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At least 19 recordsLinked to original sources
PubMed2002

The incidence of anaphylaxis following intravenous phytonadione (vitamin K1): a 5-year retrospective review.

BACKGROUND: Phytonadione (vitamin K1) administered intravenously (i.v.) has been associated with anaphylaxis, although the incidence is not known. The anaphylaxis is thought to be attributable to the solubilizing vehicle, polyethoxylated castor oil (Cremophor EL, BASF AG, Ludwingshafen, Germany). OBJECTIVE: To estimate the incidence of anaphylaxis after i.v. administration of phytonadione. METHODS: A retrospective review of anaphylaxis after i.v. phytonadione over a 58-month period at a large academic center was performed. During the period of the study a protocol for the administration of i.v. phytonadione was in place. A review of computerized records and survey of staff identified cases of anaphylaxis meeting predefined inclusion criteria. In addition, a literature review was performed for articles concerning anaphylaxis after i.v. phytonadione. RESULTS: Over the 58 months of the study, a total of 6,572 doses of i.v. phytonadione were administered. Two cases of anaphylaxis after i.v. phytonadione were identified. The incidence of anaphylaxis was 3 per 10,000 doses with 95% confidence intervals of 0.04 to 11 per 10,000 doses. The literature review identified 14 cases meeting inclusion criteria with no reviews of the literature or estimates of incidence. CONCLUSIONS: The incidence of anaphylaxis after i.v. phytonadione is overall comparable or slightly less than other drugs known to cause anaphylaxis. We do not recommend routine pretreatment with antihistamines or corticosteroids before administration of phytonadione.

Adult↗
PubMed2001

Efficacy and safety of intravenous phytonadione (vitamin K1) in patients on long-term oral anticoagulant therapy.

OBJECTIVES: To determine the safety and efficacy of intravenously administered phytonadione (vitamin K1) in patients on routine oral warfarin anticoagulation. PATIENTS AND METHODS: This retrospective cohort study comprised adults who were taking warfarin, were not bleeding, and received intravenous phytonadione anticoagulation therapy before a diagnostic or therapeutic procedure between September 1, 1994, and March 31, 1996. The main outcome measures were adverse reactions to intravenously administered phytonadione, prothrombin-international normalized ratio time values, the incidence of bleeding and thrombosis after the procedure, and the time between the procedure and return to anticoagulation after resumption of warfarin treatment. RESULTS: Two (1.9%) of the 105 patients studied had suspected adverse reactions to intravenous phytonadione (dyspnea and chest tightness during infusion in both). For the 82 patients who underwent a procedure, the median time from phytonadione to procedure onset was 27 hours (range, 0.7-147 hours), which was significantly less for patients receiving an initial phytonadione dose of more than 1 mg (P=.009). None had thromboembolism after surgery, although 2 (2.4%) of the 82 patients had procedure-associated major bleeding. For the 60 patients resuming warfarin therapy after a procedure, the median time to return to therapeutic anticoagulation was 4.1 days (range, 0.8-31.7 days) and was unaffected by the phytonadione dosage. CONCLUSIONS: Intravenous phytonadione appears to be safe and is effective for semiurgent correction of long-term oral anticoagulation therapy before surgery. In small doses, it does not prolong the patient's time to return to therapeutic anticoagulation.

Administration, Oral↗
PubMed2003

Comparison of oral vs intravenous phytonadione (vitamin K1) in patients with excessive anticoagulation: a prospective randomized controlled study.

