July 31, 2016
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Lysodren

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Lysodren




Indications
Dosage
How Supplied

INDICATIONS

LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma.

DOSAGE AND ADMINISTRATION

Recommended Dose

The recommended initial dose of LYSODREN is 2 g to 6 g orally, in three or four divided doses per day. Increase doses incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated.

LYSODREN is a cytotoxic drug. Follow applicable special handling and disposal procedures.

Dose Modifications

Adrenal Crisis In The Setting Of Shock Or Severe Trauma

Discontinue LYSODREN until recovery [see WARNINGS AND PRECAUTIONS].

Central Nervous System (CNS) Toxicity

Discontinue LYSODREN until symptoms resolve. Seven to 10 days after symptoms resolve, restart at a lower dose (for example, decrease by 500-1000 mg) [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

500 mg white, round, biconvex, scored tablets, bisected on one side and impressed with “BL” over “L1” on the other side.

Storage And Handling

LYSODREN tablets are supplied as 500 mg white, round, biconvex, scored tablets, bisected on one side and impressed with “BL” over “L1” on the other side.

100 tablets per bottle: NDC 0015-3080-60

Store bottles at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F-86°F).

Mitotane is a cytotoxic drug. Follow applicable special handling and disposal procedures [see REFERENCES].

REFERENCES

1. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

Manufactured for: Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA. Revised: March 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/28/2016

Indications
Dosage
How Supplied

Lysodren - User Reviews

Lysodren User Reviews

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Here is a collection of user reviews for the medication Lysodren sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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