phytonadione

Generic Name: phytonadione (fye toe na DYE own)
Brand names: Mephyton, Vitamin K1, Aquamephyton, Konakion

What is phytonadione?

Phytonadione is a man-made form of vitamin K. Phytonadione is important in the production of substances that cause the blood to clot.

Phytonadione is used to treat vitamin K deficiency and to treat certain bleeding or blood clotting problems.

Phytonadione may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about phytonadione?

Tell your doctor and dentist that you are taking phytonadione before having any type of surgery.

What should I discuss with my healthcare provider before taking phytonadione?

Phytonadione may affect other medical conditions or treatments. Talk to your doctor before taking phytonadione if you have other health problems or conditions, or if you take other medications.

Phytonadione is in the FDA pregnancy category C. This means that it is not known whether phytonadione will be harmful to an unborn baby. Do not take phytonadione without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether phytonadione passes into breast milk and if it will affect a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take phytonadione?

Take phytonadione exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each oral dose with a full glass of water.

Injectable forms of phytonadione are usually administered by a healthcare professional. If you are injecting phytonadione at home, your doctor or nurse will give you detailed instructions regarding preparation, administration, and storage of the medication.

Do not take more phytonadione than is prescribed.

It is important to take phytonadione regularly to get the most benefit.

Your doctor may want you to have blood tests or other medical evaluations during treatment with phytonadione to monitor progress and side effects.

Store phytonadione at room temperature away from moisture and heat. Protect phytonadione from light, as light decreases the effectiveness of the medication.

What happens if I miss a dose?

Contact your doctor if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a phytonadione overdose are not known.

What should I avoid while taking phytonadione?

Tell your doctor and dentist that you are taking phytonadione before having any type of surgery.

Phytonadione side effects

Seek emergency medical attention or contact your doctor immediately if you experience any serious side effects from phytonadione such as:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• dizziness;

• fast or irregular heartbeats; or

• increased sweating.

Other less serious side effects may be more likely to occur. Continue to use phytonadione and talk to your doctor if you experience

• flushing of the face;

• an unusual taste in the mouth; or

• pain or irritation at the injection site (injectable form).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Phytonadione Dosing Information

Usual Adult Dose for Hypoprothrombinemia -- Anticoagulant Induced:

Active   Rapid        
INR   Bleed    Reversal   Therapy & Follow-Up Comment
<6      No         No           Omit 1 to 4 anticoagulant doses and
                                        reduce dosage when resume therapy.
<10    No         Yes          Prior to surgical or dental procedures
                                        give 0.5 to 1 mg IM, subcutaneously, 
                                        or IV.  Check INR in 8 hours.  May 
                                        repeat 0.5 mg in 24 hours if needed. 
6-10   No         No            Omit 1 to 4 anticoagulant doses.  May
                                        consider phytonadione 0.5 to 2 mg orally, 
                                        IM, subcutaneously, or IV.  Check INR 
                                        in 8 hours (12 to 48 hours if given orally).  
                                        May repeat 0.5 mg in 24 to 48 hours if 
                                        needed.
10-20  No         No           Phytonadione 3 to 5 mg orally, IM, 
                                        subcutaneously, or IV.  Check INR in 
                                        8 hours (12 to 48 hours if given orally).  
                                        May repeat 0.5 mg in 24 hours if needed.
> 20 or Yes       --             Phytonadione 10 mg IM, subcutaneously, 
                                        or IV.  Check INR every 6 hours and 
                                        repeat dose every 12 hours as needed.  
                                        In acute situations, give fresh frozen 
                                        plasma or factor concentrates and 
                                        phytonadione 10 mg, to be repeated 
                                        as needed.

Usual Adult Dose for Hypoprothrombinemia -- Not Associated with Anticoagulant Therapy:

2.5 to 25 mg orally, IM, subcutaneously, or IV.
The dosage, frequency, and route of administration should be determined by the severity of the condition.
If there is no bleeding and INR < 20: 2.5 to 5 mg (up to 10 mg) may be given orally, IM, subcutaneously, or IV.
For active bleeding: 10 to 25 mg IM, subcutaneously, or IV.
When given by injection, the effects may not be apparent for up to 8 hours. Therefore, a transfusion with fresh frozen plasma or factor concentrates is recommended in serious or life-threatening situations. The INR may be checked in 8 to 12 hours following parenteral therapy or 12 to 48 hours following oral therapy, and dosage repeated if necessary.

Usual Adult Dose for Hypoprothrombinemia -- Prophylaxis:

2.5 to 10 mg orally or 1 to 10 mg IM, depending on the patient's condition. Malabsorption syndromes: 10 mg IM monthly.
Surgical correction of biliary obstruction: 5 mg IM once a day for 3 days prior to surgery.
Prolonged antibiotics in at risk patients: 10 mg orally, IM, or subcutaneously prior to or concurrent with the first antibiotic dose.
Malnourished, debilitated, or TPN patients: 1 mg IM once a week.

Usual Pediatric Dose for Hypoprothrombinemia -- Anticoagulant Induced:

> 1 month to 12 years:
No bleeding, rapid reversal needed, anticoagulation to continue: 0.5 to 2 mg IV or subcutaneously once.
No bleeding, rapid reversal needed, patient NOT continuing anticoagulation: 2 to 5 mg IV or subcutaneously once.
Significant bleeding, not life-threatening: 0.5 to 2 mg IV or subcutaneously.
Significant bleeding and life-threatening: 5 mg IV.

Usual Pediatric Dose for Vitamin K Deficiency:

> 1 month to 12 years:
2.5 to 5 mg orally once every 24 hours. Alternatively, 1 to 2 mg IV, IM or subcutaneously may be administered.

What other drugs will affect phytonadione?

Before taking phytonadione, tell your doctor about all other medicines you are taking, especially any of the following:

• warfarin (Coumadin);

• mineral oil;

• orlistat (Xenical);

• cholestyramine (Questran, Prevalite);

• a salicylate such as aspirin (Acuprin, Ecotrin, Ascriptin, Bayer, others); choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid);

• a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Anaprox, Aleve), diclofenac (Voltaren, Cataflam), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), or tolmetin (Tolectin); or

• an antibiotic.

You may not be able to take phytonadione, or you may require a dosage adjustment or special monitoring during treatment.

Medications other than those listed here may also interact with phytonadione. Tell your doctor about all other prescription and over-the-counter medicines that you take, including vitamins, minerals, and herbal products.

Where can I get more information?

• Your pharmacist has more information about phytonadione written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.05. Revision Date: 4/12/2009 4:40:06 PM.