Phytonadione

Drug overview for PHYTONADIONE (phytonadione):

Generic name: PHYTONADIONE
Drug class: Vitamin K
Therapeutic class: Electrolyte Balance-Nutritional Products

Phytonadione is a fat-soluble naphthoquinone derivative that is identical to naturally occurring vitamin K1.

Phytonadione is used in the prophylaxis and/or treatment of coagulation disorders due to faulty formation of factors II, VII, IX, and X caused by vitamin K deficiency or interference with vitamin K activity. Phytonadione is more effective than, and is preferred to, other vitamin K preparations in the presence of impending or actual hemorrhage. However, because phytonadione may require 3 hours or longer to stop active bleeding, administration of clotting factors (e.g., prothrombin complex concentrate (human)), fresh whole blood, or plasma may be necessary for more rapid control of severe bleeding.

DRUG IMAGES

PHYTONADIONE 1 MG/0.5 ML SYR

The following indications for PHYTONADIONE (phytonadione) have been approved by the FDA:

Indications:
Antibiotic-induced hypoprothrombinemia
Anticoagulant-induced prothrombin deficiency
Hemorrhagic disease of newborn due to vitamin K deficiency
Hypoprothrombinemia
Prevention of hemorrhagic disease of newborn due to vitamin K deficiency
Vitamin K deficiency induced hypoprothrombinemia

Professional Synonyms:
Antibiotic-induced decreased serum factor II
Antibiotic-induced decreased serum prothrombin
Anticoagulant-induced serum factor II deficiency
Anticoagulant-induced serum prothrombin deficiency
Anticoagulant-related prothrombin deficiency
Decreased serum factor II due to vitamin K deficiency
Decreased serum prothrombin due to vitamin K deficiency
Decreased serum prothrombin
Factor II deficiency
Hemorrhagic disease of newborn
Neonatal hemorrhagic diathesis
Neonatal hemorrhagic disease prevention
Neonatal hemorrhagic predisposition due to low vitamin K
Neonatal predisposition to bleed due to low vitamin K
Prevention of vitamin K deficiency bleeding in newborn
Vitamin K deficiency bleeding in newborn

The following dosing information is available for PHYTONADIONE (phytonadione):

Dosing
Administration
PHYTONADIONE
PHYTONADIONE

Dose, frequency of administration, and duration of treatment with phytonadione depend on the severity of the prothrombin deficiency and the response of the patient; the lowest effective dose of phytonadione should be used.

Phytonadione may be administered orally or parenterally (IV, IM, or subcutaneously). The parenteral preparation also has been administered orally+ in neonates. The route of administration of phytonadione depends on the severity of the prothrombin deficiency and the risks associated with administration by each route.

The manufacturers state that because of the possibility of severe adverse reactions (see Cautions: Adverse Effects), IV or IM administration is indicated only when other routes of administration are not feasible and the serious risk is justified. However, the effects of phytonadione have been reported to be delayed and/or unpredictable following subcutaneous injection, and subcutaneous administration may be less effective for reversal of excessive anticoagulation than IV or oral administration. The American College of Chest Physicians (ACCP) and other clinicians recommend IV administration of phytonadione in emergency situations for major bleeding due to vitamin K-antagonist anticoagulants because of its more rapid onset; these clinicians recommend that subcutaneous administration be avoided.

Oral administration of phytonadione usually reduces international normalized ratio (INR) levels in 24-48 hours and generally is recommended over parenteral administration in selected asymptomatic (nonbleeding) patients with hypoprothrombinemia due to vitamin K-antagonist anticoagulants. In patients with decreased bile secretion, bile salts (e.g., ox bile extract 300 mg or dehydrocholic acid 500 mg) should be given with each oral dose of phytonadione to ensure absorption. Parenteral administration is indicated in patients who are unable to retain or absorb the drug from the GI tract.

When phytonadione injection is administered IV, it should be injected at a rate not exceeding 1 mg/minute. The drug may be diluted for infusion with 0.9% sodium chloride, 5% dextrose, or 5% dextrose in 0.9%

sodium chloride injection; other diluents that may contain benzyl alcohol should not be used. (See Cautions: Pediatric Precautions.) The drug should be administered immediately after dilution, and any unused portion of the dilution and the unused contents of the ampul or vial should be discarded. The infusion container must be protected from light at all times. (See Chemistry and Stability: Stability.)

Dosing information for PHYTONADIONE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
PHYTONADIONE 1 MG/0.5 ML SYR	Maintenance	Adults inject 1.25 milliliters (2.5 mg) by subcutaneous route x1 dose; may be repeated in 6 to 8 hours after the first dose

Generic dosing information for PHYTONADIONE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
PHYTONADIONE 1 MG/0.5 ML SYR	Maintenance	Adults inject 1.25 milliliters (2.5 mg) by subcutaneous route x1 dose; may be repeated in 6 to 8 hours after the first dose

The following drug interaction information is available for PHYTONADIONE (phytonadione):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 1 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Selected Anticoagulants (Vitamin K antagonists)/Vitamin K SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Anticoagulants interfere with the activation of vitamin K-dependent clotting factors. Vitamin K administration may reverse this effect. CLINICAL EFFECTS: The pharmacological effect of anticoagulants may be reversed resulting in thrombus formation. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving anticoagulants should avoid eating unusual increases in foods high in vitamin K content. The time of highest risk for a coumarin-type drug interaction is when the precipitant drug is initiated or discontinued. Contact the prescriber before initiating, altering the dose or discontinuing either drug. DISCUSSION: Numerous reports have demonstrated that vitamin K interferes with the hypoprothrombinemic effects of anticoagulants. However, reports of clinically important consequences are uncommon. A clearer understanding of the mechanism by which these drugs act has made it possible to use vitamin K to control bleeding side effects of warfarin therapy. One should be aware of the vitamin K content of enteral feeding products being administered to patients on anticoagulant therapy. Prothrombin time should be monitored when these products are given.	ANISINDIONE, DICUMAROL, JANTOVEN, PHENINDIONE, WARFARIN SODIUM

Drug Interaction

Drug Names

Selected Anticoagulants (Vitamin K antagonists)/Vitamin K

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Anticoagulants interfere with the activation of vitamin K-dependent clotting factors. Vitamin K administration may reverse this effect.

CLINICAL EFFECTS: The pharmacological effect of anticoagulants may be reversed resulting in thrombus formation.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients receiving anticoagulants should avoid eating unusual increases in foods high in vitamin K content. The time of highest risk for a coumarin-type drug interaction is when the precipitant drug is initiated or discontinued. Contact the prescriber before initiating, altering the dose or discontinuing either drug.

DISCUSSION: Numerous reports have demonstrated that vitamin K interferes with the hypoprothrombinemic effects of anticoagulants. However, reports of clinically important consequences are uncommon. A clearer understanding of the mechanism by which these drugs act has made it possible to use vitamin K to control bleeding side effects of warfarin therapy.

One should be aware of the vitamin K content of enteral feeding products being administered to patients on anticoagulant therapy. Prothrombin time should be monitored when these products are given.

ANISINDIONE, DICUMAROL, JANTOVEN, PHENINDIONE, WARFARIN SODIUM

There are 0 moderate interactions.

Contraindication List
Hemolytic anemia from pyruvate kinase and g6PD deficiencies

The following adverse reaction information is available for PHYTONADIONE (phytonadione):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 8 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Cyanosis Dizziness Hyperbilirubinemia Hyperhidrosis Hypersensitivity drug reaction Hypotension Skin lesion

There are 11 less severe adverse reactions.

More Frequent	Less Frequent
None.	Dysgeusia Flushing Injection site sequelae Skin swelling

Rare/Very Rare
Dyspnea Eczema Erythema Erythema dyschromicum perstans Pseudoscleroderma Tachycardia Urticaria

The following precautions are available for PHYTONADIONE (phytonadione):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Reproduction studies have not been conducted in animals, and it is not known if phytonadione has teratogenic effects.

No enhanced Lactation information available for this drug.

No enhanced Geriatric Use information available for this drug.

Antibiotic-induced hypoprothrombinemia
D68.4	Acquired coagulation factor deficiency
Anticoagulant-induced prothrombin deficiency
D68.4	Acquired coagulation factor deficiency
Hemorrhagic disease of newborn due to vitamin K def
P53	Hemorrhagic disease of newborn
Hypoprothrombinemia
D68.4	Acquired coagulation factor deficiency
Vitamin K deficiency induced hypoprothrombinemia
D68.4	Acquired coagulation factor deficiency