WARNING — INTRAVENOUS AND INTRAMUSCULAR USE
Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.
VITAMIN K1 SUMMARY
Injectable Emulsion, USP
Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol.
Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is indicated in 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.
Vitamin K1 Injection is indicated in:
anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
prophylaxis and therapy of hemorrhagic disease of the newborn;
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;
other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.
Published Studies Related to Vitamin K1 (Phytonadione)
Differential effects of vitamin K1 on AFP and DCP levels in patients with unresectable HCC and in HCC cell lines. [2011.06]
CONCLUSIONS: Vitamin K1 was non-toxic at high doses, strongly inhibited plasma DCP levels, but weakly suppressed AFP levels. The results provide evidence that the two tumor markers are not directly linked and that DCP levels may not reflect HCC cell growth, as DCP levels were decreased in patients without AFP change, and were suppressed in vitro at 1% of the vitamin K1 concentration needed to inhibit AFP.
Nutritional supplementation of hop rho iso-alpha acids, berberine, vitamin D, and vitamin K produces a favorable bone biomarker profile supporting healthy bone metabolism in postmenopausal women with metabolic syndrome. [2011.05]
Metabolic syndrome poses additional risk for postmenopausal women who are already at risk for osteoporosis. We hypothesized that a nutritional supplement containing anti-inflammatory phytochemicals and essential bone nutrients would produce a favorable bone biomarker profile in postmenopausal women with metabolic syndrome...
Vitamin K1 supplementation to improve the stability of anticoagulation therapy with vitamin K antagonists: a dose-finding study. [2011.04]
BACKGROUND: Poor anticoagulant stability in patients using vitamin K antagonists is a risk factor for both bleeding and thrombosis. In previous studies supplementation with low dose vitamin K(1) was shown to improve the stability of anticoagulant control. We set up a study to confirm earlier reports and to determine the optimal daily dose of vitamin K(1) in preparation of a large study with clinical endpoints... CONCLUSIONS: In patients starting vitamin K antagonists, supplementation with low dose vitamin K(1) resulted in an improvement of time that anticoagulation was within the therapeutic range. Differences between doses were, however, small and the improvement is unlikely to be of clinical relevance. For future studies we recommend selecting only patients with instable anticoagulant control. (This study was registered at www.isrctn.org as ISRCTN37109430).
The cost effectiveness of a randomized controlled trial to establish the relative efficacy of vitamin K1 compared with alendronate. [2011.01]
CONCLUSIONS: It is concluded that an RCT recruiting between 2000 and 5000 women per arm to evaluate the relative efficacy of alendronate and vitamin K(1) appears to be cost effective for informing decision making in England and Wales.
Hop rho iso-alpha acids, berberine, vitamin D3 and vitamin K1 favorably impact biomarkers of bone turnover in postmenopausal women in a 14-week trial. [2010.05]
Osteoporosis is a major health issue facing postmenopausal women... Treatment with hop rho iso-alpha acids, berberine sulfate trihydrate, vitamin D(3) and vitamin K(1) produced a more favorable bone biomarker profile that supports a healthy bone metabolism.
Clinical Trials Related to Vitamin K1 (Phytonadione)
Safety Study of a Vitamin E Supplement in Normal Volunteers and Those With Both Allergy and Asthma [Recruiting]
Gamma tocopherol (gt) is a naturally occurring form of vitamin E that is found in many foods, and is also commercially available as a vitamin supplement. The purpose of this Phase 1 research study is to see if two doses of gt, 600mg and 1200mg, are safe (do not cause gastrointestinal distress or other problems), and can cause changes in your blood levels of gt and other antioxidants. This study will also examine if there is a difference in response between asthmatic and non-asthmatic adults when taking the same dose of gt. Phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation.
Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption? [Completed]
Vitamin B12 is an essential nutrient for normal DNA-synthesis and must be supplied by animal
products. Vitamin B12 deficiency may cause anemia and irreverible neurological damage.
Laboratory tests are used for diagnosis of vitamin B12 deficiency, and following the
diagnosis, the cause of the vitamin B12 deficiency has to be clarified. For years a test
called Shilling’s test has been used for evaluation of the vitamin B12 absorption. However,
the Schilling’s test is no longer easy accessible because of increasing difficulties to
obtain the radioactively labeled vitamin B12 requested, and native human intrinsic factor for
Schilling’s test II (absorption of vitamin B12 attached to intrinsic factor) is no longer
available in most countries. Recently, human intrinsic factor unsaturated with vitamin B12
has been expressed in the plant Arabidopsis thaliana. The purpose of this study was to
examine whether recombinant human intrinsic factor is able to promote the uptake of vitamin
B12 in patients with evident vitamin B12 deficiency.
Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development [Completed]
Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in
infants. We have earlier investigated cobalamin status in healthy children and we observed
metabolic evidence of impaired cobalamin status during the first 6 months, but not later in
The purpose of this study is to determine if cobalamin supplementation may influence the
metabolic profile related to cobalamin status in infants.
Dose-Finding Study for Vitamin K2 in Human Volunteers [Completed]
Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular
health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins,
menaquinone-7 (MK-7) has been identified as the most effective cofactor for the carboxylation
reaction of Gla-proteins such as osteocalcin and matrix-gla protein. The question remains
which dosage of MK-7 leads to optimal carboxylation levels of these proteins.
The primary objective of this double-blind randomized intervention study is to establish the
optimal dose of MK-7 for carboxylation of the vitamin K-dependent proteins osteocalcin in
bone and matrix-gla protein in the vessel wall. The optimal dose will be the concentration at
which osteocalcin and matrix-gla protein are > 90% in the active (=carboxylated) form.
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy [Active, not recruiting]
Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been
assumed that these two forms maintain blood vitamin D equally. However, this may not be the
case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D.
Additionally, it will evaluate whether once per month vitamin D dosing is as effective in
maintaining blood vitamin D levels as daily dosing.
Page last updated: 2011-12-09