部份中文维生素K1处方资料（仅供参考）
通用名称：维生素K1注射液
商品名称：Vitamin K1 Injection
英文名称：PHYTONADIONE
成份
本品主要成份为：维生素K1
药理毒理
本品为维生素类药。维生素k是肝脏合成因子Ⅱ、Ⅶ、Ⅸ、Ⅹ所必须的物质。维生素k缺乏可引起这些凝血因子合成障碍或异常，临床可见出血倾向和凝血酶原时间延长。
药代动力学
肌内注射1－2小时起效，3－6小时止血效果明显，12－14小时后凝血酶原时间恢复正常。本品在肝内代谢，经肾脏和胆汁排出。
适应症
用于维生素k缺乏引起的出血，如梗阻性黄疸、胆瘘、慢性腹泻等所致出血，香豆素类、水杨酸钠等所致的低凝血酶原血症，新生儿出血以及长期应用广谱抗生素所致的体内维生素k缺乏。
用法和用量
1、低凝血酶原血症：肌内或深部皮下注射，每次10mg，每日1－2次，24小时内总量不超过40mg。
2、预防新生儿出血：可于分娩前12－24小时给母亲肌注或缓慢静注2－5mg。也可在新生儿出生后肌内或皮下注射0.5-1mg，8小时后可重复。
3、本品用于重症患者静注时，给药速度不应超过1mg/分。
不良反应
偶见过敏反应。静注过快，超过5mg/分，可引起面部潮红、出汗、支气管痉挛、心动过速、低血压等，曾有快速静脉注射致死的报道。肌注可引起局部红肿和疼痛。新生儿应用本品后可能出现高胆红素血症，黄疸和溶血性贫血。
禁忌
严重肝脏疾患或肝功不良者禁用。
注意事项
（1）有肝功能损伤的患者，本品的疗效不明显，盲目加量可加重肝损伤。
（2）本品对肝素引起的出血倾向无效。外伤出血无必要使用本品。
（3）本品用于静脉注射宜缓慢，给药速度不应超过1mg/分。
（4）本品应避免冻结，如有油滴析出或分层则不宜使用，但可在避光条件下加热至70－80oC，振摇使其自然冷却，如澄明度正常则仍可继续使用。
孕妇及哺乳期用药
本品可通过胎盘，故对临产孕妇应尽量避免使用。
儿童用药
新生儿出血症；肌肉或皮下注射，每次1mg，8小时后可重复给药。
药物相互作用
本品与苯妥英钠混合2小时后可出现颗粒沉淀，与维生素C、维生素B12、右旋糖酐混合易出现混浊。与双香豆素类口服抗凝剂合用，作用相互抵消。水杨酸类、磺胺、奎宁、奎尼丁等也影响维生素k1的效果。
药物过量
药物大剂量或超剂量可加重肝损害。
包装
VITAMIN K1 10MG/ML 1ML AMP HP 25/PAC  PHYTONADIONE  PFIZER INC  NDC：00409-9158-01  $2,638.64
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DESCRIPTION
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. It has a molecular weight of 450.70.Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H46O2 and its structural formula is:Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Each milliliter contains phytonadione 2 or 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive.
CLINICAL PHARMACOLOGY
Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) aqueous dispersion 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). The prothrombin test is sensitive to the levels of three of these four factors−II, VII, and X. 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. The resulting gamma-carboxy-glutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood.Phytonadione is readily absorbed following intramuscular administration. After absorption, phytonadione is initially concentrated in the liver, but the concentration declines rapidly. Very little vitamin K accumulates in tissues. Little is known about the metabolic fate of vitamin K. Almost no free unmetabolized vitamin K appears in bile or urine.In normal animals and humans, phytonadione is virtually devoid of pharmacodynamic activity. However, in animals and humans deficient in vitamin K, the pharmacological action of vitamin K is related to its normal physiological function, that is, to promote the hepatic biosynthesis of vitamin K dependent clotting factors.The action of the aqueous dispersion, when administered intravenously, is generally detectable within an hour or two and hemorrhage is usually controlled within 3 to 6 hours. A normal prothrombin level may often be obtained in 12 to 14 hours.In the prophylaxis and treatment of hemorrhagic disease of the newborn, phytonadione has demonstrated a greater margin of safety than that of the water-soluble vitamin K analogues.
INDICATIONS AND USAGE
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.
CONTRAINDICATION
Hypersensitivity to any component of this medication.
WARNINGS
Benzyl alcohol as a preservative in Bacteriostatic Sodium Chloride Injection has been associated with toxicity in newborns. Data are unavailable on the toxicity of other preservatives in this age group. There is no evidence to suggest that the small amount of benzyl alcohol contained in Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP), when used as recommended, is associated with toxicity.An immediate coagulant effect should not be expected after administration of phytonadione. It takes a minimum of 1 to 2 hours for measurable improvement in the prothrombin time. Whole blood or component therapy may also be necessary if bleeding is severe.Phytonadione will not counteract the anticoagulant action of heparin.When vitamin K1 is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy. Phytonadione is not a clotting agent, but overzealous therapy with vitamin K1 may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and prothrombin time should be checked regularly as clinical conditions indicate.Repeated large doses of vitamin K are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. Failure to respond to vitamin K may indicate that the condition being treated is inherently unresponsive to vitamin K.Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they required large amounts of calcium and phosphate solutions, which contain aluminum.Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
DRUG INTERACTIONS
Temporary resistance to prothrombin-depressing anticoagulants may result, especially when larger doses of phytonadione are used. If relatively large doses have been employed, it may be necessary when reinstituting anticoagulant therapy to use somewhat larger doses of the prothrombin-depressing anticoagulant, or to use one which acts on a different principle, such as heparin sodium.Laboratory TestsProthrombin time should be checked regularly as clinical conditions indicate.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
Studies of carcinogenicity, mutagenesis or impairment of fertility have not been conducted with Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP).
