HYDROCORTISONE VIATRIS 4 hydrocortisone 4 mg tablet bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

hydrocortisone, Quantity: 4 mg

Tilgjengelig fra:

Alphapharm Pty Ltd

INN (International Name):

Hydrocortisone

Legemiddelform:

Tablet, uncoated

Sammensetning:

Excipient Ingredients: maize starch; magnesium stearate; lactose monohydrate; povidone

Administreringsrute:

Oral

Enheter i pakken:

50, bulk tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

INDICATIONS AS AT 6 May 1992: Hydrocortisone is indicated for replacement therapy in Addison's disease or chronic adrenocortical insufficiency secondary to hypopituitarism.

Produkt oppsummering:

Visual Identification: Round, biconvex, white tablet marked "H/4" on one side, "G" on reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2017-09-21

Informasjon til brukeren

HYDROCORTISONE VIATRIS 4;
HYDROCORTISONE VIATRIS 20
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING HYDROCORTISONE VIATRIS?
HYDROCORTISONE VIATRIS contains the active ingredient hydrocortisone.
HYDROCORTISONE VIATRIS is used to replace
the hydrocortisone in patients whose adrenal glands do not produce
enough naturally. This occurs in conditions such as Addison's
disease or when the adrenal glands are damaged or not working
properly.
For more information, see Section 1. Why am I using HYDROCORTISONE
VIATRIS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE HYDROCORTISONE VIATRIS?
Do not use if you have ever had an allergic reaction to hydrocortisone
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
HYDROCORTISONE VIATRIS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with HYDROCORTISONE VIATRIS and affect
how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE HYDROCORTISONE VIATRIS?
•
The dose varies from patient to patient. Your doctor will tell you how
many tablets you need to take each day and when to take
them. This depends on your condition and whether or not you are taking
any other medicines.
•
Swallow the tablets with a glass of milk, or take HYDROCORTISONE
VIATRIS with food.
More instructions can be found in Section 4. How do I use
HYDROCORTISONE VIATRIS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING HYDROCORTISONE VIATRIS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
HYDROCORTISONE VIATRIS
•
If you become pregnant while takin

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
HYDROCORTISONE VIATRIS 4
HYDROCORTISONE VIATRIS 20
_Hydrocortisone tablets _
1
NAME OF THE MEDICINE
Hydrocortisone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone, also known as cortisol, is a white or almost white,
odourless crystalline powder. It is practically
insoluble in water; sparingly soluble in ethanol (96%) and in acetone;
slightly soluble in chloroform; very slightly
soluble in ether. It melts at about 214

C, with decomposition.
Each HYDROCORTISONE VIATRIS 4 tablet contains 4 mg of hydrocortisone.
Each HYDROCORTISONE VIATRIS 20 tablet contains 20 mg of
hydrocortisone.
Excipients with known effect: sulfites and sugars as lactose
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
HYDROCORTISONE VIATRIS 4 mg tablet: white, scored, marked H/4 on one
side, G on reverse
HYDROCORTISONE VIATRIS 20 mg tablet: white, scored, marked H/20 on one
side, G on reverse
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hydrocortisone is indicated for replacement therapy in Addison's
disease or chronic adrenocortical insufficiency
secondary to hypopituitarism.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage requirements are variable and must be individualised on the
basis of the disease and the response of the
patient.
A typical dose in adults is hydrocortisone 30 mg daily in divided
doses. Dosage may be increased if clinically
necessary. Patients should be advised to take their hydrocortisone
replacement therapy with meals or a glass of
milk or antacid because the drug may increase gastric acidity.
Approximately 2/3 of the dose should be taken in
the morning and 1/3 at about 4pm. Some individuals may exhibit
irritability or insomnia after initiation of
therapy; in these the dosage should be reduced. Smaller doses may also
be necessary in patients with
hypertension, diabetes mellitus, or active tuberculosis.
Supplementary administration of fludrocortisone, 0.05 to 0.1 mg daily
by mouth, is required to replace
mineralocorticoid deficiency.