KAPPADIONE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for KAPPADIONE (KAPPADIONE).
Provides vitamin K activity necessary for hepatic synthesis of clotting factors II, VII, IX, and X.
| Metabolism | Hepatic; rapidly metabolized via side chain oxidation and conjugation. |
| Excretion | Primarily excreted via bile into feces; minimal renal excretion (<5% unchanged in urine). |
| Half-life | Terminal elimination half-life is approximately 2-3 hours for phylloquinone (K1); clinical effect on clotting factors lasts 24-48 hours due to prolonged hepatic action. |
| Protein binding | Highly protein bound (>99%), primarily to lipoproteins. |
| Volume of Distribution | Vd approximately 0.7-1.0 L/kg, indicating distribution into extravascular tissues, particularly liver. |
| Bioavailability | Oral bioavailability is low and variable (approximately 50% due to limited absorption and first-pass metabolism); IM/IV routes provide 100% bioavailability. |
| Onset of Action | IV: 1-2 hours for reversal of warfarin; IM: 6-10 hours; Oral: 6-12 hours. |
| Duration of Action | Duration of action lasts 24-48 hours for reversal of anticoagulation; longer for synthetic vitamin K analogues (e.g., menadione). |
Adults: 5-10 mg subcutaneously, intravenously, or intramuscularly once; may repeat in 12-48 hours if needed. For oral anticoagulant reversal: 1-5 mg orally.
| Dosage form | INJECTABLE |
| Renal impairment | No adjustment required for any GFR level; kappadione is hepatically metabolized and not renally excreted. |
| Liver impairment | Child-Pugh Class A: No adjustment. Child-Pugh Class B: Use with caution; consider lower initial doses (e.g., 2-5 mg) due to potential coagulation factor synthesis impairment. Child-Pugh Class C: Avoid use unless vitamin K deficiency is confirmed and benefits outweigh risks; if used, monitor INR closely. |
| Pediatric use | Neonates: 0.5-1 mg intramuscularly once at birth. Infants: 1-2 mg intramuscularly or subcutaneously once. Children: 5-10 mg intramuscularly or subcutaneously once; may repeat if needed. Doses based on 0.3-0.6 mg/kg for reversal; maximum 10 mg. |
| Geriatric use | No specific dose adjustment required; but use caution due to higher risk of thromboembolic events and polypharmacy; start at lower end of dosing range (e.g., 1-5 mg orally) and monitor INR. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for KAPPADIONE (KAPPADIONE).
| Breastfeeding | Vitamin K is naturally present in breast milk. KAPPADIONE is excreted into human milk in small amounts; M/P ratio is not established. The American Academy of Pediatrics considers vitamin K compatible with breastfeeding. Use with caution in nursing mothers; no adverse effects in infants are expected at maternal therapeutic doses. |
| Teratogenic Risk | KAPPADIONE (phytonadione) is a synthetic form of vitamin K. There are no well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Vitamin K is essential for the synthesis of clotting factors; deficiency can lead to fetal bleeding. The drug should be used during pregnancy only if clearly needed. There is no evidence of teratogenicity from the limited human data, but theoretical risks exist from the preservative benzyl alcohol in some parenteral formulations, associated with gasping syndrome in neonates. |
■ FDA Black Box Warning
Intravenous administration has been associated with severe reactions including anaphylaxis, cardiac arrest, and death. Reserve IV use for when other routes are not feasible and have resuscitation equipment available.
| Serious Effects |
["Known hypersensitivity to vitamin K or any component","Severe liver disease (relative)"]
| Precautions | ["Risk of severe hypersensitivity reactions with IV use","Not effective for hereditary hypoprothrombinemia","Use with caution in patients with hepatic impairment","Monitor INR during therapy"] |
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| Fetal Monitoring | Monitor maternal prothrombin time and INR to ensure adequate dosing. In neonates of mothers receiving high doses, monitor for signs of hyperbilirubinemia and hemolytic anemia due to potential oxidant stress from the preservative benzyl alcohol. No specific fetal monitoring required beyond routine prenatal care. |
| Fertility Effects | No known adverse effects on fertility. Vitamin K is a fat-soluble vitamin essential for normal reproductive function; deficiency may impair fertility, but supplementation at recommended doses does not impair fertility. |