METOPIRONE Capsules (2016)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Metopirone Capsules 250mg.
Qualitative and quantitative composition
Metyrapone BP 250mg.
Pharmaceutical form
Yellowish-white, oblong, opaque, soft gelatin capsules printed HRA on one side in red ink.
Therapeutic indications
A diagnostic aid in the differential diagnosis of ACTH-dependent Cushings syndrome. The management of patients with Cushings syndrome. In conjunction with glucocorticosteroids in the treatment of resistant ...
Posology and method of administration
Adults The capsules should be taken with milk or after a meal, to minimise nausea and vomiting, which can lead to impaired absorption. For use as a diagnostic aid: the patient must be hospitalised. Urinary ...
Contraindications
Primary adrenocorticol insufficiency. Hypersensitivity to Metopirone or to any of the excipients. Pregnancy.
Special warnings and precautions for use
In relation to use as a diagnostic aid: anticonvulsants (eg phenytoin, barbiturates), anti-depressants and neuroleptics (eg amitriptyline, chlorpromazine), hormones that affect the hypothalamo-pituitary ...
Interaction with other medicinal products and other forms of interaction
Anticonvulsants (e.g. phenytoin, barbiturates), psychotropic drugs (e.g. amitriptyline, chlorpromazine, alprazolam), hormone preparations, corticosteroids, antithyroid agents and cyproheptadine may affect ...
Fertility, pregnancy and lactation
Pregnancy Unless the potential benefit outweighs the risk to the foetus Metopirone should not be given to pregnant women, since the drug can impair the biosynthesis of foetalplacental steroids. Animal ...
Effects on ability to drive and use machines
Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness and sedation.
Undesirable effects
Adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); ...
Overdose
Signs and symptoms The clinical picture of acute Metopirone poisoning is characterised by gastrointestinal symptoms and acute adrenocortical insufficiency. Laboratory findings: hyponatraemia, hypochloraemia, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Diagnostic agent, test for pituitary function ATC code: V04CD01 Metopirone inhibits the enzyme responsible for the 11β-hydroxylation stage in the biosynthesis of cortisol and ...
Pharmacokinetic properties
Metyrapone is rapidly absorbed and eliminated from the plasma. Peak plasma levels usually occur one hour after ingestion of Metopirone; after a dose of 750mg Metopirone, plasma drug levels average 3.7μg/ml. ...
Preclinical safety data
Pre-clinical data for Metopirone (metyrapone) reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity. Metopirone was not mutagenic with or without metabolic ...
List of excipients
Capsule contents: Glycerin Polyethylene glycol 400 Polyethylene glycol 4000 Water Capsule shell: Sodium ethylparaben Ethyl vanillin Gelatin Glycerin 85% P-methoxy acetophenone Sodium propylparaben Titanium ...
Incompatibilities
None stated.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Protect from moisture and heat. Store below 30°C.
Nature and contents of container
High density polyethylene bottles of 100 capsules with child resistant polypropylene closure.
Special precautions for disposal and other handling
None stated.
Marketing authorization holder
Laboratoire HRA Pharma, 15 rue Béranger, 75003, Paris, France
Marketing authorization number(s)
PL 17836/0007
Date of first authorization / renewal of the authorization
25 June 1998
Date of revision of the text
16/12/2016
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
