PREDSOLONE SYRUP

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

PREDNISOLONE

Saadav alates:

DYNAPHARM (M) SDN BHD

INN (Rahvusvaheline Nimetus):

PREDNISOLONE

Ühikuid pakis:

100 ml; 60 ml

Valmistatud:

DYNAPHARM (M) SDN BHD

Infovoldik

Consumer Medication Information Leaflet (RiMUP)
PREDSOLONE SYRUP
Prednisolone (2.5 mg / 5ml)
1
What is in this leaflet
1.
What Predsolone Syrup is used for
2.
How Predsolone Syrup works
3.
Before you use Predsolone Syrup
4.
How to use Predsolone Syrup
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Predsolone
Syrup
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
What Predsolone Syrup is used for
Predsolone Syrup is used for conditions
that are responsive to this type of steroid
therapy such as asthma, skin reactions
and inflammatory bowel disease.
How Predsolone Syrup works
Prednisolone has anti-inflammatory
action, anti-allergic, anti-shock (sudden
drop of blood flow) and act to suppress
or prevent the immune response.
Before you use Predsolone Syrup
- When you must not use it
Do not use Predsolone Syrup if you
have:
- Fragile bones
- Active ulcer or mental disorder
- Infections unless effective with
specific concurrent medicines
- Undergoing immunisations.
Pregnancy and lactation
Do not take Predsolone Syrup if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Predsolone Syrup if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
Some medicines may increase the
effects of Predsolone Syrup and your
doctor may wish to monitor you
carefully if you are taking these
medicines (including some medicines
for HIV such as cobicistat)
- Before you start use it
Tell your doctor or pharmacist if you
have:
- Diabetes
- Stomach or intestinal ulcer
- Heart disease
- High blood pressure
- High lipid (fats) content in blood
- Underactive thyroid gland
- Muscle weakness
- Kidney function impairment or stones
- Pheochromocytoma (a tumour of the
adrenal gland)
Talk to your doctor before taking
Predsolone Syrup, if you have:
Systemic sclerosis (an autoimmune
disorder). Taking daily doses of 15mg or
more may increase the risk of a serious
complication called scleroderma renal
crisis which may cau

Toote omadused

PREDSOLONE SYRUP
MAL19910171AZ
DESCRIPTION:
SYRUP
Colour
:
Red
Flavour
:
Apricot
CONTENT:
Each 5 ml contains:
Prednisolone .........................................................
2.5 mg
Preservatives: Methyl Paraben 0.1% w/v, Propyl Paraben 0.01% w/v &
Sodium Benzoate 0.1% w/v
PHARMACODYNAMICS:
Prednisolone is a synthetic adrenocorticoid hormone. It has
anti-inflammatory action, a weaker sodium-retaining effect than
cortisone in normal dosage, anti-allergic, antishock and
immunosuppressant action. At cellular level, it diffuses across cell
membranes and complexes then enter the cell nucleus, bind to DNA and
stimulate transcription of mRNA and subsequent protein
synthesis of various enzymes thought to be responsible for the
glucocorticoid effects and mineralocorticoid effects.
PHARMACOKINETICS:
Prednisolone is absorbed after oral administration. The biological
half-life is about 3 hours. About 50 % is bound to plasma proteins.
It is metabolised by reduction to 20-dihydroprednisolone,
20-dihydroprednisone and hydrocortisone and conjugation occur to some
extent. About 10 to 30 % of a dose is excreted in the urine as
unchanged prednisolone and the remainder as metabolites, 60 to 80 %
of which is conjugated; a dose is completely excreted in 3 days.
Prednisolone is excreted in milk in insignificant amounts.
INDICATION:
Corticosteroid indicated conditions include allergic disorders such as
bronchial asthma & allergic skin reactions; blood disorders;
selected collagen & rheumatic disorders; connective tissue disorders;
gastrointestinal disorders such as inflammatory bowel disease,
and also disorders responsive to adrenocortical hormone therapy.
RECOMMENDED DOSE:
Adults
:
5 - 60 mg daily in 2 - 4 divided doses depending on the disease being
treated.
Children :
0.14 - 2 mg/kg body weight in 4 divided doses or 4 - 6 mg/meter square
daily in 4 divided doses.
ROUTE OF ADMINISTRATION:
FOR ORAL USE ONLY
CONTRAINDICATIONS:
Osteoporosis; active ulcer, psychoses or severe psychoneuroses.
Systematic fungal infections. Acute infec