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Side Effects & Adverse Reactions
WARNING:
WARNING - INTRAVENOUS USE: Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some animals have exhibited these severe reactions on receiving phytonadione for the first time. Therefore, the INTRAVENOUS route should be restricted to those situations where other routes are not feasible and serious risk involved is considered justified. |
An immediate coagulant effect should not be expected after administration of phytonadione. A minimum of 1 to 2 hours is required 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS:
K-Ject Injection is indicated in 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.
K-Ject Injection is indicated in cattle, calves, horses, swine, sheep, goats, dogs, and cats to counter hypoprothrombinemia induced by ingestion of anticoagulant rodenticides. K-Ject Injection is also indicated to counter hypoprothrombinemia caused by consumption of bishydroxycoumarin found in a spoiled and moldy sweet clover.
History
There is currently no drug history available for this drug.
Other Information
K-JECT
(Vitamin K1 Injection)
Phytonadione Aqueous Colloidal Solution
10 mg/mL
FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
CAUTION: Federal law restricts this drug to use by or on the order of a lincensed veterinarian
Net Contents: 100 mL
Multiple Dose Vial
For complete warnings and additional information see enclosed insert.
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.
K-Ject Injection is a yellow, sterile, aqueous colloidal solution of Vitamin K1, with a pH of 5.0 to 7.0, available for injection by the intravenous, intramuscular and subcutaneous routes.
EACH mL CONTAINS: Phytonadione 10 mg; Polyoxyethylated fatty acid derivative 65 mg; Dextrose monohydrate 37.5 mg; Butylated hydroxyanisole 1 mg; Butylated hydroxytoluene 1 mg; Citric acid 8.4 mg; Sodium phosphate 17.2 mg; with Benzyl Alcohol 0.9% w/v added as a preservative.
Sources
K-ject Manufacturers
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Butler Animal Health
K-ject | Butler Animal Health
DOSAGE AND ADMINISTRATION: Cattle, Calves, Horses, Swine, Sheep, and Goats: Acute hypoprothrombinemia (with hemorrhage) and Non-acute hypoprothrombinemia - 0.5 - 2.5 mg/kg subcutaneously OR intramuscularly.
Dogs and Cats: Acute hypoprothrombinemia (with hemorrhage) and Non-acute hypoprothrombinemia - 0.25 - 5.0 mg/kg subcutaneously OR intramuscularly. Use higher end of dose for second generation rodenticides.
Whenever possible, K-Ject Injection should be given by the subcutaneous or intramuscular route. When intravenous administration is considered unavoidable, the drug should be diluted and injected very slowly, not exceeding 1 mg per minute.
DIRECTIONS FOR DILUTION: K-Ject Injection may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. 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.
Whole blood or component therapy may be indicated if bleeding is excessive. This therapy, however, does not correct the underlying disorder and K-Ject Injection should be given concurrently. In the event of shock or excessive blood loss, the use of whole blood component therapy is indicated.
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