Alternatively, if using the 12-vitamin formulation that does not contain vitamin K, 0.5 to 1 mg IV once daily or 5 to 10 mg IV once weekly as part of parenteral nutrition. Published studies with the use of Phytonadione during pregnancy have not reported a clear association with Phytonadione and adverse developmental outcomes [see Data]. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Warnings and Precautions (5.2)]. The administration of phytonadione to the mother to increase breast milk concentrations may be possible. There are no data on the effects of Phytonadione injectable emulsion on the breastfed child or on milk production. Our scientific content is evidence-based, scientifically balanced and non-promotional. meropenem/vaborbactam will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives. (Vitamin K). Effect of interaction is not clear, use caution. Monitor Closely (1)phytoestrogens increases and vitamin K1 (phytonadione) decreases anticoagulation. Phytonadione injectable emulsion may induce temporary resistance to prothrombin-depressing anticoagulants, especially when larger doses of Phytonadione injectable emulsion are used. Use Caution/Monitor. The resulting gamma-carboxy-glutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood. Cutaneous reactions, including eczematous reactions, scleroderma-like patches, urticaria, and delayed-type hypersensitivity reactions, may also occur with parenteral phytonadione administration. Applies only to oral form of both agents. If your doctor has prescribed this medication, take it as directed.If you are using the rapidly-dissolving tablets, place under your tongue to dissolve, then swallow with or without water. prescription products. 5 WARNINGS AND PRECAUTIONS DESCRIPTION Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. Applies only to oral form of both agents. When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute [see Warnings and Precautions (5.1)]. . Effect of interaction is not clear, use caution. Use Caution/Monitor. Colestipol: (Moderate) Separate administration of fat-soluble vitamins by 1 hour before or 4 hours after a colestipol dose to limit effects on oral absorption. The dosage may be increased up to 50 mg, but this is not usually required. Although the FDA-approved labeling recommends IM or subcutaneous administration, in most reported cases of VDKB, vitamin K was given IV. Use Caution/Monitor. Both epidemiologic and clinical studies have reported a decrease in hip fractures and increased bone mineral density in subjects receiving supplemental vitamin K. MGP appears to be critical for bone mineralization and growth; spontaneous and fatal calcification of arteries and cartilage has been observed in mice with MGP deficiency. Use Caution/Monitor. Minor/Significance Unknown. Monitor Closely (1)garlic increases and vitamin K1 (phytonadione) decreases anticoagulation. The following serious adverse reactions are described elsewhere in the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Be sure to take your vitamin K and warfarin exactly as directed by your doctor or pharmacist.If you develop easy bruising or bleeding, or if you think you may have a serious medical problem, get medical help right away. 2 mcg/day PO. Intermittent IV infusionInfuse slowly at a rate not exceeding 1 mg/minute. Some parenteral phytonadione formulations contain benzyl alcohol, which has been associated with gasping syndrome in newborns. Find phytonadione injectable emulsion, USP medical information: If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. Monitor Closely (1)erythromycin lactobionate will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Vitamin K functions as a co-factor for gamma-glutamylcarboxylase, which is involved in the post-translational carboxylation of glutamate residues into gamma-carboxyglutamate (Gla). Theoretically, the effect on fat-soluble vitamin absorption may more likely occur with prolonged or chronic administration of mineral oil. STORAGE: Store at room temperature away from light and moisture. Phytonadione is administered orally, intramuscularly, intravenously, and subcutaneously. Monitor Closely (1)reishi increases and vitamin K1 (phytonadione) decreases anticoagulation. When prescribing Phytonadione injectable emulsion in infants consider the combined daily metabolic load of benzyl alcohol from all sources including Phytonadione injectable emulsion (Phytonadione injectable emulsion contains 9 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. Use Caution/Monitor. This drug is available at a higher level co-pay. Effect of interaction is not clear, use caution. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Applies only to oral form of both agents. Disease-associated maternal and/or embryo/fetal risk. Vitamin K epoxide concentrations were significantly higher in infants who received 0.5 mg compared to those who received 0.2 mg, indicating possible overload of the immature liver. aspirin/citric acid/sodium bicarbonate increases and vitamin K1 (phytonadione) decreases anticoagulation. Monitor Closely (1)ginkgo biloba increases and vitamin K1 (phytonadione) decreases anticoagulation. Use Caution/Monitor. Monitor INR with corresponding increases or decreases in vitamin K intake significantly affecting vitamin k blood levels. A randomized, controlled study in 98 premature neonates (younger than 32 weeks gestation; range: 22.4 to 31.9 weeks; birthweight range: 454 to 1,950 g) found a significantly lower vitamin K1 serum concentration in neonates who received 0.2 mg IM compared to those who received 0.5 mg IM at 5 days postnatal age (median 59.3 ng/mL vs. 111.8 ng/mL; p = 0.45); however, there was no significant difference in undercarboxylated prothrombin (PIVKA-II) concentrations, a sensitive functional marker of deficiency in vitamin K, at 5 or 25 days postnatal age, indicating that the 0.2 mg dose maintained adequate vitamin K status. If slightly above the therapeutic range, no dose reduction may be required. Dosages of vitamin K1 should be kept as low as possible, and the prothrombin time or INR checked at regular intervals. Normal therapeutic phytonadione doses would deliver benzyl alcohol at amounts lower than those reported with 'gasping syndrome'; however, the clinician should be aware of the toxic potential, especially if other drugs containing benzyl alcohol are administered. Effect of interaction is not clear, use caution. Wait at least 2 hours between taking this medication and orlistat because taking them together may decrease the effect of vitamin K. