Frequently Asked Questions
Mephyton (Phytonadione)
Can I use this medication if I use herbal supplements?
Little is known about the interaction of herbal supplements and Mephyton, so please ask your physician.
Can I take this medication if I am pregnant or contemplate becoming pregnant?
Only your physician will be able to answer this question in your situation.
Will this drug affect my menstrual cycle?
Only your physician will be able to answer this question in your situation.
I already take a multivitamin that contains Vitamin K, should I stop that or can I continue taking that multivitamin?
Only your physician will be able to answer this question in your situation.
Are there any special dietary restrictions while I am taking this medication?
Only your physician will be able to answer this question in your situation.
Is it necessary that I take this medication at the same time each day?
Please ask your physician.
What should I do if I miss a dose?
Please ask your physician.
Do I have lab work monitored while taking this medication?
Your physician will determine what lab work needs to be done at what interval for your condition.
Are there any special storage requirements for this medication?
Vitamin K is rapidly degraded by light; therefore Mephyton should be protected from direct light and should be in original container at room temperature until the contents have been used.
Why has my urine changed color?
Phytonadione is a vitamin which is a clear, yellow to amber, viscous and nearly odorless liquid. We don’t have any information that would suggest that it could change the color or your urine, however you may want to discuss this with your physician.
Can I go out in the sun if I take this medication?
YES.
Does this medication increase my risk of stroke?
Please ask your physician.
Can I safely drink alcoholic beverages if I take this medication?
Please ask your physician.
What are some of the side effects I could experience if I take this medication?
Please ask your physician.
Do I have to increase my fluid intake if I am on this medication?
NO.
Is there anyone who should not take this medication?
Repeated large doses of vitamin K are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. Before taking any medication, you should discuss this with your doctor.
What products are contraindicated while using this medication?
Please ask your physician.
Why does Mephyton have to be stored in its original package?
The active ingredient in Mephyton is light sensitive and will degrade over time with exposure to light. While the bottle provides significant protection from light exposure, the carton provides added protection from light.
Does Mephyton contain Yellow #4?
There is no yellow #4 in Mephyton. The color of the tablets comes from the active ingredient – Vitamin K.
What is the stability and dosage for the smallest dosage possible for Mephyton?
The Mephyton tablet is scored to allow delivery of a dose as low as 2.5 mg with reasonable dose uniformity.
Pregnancy, Nursing, and Pediatric Use for MEPHYTON®
Pregnancy
Pregnancy Category C: Animal reproduction studies have not been conducted with MEPHYTON. It is also not known whether MEPHYTON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MEPHYTON should be given to a pregnant woman only if clearly needed.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established with MEPHYTON. Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, have been reported with vitamin K.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when MEPHYTON is administered to a nursing woman.
Can you prepare MEPHYTON as an oral liquid formulation?
Aton Pharma does not market a liquid formulation.
What is the amount of lactose in each tablet of Mephyton?
Each tablet of Mephyton contains 67.6 mg of lactose.
Indications
MEPHYTON® (PHYTONADIONE) is indicated in 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.
MEPHYTON tablets are indicated in: anticoagulant-induced prothrombin
deficiency caused by coumarin or indanedione derivatives; hypoprothrombinemia
secondary to antibacterial therapy; hypoprothrombinemia secondary
to administration of salicylates; hypoprothrombinemia secondary to
obstructive jaundice or biliary fistulas but only if bile salts are administered
concurrently, since otherwise the oral vitamin K will not be absorbed.
Important Safety Information
MEPHYTON (PHYTONADIONE) is contraindicated in patients with hypersensitivity to any component of this medication. An immediate coagulation effect should not be expected after administration. MEPHYTON will not counteract the anticoagulant action of heparin. 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. Failure to respond to vitamin K may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
PLEASE SEE FULL PRESCRIBING INFORMATION.
