Phytonadione (injection): Difference between revisions

Phytonadione (injection)
	Black Box Warning
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

VisualWikitext

Revision as of 13:05, 18 May 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Shanshan Cen, M.D. [2]

Disclaimer

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Black Box Warning

WARNING — INTRAVENOUS AND INTRAMUSCULAR USE:

See full prescribing information for complete Boxed Warning.

ConditionName: Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.

Overview

Phytonadione (injection) is a vitamin that is FDA approved for the treatment of 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. It's also been used as a prophylaxis of hemorrhagic disease of the newborn. There is a Black Box Warning for this drug as shown here. Common adverse reactions include skin reaction.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;

prophylaxis and therapy of hemorrhagic disease of the newborn;

hypoprothrombinemia due 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 pancreas, 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Phytonadione (injection) in adult patients.

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Phytonadione (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Phytonadione (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Phytonadione (injection) in pediatric patients.

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Phytonadione (injection) in pediatric patients.

Contraindications

Condition1

Warnings

WARNING — INTRAVENOUS AND INTRAMUSCULAR USE:

See full prescribing information for complete Boxed Warning.

ConditionName: Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Phytonadione (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Phytonadione (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Phytonadione (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Phytonadione (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Phytonadione (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Phytonadione (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Phytonadione (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Phytonadione (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Phytonadione (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Phytonadione (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Phytonadione (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Phytonadione (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Phytonadione (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Phytonadione (injection) in the drug label.

Description

IV Compatibility

There is limited information regarding IV Compatibility of Phytonadione (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Phytonadione (injection) in the drug label.

Pharmacology

There is limited information regarding Phytonadione (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Phytonadione (injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Phytonadione (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Phytonadione (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Phytonadione (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Phytonadione (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Phytonadione (injection) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Phytonadione (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Phytonadione (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Phytonadione (injection) in the drug label.

Precautions with Alcohol

Alcohol-Phytonadione (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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[1] Empty citation (help)

[www.ismp.org-2] "http://www.ismp.org". External link in |title= (help)

[1]

[2]

@@ Line 1: / Line 1: @@
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+|authorTag={{SC}}
+|genericName=phytonadione
 |aOrAn=a
+|drugClass=vitamin
 |indicationType=treatment
+|indication=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. It's also been used as a prophylaxis of hemorrhagic disease of the newborn
 |hasBlackBoxWarning=Yes
-|adverseReactions=<!--Black Box Warning-->
+|adverseReactions=skin reaction
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-* Content
+Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.
+|fdaLIADAdult=====Indications====
+anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
-<!--Adult Indications and Dosage-->
+prophylaxis and therapy of hemorrhagic disease of the newborn;
-<!--FDA-Labeled Indications and Dosage (Adult)-->
+hypoprothrombinemia due to antibacterial therapy;
-|fdaLIADAdult======Condition1=====
-* Dosing Information
+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;
-:* Dosage
+other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.
-=====Condition2=====
-* Dosing Information
-:* Dosage
-=====Condition3=====
-* Dosing Information
-:* Dosage
-=====Condition4=====
-* Dosing Information
-:* Dosage
-<!--Off-Label Use and Dosage (Adult)-->
-<!--Guideline-Supported Use (Adult)-->
 |offLabelAdultGuideSupport======Condition1=====