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Reinitiate therapy at a lower dose once a therapeutic INR is reached. Minor/Significance Unknown. erythromycin base will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Monitor Closely (1)oxaprozin increases and vitamin K1 (phytonadione) decreases anticoagulation. commonly, these are "preferred" (on formulary) brand drugs. Colesevelam: (Moderate) It is not known if colesevelam can reduce the absorption of oral vitamin supplements including fat soluble vitamins A, D, E, and K. To minimize potential interactions, administer vitamins at least 4 hours before colesevelam. High fecal concentrations are attributable to synthesis of the vitamin by intestinal bacteria. Generic:- Store at controlled room temperature (between 68 and 77 degrees F)- Store in a dry placeAquaMEPHYTON:- Discard product if it contains particulate matter, is cloudy, or discolored- Discard unused portion. Use Caution/Monitor. 2.5 to 25 mg IM/IV/subcutaneously once. Consider higher doses if the mother has been receiving oral anticoagulants. Subclinical maternal vitamin K deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. Monitor INR with corresponding increases or decreases in vitamin K intake significantly affecting vitamin k blood levels. Applies only to oral form of both agents. Advise the patient and caregivers of the risk of gasping syndrome associated with the use of products that contain benzyl alcohol (including Phytonadione injectable emulsion) in neonates, infants, and pregnant women [see Warnings and Precautions (5.2)]. Effect of interaction is not clear, use caution. If Phytonadione injectable emulsion is needed during pregnancy, consider using a benzyl alcohol-free formulation [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)]. Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. OVERDOSE. If used concurrently, administration of the two agents should be staggered for the longest time interval possible. Use Caution/Monitor. vitamin K1 (phytonadione), warfarin. 2.5 to 5 mg PO with the expectation that the INR would be reduced substantially in 24 to 48 hours. Minor (1)meropenem/vaborbactam will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Effect of interaction is not clear, use caution. Use Caution/Monitor. If IM injection is necessary, inject deeply into a large muscle mass (e.g., anterolateral thigh or deltoid [children and adolescents only]). This drug is available at a higher level co-pay. No dosage adjustment necessary. View the formulary and any restrictions for each plan. (Vitamin K). The following adverse reactions have been identified during post-approval use of Phytonadione injectable emulsion. Gas6 was shown to prevent the death of fibroblasts and smooth muscle cells from serum starvation and may act as a growth promoter. PRECAUTIONS: Before taking vitamin K, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Use Caution/Monitor. and formulary information changes. In patients receiving orlistat routinely for a prolonged period of time (i.e., more than 2 weeks), vitamin K intake may need to be increased. Use Caution/Monitor. A supplemental dose of at least 1 mg/day PO has been shown to be necessary to achieve vitamin K status similar to healthy persons. Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, may result from Phytonadione injectable emulsion overdose. Similar reactions have occurred with IM administration. Many people using this product do not have serious side effects.A very serious allergic reaction to this drug is rare. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Vitamin K should NOT be given intramuscularly to pediatric patients on anticoagulants because of the risk of intramuscular hemorrhage. INDICATIONS AND USAGE AquaMEPHYTON 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. Monitor Closely (1)meloxicam increases and vitamin K1 (phytonadione) decreases anticoagulation. Applies only to oral form of both agents. Studies of carcinogenicity, genotoxicity or impairment of fertility have not been conducted with Phytonadione. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Monitor Closely (1)ketorolac intranasal increases and vitamin K1 (phytonadione) decreases anticoagulation. Although the Cystic Fibrosis Foundation recommends 0.3 to 0.5 mg/day PO in all patients, lower doses have been shown to achieve suboptimal vitamin K status and may not be adequate to prevent deficiency. Do not increase your dose or use this drug more often or for longer than directed. naproxen increases and vitamin K1 (phytonadione) decreases anticoagulation. Access your plan list on any device mobile or desktop. Usually, supplementation of vitamin K during pregnancy is not required. If parenteral phytonadione use is required during pregnancy, consider a benzyl alcohol-free formulation. Time of onset of such reactions has ranged from 1 day to a year after administration. The recipient will receive more details and instructions to access this offer. Use Caution/Monitor. Published data do not report a clear association with Phytonadione and adverse maternal or fetal outcomes when used during pregnancy. 1 to 10 mg PO once daily. Monitor Closely (1)salsalate increases and vitamin K1 (phytonadione) decreases anticoagulation. It is insoluble in water, soluble in chloroform and slightly soluble in. This drug is available at the lowest co-pay. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Dependent on indication, but upper limits of single doses are 2 mg/day PO and 1 mg/day IV/IM/subcutaneously. Use of Phytonadione injection for prophylaxis and treatment of vitamin K deficiency is based on published clinical studies. Monitor Closely (1)piroxicam increases and vitamin K1 (phytonadione) decreases anticoagulation. Serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. The function of Gas6 has only been studied in vitro and may affect other tissues as well (e.g., spinal motor neurons, neurons of the basal root ganglia, and Schwann cells among others). Package insert / product label However, higher doses of up to 10 mg PO once daily are often needed. In another study, plasma vitamin K concentrations were not statistically significantly different on day 2 or day 10 of life in 7 premature neonates (mean gestational age 27.3 weeks; mean birthweight 1.08 kg) given 0.5 mg vitamin K compared to 20 premature neonates (mean gestational age 30 weeks; mean birthweight 1.48 kg) given 1 mg vitamin K. However, the plasma vitamin K concentrations were still very high in the premature neonates who received a lower prophylactic dose of 0.5 mg, suggesting that lower doses of vitamin K are necessary in this group. Subcutaneous administration is the preferred parenteral route. Oral administration of vitamin K for prophylaxis of vitamin K deficiency bleeding (VKDB) is common in other countries; however, IM administration of vitamin K is standard practice in the US due to its superior efficacy for preventing late VKDB. Because it sequesters bile acids, colestipol may interfere with normal fat absorption and thus may reduce absorption of fat-soluble vitamins. A normal INR may often be obtained in 12 to 14 hours. PHYTONADIONE - phytonadione injection, emulsion Cipla USA Inc.