Adult Dosing

Anticoagulant induced prothrombin deficiency

• 2.5-10 mg or up to 25 mg (rarely 50 mg) IM/IV/SC, may repeat after 6-8 hrs, depending upon prothrombin time

Hypoprothrombinemia due to other causes

• 2.5-25 mg (rarely 50 mg) IM/IV/SC, may repeat PRN, depending upon prothrombin time

• Use IV or IM only when unavoidable, see black box warnings
• Give intravenous administration only when considered unavoidable, administer very slowly not exceeding 1 mg/minute
• Dilute phytonadione with 0.9% sodium chloride injection, 5% dextrose injection for IV administration

Pediatric Dosing

Prophylaxis of Hemorrhagic Disease of the Newborn

• 0.5-1 mg IM, within 1 hr of birth

Treatment of Hemorrhagic Disease of the Newborn

• 1 mg IM/SC x 1; may need higher dose if mother has been receiving oral anticoagulants

[Outline]

• Adult Dosing
• Pediatric Dosing

• Management of coagulation disorders due to faulty formation of factors II, VII, IX, and X when caused by vitamin K deficiency or interference with vitamin K activity
• Anticoagulant-induced prothrombin deficiency
• Hypoprothrombinemia secondary to antibacterial therapy
• Prophylaxis and therapy of hemorrhagic disease of the newborn
• Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K
• Other drug-induced hypoprothrombinemia that interferes with vitamin K metabolism

• Hypersensitivity to any of the ingredient of the product
• Hereditary hypoprothrombinemia
• Over anticoagulation due to heparins

• Limit IV and IM routes to those situations where the SC route is not feasible and the serious risk involved is considered justified
• Severe reactions, including fatalities such as shock and cardiac and/or respiratory arrest have been reported during and immediately after IV and IM administration of phytonadione. This has occurred even when precautions have been taken to dilute the phytonadione to avoid rapid infusion via IV administration. These severe reactions have been reported in some patients on receiving phytonadione for the first time. Therefore IV and IM administration should be used only in those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Repeated large dose is not indicated in liver diseases, dose adjustments not defined

• Phytonadione do not have immediate coagulant effect, it takes 1-2 hrs for measurable improvement in the prothrombin time
• Anticoagulant effect of heparin will not be counteracted by phytonadione
• Anticoagulant therapy is still being indicated, when vitamin K1 is used to correct excessive anticoagulant-induced hypoprothrombinemia, as patient may again face the clotting hazards existing prior to starting the anticoagulant therapy
• Check the prothrombin time regularly as clinical conditions indicate and use the lowest possible dose of phytonadione. Phytonadione is not a clotting agent, but overzealous therapy with vitamin K1 may restore conditions which originally permitted thromboembolic phenomena
• In liver disease, if the response to initial use of the vitamin is unsatisfactory, repeated large doses of vitamin K are not acceptable
• Failure to respond to vitamin K may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K
• Benzyl alcohol used as preservative in sodium chloride injection has been associated with Gasping Syndrome in premature infants
• Aluminum content of this product can be toxic, prolonged parenteral administration in patients with impaired kidney function can lead to toxic level of aluminum. Premature patients are at higher risk because their kidneys are immature, and they required large amounts of calcium and phosphate solutions, which contain aluminum
• Aluminum level greater than 4-5 mcg/kg/day is associated with CNS and bone toxicity

Cautions: Use cautiously in

• Hepatic impairment
• Neonates
• Elderly patients

Pregnancy Category:C

Breastfeeding: Safety unknown, manufacturer advises caution.

• CNS: Dizziness
• CV: Rapid and weak pulse, hypotension, cyanosis
• RESP: Dyspnea
• GI: Unusual taste, hyperbilirubinemia (neonates)
• DERM: Flushing, profuse sweating, erythematous, indurated pruritic plaques
• LOCAL: Pain, inflammation, tenderness
• MISC: Allergic sensitivity, anaphylactoid reaction, especially with IV and IM administration

• Antifibrinolytic agent, vitamin K; its a essential cofactor for the gamma-carboxylase enzymes for the hepatic synthesis of blood coagulation factors II (prothrombin), VII, IX, and X
• Adequately absorbed from the GI tract only if bile salts are present
• Metabolized by liver
• Excreted in urine and bile, no free unmetabolized vitamin K appears in bile or urine
• Half-life: Unknown

US Trade Name(s)

• Only generic available

US Availability

phytonadione (generic)

• INJ: 1 mg/0.5 mL (single dose vial)

vitamin K (generic)

• INJ: 1 mg/0.5 mL (1 mL amp)
• INJ: 10 mg/mL (1 mL amp)

Canadian Trade Name(s)

• Only generic available

Canadian Availability

vitamin K1 (generic)

• INJ: 2 mg/mL
• INJ: 10mg/mL

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Konakion
• Konakion MM Paediatric

Australian Availability

Konakion

• INJ: 10 mg/mL

Konakion MM Paediatric

• INJ: 2 mg/0.2 mL

[Outline]

Nutrition/Electrolytes

Vitamins