of potent
corticosteroids to large areas (30% of the body surface area or more) and/or
over long periods (more than 2 weeks) may lead to onset of the following
Hair follicle inflammation (folliculitis),
increased and intensified hair growth (hypertrichosis), skin bleaching (hypopigmentation),
so-called steroid-acne and telangiectasia linear skin lesions ( striae cutis
distensae, striae atrophicae) affecting notably the limbs (occurring more
usually in adolescents), cutaneous atrophy, post-atrophy ecchymoses and
Disruption of the
pituitary-adrenal axis on systemic uptake of the drug through the skin may
also occur, particularly upon occlusive treatment of large areas.
Corticosteroids may give rise to
perioral dermatitis or create or aggravate rosacea of the face, wound
healing may be impaired in the case of atonic wounds, sores, leg ulcers (see
Potential systemic effects: see
Special Warnings and precautions for use.
SPECIAL WARNINGS AND
PRECAUTIONS FOR USE
The prolonged use on the face of
high-potency corticosteroids can give rise to a corticosteroid-induced
dermatitis which is paradoxically corticosteroid-responsive. A rebound
effect is observed at each interruption of treatment. Progressive and
particularly difficult withdrawal is then require.
Due to the possibility of
absorption of corticosteroids into the general circulation, treatment of
large areas or under occlusion may give rise to the effects of systemic
corticosteroid therapy, particularly in the infant and small child. These
effects consist of Cushing syndrome and growth inhibition: these untoward
effects disappear upon interruption of treatment but abrupt withdrawal can
result in acute adrenal insufficiency. it is preferable to avoid use of
corticosteroids in the infant and particular attention must be given to the
likelihood of spontaneous occlusion. In the case of a bacterial or fungal
infection of a corticosteroid-responsive dermatosis, either a specific
antimicrobial treatment must precede the use of the corticosteroid or
possibly, and in only certain cases, a combination of cortico-steroid plus
specific treatment may be used.
If local intolerance occurs,
treatment must be interrupted and the cause investigated.
In the event of application to
the eyelid, the duration of treatment must be limited. Prolonged application
exposes the patient to the risk of ptosis or glaucoma and a rebound effect
can be observed.
Pregnancy and lactation
The use of Efficort during the
first 3 months of pregnancy should be avoided unless the benefit outweighs
any potential risks to the fetus.
It is not known whether this drug
is excreted in animal or human milk. Because many drugs are excreted in
human milk, caution should be exercised when Efficort is administered to
nursing mothers. In this event, the product should not be used on the chest.
Efficort is for cutaneous use
only. If the medication is applied excessively, no more rapid or better
results will be obtained and the undesirable effects described above may be
increased and intensified.
INTERACTION WITH OTHER
MEDICATIONS AND OTHER FORMS OF INTERACTION
Hydrolysis by alkaline agents: do
not use alkaline antiseptics prior to applying Efficort.
Incompatibility with oxidative
The concomitant use of other
adrenocorticosteroids in the form of tablets, drops or injections may
intensify the side effects.
DOSAGE AND METHOD OF
Unless otherwise prescribed,
Efficort should be applied once to twice daily in a thin layer over the
affected skin areas. For the application to be reasonable it is advisable to
dab a small amount of product on to several sites at the affected areas and
to gently massage in until it has been completely absorbed.
Application should be limited to
twice a day. An increase in the number of daily applications would be likely
to aggravate the side effects without improving the therapeutic efficacy of
Treatment of large areas or long
term therapy (3 weeks or more) require clinical monitoring. In any case the
duration of treatment prescribed by the physician must be strictly observed.
If required, an occlusive dressing could be prescribed by the physician.
In case of certain dermatological
conditions ( psoriasis, dermatitis, ...) a gradual withdrawal might be
desirable. this may be achieved by reducing the frequency of application
and/ or the use of a more dilute or less potent corticosteroid.
Infants and young children
Unless otherwise prescribed, one
daily application is generally adequate.
Continuous daily treatment should
be limited to a short period (about 1 week). If used for a longer duration,
periodical steroid-free breaks should be interposed.
Occlusive dressings should be
avoided in infants and young children.
Instructions for use /
Squeeze the tube gently at its
base to place a quantity of cream on the fingertips sufficient to cover the
area to be treated. Wash hands thoroughly and replace cap tightly after use.
EFFECTS ON THE ABILITY TO
DRIVE AND USE MACHINES
Based on the pharmacodynamic
profile and extensive clinical experience, performance related to driving
and using machines should not be affected.
This medicine should not be sued
after the expiry date (Exp. Date) shown on the pack.
Store at room temperature (not
exceeding 25°C). Keep out of reach of children.
Efficort Cream is packed in 15g
and 30g white polypropylene tubes fitted with white polypropylene screw
Efficort Lipocream is packaged in
15g and 30g collapsible aluminium tubes coated internally with an epoxy-phenolic
type resin and fitted with white poly propylene screw caps.