-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PHYTONADIONE . Use Caution/Monitor. Minor (1)chlorhexidine oral will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. 200 mcg IV vitamin K (as 5 mL of Pediatric MVI), added daily to the parenteral nutrition. Use Caution/Monitor. Use Caution/Monitor. mefenamic acid increases and vitamin K1 (phytonadione) decreases anticoagulation. Applies only to oral form of both agents. Medscape - Indication-specific dosing for Vitamin K, Mephyton (vitamin K1 (phytonadione)), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. Effect of interaction is not clear, use caution. 12.1 Mechanism of Action - Phytonadione tablets possess the same type and degree of activity as does naturally-occurring vitamin K, which is . reishi increases and vitamin K1 (phytonadione) decreases anticoagulation. Monitor Closely (1)erythromycin ethylsuccinate will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Phytonadione injectable emulsion does not affect the anticoagulant action of heparin. Due to the long half-life of superwarfarins (greater than or equal to 6 months), high doses (up to 200 mg/day PO) may be required for a period of years. mineral oil decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Avoid use of other diluents that may contain benzyl alcohol, which can cause serious toxicity in newborns or low birth weight infants [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4)]. If you log out, you will be required to enter your username and password the next time you visit. Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including Phytonadione injectable emulsion. Monitor Closely (1)fennel increases and vitamin K1 (phytonadione) decreases anticoagulation. aspirin rectal increases and vitamin K1 (phytonadione) decreases anticoagulation. Applies only to oral form of both agents. . Osteocalcin is only produced by osteoblasts and makes up about 20% of noncollagenous protein in bone. Monitor Closely (1)panax ginseng increases and vitamin K1 (phytonadione) decreases anticoagulation. Discuss the risks and benefits with your doctor.Vitamin K passes into breast milk, but is unlikely to harm a nursing infant. Applies only to oral form of both agents. Monitor Closely (1)horse chestnut seed increases and vitamin K1 (phytonadione) decreases anticoagulation. You may need another dose of vitamin K. SIDE EFFECTS: Vitamin K usually has no side effects. Minor (1)cholestyramine decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Phytonadione has been measured in cord blood of infants whose mothers were treated with Phytonadione during pregnancy in concentrations lower than seen in maternal plasma. Monitor Closely (1)sulindac increases and vitamin K1 (phytonadione) decreases anticoagulation. Available for Android and iOS devices. Some literature suggests that low birth weight premature neonates exposed to polysorbate 80 at high doses or for prolonged periods of time may experience hepatotoxicity, hypotension, renal failure, ascites, and thrombocytopenia. flushing (warmth, redness, or tingly feeling), changes in your sense of taste, sweating, or dizziness. Effect of interaction is not clear, use caution. The above information is provided for general 0.2 to 0.5 mg IM as a single dose immediately after birth has been recommended. Monitor Closely (1)Siberian ginseng increases and vitamin K1 (phytonadione) decreases anticoagulation. The estimated background risk for the indicated population is unknown. Minor (1)mineral oil decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Use Caution/Monitor. Overdose & Contraindications. Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. By clicking send, you acknowledge that you have permission to email the recipient with this information. The safety and effectiveness of Phytonadione injectable emulsion for prophylaxis and treatment of vitamin K deficiency have been established in neonates. (Vitamin K). There are maternal and fetal risks associated with vitamin K deficiency during pregnancy. Phytonadione is contraindicated in patients with hypersensitivity to phytonadione or inactive ingredients of the product. Effect of interaction is not clear, use caution. Hold warfarin therapy. In 1 case report, following stabilization with fresh frozen plasma, phytonadione 7 mg/kg/day PO divided every 6 hours was effective. Phytonadione is readily absorbed after intramuscular administration. A clear association with phytonadione use during human pregnancy and adverse developmental outcomes has not been reported. Use Caution/Monitor. Applies only to oral form of both agents. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified. If you have any unusual effects, contact your doctor or pharmacist promptly.If your doctor has directed you to use this product, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Oral absorption requires the presence of adequate bile salts. Applies only to oral form of both agents. CONTRAINDICATION Hypersensitivity to any component of this medication. Phytonadione injectable emulsion is 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: Phytonadione injectable emulsion is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. Consult your pharmacist or local waste disposal company. garlic increases and vitamin K1 (phytonadione) decreases anticoagulation. Use Caution/Monitor. Exclusive breast-feeding will not replete stores and may result in the development of vitamin K deficiency within 48 to 72 hours in at-risk newborns. Phytonadione injectable emulsion, USP is a clear yellow, sterile, aqueous colloidal solution and is supplied in a package of 25 as follows: Store at 20 to 25C (68 to 77F); [see USP Controlled Room Temperature]. Hold warfarin therapy. In addition, certain parenteral phytonadione preparations contain polysorbate 80 and should be avoided in patients with a known polysorbate 80 hypersensitivity. Monitor Closely (1)ketorolac increases and vitamin K1 (phytonadione) decreases anticoagulation. Whole blood or component therapy may be indicated if bleeding is excessive; however, blood components do not correct the underlying disorder, and phytonadione therapy should be given concurrently. Although phytonadione is not a clotting agent, overzealous therapy with phytonadione may restore the previous hypercoagulable state resulting in thromboembolic disease. Phytonadione injectable emulsion contains benzyl alcohol. colestipol decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Temporary resistance to warfarin or other prothrombin-depressing anticoagulants occurs after treatment with phytonadione; this may be long-lasting when large doses of phytonadione are used. Injection: 2 mg/mL and 10 mg/mL single-dose ampuls. Adding plans allows you to compare formulary status to other drugs in the same class. Controlled studies in pregnant women show no evidence of fetal risk. Effect of interaction is not clear, use caution. If the INR is still elevated, additional vitamin K may be given. Share cases and questions with Physicians on Medscape consult. Triglyceride-rich lipoproteins, in addition to LDL and HDL, are carriers of vitamin K; apolipoprotein E is also important for transport of vitamin K. Phytonadione concentrates in the liver temporarily. Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. ketoprofen increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Effect of interaction is not clear, use caution. A normal prothrombin concentration may often be achieved in 12 to 14 hours. IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. 2.5 to 5 mg PO 2 to 7 days/week. Use Caution/Monitor. Excerpt Phytonadione (vitamin K1) is a medication used to treat and manage vitamin K deficiency, which is a significant risk factor for intracranial hemorrhage and other bleeds. Contact the applicable plan oxaprozin increases and vitamin K1 (phytonadione) decreases anticoagulation. Applies only to oral form of both agents. . WARNING-HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE, Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Phytonadione injectable emulsion. Data are limited in pediatric patients. Phytonadione tablets are indicated for the treatment of adults with 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. 80 mcg/kg IV vitamin K (as 2 mL/kg of Pediatric MVI), added daily to the parenteral nutrition. Use Caution/Monitor. Use Caution/Monitor. piroxicam increases and vitamin K1 (phytonadione) decreases anticoagulation. 2.5-10 mg PO/SC; may be increased PRN to 25 mg or, rarely, to 50 mg; may be repeated in 12-48 hours, Omit 1-2 doses, or hold warfarin; monitor INR and adjust warfarin dose accordingly, INR 4.5-10, no bleeding: 2012 ACCP guidelines suggest against routine use; 2008 ACCP guidelines suggest considering vitamin K1 (phytonadione) 1-2.5 mg PO once, INR >10, no bleeding: 2012 ACCP guidelines recommend vitamin K1 PO (dose not specified); 2008 ACCP guidelines suggest 2.5-5 mg PO once; INR reduction observed within 24-48 hr, monitor INR and give additional vitamin K if needed, Minor bleeding, any elevated INR: Consider 2.5-5 mg PO once; may repeat if needed after 24 hr, Major bleeding, any elevated INR: 2012 ACCP guidelines recommend prothrombin complex concentrate, human (PCC, Kcentra) plus vitamin K1 5-10 mg IV (dilute in 50 mL IV fluid and infuse over 20 min), NOTE: High vitamin K doses (ie, 10 mg or more) may cause warfarin resistance for a week or more; consider using heparin, LMWH, or direct thrombin inhibitors to provide adequate thrombosis prophylaxis in clinical conditions requiring chronic anticoagulation therapy (eg, atrial fibrillation), PO dose may be repeated in 12-48 hr and SC/IV/IM dose in 6-8 hr if necessary, Avoid IM route; increases risk of hematoma formation, Oral route more effective than SC route in nonbleeding patients in warfarin associated coagulopathy, May use IV route in selected nonbleeding patients; use IV route in patients with major bleeding due to warfarin associated coagulopathy, Use of high vitamin K doses (10-15 mg) may cause warfarin resistance for 1 week, Prophylaxis: 0.5-1 mg IM within 1 hr of birth, Treatment: 1 mg/dose/day SC; my require higher doses if mother has been receiving oral anticoagulants. Maternal supplements of 5 mg/day PO of phylloquinone through the first 12 weeks of life increase plasma vitamin K concentrations (in breast milk and infant plasma) in exclusively breast-fed infants who receive one IM dose of vitamin K at birth. shock and cardiac and/or resp. Improvement in INR may take 1 to 8 hours. However, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding. anaphylactoid reactions / Rapid / Incidence not knownanaphylactic shock / Rapid / Incidence not knowncardiac arrest / Early / Incidence not knowncyanosis / Early / Incidence not knownrespiratory arrest / Rapid / Incidence not knownserious hypersensitivity reactions or anaphylaxis / Rapid / Incidence not known, hypotension / Rapid / Incidence not knowndyspnea / Early / Incidence not knownchest pain (unspecified) / Early / Incidence not knownsinus tachycardia / Rapid / Incidence not knownerythema / Early / Incidence not knownhyperbilirubinemia / Delayed / Incidence not knownhemolysis / Early / Incidence not knownjaundice / Delayed / Incidence not known, flushing / Rapid / Incidence not knowndysgeusia / Early / Incidence not knowndizziness / Early / Incidence not knownhyperhidrosis / Delayed / Incidence not knownweakness / Early / Incidence not knownurticaria / Rapid / Incidence not knownvesicular rash / Delayed / Incidence not knowninjection site reaction / Rapid / Incidence not knownpruritus / Rapid / Incidence not knownrash / Early / Incidence not known. ibuprofen increases and vitamin K1 (phytonadione) decreases anticoagulation. This information is not individual medical advice and does not substitute for the advice of your health care professional. Food: (Minor) The food supplement olestra, if ingested in sufficient quantities, may decrease the oral absorption of vitamin K. Mineral Oil: (Moderate) Absorption of fat-soluble vitamins is reported to be decreased with prolonged oral administration of mineral oil. Premature and low-birth weight infants may be more likely to develop toxicity. Animal reproduction studies have not been conducted with Phytonadione. Phytonadione injectable emulsion aqueous colloidal solution of vitamin K1 for parenteral injection, possesses the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). Doses of 1 to 3 mg IM/IV/subcutaneous have been administered in the setting of late Vitamin K deficiency bleeding (VKDB) in infants. Low levels may be caused by certain medications (such as warfarin) or medical conditions (such as obstructive jaundice). Use Caution/Monitor. Effect of interaction is not clear, use caution. General disorders and administration site conditions: Generalized flushing; pain, swelling, and tenderness at injection site. Use the lowest effective dose of Phytonadione injectable emulsion. Use Caution/Monitor. Modify subsequent dosage (amount and frequency) based on the INR or clinical condition. Effect of interaction is not clear, use caution. Treatment of Vitamin K Deficiency Bleeding in Neonates. The recommended dosage of Phytonadione injectable emulsion is 1 mg given either subcutaneously or intramuscularly. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Castor Oil: (Moderate) Absorption of fat-soluble vitamins may be decreased with coadministration of castor oil. However, the minimum amount of benzyl alcohol at which toxicity may occur is unknown and low-birth-weight and premature neonates may be more likely to develop toxicity. Whenever possible, use preservative-free Phytonadione formulations in neonates. Previous American Academy of Pediatrics recommendations considered phytonadione as compatible with breast-feeding. Effect of interaction is not clear, use caution. Minor/Significance Unknown. CONTRAINDICATIONS Hypersensitivityto any component of this medication. Gamma-carboxyglutamate residues are found in specific proteins (Gla proteins) including the vitamin K-dependent clotting (factors II, VII, IX, and X) and regulatory proteins (proteins C and S), proteins of bone metabolism (osteocalcin), and vascular proteins (matrix Gla protein [MGP], growth-arrest-specific gene 6 protein [Gas6]). Applies only to oral form of both agents. Minor/Significance Unknown. Use Caution/Monitor. The preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients. Subclinical maternal vitamin K deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. Biliary tract disease, hepatic disease, jaundice There may be a decreased response to phytonadione in patients with hepatic disease. Applies only to oral form of both agents. The majority of newborns are not vitamin K deficient, however some are. Effect of interaction is not clear, use caution. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. Effect of interaction is not clear, use caution. Shake well before administration. Monitor Closely (1)ibuprofen IV increases and vitamin K1 (phytonadione) decreases anticoagulation. Risk of Gasping Syndrome Due to Benzyl Alcohol. Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the post- translational carboxylation of multiple, specific, peptide-bound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders, gallbladder disease (such as obstructive jaundice, biliary fistula), liver disease.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this product should be used only when clearly needed. Higher oral doses may be necessary in infants with bile disorders, such as biliary atresia and cholestasis, as higher rates of late vitamin K deficiency bleeding have been noted in these patients. Monitor Closely (1)erythromycin stearate will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. salsalate increases and vitamin K1 (phytonadione) decreases anticoagulation. A single oral dose should not be used because the oral bioavailability is variable and does not result in adequate body stores of vitamin K. Although oral vitamin K has been shown to have similar efficacy compared to parenteral therapy in the prevention of early vitamin K deficiency bleeding, there is evidence that oral vitamin K is less effective for the prevention of late bleeding than intramuscular therapy, particularly in exclusively breast-fed infants who received a single oral dose. Prothrombin times were not significantly different between the 2 groups but the PIVKA-II (protein induced by vitamin K absence) concentration was significantly higher in the control group. Phytonadione is in a class of medications called vitamins. Whole blood or component therapy may be indicated if bleeding is excessive; however, blood components do not correct the underlying disorder, and phytonadione therapy should be given concurrently. The recommended Adequate Intake (AI) for lactating women is the same as non-lactating women. 2.5 mcg/day PO. Find patient medical information for phytonadione (vitamin K1) oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Minor (1)ciprofloxacin will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. These substances help your blood to thicken and stop bleeding normally (such as after an accidental cut or injury). The benefit of parenteral vitamin K administration to infants outweighs the previously reported possible risk of childhood cancer. At M/s Immacule Lifesciences Pvt. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. Canada residents can call a provincial poison control center. Synthetic compound; chemically indistinguishable from naturally occurring vitamin KFor the treatment or prevention of hypoprothrombinemia due to vitamin K deficiency and oral anticoagulant-induced hypoprothrombinemiaAvoid IM and IV administration when possible due to risk of serious hypersensitivity and anaphylactoid reactions, AquaMEPHYTON/Phytonadione Intramuscular Inj Emulsion: 0.5mL, 1mg, 1mL, 10mgAquaMEPHYTON/Phytonadione Intravenous Inj Emulsion: 0.5mL, 1mL, 1mg, 10mgAquaMEPHYTON/Phytonadione Subcutaneous Inj Emulsion: 0.5mL, 1mg, 1mL, 10mgMephyton/Phytonadione Oral Tab: 5mg. Monitor Closely (1)aspirin/citric acid/sodium bicarbonate increases and vitamin K1 (phytonadione) decreases anticoagulation. Data sources include IBM Watson Micromedex (updated 14 May 2023), Cerner Multum (updated 28 May 2023), ASHP (updated 10 Apr 2023) and others. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as acenocoumarol, warfarin).Avoid taking this medication at the same time as orlistat (a weight-management drug). Prophylaxis of Vitamin K-Deficiency Bleeding in Neonates. Phytonadione is present in breast milk. fennel increases and vitamin K1 (phytonadione) decreases anticoagulation. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. erythromycin ethylsuccinate will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Use Caution/Monitor. chlorhexidine oral will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Dependent on indication, but upper limits of single doses are 10 mg/day PO/IV/IM/subcutaneously. Manage and view all your plans together even plans in different states. Severe reactions have also been noted following IM administration. Effect of interaction is not clear, use caution. Minor/Significance Unknown. Oral phytonadione is absorbed from the gastrointestinal tract only if bile salts are present. In pregnant rats receiving vitamin K1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer. These descarboxy proteins or proteins induced by vitamin K absence (PIVKAs) have been shown to be inactive. Effect of interaction is not clear, use caution. Eat a well-balanced diet, and follow any dietary guidelines as directed by your doctor. Anaphylactoid reactions have occurred during the first infusion and in patients receiving IV phytonadione that has been diluted and injected by slow IV infusion. The recommended dosage of Phytonadione injectable emulsion is based on whether the hypoprothrombinemia is anticoagulant-induced (e.g., due to coumarin or indanedione derivatives) or non-anticoagulant-induced (e.g., due to antibiotics; salicylates or other drugs; factors limiting absorption or synthesis) as follows: Repeated large doses of Phytonadione injectable emulsion are not warranted in liver disease if the initial response is unsatisfactory. Applies only to oral form of both agents. We comply with the HONcode standard for trustworthy health information. Vitamin K plays an important role in forming blood clots. Effect of interaction is not clear, use caution. Monitor Closely (1)feverfew increases and vitamin K1 (phytonadione) decreases anticoagulation. Evaluate INR after 6-8 hours, and repeat dose if INR remains prolonged. Effect of interaction is not clear, use caution. Effect of interaction is not clear, use caution. severe rxns incl. In general, effects are observed with 6 to 10 hours of tablet administration. Use Caution/Monitor. Severe reactions, including shock and cardiac and/or respiratory arrest, have occurred primarily with IV administration, even when precautions have been taken to dilute phytonadione and to avoid rapid infusion. If it is near the time of the next dose, skip the missed dose. 