Phytonadione (Injection)

Phytonadione (Injection) is used to treat bleeding or blood clotting issues caused by a lack of vitamin K, certain medications (like warfarin), or medical conditions (such as obstructive jaundice and 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 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.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know if you have other types of allergies, like those to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems in neonates that would limit the use of phytonadione (Injection). Safety and effectiveness have not been established in children aged 6 months to 17 years.

Geriatric

There is no information available on how age affects the use of phytonadione (Injection) in older adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines can be used together even if an interaction might happen. If you are using this medicine, it is very important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

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

• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or consuming certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Liver disease—Use with caution. The effects may be stronger because the medicine may be removed from the body more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but 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
• 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 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.

In the U.S.

• Aquamephyton

Available Dosage Forms:

• Emulsion
• Solution

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin K (class)

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.