MEPHYTON- phytonadione tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bausch Health US LLC

INN (International Name):

phytonadione

Composition:

phytonadione 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mephyton is 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. Mephyton is 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 defects and miscarriage in clinica

Product summary:

Mephyton® 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 0187-1704-05 bottles of 100. 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 Mephyton from light. Store in tightly closed original container and carton until contents have been used.

Authorization status:

New Drug Application

Summary of Product characteristics

MEPHYTON- PHYTONADIONE TABLET
BAUSCH HEALTH US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEPHYTON. SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEPHYTON.
MEPHYTON (PHYTONADIONE TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 1955
INDICATIONS AND USAGE
Mephyton is 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) (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 BAUSCH HEALTH US, LLC
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 mg to 25 mg or
more (2.2)
Must