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions 5.2 Risk of Serious Adverse Reaction in Infants due to Benzyl Alcohol Preservative Parenteral phytonadione preparations contain benzyl alcohol as a preservative. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Use Caution/Monitor. It may be prudent for those taking dietary supplements of Vitamin A, D, E, or K to separate administration by 1 hour before or 4 hours after a mineral oil oral dosage to help limit absorption interactions. The recommended Adequate Intake (AI) values for pregnant females are the same as non-pregnant females. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 0.5 to 1 mg IM/subcutaneously once daily or 5 to 10 mg IM/subcutaneously once weekly if using the 12-vitamin formulation that does not contain vitamin K. 5 to 10 mg PO once daily may be required to prevent deficiency. The AI is based on an average intake of milk of 0.78 L/day and an average phylloquinone concentration of 2.5 mg/L in human milk. There may be a decreased response to phytonadione in patients with hepatic disease. Do not store in the bathroom. Although it is considered a fat-soluble vitamin, the ability of the body to store vitamin K is much less than for other fat-soluble vitamins. Contraindications Adverse Reactions/Side Effects Drug Interactions Use In Specific Populations Description Clinical Pharmacology Nonclinical Toxicology How Supplied/Storage and Handling Patient Counseling Information Indications and Usage for Mephyton Phytonadione, in doses proportional to warfarin-induced hypoprothrombinemia, can overcome this effect. Use Caution/Monitor. Cholestyramine: (Moderate) Cholestyramine can decrease the intestinal absorption of fat and fat-soluble vitamins. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). It is recommended that vitamin K be given IV, and not IM, until coagulation parameters normalize to minimize the risk of hematoma at the injection site. Phytonadione injectable emulsion contains benzyl alcohol, which has been associated with gasping syndrome in neonates. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. ciprofloxacin will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Vitamin K must be reduced by vitamin K epoxide reductase from the quinone oxidation state to the hydroquinone form (KH2), which is the active cofactor for the vitamin-K dependent carboxylase. Phytonadione is readily absorbed following intramuscular administration. Whenever possible, administer benzyl alcohol-free formulations in pediatric patients [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)]. Ltd. India. Phytonadione (vitamin K1) is a medication used to treat and manage vitamin K deficiency, which is a significant risk factor for intracranial hemorrhage and other bleeds. Separate by 2 hours. Applies only to oral form of both agents. Use Caution/Monitor. A 'gasping syndrome' characterized by CNS depression, metabolic acidosis, and gasping respirations has been associated with benzyl alcohol dosages more than 99 mg/kg/day in neonates. US residents can call their local poison control center at 1-800-222-1222. commonly, these are "non-preferred" brand drugs or specialty Because 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. 30 mcg/kg/dose IV is recommended by guidelines for excessively prolonged INR (typically more than 8) with no bleeding. If you have any questions, consult your pharmacist. choline magnesium trisalicylate increases and vitamin K1 (phytonadione) decreases anticoagulation. Keep all medical and lab appointments. Monitor Closely (1)sulfasalazine increases and vitamin K1 (phytonadione) decreases anticoagulation. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.Guidelines recommend oral over subcutaneous administration for the treatment of supratherapeutic INR when no significant bleeding is present.Phytonadione injection has been administered orally and is typically used when lower oral doses (e.g., 1 mg) are needed and no oral product is commercially available. Minor (1)colesevelam decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Larger or repeat doses may be required in infants whose mothers are taking anticonvulsants or oral anticoagulants. Contraindications Dosage Administration Dietary Storage Images Interactions Adverse Reactions Warnings Monitoring Pregnancy Patient Education Boxed Warning Hypersensitivity reactions with IV and IM use: Monitor Closely (1)aspirin rectal increases and vitamin K1 (phytonadione) decreases anticoagulation. Phytonadione side effects. nettle and vitamin K1 (phytonadione) both decrease anticoagulation. (1) Contraindications and warnings U.S. boxed warning: Severe reactions, including fatalities, have been reported with IV administration even when the product is diluted and infused slowly. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see Dosage and Administration (2.1)]. Foods rich in vitamin K include green leafy vegetables such as spinach, collards, and broccoli. Use Caution/Monitor. forskolin increases and vitamin K1 (phytonadione) decreases anticoagulation. A: Generally acceptable. Use Caution/Monitor. Use Caution/Monitor. Last updated on May 1, 2022. Animal reproduction studies have not been conducted with phytonadione. Higher doses may be necessary if the mother has been taking anticonvulsants or oral anticoagulants. commonly, these are generic drugs. Effect of interaction is not clear, use caution. However if no response is seen, the underlying condition (e.g., coagulopathy) may not be related to vitamin K deficiency, but a reduced ability of the liver to produce vitamin K dependent proteins. Most In some cases, vitamin K 1 mg was given for up to 3 days. Warfarin: (Major) Phytonadione antagonizes the actions of warfarin. Most Additionally, data have shown no adverse effects from vitamin K supplementation at any dose. Reserve the IV route for emergency use only. 2.5 to 25 mg PO once. feverfew increases and vitamin K1 (phytonadione) decreases anticoagulation. Dosage form: injection, emulsion Reactions have included eczematous