LEUCOVORIN CALCIUM tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

American Health Packaging

INN (International Name):

LEUCOVORIN CALCIUM

Sammensetning:

LEUCOVORIN 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Leucovorin calcium tablets are indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin is improper therapy for pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin B 12 . A hematologic remission may occur while neurologic manifestations continue to progress.

Produkt oppsummering:

Leucovorin Calcium Tablets USP, 25 mg are available as pale green, round, unscored, biconvex tablets, debossed with b on one side and 485 on the other side, packaged in Unit dose packages of 20 (2 x 10) NDC 60687-227-94. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Protect from light and moisture. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LEUCOVORIN CALCIUM- LEUCOVORIN CALCIUM TABLET
AMERICAN HEALTH PACKAGING
----------
LEUCOVORIN CALCIUM TABLETS USP
RX ONLY
8422794/0821F
DESCRIPTION
Leucovorin Calcium Tablets USP contain either 5 mg or 25 mg leucovorin
as the calcium
salt of
_N_-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]
amino]benzoyl]- _L_-glutamic acid. This is equivalent to 5.4 mg or
27.01 mg of anhydrous
leucovorin calcium, respectively. In addition, each tablet contains
the following inactive
ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose
monohydrate,
magnesium stearate, and microcrystalline cellulose. The 25 mg tablet
also contains D&C
yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake.
Leucovorin is a water soluble form of reduced folate in the folate
group; it is useful as an
antidote to drugs which act as folic acid antagonists. These tablets
are intended for oral
administration only.
The structural formula is as follows:
C
H
CaN
O
              M.W. 511.5
CLINICAL PHARMACOLOGY
Leucovorin is a racemic mixture of the diastereoisomers of the
5-formyl derivative of
tetrahydrofolic acid. The biologically active compound of the mixture
is the (-)- _L_-isomer,
known as _Citrovorum factor_, or (-)-folinic acid. Leucovorin does not
require reduction by
the enzyme dihydrofolate reductase in order to participate in
reactions utilizing folates as
a source of “one-carbon” moieties. Following oral administration,
leucovorin is rapidly
absorbed and enters the general body pool of reduced folates. The
increase in plasma
and serum folate activity (determined microbiologically with
_Lactobacillus casei_) seen
after oral administration of leucovorin is predominantly due to
5-methyltetrahydrofolate.
Twenty normal men were given a single, oral 15 mg dose (7.5 mg/m
) of leucovorin
20
21
7
7
2
calcium and serum folate concentrations were assayed with _L. casei_.
Mean values
observed (± one standard error) were:
1. Time to peak serum folate concentration: 1.72 ± 0.0