NDC 70771-1318 Phytonadione

Phytonadione

NDC Product Code 70771-1318

NDC Code: 70771-1318

Proprietary Name: Phytonadione Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Product Characteristics
Color(s):
YELLOW (C48330 - LIGHT YELLOW TO YELLOW)
Shape: ROUND (C48348)
Size(s):
7 MM
Imprint(s):
1014
Score: 2

Code Structure
  • 70771 - Cadila Healthcare Limited
    • 70771-1318 - Phytonadione

NDC 70771-1318-1

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

NDC 70771-1318-4

Package Description: 10 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK (70771-1318-2)

NDC Product Information

Phytonadione with NDC 70771-1318 is a a human prescription drug product labeled by Cadila Healthcare Limited. The generic name of Phytonadione is phytonadione. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cadila Healthcare Limited

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

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat 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.


Phytonadione Active Ingredient(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Administration Route(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipWhat 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)
  • 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cadila Healthcare Limited
Labeler Code: 70771
FDA Application Number: ANDA210189 Additional informationCallout TooltipWhat 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat 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: 02-22-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Phytonadione Product Label Images

Phytonadione 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, very viscous odorless or practically odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.70.Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is:Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

Clinical Pharmacology

Phytonadione tablets, USP 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 post-translational 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 bio synthesis of vitamin K-dependent clotting factors.Phytonadione tablets, USP generally exert their effect within 6 to 10 hours.

Indications And Usage

  • Phytonadione tablets, USP are 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.Phytonadione tablets, USP 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 pro thrombin 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 phytonadione tablets, USP from light. Store phytonadione tablets, USP in closed original carton until contents have been used. (See also 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 phytonadione tablets, USP.Phytonadione tablets, USP at concentrations up to 2000 mcg/plate with or without metabolic activation, was negative in the Ames microbial mutagen test.

Pregnancy

Pregnancy Category CAnimal reproduction studies have not been conducted with phytonadione tablets, USP. It is also not known whether phytonadione tablets, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phytonadione tablets, USP should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established with phytonadione tablets, USP. 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 phytonadione tablets, USPis administered to a nursing woman.

Geriatric Use

Clinical studies of phytonadione tablets, USP 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.

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

Phytonadione Tablets, USP Summary of Dosage Guidelines(See circular text for details)AdultsInitial DosageAnticoagulant-Induced Prothrombin Deficiency (caused by coumarin or indanedione derivatives)2.5 mg to 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 to 25 mg or more (rarely up to 50 mg)

Anticoagulant-Induced Pro Thrombin 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 pro thrombin 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, USP. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione tablets, USP 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 pro per 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 USP, 5 mg are light yellow to yellow colored, round shaped, uncoated tablets engraved with "10 14" on one side and break line on other side and are supplied as follows:NDC 70771-1318-1 in bottle of 100 tabletsNDC 70771-1318-4 in carton of 100 tablets (10 x 10 unit-dose)

Storage

Store in tightly closed original container 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, USP from light. Store in tightly closed original container and carton until contents have been used (See PRECAUTIONS, General).Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Please address medical inquiries to, MedicalAffairs@zydususa.com Tel.: 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Other

Manufactured by:Cadila Healthcare LimitedMatoda, Ahmedabad, India.Rev.: 02/19

* Please review the disclaimer below.

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