Phytonadione (Page 2 of 2)

Anticoagulant-Induced Prothrombin Deficiency in Adults

To correct excessively prolonged prothrombin times caused by oral anticoagulant therapy, 2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required. Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition (see WARNINGS). If, in 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated.

Hypoprothrombinemia Due to Other Causes in Adults

If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent phytonadione tablets. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione tablets is required in addition to discontinuation or reduction of interfering drugs.

A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.

The oral route should be avoided when the clinical disorder would prevent proper absorption. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.

HOW SUPPLIED

Phytonadione tablets, 5 mg vitamin K 1 , are yellow, round, scored, compressed tablets, coded VRX 405 on one side and MEPHYTON on the other. They are supplied as follows:

  1. NDC 50268-661-13 (10 tablets per card, 3 cards per carton).

Storage:

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° 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 (see PRECAUTIONS, General).

Manufactured for:

AvKARE

Pulaski, TN 38478

Mfg. Rev. 08/20

AV 02/21 (P)

Mephyton is a trademark of Bausch Health Companies Inc. or its affiliates.

© 2020 Bausch Health Companies Inc. or its affiliates

Package/Label Display Panel

5mg
(click image for full-size original)

PHYTONADIONE
phytonadione tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-661(NDC:68682-170)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 5 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA
SILICON DIOXIDE
MAGNESIUM STEARATE
STARCH, CORN
TALC
CALCIUM PHOSPHATE, UNSPECIFIED FORM
LACTOSE, UNSPECIFIED FORM
Product Characteristics
Color yellow (pale yellow) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code VRX;405;MEPHYTON
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-661-13 30 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-661-11)
1 NDC:50268-661-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-661-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA010104 02/19/2021
Labeler — AvPAK (832926666)

Revised: 02/2021 AvPAK

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.