BACKGROUND: Treatment of patients with excessive anticoagulation is routinely done by intravenous phytonadione (vitamin K1). Oral administration of phytonadione has been shown to be an effective alternative to the intravenous route, but these methods have never been compared directly. Our objective was to compare efficacy and safety of intravenous vs oral phytonadione treatment in patients with excessive anticoagulation without bleeding. METHODS: The study was a prospective randomized controlled trial of consecutive patients presenting with excessive anticoagulation without major bleeding. Patients with a baseline international normalized ratio (INR) of 6 to 10 (n = 44, 47 episodes) received either intravenous or oral phytonadione (0.5 mg or 2.5 mg, respectively), and patients with an INR greater than 10 (n = 17, 19 episodes) received 1 mg or 5 mg, respectively. Efficacy and safety end points were sequential INR changes and the proportion of patients achieving therapeutic range (INR, 2-4), overcorrection (INR<2.0), or undercorrection (INR>4.0) INR values. RESULTS: Sixty-six episodes of excessive anticoagulation were studied. In patients with baseline INR 6-10 the response to intravenous phytonadione was more rapid than in the oral group, and the proportion of patients reaching therapeutic range INR at 6 hours (11/24 vs 0/23) and at 12 hours (16/24 vs 8/23) was significantly higher. However, mean +/- SD INR values were similar for both groups at 24 hours (2.9 +/- 0.8 vs 2.6 +/- 0.8). Patients in the intravenous group tended to be more often (7/24 vs 2/23) overcorrected (INR<2). In patients with baseline INR values greater than 10 efficacy and safety were comparable for both routes of administration. CONCLUSION: Oral administration of phytonadione had similar efficacy and safety as intravenously administered phytonadione and may be suitable for treatment of patients with excessive anticoagulation.

Administration, Oral↗
PubMedDate not supplied

Time course of reversal of anticoagulant effect of warfarin by intravenous and subcutaneous phytonadione.

BACKGROUND: Excessive anticoagulation increases the risk of hemorrhagic complications associated with oral anticoagulant therapy. Oral or parenteral phytonadione is used to reverse excessive anticoagulation. Intravenous (IV) phytonadione, while effective, is associated with a small risk of serious anaphylactic reactions. Subcutaneous (SC) administration is safer, but there is little information on its relative efficacy in small doses. METHODS: Twenty-two patients with asymptomatic prolongation of prothrombin time were prospectively randomized and treated with 1 mg of phytonadione IV or 1 mg SC. Prothrombin time was measured at baseline and at 8 and 24 hours after phytonadione administration and expressed as international normalized ratio (INR). RESULTS: Mean INR at baseline was 8.0 and 8.5 in the IV and SC groups, respectively (P = .70). At 8 hours, mean INR was 4.6 in the IV group and 8.0 in the SC group (P = .006), and at 24 hours, mean INR was 3.1 in the IV group and 5.0 in the SC group (P = .009). Mean decrease in INR 8 hours after administration of phytonadione was 3.4 in the IV group and 0.4 in the SC group (P = .02), and mean decrease in INR after 24 hours was 4.9 in the IV group and 3.4 in the SC group (P = .18). CONCLUSIONS: For patients who are excessively anticoagulated with warfarin, small doses of SC phytonadione may not correct the INR as rapidly or as effectively as when administered IV. Higher doses must be considered for more rapid and complete reversal of anticoagulation by the SC route.

Anticoagulants↗
PubMed2000

Randomized, placebo-controlled trial of oral phytonadione for excessive anticoagulation.

STUDY OBJECTIVE: To compare the efficacy of managing excessive anticoagulation in the absence of bleeding by either omitting warfarin therapy alone or administering oral phytonadione in addition to omitting warfarin therapy. DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: Clinical pharmacy anticoagulation service in a group model health maintenance organization. SUBJECTS: Thirty nonbleeding patients with international normalized ratios (INRs) ranging from 6.0-10.0. INTERVENTIONS: Patients were randomized to receive either a single oral dose of phytonadione 2.5 mg or placebo. Both groups omitted warfarin doses until the INR became less than or equal to 4.0. MEASUREMENTS AND RESULTS: The mean calculated time to reach an INR of 4.0 was significantly greater in the placebo than the phytonadione group (2.6 vs 1.4 days, p=0.006). Overcorrection of anticoagulation was significantly more common in patients receiving phytonadione. Overt warfarin resistance was not observed in either group after reinitiating warfarin therapy. No major bleeding or thromboembolic complications occurred, and minor bleeding episodes were similar in both groups. CONCLUSION: The addition of oral phytonadione 2.5 mg reduced the time to achieve an INR of 4.0 by approximately 1 day compared with omitting warfarin therapy alone. Adverse events did not differ between the two groups. Both strategies were effective in managing asymptomatic patients with INRs of 6.0-10.0. Oral phytonadione may be most appropriate for patients at high risk for bleeding in whom the benefit of prompt INR reduction would outweigh the thromboembolic risk associated with INR overcorrection.