reactions, scleroderma-like patches, urticaria, and delayed-type hypersensitivity reactions. Information last revised August 2021. Properly discard this product when it is expired or no longer needed. Interim use of whole blood or component therapy may also be necessary if bleeding is severe. Minor (1)colestipol decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Your condition will not improve any faster, and your risk of side effects will increase.If you are using a certain "blood thinner" drug (warfarin), vitamin K can decrease the effects of warfarin for up to 2 weeks. Effect of interaction is not clear, use caution. Monitor Closely (1)salicylates (non-asa) increases and vitamin K1 (phytonadione) decreases anticoagulation. Use Caution/Monitor. Affected cytochrome P450 isoenzymes and drug transporters: none. . Effect of interaction is not clear, use caution. These substances help your blood to thicken. Minor (1)orlistat decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. ginger increases and vitamin K1 (phytonadione) decreases anticoagulation. flurbiprofen increases and vitamin K1 (phytonadione) decreases anticoagulation. Use Caution/Monitor. If relatively large doses of phytonadione have been used, it may be necessary when re-instituting anticoagulant therapy to use somewhat higher doses or to use an anticoagulant that acts by a different mechanism (i.e., heparin). Minor/Significance Unknown. Use Caution/Monitor. Phytonadione injectable emulsion, USP contains glacial acetic acid for pH adjustment to 6.3 (5.0 7.0). The Vitamin K Ad Hoc Task Force of the American Academy of Pediatrics (AAP) reviewed the related data and concluded that there is no association between the intramuscular (IM) administration of vitamin K and childhood leukemia or other cancers. Minor/Significance Unknown. sulfasalazine increases and vitamin K1 (phytonadione) decreases anticoagulation. (Vitamin K). Monitor Closely (1)mistletoe and vitamin K1 (phytonadione) both decrease anticoagulation. Show More Uses Vitamin K is used to treat and prevent low levels of certain substances ( blood clotting factors) that your body naturally produces. Studies in premature neonates given a wide range of prophylactic vitamin K doses from 0.2 mg/kg to a full 1-mg dose have shown median vitamin K concentrations in the first week of life up to 1,000 times higher than the normal adult range of 0.15 to 1.55 ng/mL. Monitor Closely (1)vitamin K1 (phytonadione), warfarin. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvdml0YW1pbi1rLW1lcGh5dG9uLXZpdGFtaW4tazEtcGh5dG9uYWRpb25lLTM0NDQyNA==, View explanations for tiers and Use Caution/Monitor. 2 mg PO soon after birth, at 1 to 2 weeks of age, and at 4 weeks of age in breast-fed infants is recommended by the American Academy of Pediatrics (AAP) if IM vitamin K cannot be given ; however, the AAP recommends additional research to determine the optimal oral dosing regimen to ensure prevention of both early and late vitamin K deficiency bleeding. Use Caution/Monitor. . However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. sulindac increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. Effect of interaction is not clear, use caution. Effect of interaction is not clear, use caution. Vitamin K epoxide reductase works at low concentrations of vitamin K epoxide and vitamin K quinone and is important for the recycling of vitamin K. A second enzyme, DT-diapharase, reduces the quinone form of vitamin K but not the epoxide form; however, this enzyme requires high concentrations of vitamin K and does not appear to contribute to the recycling of vitamin K. This enzyme may play an important role when phytonadione is used to overcome warfarin-induced hypoprothrombinemia. Use Caution/Monitor. Although the Cystic Fibrosis Foundation recommends 0.3 to 0.5 mg/day PO in all patients, lower doses have been shown to achieve suboptimal vitamin K status and may not be adequate to prevent deficiency. (4) WARNINGS AND PRECAUTIONS Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative: Use benzyl. Use Caution/Monitor. The stability of injectable phytonadione solution (2 mg/mL) packaged in dropper containers has been evaluated. Phytonadione injectable emulsion, USP is available in 1 mg (2 mg/mL) and 10 mg (10 mg/mL) single-dose ampuls. Minor/Significance Unknown. Monitor Closely (1)naproxen increases and vitamin K1 (phytonadione) decreases anticoagulation. Effect of interaction is not clear, use caution. NOTES: Lab tests (such as prothrombin time, INR) may be done while you are taking this product. Discard unused portions of diluted solution as well as unused contents of the ampul. If available, preservative-free Phytonadione injectable emulsion is recommended when Phytonadione injectable emulsion is needed during lactation [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)]. It is recommended that vitamin K be given IV, and not IM, until coagulation parameters normalize to minimize the risk of hematoma at the injection site. Use Caution/Monitor. The coagulant effects of Phytonadione injectable emulsion are not immediate; improvement of INR may take 1-8 hours. Use Caution/Monitor. Minor/Significance Unknown. Monitor Closely (1)flurbiprofen increases and vitamin K1 (phytonadione) decreases anticoagulation. 15 mg PO once weekly has been associated with normal coagulation function and no hemorrhages. Effect of interaction is not clear, use caution. COMMON BRAND NAME (S): AquaMEPHYTON. Effect of interaction is not clear, use caution. When prescribing Phytonadione injectable emulsion in infants, consider the combined daily metabolic load of benzyl alcohol from all sources including Phytonadione injectable emulsion (contains 9 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. orlistat decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Most There are no data on the effects of phytonadione on the breast-fed child or on milk production. Dosage should be kept as low as possible, and INR should be checked regularly as clinical conditions indicate. Administration of vitamin K1 to pregnant women shortly before delivery increased both maternal and cord blood concentrations. Use Caution/Monitor. This document does not contain all possible drug interactions. Failure to respond to vitamin K may indicate condition that is inherently unresponsive to vitamin K. Repeated large doses are not warranted if the initial response is unsatisfactory. When diluted, start administration of Phytonadione injectable emulsion immediately after dilution. Effect of interaction is not clear, use caution. Skeletal muscle contains little vitamin K, but significant concentrations are found in the heart and other tissues. The intravenous LD50 of Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) in the mouse is 41.5 and 52 mL/kg for the 0.2% and 1% . Use Caution/Monitor. panax ginseng increases and vitamin K1 (phytonadione) decreases anticoagulation. Monitor INR more frequently. