PHYTONADIONE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

American Health Packaging

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Phytonadione tablets, USP are 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. Phytonadione tablets, USP are indicated in: - anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; - hypoprothrombinemia secondary to antibacterial therapy; - hypoprothrombinemia secondary to administration of salicylates; - hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed. Hypersensitivity to any component of this medication.

Produktbesonderheiten:

Phytonadione Tablets USP, 5 mg are light yellow to yellow colored, round shaped, uncoated tablets engraved with "10 14" on one side and break line on other side and are supplied as follows: Unit dose packages of 20 (2 x 10) NDC 60687-600-94 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Always protect phytonadione tablets, USP from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries about the drug to [e-mail] or Tel.: [phone] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For more information about the packaging or labeling, call American Health Packaging at 1-800-707-4621.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

PHYTONADIONE- PHYTONADIONE TABLET
AMERICAN HEALTH PACKAGING
----------
PHYTONADIONE TABLETS, USP
8460094/0121
RX ONLY
DESCRIPTION
Phytonadione is a vitamin which is a clear, yellow to amber, very
viscous odorless or
practically odorless liquid. It is soluble in dehydrated alcohol, in
benzene, in chloroform,
in ether and slightly soluble in alcohol. It has a molecular weight of
450.70.
Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular
formula is C
H
O
and its structural formula is:
Each uncoated phytonadione tablet, USP for oral administration
contains 5 mg of
phytonadione, USP and contains following inactive ingredients:
croscarmellose sodium,
colloidal silicon dioxide, hydroxypropyl cellulose, lactose
monohydrate, magnesium
stearate and microcrystalline cellulose.
CLINICAL PHARMACOLOGY
Phytonadione tablets, USP 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 post-translational 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
31
46
2
bile or urine.
In normal animals and humans, phytonadione