METOPIRONE 250 metyrapone 250mg capsule bottle

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

metyrapone, Quantity: 250 mg

Commercializzato da:

Chiesi Australia Pty Ltd

Forma farmaceutica:

Capsule, soft

Composizione:

Excipient Ingredients: macrogol 400; sodium ethyl hydroxybenzoate; sodium propyl hydroxybenzoate; macrogol 4000; glycerol; Gelatin; purified water; acetanisole; ethyl vanillin; titanium dioxide; propylene glycol; hypromellose; isopropyl alcohol; aluminium chloride; sodium hydroxide; cochineal

Via di somministrazione:

Oral

Confezione:

50

Classe:

Medicine Registered

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Diagnostic use,? For the diagnosis of latent ACTH deficiency such as in cases of known pituitary dysfunction or of a suspected pituitary tumour, as well as before and after surgical intervention in the region of the pituitary; and, to assess the degree of ACTH suppression during or after glucocorticoid therapy.,? For the differential diagnosis of states of adrenocortical hyperfunction in Cushing's Syndrome.

Dettagli prodotto:

Visual Identification: white to yellowish white oblong opaque soft gelatin capsule marked HRA on one side in red ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

1991-08-02

Foglio illustrativo

METOPIRONE
®
VER 1.0 JUNE 2021
1
METOPIRONE
®
_metyrapone _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Metopirone.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. Some more recent
information on the medicine may be
available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Metopirone
against the benefits they expect it
will give you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT METOPIRONE IS
USED FOR
Metopirone belongs to a group of
medicines called diagnostic agents. It
acts by reducing the production of
the adrenal gland hormones: cortisol
and corticosterone (which are also
called corticosteroids).
Metopirone is used as a test to find
out if ACTH (Adrenocorticotropic
hormone, a natural body hormone
acting on corticosteroid secretion), is
being produced properly.
Changes in the production of ACTH
may happen for a number of reasons,
for example, due to changes in the
function of the adrenal or pituitary
gland, or due to treatment with
certain medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT HOW METOPIRONE
WORKS OR WHY THE METOPIRONE TEST
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription. It is not
addictive.
BEFORE YOU TAKE
METOPIRONE
_WHEN YOU MUST NOT TAKE IT _
IF ANY OF THE FOLLOWING APPLY TO
YOU, TELL YOUR DOCTOR WITHOUT
TAKING METOPIRONE.
DO NOT TAKE METOPIRONE IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO
METYRAPONE (THE ACTIVE INGREDIENT)
OR TO ANY OF THE OTHER INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Some of the symptoms

Scheda tecnica

METOPIRONE PI v1.0
1
AUSTRALIAN PRODUCT INFORMATION –
METOPIRONE
® (METYRAPONE) SOFT CAPSULE
1.
NAME OF THE MEDICINE
Metyrapone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metopirone is supplied as soft gelatin capsules each containing 250 mg
of metyrapone.
Excipients with known effects: Sodium ethyl hydroxybenzoate, sodium
propyl hydroxybenzoate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Metopirone capsules 250 mg are white to yellowish white oblong soft
gelatin capsules marked HRA on one
side in red ink.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_DIAGNOSTIC USE _
•
For the diagnosis of latent ACTH deficiency such as in cases of known
pituitary dysfunction
or of a suspected pituitary tumour, as well as before and after
surgical intervention in the
region of the pituitary; and, to assess the degree of ACTH suppression
during or after
glucocorticoid therapy.
•
For
the
differential
diagnosis
of
states
of
adrenocortical
hyperfunction
in
Cushing's
Syndrome.
4.2 DOSE AND METHOD OF ADMINISTRATION
_DIAGNOSTIC AGENT _
SHORT SINGLE DOSE TEST (WHICH CAN BE CARRIED OUT IN AMBULANT PATIENTS)
FOR THE DIAGNOSIS OF LATENT
ACTH DEFICIENCY:
In the short single-dose test, 11-desoxycortisol (Compound S) and/or
ACTH are determined in the plasma
following a single dose of Metopirone. At around midnight, the patient
is given 1 to 2 g of Metopirone (30
mg/kg - adults or children) together with yogurt or milk. Eight hours
later, a sample of whole venous blood is
taken, centrifuged at 4°C and the plasma deep frozen at -20°C,
immediately. Afterwards a prophylactic dose
of 50 mg cortisone acetate should be administered.
_Assessment: _
The accepted normal values employed will depend on the method used for
assaying ACTH and 11-
desoxycortisol and may vary in different laboratories. A rise in
plasma ACTH to at least 44 pmol/litre (200
ng/litre), or in 11-desoxycortisol to over 0.2 µmol/litre (70
µg/litre), usually indicates a normal ACTH reserve.
Patients in whom adrenocort