REDIPRED prednisolone 25mg/5mL (as sodium phosphate) oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prednisolone sodium phosphate, Quantity: 6.72 mg/mL (Equivalent: prednisolone, Qty 5 mg/mL)

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: disodium edetate; dibasic sodium phosphate; propyl hydroxybenzoate; sorbitol solution (70 per cent) (non-crystallising); methyl hydroxybenzoate; purified water; monobasic sodium phosphate; Flavour

Administration route:

Oral

Units in package:

100ml, 30ml

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Wherever corticosteroid therapy is indicated.

Product summary:

Visual Identification: Clear, colourless to slightly yellow, raspberry flavoured solution; Container Type: Bottle; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-03-11

Patient Information leaflet

REDIPRED - Consumer Medicine Information
Page 1 of 5
REDIPRED
_prednisolone sodium phosphate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about REDIPRED. It does
not contain all the information that is
known about this medicine. 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 taking REDIPRED
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 REDIPRED IS
USED FOR
REDIPRED is used in the treatment
of many different conditions. Some
of these conditions include: severe
allergies, severe or chronic asthma,
skin problems, arthritis,
inflammatory diseases of the bowel,
cancer and "auto-immune" diseases.
REDIPRED is also used to prevent or
reduce the symptoms of
inflammation (such as swelling,
redness, pain, tenderness or itching)
in any part of the body. These
symptoms can occur in response to
injury or can be caused by many
different conditions.
It works by entering inflammatory
cells and blocking the inflammatory
reaction. REDIPRED is only able to
prevent or reduce symptoms of your
condition, it does not cure it.
REDIPRED belongs to a group of
medicines called corticosteroids. It is
a synthetic version of a naturally
occurring body hormone called
cortisol. This hormone is made by
the adrenal glands which lie just
above your kidneys.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY REDIPRED
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
REDIPRED is only available with a
doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE REDIPRED IF YOU
HAVE EVER HAD AN ALLERGIC REACTION
TO:

prednisolone or prednisone

any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic rea

Summary of Product characteristics

REDIPRED – product information
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
REDIPRED
(PREDNISOLONE SODIUM PHOSPHATE)
ORAL LIQUID
1
NAME OF THE MEDICINE
Prednisolone sodium phosphate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
REDIPRED contains the active prednisolone sodium phosphate 6.72 mg/1
mL which is
equivalent to prednisolone 5 mg/1 mL.
It contains excipients with known effect, sorbitol solution (70%)
non-crystallising, methyl
hydroxybenzoate and propyl hydroxybenzoate. For the full list of
excipients, see Section 6.1
List of excipients.
3
PHARMACEUTICAL FORM
REDIPRED is a raspberry flavoured, clear, colourless to slightly
yellow solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Wherever corticosteroid therapy is indicated.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The severity, prognosis, expected duration of the disease, and the
patient's reaction to
medication are primary factors in determining dosage.
ADULTS:
The initial adult dosage may range from 20 to 40 mg daily, but can be
60 to 80 mg daily if
necessary, depending on the disease being treated.
Maintenance dosage: Usually 5 to 20 mg daily.
In long term therapy the ideal dosage should not be greater than 40 mg
per day so as to
minimise side-effects. It is usually administered in 2-4 divided doses
or as a single daily
dose after breakfast or on alternate days.
Alternate-Day Therapy
Alternate-day therapy is the dosage regimen of choice for long-term
oral glucocorticoid
treatment of most conditions. In alternate-day therapy, a single dose
is administered every
other morning. This regimen provides relief of symptoms while
minimizing adrenal
suppression, protein catabolism, and other adverse effects. However,
some patients may
require daily glucocorticoid therapy because symptoms of the
underlying disease cannot be
controlled by alternate-day therapy.
REDIPRED – product information
Page 2 of 11
ELDERLY:
As for adults - though the dose should be the minimum necessary to
achieve the desired
therapeutic effect.
CHILDREN:
Initial dosage: 0.5 mg/kg