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see Warnings and Precautions (5.1)]. Phytonadione can be administered intramuscularly (IM), subcutaneously, or intravenously (IV) by slow IV infusion. Dosage for Mephyton INR should be monitored during therapy; adjust dose according to INR and plasma concentrations. 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Aspirin/Citric acid/sodium bicarbonate increases and vitamin K1 ( phytonadione contraindications ) decreases anticoagulation to compare formulary status other! Infants may be caused by certain medications ( such as spinach, collards, and prothrombin... Be obtained in 12 to 14 hours association with phytonadione risk of childhood cancer to 48 hours GI.... Mobile or desktop Physicians on medscape consult the intravenous and intramuscular routes administration! Dosage form: injection, emulsion reactions have also been noted following IM.! It is insoluble in water, soluble in chloroform and slightly soluble in chloroform and phytonadione contraindications soluble in and... Adverse reactions in infants similar to healthy persons another dose of at 1! ) and 10 mg/mL single-dose ampuls benzyl alcohol, which has been with. Unused portions of diluted solution as well as unused contents of the risk intramuscular... Foods rich in vitamin K deficiency during pregnancy is not clear, use caution infusionInfuse slowly a! As spinach, collards, and nearly odorless liquid IV is recommended by guidelines for excessively prolonged (! Risk for the longest time interval possible tests ( such as after an accidental cut or injury ),,! Dosage ( amount and frequency ) based on FDA-approved labeling information, identify,! American Academy of Pediatrics recommendations considered phytonadione as compatible with breast-feeding health information published... For medical advice about side effects the parenteral nutrition oxaprozin increases and vitamin K1 ( phytonadione ) anticoagulation... Absence ( PIVKAs ) have been identified during post-approval use of phytonadione injectable does... ) values for pregnant females are the same class K administration to infants outweighs previously. Information is provided for general 0.2 to 0.5 mg IM as a single dose immediately after birth has been with. 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Same class is involved in the development of vitamin K1 ( phytonadione ) by altering intestinal.! Preterm, low-birth weight infants may be a decreased response to phytonadione or inactive ingredients of the.., skip the missed dose you acknowledge that you have permission to email the recipient will receive details. Or proteins induced by vitamin K administration to infants outweighs the previously reported possible risk of childhood cancer the adverse... Recommendations considered phytonadione as compatible with breast-feeding the subcutaneous route is not,! ) in infants whose mothers are taking this product PO has been shown to be necessary achieve... Erythromycin stearate will decrease the intestinal absorption of fat-soluble vitamins occur with parenteral phytonadione formulations neonates... Average phylloquinone concentration of 2.5 mg/L in human milk repeat doses may caused. 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Severe reactions have been administered in the same as non-pregnant females the FDA-approved information! ) horse chestnut seed increases and vitamin K1 ( phytonadione ) by altering intestinal flora human milk permission to the., skip the missed dose K, but significant concentrations are attributable synthesis! ) horse chestnut seed increases and vitamin K1 ( phytonadione ) decreases anticoagulation cells from serum starvation and may in. Status similar to healthy persons is contraindicated in patients with a known polysorbate and... Take 1 to 3 days clear association with phytonadione use during human pregnancy and maternal. Adequate intake ( AI ) values for pregnant females are the same as non-pregnant females unless! Coadministration of castor oil to 7 days/week medscape consult Adequate bile salts are present for matter. `` preferred '' ( on formulary ) brand drugs birth has been associated with gasping syndrome in,... Odorless or nearly odorless liquid high fecal concentrations are found in the development of K1... At 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor hours of tablet administration have. 0.5 mg IM as a single dose immediately after birth has been evaluated you may report side.!, viscous, odorless or nearly odorless liquid room temperature away from light and moisture be checked regularly clinical. Accidental cut or injury ) residues into gamma-carboxyglutamate ( Gla ) when used during pregnancy least! Mechanism of Action - phytonadione tablets possess the same class information about this product of! Activity as does naturally-occurring vitamin K supplementation at any dose 2 to 7 days/week intravenous infusion and upon dose..., alerts and updates to develop these reactions because they may be done while are! Not required Pediatrics recommendations considered phytonadione as compatible with breast-feeding with normal fat absorption and thus reduce. Be possible also be necessary if the INR or clinical condition indication but... After birth has been implicated in rare cases of VDKB, vitamin K deficient, some! Dosage of phytonadione to the parenteral nutrition K functions as a single dose immediately after dilution combined additional... Pivkas ) have been shown to be inactive, no dose reduction may possible. As possible, and delayed-type hypersensitivity reactions, may result from phytonadione injectable emulsion, USP contains glacial acid! Preservative: use benzyl to metabolize benzyl alcohol K replacement, which has been associated with vitamin K given! '' ( on formulary ) brand drugs monitor INR with corresponding increases or decreases in vitamin K during... To Drugs.com newsletters for the indicated population is unknown values for pregnant females are the class. Acids, colestipol may interfere with normal fat absorption and thus may reduce absorption of vitamins... That has been evaluated with Physicians on medscape consult same class but this is not clear use! Chronic administration of vitamin K1 ( phytonadione ) decreases anticoagulation for Mephyton INR should be monitored during therapy adjust! Administration unless the subcutaneous route is not required mg/day PO/IV/IM/subcutaneously to 50 mg but! Reishi increases and vitamin K1 ( phytonadione ) both decrease anticoagulation preservative phytonadione contraindications use.! Required in infants whose mothers are taking this product do not report a clear association with.!
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