No

Vitamin, Fat Soluble

Prevention and treatment of hypoprothrombinemia caused by drug-induced or anticoagulant-induced vitamin K deficiency, hemorrhagic disease of the newborn; phytonadione is more effective and is preferred to other vitamin K preparations in the presence of impending hemorrhage; oral absorption depends on the presence of bile salts

C

Hypersensitivity to phytonadione or any component

Severe reactions resembling anaphylaxis or hypersensitivity have occurred rarely during or immediately after I.V. administration (even with proper dilution and rate of administration); restrict I.V. administration for emergency use only; ineffective in hereditary hypoprothrombinemia, hypoprothrombinemia caused by severe liver disease; severe hemolytic anemia has been reported rarely in neonates following large doses (10-20 mg) of phytonadione

<1%: Transient flushing reaction, rarely hypotension, cyanosis, dizziness (rarely), pain, abnormal taste, GI upset (oral), hemolysis in neonates and in patients with G-6-PD deficiency, tenderness at injection site, dyspnea, diaphoresis, anaphylaxis, hypersensitivity reactions

Decreased effect: Warfarin sodium, dicumarol, anisindione effects antagonized by phytonadione; mineral oil may decrease GI absorption of vitamin K

Protect injection from light at all times; may be autoclaved

Promotes liver synthesis of clotting factors (II, VII, IX, X); however, the exact mechanism as to this stimulation is unknown. Menadiol is a water soluble form of vitamin K; phytonadione has a more rapid and prolonged effect than menadione; menadiol sodium diphosphate (K₄) is half as potent as menadione (K₃).

Onset of increased coagulation factors: Oral: Within 6-12 hours; Parenteral: Within 1-2 hours; prothrombin may become normal after 12-14 hours

Absorption: Oral: Absorbed from the intestines in the presence of bile

Metabolism: In the liver rapidly

Elimination: In bile and urine

I.V. route should be restricted for emergency use only

Infants: 1-5 mcg/kg/day

Adults: 0.03 mcg/kg/day

Hemorrhagic disease of the newborn:

Prophylaxis: I.M.: 0.5-1 mg within 1 hour of birth

Treatment: I.M., S.C.: 1-2 mg/dose/day

Oral anticoagulant overdose:

Infants: I.M., S.C.: 1-2 mg/dose every 4-8 hours

Children and Adults: Oral, I.M., I.V., S.C.: 2.5-10 mg/dose; rarely up to 25-50 mg has been used; may repeat in 6-8 hours if given by I.M., I.V., S.C. route; may repeat 12-48 hours after oral route

Vitamin K deficiency: Due to drugs, malabsorption or decreased synthesis of vitamin K

Infants and Children:

Oral: 2.5-5 mg/24 hours

I.M., I.V.: 1-2 mg/dose as a single dose

Adults:

Oral: 5-25 mg/24 hours

I.M., I.V.: 10 mg

PT

May rarely cause dizziness

None reported

No information available to require special precautions

No effects or complications reported

Oral: Take only as directed; do not take more or more often than prescribed. Avoid excessive or increased intake of vitamin K containing food (eg, green leafy vegetables, dairy products, meats) unless recommended by prescriber. Avoid alcohol and any OTC or prescribed medications containing aspirin that are not approved by prescriber. Report bleeding gums; blood in urine, stool, or vomitus; unusual bruising of bleeding; or abdominal cramping. Pregnancy precautions: Inform prescriber if you are or intend to be pregnant.

I.V. administration: Dilute in normal saline, D₅W or D₅NS and infuse slowly; rate of infusion should not exceed 1 mg/minute. This route should be used only if administration by another route is not feasible for phytonadione; I.V. administration should not exceed 1 mg/minute; for I.V. infusion, dilute in PF (preservative free) D₅W or normal saline.

Injection:

Aqueous colloidal: 2 mg/mL (0.5 mL); 10 mg/mL (1 mL, 2.5 mL, 5 mL)

Aqueous (I.M. only): 2 mg/mL (0.5 mL); 10 mg/mL (1 mL)

Tablet: 5 mg

A 1 mg/mL oral suspension was stable for only 3 days when refrigerated when compounded as follows:

Shake well before using and keep in refrigerator

Nahata MC and Hipple TF, Pediatric Drug Formulations, 3rd ed, Cincinnati, OH: Harvey Whitney Books Co, 1997.

Barash P, Kitahata LM, and Mandel S, "Acute Cardiovascular Collapse After Intravenous Phytonadione," Anesth Analg, 1976, 55(2):304-6.

Harrell CC and Kline SS, "Oral Vitamin K1: An Option to Reduce Warfarin's Activity," Ann Pharmacother, 1995, 29(12):1228-32.

Hopkins CS, "Adverse Reaction to a Cremophor-Containing Preparation of Intravenous Vitamin K," Intensive Therapy Clin Monit, 1988, 9:254-5.

Martinez-Abad M, Delgado F, Palop V, et al, "Vitamin K₁ and Anaphylactic Shock," DICP, 1991, 25(7-8):871-2.

Michelson AD, Bovill E, Monagle P, et al, "Antithrombic Therapy in Children," Chest, 1998, 114(5 Suppl):748S-69S.

Shearer MJ, "Vitamin K," Lancet, 1995, 345(8944):229-34.