Phytonadione 5 mg Tablet, 30-count — NDC 16714-973-02 (Billing 16714-0973-02)
This is a package of 30 tablets of Phytonadione 5 mg Tablet from Northstar Rx LLC., marketed since Mar 2022 and currently FDA-listed; retail pharmacies pay about $8.83 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 16714-973-02 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 16714 labeler · 973 product · 02 package
- Package marketed since
- Mar 22, 2022
- Sample package
- Yes — professional sample, not for sale
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 30 EA per package
- Barcode (UPC-A, from the NDC)
- 3 1671497302 9
- Medicaid fills, this package
- 273 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Phytonadione (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 002305
- GCN: 94711
- GPI-14 (Medi-Span): 77204030000305
- HICL (First Databank): 001040
- AHFS class code: 88:24.00.00
- RxCUI (RxNorm): 198102
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Warfarin Reversal Agent class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 called vitamins. It works by providing vitamin K that is needed for blood to clot normally in the body.
Read the full MedlinePlus article ↗- It's vitamin K1. It helps your blood clot when vitamin K is low or blocked, for example by a blood thinner like warfarin, some antibiotics, or conditions that limit absorption. The...
- The tablets are taken by mouth, and your prescriber may add bile salts if your body doesn't make enough bile. The injection is given by a healthcare professional, preferably under...
- It isn't instant. Your INR may take 1 to 8 hours to improve, and after an IV dose a normal INR is often reached in about 12 to 14 hours. If bleeding is severe, you may need other t...
- Some people feel dizzy, flushed, or sweaty, notice an odd taste, or have a fast heartbeat. Injection-site soreness can happen. Get emergency help for trouble breathing, chest pain,...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $8.826 | $264.77 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $15.38 | $461.26 / 30 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 16714-0973-01 16714-973-01 | 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE | $31.22 / ea | $3,121.94 | 2022-03-22 | — | Discontinued by firm |
| 16714-0973-02 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE Sample | $8.83 / ea | $264.77 | 2022-03-22 | — | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($8.83 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 16714-0973-01?
What NDC number is used to bill for this package of Phytonadione 5 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Phytonadione 5 mg 00904-6882-10 | Major | 20 tablets | $8.826 | AB | Availability likely | — |
| Phytonadione 5 mgthis 16714-0973-02 | Northstar | 30 tablets | $8.826 | AB | Availability likely | — |
| Phytonadione 5 mg 60687-0381-94 | American | 20 tablets | $8.826 | AB | Availability likely | — |
| Phytonadione 5 mg 69097-0999-02 | Cipla | 30 tablets | $8.826 | AB | Availability likely | — |
| Phytonadione 5 mg 70710-1014-01 | Zydus | 100 tablets | $8.826 | AB | Availability likely | — |
| Phytonadione 5 mg 76282-0740-30 | Exelan | 30 tablets | $8.826 | AB | Availability likely | — |
| Phytonadione 5 mg 42291-0566-30 | AvKARE | 30 tablets | — | AB | Discontinued | — |
| Phytonadione 5 mg 50228-0333-01 | ScieGen | 100 tablets | — | AB | FDA listed | — |
| Phytonadione 5 mg 67046-1581-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Phytonadione 5 mg 69238-1051-01 | Amneal | 100 tablets | — | AB | FDA listed | — |
| Phytonadione 5 mg 70771-1318-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Phytonadione 5 mg 72134-0008-01 | Agnitio | 100 tablets | — | AB | FDA listed | — |
| Phytonadione 5 mg 48433-0160-03 | Safecor | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Phytonadione inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Northstar Rx LLC. labeler code 16714
- Ketoconazole 20 mg/g Cream NDC 16714-955-01
- Dapsone 50 mg/g Gel NDC 16714-956-01
- Abiraterone Acetate 250 mg Tablet NDC 16714-963-01
- Aspirin and Dipyridamole 25 mg; 200 mg Capsule, Extended Release NDC 16714-964-01
- testosterone 20.25 mg/1.25g Gel NDC 16714-968-02
- testosterone 40.5 mg/2.5g Gel NDC 16714-969-02
- Dapsone 75 mg/g Gel NDC 16714-975-01
- propofol 10 mg/mL Injection, Emulsion NDC 16714-977-20
- Esomeprazole Magnesium 20 mg Capsule, Delayed Release NDC 16714-979-01
- Esomeprazole Magnesium 40 mg Capsule, Delayed Release NDC 16714-980-01
- clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g Gel NDC 16714-984-25
- Triamcinolone Acetonide .25 mg/g Cream NDC 16714-985-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Phytonadione 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. anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; hypoprothrombinemia secondary to antibacterial therapy; 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 pancrease, and regional enteritis; Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.
Phytonadione 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: 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 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 be given with bile salts when endogenous supply of bile to gastrointestinal track is deficient. ( 2.1 )
2.1Dosing Considerations Avoid the oral route 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. The coagulant effects of phytonadione tablets are not immediate; improvement of international normalized ratio (INR) may take 1 to 8 hours.
Interim use of whole blood or component therapy may also be necessary if bleeding is severe. Phytonadione tablets will not counteract the anticoagulant action of heparin. When phytonadione tablets are 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.
