PHYTONADIONE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Oceanside Pharmaceuticals

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Phytonadione tablets are indicated for the treatment of adults with 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 are contraindicated in patients with a history of a hypersensitivity reaction to phytonadione or inactive ingredients [ see Description (11) ] . Risk Summary Published studies with the use of phytonadione during pregnancy have not reported a clear association with phytonadione and adverse developmental outcomes [see Data]. There are maternal and fetal risks associated with vitamin K deficiency during pregnancy [see Clinical Considerations]. Animal reproduction studies have not been conducted with phytonadione. The estimated background risk for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect

Περίληψη προϊόντος:

Phytonadione Tablets, 5 mg, are clean, pale yellow, semi-glossy, round, flat, beveled edge, scored and debossed with “VRX” above “405” on one side and debossed with “MEPHYTON” on the other side. They are supplied as follows: NDC 68682-170-30 bottles of 30. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Always protect phytonadione tablets from light. Store in tightly closed original container and carton until contents have been used.

Καθεστώς αδειοδότησης:

New Drug Application Authorized Generic

Αρχείο Π.Χ.Π.

PHYTONADIONE- PHYTONADIONE TABLET
OCEANSIDE PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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: 1995
INDICATIONS AND USAGE
Phytonadione tablets are a vitamin K replacement indicated for the
treatment of adults with 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:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg (3)
CONTRAINDICATIONS
ADVERSE REACTIONS
Most common adverse reactions are transient “flushing sensations”,
“peculiar” sensations of taste and
instances of dizziness, rapid and weak pulse, profuse sweating, brief
hypotension, dyspnea, and cyanosis.
(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT OCEANSIDE
PHARMACEUTICALS AT 1-800-
321-4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Considerations
2.2 Recommended Dosage
Anticoagulant-induced prothrombin deficiency caused by coumarin or
indanedione derivatives; (1)
Hypoprothrombinemia secondary to antibacterial therapy; (1)
Hypoprothrombinemia secondary to factors limiting absorption or
synthesis of vitamin K, e.g.,
obstructive jaundice, biliary fistula, sprue, ulcerative colitis,
celiac disease, intestinal resection, cystic
fibrosis of the pancreas, and regional enteritis; (1)
Other drug-induced hypoprothrombinemia where it is definitively shown
that the result is due to
interference with vitamin K metabolism, e.g., salicylates. (1)
Anticoagulant-Induced Prothrombin Deficiency: 2.5 mg to 10 mg or
up to 25 mg (2.2)
Hypoprothrombinemia Due to Other Causes: 2.5