Medical Editor: John P. Cunha, DO, FACOEP
AquaMEPHYTON (phytonadione injection) is a vitamin K replacement indicated for the treatment of 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: anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives; hypoprothrombinemia due to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; and other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. AquaMEPHYTON is also indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. Common side effects of AquaMEPHYTON include:
- bluish discoloration of skin (from poor circulation or low oxygen),
- changes in taste,
- shortness of breath,
- low blood pressure (hypotension), and
- fast heart rate.
The dosage of AquaMEPHYTON is based on the patient's medical condition and response to treatment. AquaMEPHYTON is administered by injection under the skin or into a muscle or vein as directed by a physician. If AquaMEPHYTON is administered intravenously, it should be injected at a rate of no more than 1 milligram per minute to reduce the risk of serious side effects. AquaMEPHYTON may interact with anticoagulants. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using AquaMEPHYTON. AquaMEPHYTON contains benzyl alcohol, which can harm a fetus. If AquaMEPHYTON is needed during pregnancy, consider a benzyl alcohol-free formulation. AquaMEPHYTON passes into breast milk and contains benzyl alcohol. Preservative-free AquaMEPHYTON is recommended if AquaMEPHYTON is needed during lactation. Consult your doctor before breastfeeding.
Our AquaMEPHYTON (phytonadione injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Cutaneous Reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials And Post Marketing Experience
The following adverse reactions associated with the use of AquaMEPHYTON were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac Disorders: Tachycardia, hypotension
General disorders and administration site conditions: Generalized flushing pain, swelling and tenderness at injection site.
Hepatobiliary Disorders: Hyperbilirubinemia
Immune System Disorders: Fatal hypersensitivity reactions, anaphylactic reactions.
Neurologic: Dysgeusia, dizziness
Skin and Subcutaneous: Tissue Disorders: Erythema, pruritic plaques, scleroderma-like-lesions, erythema perstans.
Read the entire FDA prescribing information for AquaMEPHYTON (Phytonadione Injection)