PREGNANCY
Animal reproduction studies have not been conducted with Vitamin K1 Injection. It is also not known whether Vitamin K1 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Vitamin K1 Injection should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Vitamin K1 Injection is administered to a nursing woman.
PEDIATRIC USE
Hemolysis, jaundice, and hyperbilirubinemia in neonates, particularly those that are premature, may be related to the dose of Vitamin K1 Injection. Therefore, the recommended dose should not be exceeded (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).
ADVERSE REACTIONS
Deaths have occurred after intravenous and intramuscular administration. (See Box Warning.)Transient "flushing sensations" and "peculiar" sensations of taste have been observed, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis.Pain, swelling, and tenderness at the injection site may occur.The possibility of allergic sensitivity including an anaphylactoid reaction, should be kept in mind.Infrequently, usually after repeated injection, erythematous, indurated, pruritic plaques have occurred; rarely, these have progressed to scleroderma-like lesions that have persisted for long periods. In other cases, these lesions have resembled erythema perstans.Hyperbilirubinemia has been observed in the newborn following administration of phytonadione. This has occurred rarely and primarily with doses above those recommended (See PRECAUTIONS, Pediatric Use).
OVERDOSAGE
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% concentrations, respectively.
DOSAGE AND ADMINISTRATION
Whenever possible, Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) should be given by the subcutaneous route (See Box Warning). When intravenous administration is considered unavoidable, the drug should be injected very slowly, not exceeding 1 mg per minute.Protect from light at all times.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.Directions for DilutionVitamin K1 Injection may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Benzyl alcohol as a preservative has been associated with toxicity in newborns. Therefore, all of the above diluents should be preservative-free (See WARNINGS). Other diluents should not be used. When dilutions are indicated, administration should be started immediately after mixture with the diluent, and unused portions of the dilution should be discarded, as well as unused contents of the ampul.Prophylaxis of Hemorrhagic Disease of the NewbornThe American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of Vitamin K1 Injection 0.5 to 1 mg within one hour of birth is recommended.Treatment of Hemorrhagic Disease of the NewbornEmpiric administration of vitamin K1 should not replace proper laboratory eva luation of the coagulation mechanism. A prompt response (shortening of the prothrombin time in 2 to 4 hours) following administration of vitamin K1 is usually diagnostic of hemorrhagic disease of the newborn, and failure to respond indicates another diagnosis or coagulation disorder.Vitamin K1 Injection 1 mg should be given either subcutaneously or intramuscularly. Higher doses may be necessary if the mother has been receiving oral anticoagulants.Whole blood or component therapy may be indicated if bleeding is excessive. This therapy, however, does not correct the underlying disorder and Vitamin K1 Injection should be given concurrently.Anticoagulant-Induced Prothrombin Deficiency in AdultsTo correct excessively prolonged prothrombin time caused by oral anticoagulant therapy—2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required. Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition (See WARNINGS). If in 6 to 8 hours after parenteral administration the prothrombin time has not been shortened satisfactorily, the dose should be repeated.Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) Summary of Dosage Guidelines (See circular text for details)NewbornsDosageHemorrhagic Disease    of the Newborn    Prophylaxis0.5 to 1 mg IM within 1 hour of birth    Treatment1 mg SC or IM(Higher doses may be necessary if the mother has been receiving oral anticoagulants)AdultsInitial DosageAnticoagulant-InducedProthrombin Deficiency(caused by coumarin or indanedione derivatives)2.5 mg to 10 mg orup to 25 mg(rarely 50 mg)HypoprothrombinemiaDue to other causes(Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis)2.5 mg to 25 mg ormore (rarely up to50 mg)In the event of shock or excessive blood loss, the use of whole blood or component therapy is indicated.Hypoprothrombinemia Due to Other Causes in AdultsA dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates; antibiotics) is suggested as an alternative to administering concurrent Vitamin K1 Injection. The severity of the coagulation disorder should determine whether the immediate administration of Vitamin K1 Injection is required in addition to discontinuation or reduction of interfering drugs.
HOW SUPPLIED
Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is supplied in a package of 25 as follows:Unit of SaleConcentrationNDC 0409-9157-0125 ampuls in a package1 mg/0.5 mL(2 mg/mL)NDC 0409-9158-0125 ampuls in a package10 mg/mLStore at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Protect from light. Keep ampuls in tray until time of use.Distributed by Hospira, Inc., Lake Forest, IL 60045 USALAB-1141-1.0Revised: 04/2018
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1FC36CED-0E90-486B-B459-0414B7B9D0FB