NDC 0187-1704 Mephyton

Phytonadione

NDC Product Code 0187-1704

NDC CODE: 0187-1704

Proprietary Name: Mephyton What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Phytonadione What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Vitamin K is used to treat and prevent low levels of certain substances (blood clotting factors) that your body naturally produces. These substances help your blood to thicken and stop bleeding normally (such as after an accidental cut or injury). Low levels of blood clotting factors increase the risk for unusual bleeding. Low levels may be caused by certain medications (such as warfarin) or medical conditions (such as obstructive jaundice). Vitamin K helps to treat and prevent unusual bleeding by increasing the body's production of blood clotting factors.

Product Characteristics

Color(s):
YELLOW (C48330 - PALE YELLOW)
Shape: ROUND (C48348)
Size(s):
6 MM
Imprint(s):
VRX;405;MEPHYTON
Score: 2

NDC Code Structure

  • 0187 - Bausch Health Us Llc

NDC 0187-1704-05

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET in 1 BOTTLE

NDC Product Information

Mephyton with NDC 0187-1704 is a a human prescription drug product labeled by Bausch Health Us Llc. The generic name of Mephyton is phytonadione. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Bausch Health Us Llc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Mephyton Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHYTONADIONE 5 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ACACIA (UNII: 5C5403N26O)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)
  • CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX)
  • LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Increased Prothrombin Activity - [PE] (Physiologic Effect)
  • Reversed Anticoagulation Activity - [PE] (Physiologic Effect)
  • Vitamin K - [CS]
  • Vitamin K - [EPC] (Established Pharmacologic Class)
  • Warfarin Reversal Agent - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bausch Health Us Llc
Labeler Code: 0187
FDA Application Number: NDA010104 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-19-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Phytonadione

Phytonadione is pronounced as (fye toe na dye' one)

Why is phytonadione medication prescribed?
Phytonadione (vitamin K) is used to prevent bleeding in people with blood clotting problems or too little vitamin K in the body. Phytonadione is in a class of medications...
[Read More]
Vitamin K

Vitamin K is

...
[Read More]

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Mephyton Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Phytonadione is a vitamin which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H46O2 and its structural formula is:Mephyton (phytonadione) tablets containing 5 mg of phytonadione are yellow, compressed tablets, scored on one side. Inactive ingredients are acacia, calcium phosphate, colloidal silicon dioxide, lactose, magnesium stearate, starch, and talc.

Clinical Pharmacology

Mephyton 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.Oral phytonadione is adequately absorbed from the gastrointestinal tract only if bile salts are present. After absorption, phytonadione is initially concentrated in the liver, but the concentration declines rapidly. Very little vitamin K accumulates in tissues. Little is known about the metabolic fate of vitamin K. Almost no free unmetabolized vitamin K appears in bile or urine.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.Mephyton tablets generally exert their effect within 6 to 10 hours.

Indications And Usage

  • Mephyton is indicated in 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 tablets are indicated in:-anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;-hypoprothrombinemia secondary to antibacterial therapy;-hypoprothrombinemia secondary to administration of salicylates;-hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed.

Contraindications

Hypersensitivity to any component of this medication.

Warnings

An immediate coagulant effect should not be expected after administration of phytonadione.Phytonadione will not counteract the anticoagulant action of heparin.When vitamin K1 is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy.Phytonadione is not a clotting agent, but overzealous therapy with vitamin K1 may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and prothrombin time should be checked regularly as clinical conditions indicate.Repeated large doses of vitamin K are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. Failure to respond to vitamin K may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K.

General

Vitamin K1 is fairly rapidly degraded by light; therefore, always protect Mephyton from light. Store Mephyton in closed original carton until contents have been used. (See HOW SUPPLIED, Storage.)

Drug Interactions

Temporary resistance to prothrombin-depressing anticoagulants may result, especially when larger doses of phytonadione are used. If relatively large doses have been employed, it may be necessary when reinstituting anticoagulant therapy to use somewhat larger doses of the prothrombin-depressing anticoagulant or to use one which acts on a different principle, such as heparin sodium.

Laboratory Tests

Prothrombin time should be checked regularly as clinical conditions indicate.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies of carcinogenicity or impairment of fertility have not been performed with Mephyton. Mephyton at concentrations up to 2,000 mcg/plate with or without metabolic activation, was negative in the Ames microbial mutagen test.

Pregnancy

Animal reproduction studies have not been conducted with Mephyton. It is also not known whether Mephyton can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity. Mephyton should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established with Mephyton. Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, have been reported with vitamin K.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mephyton is administered to a nursing woman.

Geriatric Use

Clinical studies of Mephyton did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

Severe hypersensitivity reactions, including anaphylactoid reactions and deaths, have been reported following parenteral administration. The majority of these reported events occurred following intravenous administration.Transient "flushing sensations" and "peculiar" sensations of taste have been observed with parenteral phytonadione, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis.Hyperbilirubinemia has been observed in the newborn following administration of parenteral phytonadione. This has occurred rarely and primarily with doses above those recommended.To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

The intravenous and oral LD50s in the mouse are approximately 1.17 g/kg and greater than 24.18 g/kg, respectively.

Dosage And Administration

Mephyton Summary of Dosage Guidelines (See circular text for details.)AdultsInitial DosageAnticoagulant-Induced Prothrombin Deficiency(caused by coumarin or indanedione derivatives)2.5 mg-10 mg or up to 25 mg(rarely 50 mg)Hypoprothrombinemia Due to Other Causes(antibiotics; salicylates or other drugs; factors limiting absorption or synthesis)2.5 mg-25 mg or more (rarely up to 50 mg)

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 Mephyton. The severity of the coagulation disorder should determine whether the immediate administration of Mephyton 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

Mephyton tablets, 5 mg vitamin K1, are yellow, round, scored, compressed tablets, coded VRX 405 on one side and MEPHYTON on the other. They are supplied as follows:NDC 0187-1704-05 bottles of 100.

Storage:

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

Other

Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USAManufactured by:Valeant Pharmaceuticals International, Inc.Steinbach, MB R5G 1Z7, CanadaMephyton is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.©Valeant Pharmaceuticals North America LLCRev. 11/169571300-20001736

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