METOPIRONE 250

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

METYRAPONE

متاح من:

CTS LTD

ATC رمز:

V04CD01

الشكل الصيدلاني:

CAPSULES

تركيب:

METYRAPONE 250 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

HRA PHARMA RARE DISEASES, FRANCE

المجموعة العلاجية:

METYRAPONE

المجال العلاجي:

METYRAPONE

الخصائص العلاجية:

Diagnostic test for ACTH insufficiency and in the differential diagnosis of ACTH dependant Cushing’s Syndrome. For the Management of patient with endogenous Cushing’s syndrome.

تاريخ الترخيص:

2020-06-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
METOPIRONE 250, CAPSULES
Each capsule contains: Metyrapone 250 mg
Inactive and allergenic ingredients in the preparation - see Section 2
“Important
information about some of the ingredients of the medicine” and
Section 6 “Further
information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Metopirone 250 acts as a diagnostic preparation that is intended to
identify whether
you suffer from inadequate production of the hormone ACTH (a hormone
secreted by
the pituitary gland and which is responsible for cortisol secretion),
or as a diagnostic
preparation that is intended to help diagnose a specific type of
Cushing’s syndrome.
Cushing’s syndrome is a set of symptoms resulting from elevated
levels of the
cortisol hormone (a hormone produced by the adrenal gland).
Metopirone 250 is also used for treating signs and symptoms of
endogenous
Cushing’s syndrome by lowering elevated levels of cortisol.
THERAPEUTIC GROUP: Metyrapone belongs to the group of endocrine
medicines which
are also known as diagnostic preparations used to assess pituitary
gland function.
2. BEFORE USING THE MEDICINE
X
DO NOT TAKE THE MEDICINE IF:
!
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TAKING METOPIRONE 250 AS A DIAGNOSTIC PREPARATION, INFORM THE
DOCTOR IF:
•
You have, or think you may have, a condition in which your hormone
levels
are low (e.g., reduced adrenal gland production of cortisol or severe
hypopituitarism). Your doctor will perform a test to make sure the
medicine is
right for you.
•
You are sensitive (allergic) to

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metopirone 250
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metyrapone 250mg
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
Yellowish-white, oblong, opaque, soft gelatin capsules printed
‘HRA’ on one side in red ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As a diagnostic test for ACTH insufficiency and in the differential
diagnostic 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 250. The
patient is given 30 mg/kg
(maximum 3 g Metopirone 250) at midnight with yoghurt or milk to
minimize 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 measure.
(ii)
Multiple-dose test – diagnosis of ACTH insufficiency and
differential diagnosis of
adrenocortical hyperfunction in Cushing’s syndrome.
The patient must be hospitalised. In this test, urinary steroid levels
are measured. The first da