MUSTARGEN mechlorethamine hydrochloride powder for solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

MECHLORETHAMINE HYDROCHLORIDE (UNII: L0MR697HHI) (MECHLORETHAMINE - UNII:50D9XSG0VR)

Fáanlegur frá:

RECORDATI RARE DISEASES, INC.

INN (Alþjóðlegt nafn):

MECHLORETHAMINE HYDROCHLORIDE

Samsetning:

MECHLORETHAMINE HYDROCHLORIDE 10 mg in 10 mL

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

New Drug Application

Vara einkenni

MUSTARGEN- MECHLORETHAMINE HYDROCHLORIDE POWDER, FOR SOLUTION
RECORDATI RARE DISEASES, INC.
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TRITURATION OF MUSTARGEN
(MECHLORETHAMINE HCL FOR INJECTION)
RX ONLY
WARNINGS
MUSTARGEN
(mechlorethamine HCl) should be administered only under the
supervision of a
physician who is experienced in the use of cancer chemotherapeutic
agents.
This drug is HIGHLY TOXIC and both powder and solution must be handled
and administered
with care. Inhalation of dust or vapors and contact with skin or
mucous membranes, especially
those of the eyes, must be avoided. Avoid exposure during pregnancy.
Due to the toxic
properties of mechlorethamine (e.g., corrosivity, carcinogenicity,
mutagenicity, teratogenicity),
special handling procedures should be reviewed prior to handling and
followed diligently.
Extravasation of the drug into subcutaneous tissues results in a
painful inflammation. The area
usually becomes indurated and sloughing may occur. If leakage of drug
is obvious, prompt
infiltration of the area with sterile isotonic sodium thiosulfate (1/6
molar) and application of an
ice compress for 6 to 12 hours may minimize the local reaction. For a
1/6 molar solution of
sodium thiosulfate, use 4.14 g of sodium thiosulfate per 100 mL of
Sterile Water for Injection or
2.64 g of anhydrous sodium thiosulfate per 100 mL or dilute 4 mL of
Sodium Thiosulfate
Injection (10%) with 6 mL of Sterile Water for Injection.
DESCRIPTION
MUSTARGEN, an antineoplastic nitrogen mustard also known as HN2
hydrochloride, is a nitrogen
analog of sulfur mustard. It is a light yellow brown, crystalline,
hygroscopic powder that is very
soluble in water and also soluble in alcohol. Mechlorethamine
hydrochloride is designated chemically
as 2-chloro- _N_-(2-chloroethyl)- _N_-methylethanamine hydrochloride.
The molecular weight is 192.52
and the melting point is 108-111°C. The empirical formula is C
H
Cl
N•HCl, and the structural
formula is: CH
N(CH
CH
Cl)
•HCl.
Trituration of MUSTARGEN is a sterile, light yellow brown crystalline
powder for injection