ANTROQUORIL betamethasone 0.2mg/g (as valerate) cream tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

betamethasone valerate, Quantity: 0.244 mg/g (Equivalent: betamethasone, Qty 0.2 mg/g)

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

Betamethasone valerate

Pharmaceutical form:

Cream

Composition:

Excipient Ingredients: liquid paraffin; purified water; chlorocresol; cetostearyl alcohol; phosphoric acid; monobasic sodium phosphate dihydrate; cetomacrogol 1000; sodium hydroxide; white soft paraffin

Administration route:

Topical

Units in package:

100g, 5g (sample)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Antroquoril is indicated for maintenance therapy for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as atopic eczema, infantile eczema, nummular eczema, anogenital and senile pruritis, contact dermatitis, seborrhoeic dermatitis, neurodermatitis, solar dermatitis, statis dermatitis and psoriasis. INDICATIONS AS AT 16 August 1999: Antroquoril is indicated for maintenance therapy for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as atopic eczema, infantile eczema, nummular eczema, anogenital and senile pruritus, contact dermatitis, seborrhoeic dermatitis, neurodermatitis, solar dermatitis, stasis dermatitis and psoriasis

Product summary:

Visual Identification: White cream; Container Type: Tube; Container Material: Al; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1999-08-24

Patient Information leaflet

ANTROQUORIL
®
_Betamethasone valerate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Antroquoril.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Antroquoril
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ANTROQUORIL IS
USED FOR
Antroquoril contains the active
ingredient called betamethasone
valerate.
It is a type of cortisone and belongs
to the group of medicines called
corticosteroids. Antroquoril is
classified as a moderately strong
topical corticosteroid.
Antroquoril is used on the skin to
relieve the redness, swelling, itching
and discomfort of many skin
problems such as:
•
Psoriasis (a stubborn skin
disorder with raised, rough
reddened areas covered with dry,
fine silvery scales)
•
Eczema (an often itchy skin
condition with redness, swelling,
oozing of fluid, crusting which
may lead to scaling)
•
other types of dermatitis
Your doctor may have prescribed
Antroquoril for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ANTROQUORIL
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
ANTROQUORIL
_WHEN YOU MUST NOT USE IT_
DO NOT USE ANTROQUORIL IF YOU HAVE
AN ALLERGY TO:
* OTHER MEDICINES CONTAINING
BETAMETHASONE VALERATE
* ANY OTHER CORTICOSTEROID(S)
* ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
SOME SYMPTOMS OF AN ALLERGIC
REACTION INCLUDE WHEEZING, SKIN
RASH AND HIVES.
DO NOT USE ANTROQUORIL IF YOU
HAVE:
•
A VIRAL SKIN INFECTION (SUCH AS
COLD SORES, SHINGLES OR CHICKEN
POX)
•
A FUNGAL SKIN INFECTION (SUCH AS
THRUSH, TINEA OR RINGWORM)
•
TUBERCULOSIS OF THE SKIN
•
ACNE ROSACEA
•
INFLAMMATION AROUND THE
MOUTH
•
SKIN CONDITIONS WITH ULCERS
UNL

Summary of Product characteristics

S-CCDS-MK1745-MTL-082017
AUSTRALIAN PRODUCT INFORMATION –
ANTROQUORIL
® (BETAMETHASONE VALERATE) CREAM
1
NAME OF THE MEDICINE
Betamethasone valerate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Antroquoril Cream contains betamethasone valerate equivalent to
betamethasone 0.2mg/g.
EXCIPIENTS WITH KNOWN EFFECT
Antroquoril Cream contains cetostearyl alcohol and chlorocresol.
For the full list of
excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antroquoril is indicated for maintenance therapy for the relief of the
inflammatory and pruritic
manifestations of corticosteroid-responsive dermatoses such as atopic
eczema, infantile
eczema, nummular eczema, anogenital and senile pruritus, contact
dermatitis, seborrhoeic
dermatitis, neurodermatitis, solar dermatitis, stasis dermatitis and
psoriasis.
4.2 DOSE AND METHOD OF ADMINISTRATION
Apply a small amount to the affected area two or three times daily.
Refractory lesions of psoriasis and other deep seated dermatoses, such
as chronic lichen
simplex, hypertrophic lichen planus, atopic dermatitis, chronic
eczematous and lichenified hand
eruptions, recalcitrant pustular eruptions of the palms and soles,
respond better if occlusive
dressings are used.
OCCLUSIVE DRESSINGS
Apply a layer of medication over the entire lesion under a light gauze
dressing, cover with a
pliable transparent, impermeable plastic material well beyond the
edges of the treated area.
Seal the edges to normal skin by adhesive tape or other means. Leave
the dressing in place for
1 to 3 days and repeat the procedure three or four times as needed.
Occasionally, a miliary
eruption or folliculitis develops in the skin beneath the dressing and
should be treated by
removing the plastic covering and applying a topical antibiotic.
4.3 CONTRAINDICATIONS
Hypersensitivity to betamethasone valerate, other corticosteroids or
any components in
Antroquoril. Like other topical corticosteriods, Antroquoril is
contraindicated in most viral
infections