vitamin k1 injection
"To address "continuing safety concerns" about severe neutropenia associated with the atypical antipsychotic clozapine (multiple brands), the US Food and Drug Administration (FDA) is making changes to requirements for monitoring, prescribing, disp"...
Vitamin K1 Injection
(phytonadione) Injectable Emulsion, USP
Aqueous Dispersion of Vitamin K1 Ampul
Protect from light. Keep ampuls in tray until time of use.
WARNING — INTRAVENOUS AND INTRAMUSCULAR 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. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.
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 and its structural formula is:
Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Each milliliter contains phytonadione 2 or 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive.
What are the precautions when taking aqueous colloidal solution of vitamin k1 (Vitamin K1)?
Before using vitamin K, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders, kidney disease, liver disease.
This product may contain aluminum, which can infrequently build up to dangerous levels in the body. The risk may be increased if this product is used for an extended time, especially in people with kidney disease. Tell your doctor immediately if you notice any symptoms of too much aluminum in the body such as muscle weakness, bone pain, or mental changes.
Last reviewed on RxList: 11/7/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Vitamin K1 Information
- Vitamin K1 Drug Interactions Center: vitamin k inj
- Vitamin K1 Side Effects Center
- