DIPROSONE OV betamethasone 0.5 mg/g (as dipropionate) ointment tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

betamethasone dipropionate, Quantity: 0.64 mg/g (Equivalent: betamethasone, Qty 0.5 mg/g)

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

Betamethasone dipropionate

Pharmaceutical form:

Ointment

Composition:

Excipient Ingredients: white soft paraffin; propylene glycol; propylene glycol monostearate; white beeswax

Administration route:

Topical

Units in package:

30g, 30g(E), 5g(sample)

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

For the relief of the inflammatory and pruritic manifestations of resistant or severe corticosteroid responsive dermatoses. These include atopic eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus and psoriasis. DIPROSONE OV Ointment is also indicated for the maintenance of remission in chronic psoriasis.

Product summary:

Visual Identification: A smooth, uniform, white pearlescent ointment free from foreign matter; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-08

Patient Information leaflet

DIPROSONE
® OV
_(OPTIMISED VEHICLE)_
_Betamethasone dipropionate 0.05%_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DIPROSONE OV
Cream and Ointment.
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 DIPROSONE
OV against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DIPROSONE OV
IS USED FOR
DIPROSONE OV contains the active
ingredient betamethasone
dipropionate.
Betamethasone dipropionate is a very
strong corticosteroid used to decrease
inflammation, redness, itchiness and
discomfort of some skin conditions.
DIPROSONE OV Cream and
Ointment are used to treat persistent
or severe:
•
dermatitis
•
eczema (an often itchy skin
condition with redness, swelling,
oozing of fluid, crusting which
may lead to scaling)
•
acute or chronic psoriasis (a
stubborn skin disorder with
raised, rough, reddened areas
covered with dry, fine silvery
scales)
Your doctor may have prescribed
DIPROSONE OV for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DIPROSONE
OV HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
DIPROSONE OV
_WHEN YOU MUST NOT USE IT_
DO NOT USE DIPROSONE OV IF YOU
HAVE HAD AN ALLERGIC REACTION TO:
•
other medicines containing
betamethasone dipropionate
•
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 DIPROSONE OV IF YOU
HAVE:
•
a viral infection (such as cold
sores, shingles or chicken pox)
•
a fungal infection (such as thrush,
ringworm or tinea)
•
tuberculosis of the skin
•
acne rosacea
•
inflammation around the mouth
•
skin con

Summary of Product characteristics

Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION
DIPROSONE
® OV (OPTIMISED VEHICLE)
(BETAMETHASONE DIPROPIONATE)
CREAM AND OINTMENT
1
NAME OF THE MEDICINE
Betamethasone dipropionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIPROSONE OV Cream (0.05%): Each g contains 0.64 mg betamethasone
dipropionate,
equivalent to betamethasone 0.5 mg.
DIPROSONE OV Ointment (0.05%): Each g contains 0.64 mg betamethasone
dipropionate,
equivalent to betamethasone 0.5 mg.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DIPROSONE
®
OV 0.5 mg/g is supplied as cream and ointment.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DIPROSONE OV Cream and Ointment are indicated for the relief of the
inflammatory and
pruritic manifestations of resistant or severe
corticosteroid-responsive dermatoses. These
include atopic eczema, nummular eczema, contact dermatitis,
neurodermatitis, anogenital and
senile pruritus, lichen planus and psoriasis.
DIPROSONE OV Ointment is also indicated for the maintenance of
remission in chronic
psoriasis.
4.2
DOSE AND METHOD OF ADMINISTRATION
DIPROSONE OV Cream and Ointment: Apply a thin film to cover completely
the affected area
once or twice daily.
Patients with chronic psoriasis who have achieved at least a marked
improvement in their
psoriatic lesion(s) (i.e., approximately ≥80% improvement) with
DIPROSONE OV Ointment
may be maintained in remission with a pulse dosing regimen consisting
of three consecutive
applications of up to 3.5 g each of DIPROSONE OV Ointment, twelve
hours apart (e.g.,
morning, evening, following morning) to the previously affected areas
once each week. For
this purpose, the DIPROSONE OV Ointment should be applied to the
lesion sites previously
affected and treated.
Patients on this pulse dose regimen who relapse should be reverted
back to the conventional
dosing regimen.
4.3
CONTRAINDICATIONS
Hypersensitivity
to
betamethasone
dipropionate,
other
corticosteroids
or
any
of
the
components in DIPROSONE OV. Like other topical corticosteroids,
DI