LEUCOVORIN CALCIUM tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Ingenus Pharmaceuticals, LLC

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Leucovorin is 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 B12 . A hematologic remission may occur while neurologic manifestations continue to progress.

leaflet_short:

Leucovorin Calcium Tablets USP 5 mg tablets are supplied as a white to off-white, round, biconvex tablet; debossed with “ING” above “181” on one side and scoreline on other side. NDC 50742-181-30: Bottle of 30 Tablets NDC 50742-181-01: Bottle of 100 Tablets 10 mg tablets are supplied as a white to off-white, round, biconvex tablet; debossed with “ING” above “182” on one side and scoreline on other side . NDC 50742-182-12: Bottle of 12 Tablets NDC 50742-182-24: Bottle of 24 Tablets 15 mg tablets are supplied as a peach colored, round, biconvex tablet; debossed with “ING” above “183” on one side and scoreline on other side. NDC 50742-183-24: Bottle of 24 Tablets 25 mg tablets are supplied as a peach colored, round, biconvex tablet; debossed with “ING” above “184” on one side and scoreline on other side. NDC 50742-184-25: Bottle of 25 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect From Light and Moisture. References Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Rx Only 554300 Revised: 06/2019

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

LEUCOVORIN CALCIUM- LEUCOVORIN CALCIUM TABLET
INGENUS PHARMACEUTICALS, LLC
----------
LEUCOVORIN CALCIUM TABLETS USP, 5 MG, 10 MG, 15 MG AND 25 MG
RX ONLY
DESCRIPTION
Leucovorin calcium tablets USP contain either 5 mg, 10 mg, 15 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 either 5.4 mg, 10.8 mg, 16.21 mg
or 27.01 mg of anhydrous
leucovorin calcium USP, respectively. In addition, each tablet
contains the following _inactive_
_ingredients: _lactose monohydrate, anhydrous lactose,
microcrystalline cellulose, croscarmellose
sodium, colloidal silicon dioxide, magnesium stearate and FD&C yellow
#6 (15 mg and 25 mg).
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 of leucovorin calcium is:
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 calcium and serum
folate concentrations were assayed with L. casei. Mean values observed
(± one standard error) were:
a) Time to peak serum folate concentration: 1.72 ± 0.08 hours,
b) Peak serum folate concentration achieved