MEPHYTON- phytonadione tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

phytonadione (UNII: A034SE7857) (phytonadione - UNII:A034SE7857)

Available from:

Rebel Distributors Corp

INN (International Name):

phytonadione

Composition:

phytonadione 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - 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.

Product summary:

No. 7776 — Tablets MEPHYTON, 5 mg vitamin K1 , are yellow, round, scored, compressed tablets, coded MSD 43 on one side and MEPHYTON on the other. They are supplied as follows: NDC 21695-168-10 bottles of 10. Store in tightly closed original container at 25°C (77 º F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Always protect MEPHYTON from light. Store in tightly closed original container and carton until contents have been used. (See PRECAUTIONS, General.) Merck & Co., Inc. Whitehouse Station, NJ 08889, USA Issued April 2004 Printed in USA 7918719 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

New Drug Application

Summary of Product characteristics

MEPHYTON- PHYTONADIONE TABLET
REBEL DISTRIBUTORS CORP
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MEPHYTON
(PHYTONADIONE)
TABLETS
VITAMIN K
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.
1
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
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 bile or
urine.
In normal animals and humans, phytonadione is virtually devoid of
pharmacodynamic activity. However,
in animals and humans deficient in vitamin K, the pharmaco