Phytonadione (Vitamin K)
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Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
| See warnings - comments
[0 to 20 mg] [50 ml] [30 min]
[21-50 mg] [100 ml] [60 min]
Elevated INRs (See below)
| Direct quotes -8TH ed: ACCP GUIDELINES:
Management of Nontherapeutic INRs
>>>For patients with INRs above the therapeutic range but < 5.0 and with no significant bleeding, we recommend lowering the dose or omitting a dose, monitoring more frequently, and resuming therapy at an appropriately adjusted dose when the INR is at a therapeutic level. If only minimally above therapeutic range or associated with a transient causative factor, no dose reduction may be required (all Grade 1C).
>>>For patients with INRs of > or = 5.0 but < 9.0 and no significant bleeding, we recommend omitting the next one or two doses, monitoring more frequently, and resuming therapy at an appropriately adjusted dose when the INR is at a therapeutic level (Grade 1C). Alternatively, we suggest omitting a dose and administering vitamin K (1 to 2.5 mg) orally, particularly if the patient is at increased risk of bleeding (Grade 2A). If more rapid reversal is required because the patient requires urgent surgery, we suggest vitamin K (< or = 5 mg) orally, with the expectation that a reduction of the INR will occur in 24 h. If the INR is still high, we suggest additional vitamin K (1 to 2 mg) orally (Grade 2C).
>>>For patients with INRs > or = 9.0 and no significant bleeding, we recommend holding warfarin therapy and administering a higher dose of vitamin K (2.5 to 5 mg) orally, with the expectation that the INR will be reduced substantially in 24 to 48 h (Grade 1B). Clinicians should monitor the INR more frequently, administer additional vitamin K if necessary, and resume therapy at an appropriately adjusted dose when the INR reaches the therapeutic range.
>>>In patients with serious bleeding and elevated INR, regardless of the magnitude of the elevation, we recommend holding warfarin therapy and giving vitamin K (10 mg) by slow IV infusion supplemented with fresh frozen plasma, prothrombin complex concentrate (PCC), or recombinant factor VIIa, depending on the urgency of the situation. We recommend repeating vitamin K administration every 12 h for persistent INR elevation (all Grade 1C).
>>>In patients with life-threatening bleeding (eg, intracranial hemorrhage) and elevated INR, regardless of the magnitude of the elevation, we recommend holding warfarin therapy and administering fresh frozen plasma, PCC, or recombinant factor VIIa supplemented with vitamin K, 10 mg by slow IV infusion, repeated, if necessary, depending on the INR (Grade 1C).
>>>In patients with mild to moderately elevated INRs without major bleeding, we recommend that when vitamin K is to be given, it be administered orally rather than subcutaneously (Grade 1A).
Stability / Miscellaneous
| EXP: Administer shortly after preparation.
Label: Protect from light// Do not Refrigerate.
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.
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.
DOSAGE AND ADMINISTRATION--------------------------------
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 Dilution
Prophylaxis of Hemorrhagic Disease of the Newborn
Treatment of Hemorrhagic Disease of the Newborn
Anticoagulant-Induced Prothrombin Deficiency in Adults
Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is supplied in a package of 25 as follows:
Store 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.
Source: [package insert]