Aged↗
PubMed1993

Evaluation of bioavailability upon oral administration of phytonadione preparations in beagle dogs.

Bioavailability of phytonadione was investigated after oral administration to beagle dogs. The administrations of phytonadione in a surfactant solution (preparation a) and in an oleic acid solution (preparations b) greatly increased the bioavailability of phytonadione. The AUCs of preparations a and b were about 2.5 times larger than those of commercially available tablets A and C. This result well corresponded to the results of the dissolution test previously reported. The absorption of phytonadione from the gastro-intestinal tract was affected by food and the bioavailability was largely increased under non-fasted conditions. However, a large scatter was observed in the data, and it was found that the evaluation of the bioavailability of phytonadione preparations could not be done in non-fasted animals.

Administration, Oral↗
PubMed1999

Subcutaneous phytonadione for reversal of warfarin-induced elevation of the International Normalized Ratio.

The efficacy and safety of subcutaneous phytonadione in the treatment of patients with asymptomatic excessive International Normalized Ratio (INR) values secondary to warfarin therapy were evaluated. Patients at an outpatient anticoagulation clinic with an INR of 8 or more but less than 14 were given 1 mg of subcutaneous phytonadione, and patients with an INR of 14 or more but less than 20 received 2 mg. The patients were instructed to withhold warfarin therapy for the next 24 hours and to immediately report any bleeding complications. At subsequent visits, patients with an INR of 8 or more but less than 14 were given an additional 1 mg of subcutaneous phytonadione. Patients with an INR above 4.5 were instructed to withhold warfarin therapy for an additional 24 hours. Seventeen patients received the 1-mg dose (group 1), and four patients received the 2mg dose (group 2). In group 1, the mean INR reduction was 49% at 24 hours and 72% at 48 hours and the INR was below 4.5 in 93% of patients at 48 hours. In group 2, the mean INR reduction was 67% at 24 hours and 85% at 48 hours and the INR was below 4.5 in 100% of patients at 48 hours. In four group-1 patients and one group-2 patient, the INR fell below 2.0 at 48 hours. No patients reported hemorrhagic or thrombotic complications. Subcutaneous phytonadione safely lowered excessively high INR values caused by warfarin therapy.

Adult↗
PubMed1998

Comparing different routes and doses of phytonadione for reversing excessive anticoagulation.

BACKGROUND: Significant controversy exists concerning how best to reverse excessive anticoagulation (due to warfarin sodium therapy) with phytonadione (vitamin K1) while avoiding overcorrection in patients who need to have anticoagulation therapy maintained. METHODS: A retrospective review of phytonadione use in reversing excessive anticoagulation was performed in 3 institutions. The effectiveness of low-dose (< or =0.5 mg) intravenous (LDIV), high-dose (1-10 mg) intravenous (HDIV), subcutaneous (1-10 mg) (SC), and oral (2.5 or 5 mg) (PO) phytonadione was evaluated within 48 hours of administration. Anticoagulation correction (international normalized ratio [INR], > or =2.0 and < or =5.0) occurred in 5 of 8 patients in the LDIV, 5 of 9 in the HDIV, 7 of 10 in the SC, and 5 of 6 in the PO groups. Correction was inadequate (INR >5.0) in 2 of 8 patients in the LDIV, 0 of 9 in the HDIV, 3 of 10 in the SC, and 1 of 6 in the PO groups. Overcorrection (INR <2.0) occurred in 1 patient in the LDIV, 4 patients in the HDIV, 0 in the SC, and 0 in the PO groups. CONCLUSIONS: Anticoagulation correction was achieved in most patients in all 4 groups. The HDIV method was most effective in lowering the INR to less than 5.0, but overcorrection occurred more frequently (4 patients in the HDIV vs 1 patient in the LDIV and 0 patients in the SC and PO groups). Failure to achieve an INR of less than 5.0 was a greater problem in the SC group (3 patients in the SC vs 2 patients in the LDIV and 1 patient in the PO groups). The LDIV and PO methods appear to be acceptable alternatives to the HDIV and SC methods currently recommended.