2.2Recommended Dosage Anticoagulant-Induced Prothrombin Deficiency in Adults The recommended dose to correct excessively prolonged prothrombin times caused by oral anticoagulant therapy is, 2.5 to 10 mg or up to 25 mg initially. In some instances 50 mg may be required. Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition.
If, in 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, repeat the dose. Repeated large doses of phytonadione tablets are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. Failure to respond to phytonadione tablets may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K.
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. The recommended dose is 2.5 mg to 25 mg or more (sometimes up to 50 mg).
Evaluate INR after 6 to 8 hours, and repeat dose if INR remains prolonged. Modify subsequent dosage (amount and frequency) based upon the INR or clinical condition.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, light yellow to yellow colored, round-shaped, uncoated tablets engraved with "10 14" on one side and break line on other side. Tablets: 5 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Phytonadione tablets are contraindicated in patients with a history of a hypersensitivity reaction to phytonadione or inactive ingredients [see Description ( 11 )] . Hypersensitivity to any component of this medication. ( 4 )
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions associated with the use of parenteral phytonadione were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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 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 primarily with doses above those recommended. 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 Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Anticoagulants Phytonadione may induce temporary resistance to prothrombin-depressing anticoagulants, especially when larger doses of phytonadione are used. Should this occur, higher doses of anticoagulant therapy may be needed when resuming anticoagulant therapy, or a change in therapy to a different class of anticoagulant may be necessary (i.e., heparin sodium). Phytonadione does not affect the anticoagulant action of heparin.
Anticoagulants: May induce temporary resistance to prothrombin-depressing anticoagulants. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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 clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnant women with vitamin K deficiency hypoprothrombinemia may be at increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery. Subclinical vitamin K deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. Data Human Data Phytonadione has been measured in cord blood of infants whose mothers were treated with phytonadione during pregnancy in concentrations lower than seen in maternal plasma.
Administration of vitamin K 1 to pregnant women shortly before delivery increased both maternal and cord blood concentrations. Published data do not report a clear association with phytonadione and adverse maternal or fetal outcomes when used during pregnancy. However, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding.
Animal Data In pregnant rats receiving vitamin K 1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer.
8.2Lactation Risk Summary Phytonadione is present in breastmilk. There are no data on the effects of phytonadione on the breastfed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the clinical need for phytonadione and any potential adverse effects on the breastfed child from phytonadione or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established with phytonadione. Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, have been reported with vitamin K.
8.5Geriatric Use Clinical studies of phytonadione 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.
🤰 Pregnancy ▾
8.1Pregnancy 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 clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnant women with vitamin K deficiency hypoprothrombinemia may be at increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery. Subclinical vitamin K deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. Data Human Data Phytonadione has been measured in cord blood of infants whose mothers were treated with phytonadione during pregnancy in concentrations lower than seen in maternal plasma.
Administration of vitamin K 1 to pregnant women shortly before delivery increased both maternal and cord blood concentrations. Published data do not report a clear association with phytonadione and adverse maternal or fetal outcomes when used during pregnancy. However, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding.
Animal Data In pregnant rats receiving vitamin K 1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established with phytonadione. Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, have been reported with vitamin K.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of phytonadione 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Phytonadione 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. 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.
12.2Pharmacodynamics Phytonadione tablets generally exert their effect within 6 to 10 hours.
12.3Pharmacokinetics Absorption Oral phytonadione is adequately absorbed from the gastrointestinal tract only if bile salts are present. Distribution After absorption, phytonadione is initially concentrated in the liver, but the concentration declines rapidly. Very little vitamin K accumulates in tissues. Elimination Little is known about the metabolic fate of vitamin K. Almost no free unmetabolized vitamin K appears in bile or urine.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Phytonadione 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. 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 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 16714-973-01 in bottle of 100 tablets NDC 16714-973-02 in bottle of 30 tablets 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 phytonadione tablets from light. Store in tightly closed original container and carton until contents have been used.
📋 Description ▾
11 DESCRIPTION Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly 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 450.7.
Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C 31 H 46 O 2 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. Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Vitamin K 1 is fairly rapidly degraded by light; therefore, advise patients to always protect phytonadione tablets from light. Store phytonadione tablets in closed original carton until contents have been used [see How Supplied/Storage and Handling ( 16 ) ]. 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, Northstar Rx LLC at Tel.: 1-800-206-7821.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Oral phytonadione is adequately absorbed from the gastrointestinal tract only if bile salts are present. Distribution After absorption, phytonadione is initially concentrated in the liver, but the concentration declines rapidly. Very little vitamin K accumulates in tissues. Elimination Little is known about the metabolic fate of vitamin K. Almost no free unmetabolized vitamin K appears in bile or urine.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Phytonadione tablets generally exert their effect within 6 to 10 hours.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of carcinogenicity or impairment of fertility have not been performed with phytonadione. Phytonadione at concentrations up to 2,000 mcg/plate, with or without metabolic activation, was negative in the Ames microbial mutagen test.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of carcinogenicity or impairment of fertility have not been performed with phytonadione. Phytonadione at concentrations up to 2,000 mcg/plate, with or without metabolic activation, was negative in the Ames microbial mutagen test.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Phytonadione Tablets USP, 5 mg 30 tablets NDC 16714-973-02 Rx only 5 mg - 30s count