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LYSODREN Tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Lysodren 500 mg tablets.

Qualitative and quantitative composition

Each tablet contains 500 mg of mitotane. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. White, biconvex, round, scored tablets. They are bisected on one side and impressed BL over L1 on the other side.

Therapeutic indications

Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma (ACC). The effect of Lysodren on non functional adrenal cortical carcinoma is not established.

Posology and method of administration

Treatment should be initiated and followed by a suitably experienced specialist. Posology Treatment in adults should be started with 2-3 g mitotane per day and increased progressively (e.g. at two-week ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Lactation (see section 4.6). Concomitant use with spironolactone (see section 4.5).

Special warnings and precautions for use

Before the initiation of the treatment Large metastatic masses should be surgically removed as far as possible before starting mitotane treatment, in order to minimise the risk of infarction and haemorrhage ...

Interaction with other medicinal products and other forms of interaction

Spironolactone Mitotane must not be given in combination with spironolactone, since this active substance may block the action of mitotane (see section 4.3). Warfarin and coumarin-like anticoagulants ...

Pregnancy and lactation

Pregnancy Data on a limited number of exposed pregnancies indicate abnormalities on the adrenals of the foetus after exposure to mitotane. Animal reproduction studies have not been conducted with mitotane. ...

Effects on ability to drive and use machines

Lysodren has a major influence on the ability to drive and use machines. Ambulatory patients should be warned not to drive or use machines.

Undesirable effects

Safety data are based on literature (mainly retrospective studies). More than 80% of patients treated with mitotane have shown at least one type of undesirable effect. Adverse reactions listed below are ...

Overdose

Mitotane overdose may lead to central nervous system impairment especially if mitotane plasma levels are above 20 mg/L. No proven antidotes have been established for mitotane overdose. The patient should ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other antineoplastic agents ATC code: L01XX23 Mechanism of action Mitotane is an adrenal cytotoxic active substance, although it can apparently also cause adrenal inhibition ...

Pharmacokinetic properties

Absorption In a study performed in 8 patients with adrenal carcinoma treated with 2 to 3 g daily of mitotane, a highly significant correlation was found between plasma mitotane concentration and the total ...

Preclinical safety data

Non-clinical data on the general toxicity of mitotane is limited. Reproductive toxicity studies have not been performed with mitotane. However, dichlorodiphenyltrichlorethane (DDT) and other polychlorinated ...

List of excipients

Maize starch Microcrystalline cellulose (E460) Macrogol 3350 Silica colloidal anhydrous

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years. After opening: 1 year.

Special precautions for storage

Store in the original packaging.

Nature and contents of container

Square opaque white HDPE bottle having a thread on the mouth containing 100 tablets. Pack size of 1 bottle.

Special precautions for disposal and other handling

This medicinal product should not be handled by persons other than the patient and his/her caregivers, and especially not by pregnant women. Caregivers should wear disposable gloves when handling the tablets. ...

Marketing authorization holder

HRA Pharma Rare Diseases, 200 avenue de Paris, 92320, CHATILLON, France

Marketing authorization number(s)

EU/1/04/273/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 28 April 2004 Date of last renewal: 28 April 2009

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