Pronunciation:

fye-toe-na-DYE-one

Brand Names:

• Aquamephyton

Dosage Forms:

• Emulsion
• Solution

Classifications:

Therapeutic—

Nutritive Agent

Pharmacologic—

Vitamin K (class)

Uses of This Medicine:

Phytonadione injection is used to treat bleeding or blood clotting problems caused by vitamin K deficiency, certain medicines (eg, warfarin), or medical conditions (obstructive jaundice, ulcerative colitis). Phytonadione is a man-made form of vitamin K, which occurs naturally in the body. It treats and prevents low levels of blood clotting factors needed to help your blood to thicken and stop bleeding normally.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of phytonadione injection in neonates. Safety and efficacy have not been established in children 6 months to 17 years of age.

Older adults—

No information is available on the relationship of age to the effects of phytonadione injection in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, into a muscle, or into a vein. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

Check the medicine before using. It should be clear and yellow. Do not use it if it is discolored or has particles in it.

Use a new needle and syringe each time you inject your 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 injection dosage form (solution):
  • For blood clotting disorders caused by a blood thinner:
    • Adults—At first, 2.5 to 10 milligrams (mg) injected under the skin. 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) injected under the skin. 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—

Call your doctor or pharmacist for instructions.

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.

Precautions While Using This Medicine:

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

This medicine may cause a serious allergic reaction called anaphylaxis, when it is given as a shot into your muscle or vein. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Some preparations of this medicine may contain benzyl alcohol which may cause serious reactions (including gasping syndrome) to newborn or premature infants.

This medicine may cause a delayed skin reaction a day or 1 year after receiving the injection. Check with your doctor right away if you have a new rash.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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

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

Incidence not known

Bluish color of the fingernails, lips, skin, palms, or nail beds

blurred vision

confusion

cough

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

hives, itching, skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

tightness in the chest

trouble breathing

unusual tiredness or weakness

unusually warm skin

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

pain, swelling, and tenderness at the injection site

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.