Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
phytonadione (UNII: A034SE7857) (phytonadione - UNII:A034SE7857)
Bausch Health US LLC
phytonadione
phytonadione 5 mg
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application
MEPHYTON- PHYTONADIONE TABLET BAUSCH HEALTH US LLC ---------- 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 Прочитајте комплетан документ