DEFEROXAMINE MESYLATE injection, powder, lyophilized, for solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

DEFEROXAMINE MESYLATE (UNII: V9TKO7EO6K) (DEFEROXAMINE - UNII:J06Y7MXW4D)

から入手可能:

ApoPharma USA, Inc.

投与経路:

INTRAMUSCULAR

処方タイプ:

PRESCRIPTION DRUG

適応症:

Deferoxamine mesylate for injection, USP, is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias. Acute Iron Intoxication Deferoxamine mesylate is an adjunct to, and not a substitute for, standard measures used in treating acute iron intoxication, which may include the following: induction of emesis with syrup of ipecac; gastric lavage; suction and maintenance of a clear airway; control of shock with intravenous fluids, blood, oxygen, and vasopressors; and correction of acidosis. Chronic Iron Overload Deferoxamine mesylate can promote iron excretion in patients with secondary iron overload from multiple transfusions (as may occur in the treatment of some chronic anemias, including thalassemia). Long-term therapy with deferoxamine mesylate slows accumulation of hepatic iron and retards or eliminates progression of hepatic fibrosis. Iron mobilization with deferoxamine mesylate is relatively poor in patients under the age of 3 years with relati

製品概要:

Vials - each containing 500 mg of sterile, lyophilized deferoxamine mesylate Cartons of 4 vials……………………………………………NDC 52609-4505-6 Vials - each containing 2 g of sterile, lyophilized deferoxamine mesylate Cartons of 4 vials……………………………………………NDC 52609-4504-6 Each vial is for single use only.  Discard unused portion. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

認証ステータス:

Abbreviated New Drug Application

製品の特徴

DEFEROXAMINE MESYLATE- DEFEROXAMINE MESYLATE INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
APOPHARMA USA, INC.
----------
DEFEROXAMINE MESYLATE FOR INJECTION, USP
VIALS
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Deferoxamine mesylate for injection, USP, is an iron-chelating agent,
available in vials for
intramuscular, subcutaneous, and intravenous administration.
Deferoxamine mesylate is supplied as vials
containing 500 mg and 2 g of deferoxamine mesylate USP in sterile,
lyophilized form. Deferoxamine
mesylate is
_N_-[5-[3-[(5-aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-
(_N-_hydroxyacetamido) pentyl]carbamoyl]propionohydroxamic acid
monomethanesulfonate (salt), and its
structural formula is
Deferoxamine mesylate USP is a white to off-white powder. It is freely
soluble in water and slightly
soluble in methanol. Its molecular weight is 656.79.
CLINICAL PHARMACOLOGY
Deferoxamine mesylate chelates iron by forming a stable complex that
prevents the iron from entering
into further chemical reactions. It readily chelates iron from
ferritin and hemosiderin but not readily
from transferrin; it does not combine with the iron from cytochromes
and hemoglobin. Deferoxamine
mesylate does not cause any demonstrable increase in the excretion of
electrolytes or trace metals.
Theoretically, 100 parts by weight of deferoxamine mesylate is capable
of binding approximately 8.5
parts by weight of ferric iron.
Deferoxamine mesylate is metabolized principally by plasma enzymes,
but the pathways have not yet
been defined. The chelate is readily soluble in water and passes
easily through the kidney, giving the
urine a characteristic reddish color. Some is also excreted in the
feces via the bile.
INDICATIONS & USAGE
Deferoxamine mesylate for injection, USP, is indicated for the
treatment of acute iron intoxication and
of chronic iron overload due to transfusion-dependent anemias.
Acute Iron Intoxication
Deferoxamine mesylate is an adjunct to, and not a substitute for,
standard measures used in treating acute
iron intoxication,