Metopirone 250mg Capsules, soft

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

METYRAPONE

Saadav alates:

Laboratoire HRA Pharma

ATC kood:

V04CD; V04CD01

INN (Rahvusvaheline Nimetus):

METYRAPONE

Annus:

250 milligram(s)

Ravimvorm:

Capsule, soft

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Tests for pituitary function; metyrapone

Volitamisolek:

Marketed

Loa andmise kuupäev:

2012-02-03

Infovoldik

PACKAGE LEAFLET
Page 1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METOPIRONE 250 MG, SOFT CAPSULES
metyrapone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Metopirone is and what it is used for
2.
What you need to know before you take Metopirone
3.
How to take Metopirone
4.
Possible side effects
5.
How to store Metopirone
6.
Contents of the pack and other information
1.
WHAT METOPIRONE IS AND WHAT IT IS USED FOR
Metopirone contains 250 mg of metyrapone. Metyrapone belongs to a
group of medicines known as tests
for pituitary function evaluation. Metyrapone is used as a diagnostic
test to identify if you have an
insufficient level of ACTH, a hormone secreted by the pituitary gland
which controls cortisol secretion;
or Metyrapone may be used to help diagnose a specific type of
Cushing’s syndrome.
The medicine can also be used to treat the signs and symptoms of
endogenous Cushing’s syndrome by
lowering the elevated levels of cortisol (a hormone produced by the
adrenal glands). Cushing’s syndrome
is
a set of symptoms resulting from high levels of the hormone cortisol
produced in your body by the
adrenals.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METOPIRONE
DO NOT TAKE METOPIRONE AS A DIAGNOSTIC TEST FOR ACTH INSUFFICIENCY:
-
If you suffer from a condition whereby your adrenal glands do not
produce enough steroid
hormones, cortisol or aldosterone, known as Addison’s disease.
DO NOT TAKE METOPIRONE:
-
if you are allergic to metyrapone or any of the other ingredients of
this medicine listed in section

Toote omadused

Health Products Regulatory Authority
31 October 2019
CRN009FG3
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metopirone 250mg Capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Metopirone Capsule contains 250 mg metyrapone.
Excipients with known effect:
Each capsule contains 0.71 mg of sodium ethyl parahydroxybenzoate and
0.35 mg sodium propyl parahydroxybenzoate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Soft capsule.
White to yellowish-white, oblong, opaque, soft gelatin capsule
imprinted in red ink with ''HRA'' on one side and having faintly
yellowish viscous to jelly-like contents.
Capsule size: length 18.5 mm, diameter 7.5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a diagnostic test for ACTH insufficiency and in the differential
diagnosis of ACTH-dependent Cushing’s syndrome.
For the management of patients with endogenous Cushing’s syndrome
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
DIAGNOSTIC APPLICATIONS
(i) Short single-dose test – diagnosis of ACTH insufficiency
This can be performed on an ambulatory basis. In this test, plasma 11-
desoxycortisol and/or ACTH levels are determined after
a single dose of Metopirone. The patient is given 30 mg/kg (maximum 3
g Metopirone) at midnight with yoghurt or milk to
minimise nausea and vomiting.
_Paediatric population:_
The same dose as in adults is recommended in children.
The blood sample for the assay is taken early in the morning (7:30 –
8:00 hours). The plasma should be frozen as soon as
possible. The patient is then given a prophylactic dose of 50 mg
cortisone acetate.
Evaluation:
Normal values will depend on the method used to determine ACTH and
11-desoxycortisol levels. An intact ACTH reserve is
generally indicated by an increase in plasma ACTH to at least 44
pmol/L (200 ng/L) or by an increase in 11-desoxycortisol to
over 0.2 micromol/L (70 microg/L). Patients with suspected
adrenocortical insufficiency should be hospitalised overnight as a
precautionary