ANDROCUR Tablet / Solution for injection (2021)

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

Περιεχόμενα

Name of the medicinal product

ANDROCUR. Cyproterone acetate tablets 50 mg. Cyproterone acetate injection 100 mg/mL. Antiandrogen.

Indications and clinical use

ANDROCUR (cyproterone acetate) is indicated for: the palliative treatment of patients with advanced prostatic carcinoma.

Contraindications

Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...

Warnings and precautions

General Concomitant Alcohol Alcohol may reduce the antiandrogenic effect of ANDROCUR in hypersexuality. The relevance of this in prostatic carcinoma is not known; however, it would be prudent to inform ...

Adverse reactions

8.1 Adverse Reaction Overview The adverse events associated most frequently with the use of ANDROCUR are those related to the hormonal effects of the drug. These reactions usually disappear upon discontinuation ...

Drug interactions

9.2 Drug Interactions Overview Although clinical interaction studies have not been performed, since this drug is metabolized by CYP3A4, it is expected that ketoconazole, itraconazole, clotrimazole, ritonavir, ...

Dosage and administration

4.1 Dosing Considerations Patients with Hepatic Impairment The use of ANDROCUR is contraindicated in patients with liver diseases and/or with hepatic dysfunction. Patients with Renal Impairment A pharmacokinetic ...

Overdosage

There have been no reports of fatal overdosage in man with ANDROCUR (cyproterone acetate). There are no specific antidotes and treatment should be symptomatic. If oral overdosage is discovered within two ...

Action and clinical pharmacology

10.1 Mechanism of Action ANDROCUR (cyproterone acetate) is a steroid which clinically demonstrates two distinct properties: a) Antiandrogenic: Cyproterone acetate blocks the binding of dihydrotestosterone ...

Storage and stability

This information is not available for this drug product.

Special handling instructions

There are no special handling requirements for this product.

Dosage forms, composition and packaging

Table 1. Dosage forms, Strengths, Compositions and Packaging: Route of Administration Dosage Form/ Strength/ Composition Non-medicinal ingredients Oral Tablet, 50 mg Colloidal anhydrous silica, ...

Pharmaceutical information

Drug Substance Proper name: Cyproterone acetate Chemical name: 6-chloro-17α-hydroxy-1α, 2α-methylene-pregna4, 6-diene-3, 20-dione-acetate Molecular formula and molecular mass: C24H29 ...

Detailed pharmacology

A total of 24 studies have been conducted with ANDROCUR (cyproterone acetate) in patients requiring palliative treatment for advanced prostatic carcinoma. Worldwide, more than 1,000 patients have participated ...

Microbiology

No microbiological information is required for this drug product.

Toxicology

General Toxicology ANDROCUR (cyproterone acetate) has been found at low doses of 2 to 10 mg/kg to cause liver abnormalities in dogs and rats in the form of proliferative liver changes including increased ...

Marketing authorization holder

Bayer Inc., 2920 Matheson Blvd East, Mississauga, Ontario, L4W 5R6 www.bayer.ca

Submission control number

245903

Date of approval

April 26, 1985

Date of revision

May 13, 2021

Serious warnings and precautions box

Serious Warnings and Precautions ANDROCUR and ANDROCUR DEPOT should be prescribed and managed by a qualified physician experienced in the use of hormonal therapy in prostate cancer. The following are clinically ...

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf