Phytonadione
Generic Name: phytonadione
Brand Names:
Phytonadione
11 DESCRIPTION Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, viscous, odorless or 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.
Overview
11 DESCRIPTION Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, viscous, odorless or 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.
Uses
1 INDICATIONS AND USAGE Phytonadione Injectable Emulsion is a vitamin K replacement indicated for the treatment of 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 deficiency caused by coumarin or indanedione derivatives; ( 1.1 ) Hypoprothrombinemia due to antibacterial therapy; ( 1.1 ) 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; ( 1.1 ) Other drug-induced hypoprothrombinemia where is it definitely shown that the res...
Dosage
2 DOSAGE AND ADMINISTRATION Administer Phytonadione Injectable Emulsion by the subcutaneous route, whenever possible. ( 2.1 ) When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute. ( 2.1 ) 2.1 Dosing Considerations Whenever possible, administer Phytonadione Injectable Emulsion by the subcutaneous route [see Boxed Warning ] . When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute [see WARNINGS AND PRECAUTIONS ( 5.1 )] . Monitor international normalized ratio (INR) regularly and as clinical conditions indicate. Use the lowest effective dose of Phytonadione Injectable Emulsion.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS ( 5.1 )] Cutaneous Reactions [see WARNINGS AND PRECAUTIONS ( 5.3 )] Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Interactions
7 DRUG INTERACTIONS Anticoagulants: May induce temporary resistance to prothrombin-depressing anticoagulants. ( 7 ) Anticoagulants Phytonadione Injectable Emulsion may induce temporary resistance to prothrombin-depressing anticoagulants, especially when larger doses of Phytonadione Injectable Emulsion 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 Injectable Emulsion does not affect the anticoagulant action of heparin.
Warnings
WARNING – HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Phytonadione Injectable Emulsion. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. 5 WARNINGS AND PRECAUTIONS Cutaneous Reactions: May occur with parenteral use. Discontinue drug and manage medically. ( 5.3 ) 5.1 Hypersensitivity Reactions Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of Phytonadione Injectable Emulsion. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. These reactions have included shock, cardiorespiratory arrest, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea. Administer Phytonadione Injectable Emulsion subcutaneously whenever feasible. 4 CONTRAINDICATIONS Hypersensitivity to phytonadione or any other component of this medication [see WARNINGS AND PRECAUTIONS ( 5.1 )]. Hypersensitivity to any component of this medication. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary If Phytonadione is needed during pregnancy, consider using a preservative-free formulation. 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.
Storage
Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light . Store container in closed original carton until contents have been used. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. User Guide
Frequently Asked Questions
What is Phytonadione used for?▼
1 INDICATIONS AND USAGE Phytonadione Injectable Emulsion is a vitamin K replacement indicated for the treatment of 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 deficiency caused by coumarin or indanedione derivatives; ( 1.1 ) Hypoprothrombinemia due to antibacterial therapy; ( 1.1 ) 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; ( 1.1 ) Other drug-induced hypoprothrombinemia where is it definitely shown that the res...
What are the side effects of Phytonadione?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS ( 5.1 )] Cutaneous Reactions [see WARNINGS AND PRECAUTIONS ( 5.3 )] Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Phytonadione during pregnancy?▼
8.1 Pregnancy Risk Summary If Phytonadione is needed during pregnancy, consider using a preservative-free formulation. 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.
What are the important warnings for Phytonadione?▼
WARNING – HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Phytonadione Injectable Emulsion. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. 5 WARNINGS AND PRECAUTIONS Cutaneous Reactions: May occur with parenteral use. Discontinue drug and manage medically. ( 5.3 ) 5.1 Hypersensitivity Reactions Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of Phytonadione Injectable Emulsion. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. These reactions have included shock, cardiorespiratory arrest, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea. Administer Phytonadione Injectable Emulsion subcutaneously whenever feasible. 4 CONTRAINDICATIONS Hypersensitivity to phytonadione or any other component of this medication [see WARNINGS AND PRECAUTIONS ( 5.1 )]. Hypersensitivity to any component of this medication. ( 4 )
Related Medications
Arnica Montana, Ferrum Phosphoricum, Hypericum Perforatum, Thuja Occidentalis, Ledum Palustre
arnica montana, ferrum phosphoricum, hypericum perforatum, thuja occidentalis, ledum palustre
Purpose Arnica montana 8X.............................................fever, aches & pains, headache, sore throat (Leopard's bane) Ferrum phosphoricum 8X.....................................fever, inflammation (Ferrosoferric phosphate) Hypericum perforatum 8X....................................pain in the extremeties, toothache, fever (St. John's wort) Thuja occidentalis 8X..........................................sinus congestion, headache, muscular pain (White cedar) Ledum palustre 8X (Wild ro
Petroselinum Sativum, Natrum Muriaticum, Hepar (bovine), Medulla Ossis Suis, Spleen (bovine), Thymus (ovine), Saccharinum
petroselinum sativum, natrum muriaticum, hepar (bovine), medulla ossis suis, spleen (bovine), thymus (ovine), saccharinum
Non-Standardized Food Allergenic Extract [EPC]
PURPOSE: Hepar (Liver) – Support of Liver,† Medulla Ossis Suis – Relief of Achiness,† Natrum Muriaticum – Assists in Relieving Sinus Symptoms, Minor Breathing Issues, Achiness and Fever,† Petroselinum Sativum – Assists in Relieving Fever,† Saccharinum – Assists in Relieving Achiness and Fever,† Spleen – Support of Spleen,† Thymus – Support of Thymus†
Heart Drops
heart drops
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.