Home Drug Shortages Phytonadione (Vitamin K) Injection Phytonadione (Vitamin K) Injection Last Updated: November 19, 2015 Products Affected - Description All presentations are currently available Reason for the Shortage Amphastar had vitamin K injection on shortage due to increased demand for the product. Oral vitamin K is not affected by this shortage. Vitamin K injection, Amphastar 2 mg/mL, 0.5 mL SAF-T-JET prefilled syringe, 10 count (NDC 76329-1240-01) 10 mg/mL, 1 mL ampule, 25 count (NDC 00409-9158-01) Amphastar and Hospira have Vitamin K injection available. Avoid off-label oral administration of injectable Vitamin K during the shortage. Vitamin K from Amphastar contains polysorbate 80 and propylene glycol. Vitamin K from Hospira contains benzyl alcohol. The product labeling states there is no evidence to suggest toxicity of benzyl alcohol if used as recommended. November 19, September 18, August 12, June 29, 2015, University of Utah, Drug Information Service.
Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.View this article online at http://patient.info/doctor/vitamin-k-deficiencyVitamin K DeficiencyProfessional Reference articles are written by UK doctors and are based on research evidence, UK and European Guidelines. They are designed for health professionals to use, so you may find the language more technical than the condition leaflets. Vitamin K is found in green leafy vegetables and oils, such as olive, cotton seed, and soya bean. Other foods rich in vitamin K are green peas and beans, watercress, asparagus, spinach, broccoli, oats and whole wheat. Vitamin K is also synthesised by colonic bacteria.Vitamin K is an essential lipid-soluble vitamin. It is a co-factor in the synthesis of clotting factors II, VII, IX and X.[2]Vitamin K is also very important for bone health. Vitamin K deficiency is thought to cause impaired activation of bone matrix protein osteocalcin, and reduction of osteoblast function, resulting in impaired bone formation.
[3] However, the clinical significance of this has not yet been fully evaluated.There is growing evidence for a role of vitamin K in vascular health.Deficiency can occur in persons of any age but neonates are at risk of developing vitamin K deficiency bleeding (see the separate article on Vitamin K Deficiency Bleeding). This is because of a lack of vitamin K reaching the fetus across the placenta, the low level of vitamin K in breast milk and low colonic bacterial synthesis.Vitamin K deficiency is uncommon in otherwise healthy adults.Risk factorsExcessive anticoagulation with coumarins - eg, warfarin.Liver disease: for example, cirrhosis, malignancy, amyloidosis and Gaucher's disease decrease the synthesis of vitamin K-dependent factors.Malabsorption: coeliac disease, tropical sprue, Crohn's disease, ulcerative colitis, ascariasis, short bowel syndrome due to multiple abdominal surgeries, bacterial overgrowth, and chronic pancreatitis.Biliary tract disease: common duct obstruction due to stones and strictures, primary biliary cirrhosis, cholangiocarcinoma, and chronic cholestasis.
Leads to a decrease in fat absorption and so a deficiency of fat-soluble vitamins.Dietary deficiency occurs in people with malnutrition, including people with alcoholism, as well as patients undergoing long-term parenteral nutrition without vitamin K supplements.Drugs: colestyramine, salicylates, rifampin, isoniazid and barbiturates are some of the common drugs that are associated with vitamin K deficiency.Diseases with endogenously produced coagulation inhibitors (eg, lupus anticoagulant and antithrombins) and paraproteinaemias such as myeloma, may cause vitamin K deficiency.Miscellaneous causes include massive transfusion, disseminated intravascular coagulation, polycythaemia vera, nephrotic syndrome, cystic fibrosis, and leukaemia.See the separate separate article on Vitamin K Deficiency Bleeding for presentation in infants.The clinical manifestations in adults are evident only if hypoprothrombinaemia is present:Bleeding is the major symptom, especially in response to minor or trivial trauma.
Any site can be involved, including mucosal and subcutaneous bleeding, such as epistaxis, petechiae, haematoma, gastrointestinal bleeding, menorrhagia, haematuria and bleeding from gums.Vitamin K deficiency needs to be considered as a possible cause of any bleeding disorder.The differential diagnosis therefore includes leukaemia, disseminated intravascular coagulation, dysfibrinogenaemia, idiopathic thrombocytopenic purpura, scurvy, thrombotic thrombocytopenic purpura and von Willebrand's disease.Bleeding time, prothrombin time and activated partial thromboplastin time are all elevated.The most sensitive marker is the antibody test for high level of des-gamma-carboxy prothrombin (DCP) protein in vitamin K absence (PIVKA).The plasma level of vitamin K can be measured.Therapy depends on the severity of the bleeding and the underlying cause.In life-threatening bleeds, fresh frozen plasma (FFP) should be administered prior to vitamin K.Vitamin K is available as phytomenadione (vitamin K) and as the synthetic water-soluble analogue menadiol sodium diphosphate.
Intravenous (IV) injections should be given slowly, as fast IV injection can cause bronchospasm and peripheral vascular collapse.Intramuscular injections may lead to severe haematoma formation at the injection site if clotting is impaired.InfantsSee the separate article on Vitamin K Deficiency Bleeding.Haemorrhage in people taking warfarinSee the separate article on Oral Anticoagulants.Patients have a very good prognosis if the vitamin K deficiency is recognised early and treated appropriately.Morbidity correlates with severity of vitamin K deficiency, but severe bleeding can be fatal.A diet rich in vitamin K - eg, green leafy vegetables and oils (such as olive, cotton seed, and soya beans), green peas and beans, watercress, asparagus, spinach, broccoli, oats and whole wheat.Vitamin K given to neonates is very effective in preventing vitamin K deficiency bleeding.Menadiol sodium phosphate is a water-soluble synthetic vitamin K derivative that can be given orally to prevent vitamin K deficiency in malabsorption syndromes.