Administration, Oral↗
PubMed1989

Pseudoscleroderma secondary to phytonadione (vitamin K1) injections.

Two patients showed symmetrical sclerodermoid (morphea-like) skin lesions at sites of intramuscular phytonadione (vitamin K1) injections. The lesions appeared one and two years after the injections. A dense sclerosis involving the reticular dermis and subcutaneous fat was observed on histologic examination of biopsy specimens. Local adverse reactions to phytonadione are reviewed. Possible causative mechanisms for phytonadione-induced pseudoscleroderma are discussed.

Aged↗
PubMed1978

Determination of phytonadione in elemental diets by TLC-spectrophotodensitometry.

The quantitative analysis of phytonadione in several elemental diet formulations at levels ranging from 90 to 150 ppb is described. After extraction with petroleum either, the sample is cleaned up by silica gel column chromatography and separated on a TLC plate; phytonadione is determined by reflectance densitometry. Recovery data show that the method is accurate (X = 97%) and has a precision (RSD) of +/- 6%.

Chromatography, Gel↗
PubMed2004

The effects of topical application of phytonadione, retinol and vitamins C and E on infraorbital dark circles and wrinkles of the lower eyelids.

BACKGROUND: Infraorbital dark circles and wrinkles of the lower eyelids are a cosmetic problem, especially with age. AIMS: To determine whether a gel containing 2% phytonadione, 0.1% retinol and 0.1% vitamins C and E is effective in reducing dark under-eye circles and wrinkles of the lower eyelids in healthy Japanese adults. PATIENTS/METHODS: Fifty-seven adult Japanese volunteers with dark under-eye circles and wrinkles were enrolled in an open label study. The gel formulation was applied twice daily to the lower eyelid site for 8 weeks. Haemostasis, pigmentation and wrinkles were evaluated by a physician and by the patients themselves, using a digital camera and a visual analogue scale respectively, after 4 and 8 weeks of treatment. RESULTS: Topical application of the gel decreased not only haemostasis but also wrinkles after 8 weeks of treatment. Of 57 patients, 27 (47%) had reductions in haemostasis. Wrinkles were also decreased in some patients. However, pigmentation was not clearly removed by this gel. CONCLUSIONS: Topical application of the gel containing 2% phytonadione, 0.1% retinol, 0.1% vitamin C and 0.1% vitamin E was fairly or moderately effective in reducing dark under-eye circles, especially in cases of haemostasis, over a short treatment period in healthy Japanese adults. This treatment also slightly decreased wrinkles.

Journal Article↗
PubMed2000

Phytonadione therapy in a multiple-drug overdose involving warfarin.

We cared for a patient who ingested an unknown amount of acetaminophen with zopiclone and warfarin. The only liver function test that was abnormal was an increased international normalized ratio (INR), which remained elevated despite treatment with subcutaneous phytonadione and a prolonged infusion of N-acetylcysteine. An interaction between acetaminophen and warfarin may have decreased the hepatic metabolism of warfarin. The patient received numerous antibiotics that may have contributed to the increased INR. The prolonged elevation of INR also may have been due to infrequent administration of phytonadione.

Acetaminophen↗
PubMed1985

Subcutaneous sclerosis with fasciitis and eosinophilia after phytonadione injections.

We treated a case of subcutaneous sclerosis after phytonadione injections (Texier's disease) that was noteworthy for two associated features: sclerosis with inflammatory infiltrate in the fascia, and blood eosinophilia. A peculiar type of cutaneous sclerosis after phytonadione injections was described in 1972. The sclerosis in that case was first confined to the buttocks, progressively extended to both thighs, and slowly resolved. In the 38 reported cases, neither sclerosis of the fascia nor blood eosinophilia was observed.

Drug Eruptions↗
PubMed1978

Delayed cutaneous reaction to phytonadione.

A 63-year old man developed a delayed cutaneous reaction at the sites of intramuscular injections of a phytonadione (vitamin K) preparation. The patient was tested with the drug and its components by intradermal and epicutaneous application. Sensitivity to the pure phytonadione and not the other components of the preparation was documented by patch tests.

Drug Hypersensitivity↗
PubMed1994

Symptomatic brodifacoum ingestion requiring high-dose phytonadione therapy.

