Hydrocortisone

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hydrocortisone 5mg;  

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

Hydrocortisone 5 mg

Dosage:

5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Hydrocortisone 5mg   Excipient: Lactose monohydrate Magnesium stearate Maize starch Povidone Purified talc

Units in package:

Bottle, plastic, 5mg x 100, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Yangzhou Pharmaceutical Factory

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

1992-02-21

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
HYDROCORTISONE
_hydrocortisone _
5 mg and 20 mg Tablets
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING HYDROCORTISONE.
This leaflet answers some common questions
about Hydrocortisone. 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 taking
Hydrocortisone 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 HYDROCORTISONE IS USED FOR
Hydrocortisone Tablets contains the active
ingredient hydrocortisone. It belongs to a group
of medicines called corticosteroids. These are
used to replace adrenal hormones you may be
lacking in your body.
Hydrocortisone is used in replacement therapy of
an inactive or underactive adrenal gland for
example: Addison’s disease.
Hydrocortisone is used to inhibit ACTH (hormone)
secretion when taken in conjunction with
aminoglutethimide for breast cancer and cancer
of the prostate.
Your doctor may have prescribed Hydrocortisone
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY HYDROCORTISONE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with a doctor's
prescription.
Hydrocortisone is not addictive.
BEFORE YOU TAKE HYDROCORTISONE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE HYDROCORTISONE IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing hydrocortisone
•
any of the ingredients listed at the end of
this leaflet.
Some of the symptoms of an allergic reaction
may include:
•
difficulty in breathing or wheezing
•
shortness of breath
•
swelling of the face, tongue, lips, or other
parts of the body
•
hives on the skin, rash, or itching.
DO NOT TAKE HYDROCORTISONE IF:
•
you have an infection
•
you have been vaccinated recently or are
going to have any live vaccinations.
DO NOT TA

Summary of Product characteristics

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Hydrocortisone 5 mg Tablets
Hydrocortisone 20 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Hydrocortisone 5 mg Tablet contains 5 mg of hydrocortisone.
Each Hydrocortisone 20 mg Tablet contains 20 mg of hydrocortisone.
EXCIPIENT(S) WITH KNOWN EFFECT
Hydrocortisone Tablets contain lactose monohydrate.
For the full list of excipients, _see Section 6.1._
3.
PHARMACEUTICAL FORM
Hydrocortisone 5 mg Tablet: white, round, biconvex tablet having a
diameter of 6.5 mm.
Hydrocortisone 20 mg Tablet: white, round, biconvex tablet having a
diameter of 7.94 mm,
breakline on one face and dp logo on the other.
The score line on Hydrocortisone 20 mg Tablet is only to facilitate
breaking for ease of
swallowing and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Replacement therapy in Addison’s disease or chronic adrenocortical
insufficiency
secondary to hypopituitarism.
•
Inhibition of the secondary increase in ACTH secretion when
aminoglutethimide is
administered for breast or prostatic cancer.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
_AS REPLACEMENT THERAPY _
The normal requirement is 10-30 mg daily (usually 20 mg in the morning
and 10 mg at night to
mimic the circadian rhythm of the body).
2 | P a g e
_AS COMBINATION THERAPY WITH AMINOGLUTETHIMIDE _
A dosage of 40 mg daily, given as 10 mg with breakfast, 10 mg with
dinner and 20 mg at bedtime
is usually recommended.
_SPECIAL POPULATIONS _
Elderly population
Steroids should be used cautiously in the elderly, since adverse
effects are enhanced in old age,
_see Section 4.4._
When long term treatment is to be discontinued, the dose should be
gradually reduced over a
period of weeks or months, depending on dosage and duration of
therapy, _see Section 4.4._
Undesirable effects may be minimised by using the lowest effective
dose for the minimum
period, and by administering the daily requirement as a single morning
dose, or whenever
possible, as a single morning dose on alter