LEUCOVORIN CALCIUM injection, powder, lyophilized, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

LEUCOVORIN CALCIUM (UNII: RPR1R4C0P4) (LEUCOVORIN - UNII:Q573I9DVLP)

Tilgjengelig fra:

Teva Parenteral Medicines, Inc.

INN (International Name):

LEUCOVORIN CALCIUM

Sammensetning:

LEUCOVORIN 100 mg in 10 mL

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Leucovorin calcium rescue is indicated after high-dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form. Leucovorin is improper therapy for pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin B12. A hematologic remission may occur while neurologic manifestations continue to progress.

Produkt oppsummering:

Leucovorin Calcium for Injection, USP is supplied in sterile, single-dose vials. Store at room temperature, 15° to 30°C (59° to 86°F). Protect from light. Discard unused portion. Store in carton until contents are used. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed by: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. C 5/2020

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LEUCOVORIN CALCIUM- LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
TEVA PARENTERAL MEDICINES, INC.
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LEUCOVORIN CALCIUM FOR INJECTION, USP
RX ONLY
DESCRIPTION
Leucovorin is one of several active, chemically reduced derivatives of
folic acid. It is useful as an
antidote to drugs which act as folic acid antagonists.
Also known as folinic acid, Citrovorum factor, or
5-formyl-5,6,7,8-tetrahydrofolic acid, this compound
has the chemical designation of L-Glutamic acid,
_N_-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-
oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt (1:1). The
structural formula is as follows:
C
H CaN O M.W. 511.51
Leucovorin Calcium for Injection, USP is a sterile product indicated
for intramuscular (IM) or
intravenous (IV) administration and is supplied in 100 mg and 350 mg
vials. Each 100 mg vial of
Leucovorin Calcium for Injection when reconstituted with 10 mL of
sterile diluent, contains leucovorin
(as the calcium salt) 10 mg/mL. Each 350 mg vial of Leucovorin Calcium
for Injection, USP when
reconstituted with 17.5 mL of sterile diluent, contains leucovorin (as
the calcium salt) 20 mg/mL. In each
dosage form, one milligram of leucovorin calcium, USP contains 0.002
mmol of leucovorin and 0.002
mmol of calcium.
These lyophilized products contain no preservative. The inactive
ingredient is sodium chloride, USP
(added to adjust tonicity), 80 mg/vial for the 100 mg vial, and 140
mg/vial for the 350 mg vial. Sodium
hydroxide and/or hydrochloric acid are used to adjust the pH during
manufacture to approximately 6.9
for the 100 mg vial, and approximately 8.1 for the 350 mg vial.
Reconstitute with bacteriostatic water
for injection, USP, which contains benzyl alcohol (see WARNINGS
section), or with sterile water for
injection, USP.
CLINICAL PHARMACOLOGY
Leucovorin is a mixture of the diastereoisomers of the 5-formyl
derivative of tetrahydrofolic acid
(THF). The biologically active compound of the mixture is the
(-)-_l_-isomer, known as Citrovorum
factor or (-)-folinic acid.