We report the deliberate ingestion of a superwarfarin product, brodifacoum, in a 39-y-old male. He presented with prothrombin and partial thromboplastin times of 150 and 113 sec, respectively. His coagulopathy was corrected by administration of blood products and phytonadione. To maintain normal clotting studies this patient required the highest maintenance dose of phytonadione, 200 mg/d, reported to date. The patient was able to tolerate this dose for 5 mo without adverse effects.

4-Hydroxycoumarins↗
PubMed2006

Treatment of excessive anticoagulation with phytonadione (vitamin K): a meta-analysis.

BACKGROUND: Patients taking oral anticoagulants with an international normalized ratio (INR) greater than 4.0 are at increased risk for bleeding. We performed a meta-analysis to determine the effectiveness of phytonadione (vitamin K) in treating excessive anticoagulation. METHODS: The MEDLINE, EMBASE, and Cochrane Library databases were searched (without language restrictions) for articles published between January 1985 and September 2004. Randomized controlled trials or prospective, nonrandomized trials that used vitamin K to treat patients without major hemorrhage with an INR greater than 4.0 due to oral anticoagulant use were included. The primary outcome was achievement of the target INR (1.8-4.0) at 24 hours after vitamin K administration. Summary estimates were calculated using a random effects model. RESULTS: Twenty-one studies (10 randomized and 11 prospective trials) were included. Among oral vitamin K treatment arms (4, n = 75), the proportion with a target INR at 24 hours was 82% (95% confidence interval [CI], 70%-93%), which was similar to intravenous vitamin K treatment arms (6, n = 69; target INR, 77%; 95% CI, 60%-95%). Treatment arms of subcutaneous vitamin K (3, n = 58; 31%; 95% CI, 7%-55%) and placebo/observation (2, n = 27; 20%; 95% CI, 0%-47%) were less likely to achieve target INR at 24 hours. Only 1 of 21 trials appropriately assessed for adverse events, so a summary estimate for bleeding risk could not be generated. CONCLUSIONS: Limited evidence suggests that oral and intravenous vitamin K are equivalent and more effective for excessive anticoagulation than simply withholding warfarin sodium. Subcutaneous vitamin K, however, is inferior to oral and intravenous vitamin K for this indication and is similar to placebo. Whether treatment with vitamin K decreases hemorrhagic events cannot be determined from the published literature.

Anticoagulants↗
PubMed2000

Solid dosage form preparations from oily medicines and their drug release. Effect Of degree of surface-modification of silica gel on the drug release from phytonadione-loaded silica gels.

A surface-modified silica gel was produced to improve the surface affinity to an oily medicine, phytonadione (VK1). The effect of the degree of surface modification of the silica gel on the drug release behavior from the silica porous matrix was investigated. The silica gels were surface-modified using the silan coupling agent, 3-methacryloxypropyltrimethoxysilane (C7), octadecyltriethoxysilane (C18), or 3,3,3-trifluoropropyltrimethoxysilane (F3). A mixture of VK1 solution and surface-modified silica gel was evaporated under reduced pressure at room temperature, then the resulting powder was dried in vacuo. The degree of surface modification was evaluated based upon elementary analysis. The dissolution profiles of the samples were investigated in Japanese Pharmacopoeia XII, 1st fluid buffer (pH 1.2, 37+/-0.5 degrees C) containing 1.5% sodium lauryl sulfate. The FT-IR spectra of VK1-loaded surface-modified silica gels suggested that the amount of hydrogen-bonded VK1 with the silanol group on the gel surface decreased with increasing hydrophobicity of the silica gel. Since the modified group was rotating on the silica gel surface, and inhibited the adsorption of VK1 to the surface, the attractive molecular interaction between VK1 and the silica gel surface might decrease with increasing length of the modified functional group. However, the characteristics of the affinity of VK1 to the functional groups significantly differed among the groups. The VK1 release from the modified silica gels was initially rapid, slowed markedly after 1 h, and continued for more than 24 h. The amount of VK1 released from the modified surface silica gels by C7, C18 or F3 increased with increasing density of the surface modification group. The mean drug release moment (MDT) decreased with an increase in surface-modified group density.

Adsorption↗