Mephyton (Oral)

Phytonadione is used to treat bleeding or blood clotting issues caused by a lack of vitamin K, some medications (for example, warfarin), or health conditions (for example, obstructive jaundice, ulcerative colitis). Phytonadione is a synthetic version of vitamin K, which is naturally found in the body. It helps to treat and prevent low levels of blood clotting factors that are necessary for your blood to thicken and stop bleeding properly.

This medicine is available only with your doctor’s prescription.

It is very important that your doctor checks your progress at regular visits to see if the medicine is working properly and to decide if you should keep using it. Blood tests are needed to check for unwanted effects.

Do not take other medicines unless your doctor has talked about them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will balance the risks of taking the medicine against the benefits it may provide. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been conducted on how phytonadione affects children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of phytonadione. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may require caution and an adjustment in dose for those taking this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there may be an interaction. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The following interactions are noted for their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed, your doctor may change the dose or frequency of one or both medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around meal times or with certain foods due to potential interactions. Alcohol or tobacco use with certain medicines may also lead to interactions. The following interactions are noted for their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Liver disease—Use with caution. The effects may be stronger due to the slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects occur:

Incidence not known

• Bluish color of the fingernails, lips, skin, palms, or nail beds
• blurred vision
• chest tightness
• confusion
• cough
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid and weak pulse
• sweating
• trouble breathing
• unusual tiredness or weakness
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Change in taste
• feeling of warmth
• redness of the face, neck, arms and occasionally, upper chest

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Mephyton

Available Dosage Forms:

• Capsule
• Tablet

Therapeutic Class: Nutriceutical

Pharmacologic Class: Vitamin K (class)

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Your doctor will give you bile salt supplements together with this medicine. Your doctor may also give you plasma or other blood products in addition to vitamin K if your bleeding is severe.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For blood clotting disorders caused by a blood thinner: Adults—At first, 2.5 to 10 milligrams (mg). Your doctor may increase your dose as needed. However the dose is usually not more than 25 to 50 mg per day. Children—Use and dose must be determined by your doctor. For blood clotting disorders caused by a medical condition: Adults—At first, 2.5 to 25 milligrams (mg). Your doctor may increase your dose as needed. However the dose is usually not more than 50 mg per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.