Phytonadione
These highlights do not include all the information needed to use PHYTONADIONE TABLETS safely and effectively. See full prescribing information for PHYTONADIONE TABLETS.PHYTONADIONE tablets, for oral use Initial U.S. Approval: 1955
c0e38a20-7225-46a5-9730-924cbd08dbee
HUMAN PRESCRIPTION DRUG LABEL
Aug 11, 2023
ScieGen Pharmaceuticals Inc
DUNS: 079391286
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phytonadione
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 50228-333-30
Phytonadione Tablets USP,
5 mg
Each tablet contains
5 mg phytonadione, USP
30 Tablets Rx only
ScieGen Pharmaceuticals Inc.
NDC 50228-333-30
Phytonadione Tablets USP,
5 mg
30 Tablets Rx only
ScieGen Pharmaceuticals Inc.
NDC 50228-333-01
Phytonadione Tablets USP,
5 mg
Each tablet contains
5 mg phytonadione, USP
100 Tablets Rx only
ScieGen Pharmaceuticals Inc.
NDC 50228-333-01
Phytonadione Tablets USP,
5 mg
100 Tablets Rx only
ScieGen Pharmaceuticals Inc.
CONTRAINDICATIONS SECTION
4 CONTRAINDICATIONS
Phytonadione is contraindicated in patients with a history of a hypersensitivity reaction to phytonadione or inactive ingredients [see Description (11)].
Hypersensitivity to any component of this medication. (4) (4)
PATIENT COUNSELING INFORMATION
17 PATIENT COUNSELING INFORMATION
Vitamin K 1is fairly rapidly degraded by light; therefore, advise patients to always protect phytonadione from light. Store phytonadione in closed original carton until contents have been used [see How Supplied/Storage and Handling (16)].
Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788, USA.
Rev: 07/2021
CLINICAL PHARMACOLOGY SECTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Phytonadione 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.
In normal animals and humans, phytonadione is virtually devoid of pharmacodynamic activity. However, in animals and humans deficient in vitamin K, the pharmacological action of vitamin K is related to its normal physiological function, that is, to promote the hepatic biosynthesis of vitamin K-dependent clotting factors.
12.2 Pharmacodynamics
Phytonadione tablets generally exert their effect within 6 to 10 hours.
12.3 Pharmacokinetics
Absorption
Oral phytonadione is adequately absorbed from the gastrointestinal tract only
if bile salts are present.
Distribution
After absorption, phytonadione is initially concentrated in the liver, but the
concentration declines rapidly. Very little vitamin K accumulates in tissues.
Elimination
Little is known about the metabolic fate of vitamin K. Almost no free
unmetabolized vitamin K appears in bile or urine.