MEPHYTON- phytonadione tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)

Fáanlegur frá:

Carilion Materials Management

INN (Alþjóðlegt nafn):

PHYTONADIONE

Samsetning:

PHYTONADIONE 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Mephyton is indicated in the following coagulation disorders which are due to faulty formation of factors II,VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. Mephyton tablets are indicated in: Hypersensitivity to any component of this medication.

Vörulýsing:

Product: 68151-0158 NDC: 68151-0158-0 1 TABLET in a PACKAGE

Leyfisstaða:

New Drug Application

Vara einkenni

MEPHYTON- PHYTONADIONE TABLET
CARILION MATERIALS MANAGEMENT
----------
MEPHYTON
(PHYTONADIONE)
VITAMIN K TABLETS RX ONLY
DESCRIPTION
Phytonadione is a vitamin which is a clear, yellow to amber, viscous,
and nearly odorless liquid. It is
insoluble in water, soluble in chloroform and slightly soluble in
ethanol. It has a molecular weight of
450.70.
Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical
formula is C
H O and its
structural formula is:
Mephyton (phytonadione) tablets containing 5 mg of phytonadione are
yellow, compressed tablets,
scored on one side. Inactive ingredients are acacia, calcium
phosphate, colloidal silicon dioxide,
lactose, magnesium stearate, starch, and talc.
CLINICAL PHARMACOLOGY
Mephyton tablets possess the same type and degree of activity as does
naturally-occurring vitamin K,
which is necessary for the production via the liver of active
prothrombin (factor II), proconvertin
(factor VII), plasma thromboplastin component (factor IX), and Stuart
factor (factor X). The prothrombin
test is sensitive to the levels of three of these four factors – II,
VII, and X. Vitamin K is an essential
cofactor for a microsomal enzyme that catalyzes the posttranslational
carboxylation of multiple,
specific, peptide-bound glutamic acid residues in inactive hepatic
precursors of factors II, VII, IX, and
X. The resulting gamma-carboxyglutamic acid residues convert the
precursors into active coagulation
factors that are subsequently secreted by liver cells into the blood.
Oral phytonadione is adequately absorbed from the gastrointestinal
tract only if bile salts are present.
After absorption, phytonadione is initially concentrated in the liver,
but the concentration declines
rapidly. Very little vitamin K accumulates in tissues. Little is known
about the metabolic fate of vitamin
K. Almost no free unmetabolized vitamin K appears in bile or urine.
In normal animals and humans, phytonadione is virtually devoid of
pharmacodynamic activity. However,
in animals and humans deficient in vitamin K, t