Severe hypersensitivity reactions, including fatal anaphlaxis, have occurred during and immediately after IV or IM injection of phytonadione injection.
Such severe reactions have occurred despite employing measures to prevent hypersensitivity reactions, including dilution of the injection and administration by slow infusion.
These severe reactions are consistent with hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest and have occurred after initial administration.
Restrict IV and IM administration to those situations where sub-Q administration is not feasible and the serious risk associated with IV or IM administration is considered justified.
PHYTONADIONE (fye toe na DYE one) is a man-made form of vitamin K. This medicine is used to treat vitamin K deficiency or bleeding problems caused by various disorders.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for injection under the skin, into a muscle, or rarely, into a vein. It is usually given by a health care professional in a hospital or clinic setting.
If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
medicines that treat or prevent blood clots like warfarin
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. Your doctor or health care professional will schedule tests to make sure the medicine is working properly.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
bluish discoloration of lips, fingernails, or palms of hands
breathing problems
increased sweating
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
pain, inflammation, or swelling at site where injected
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Protect from light. Store in tightly closed container and original carton until contents have been used. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
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.
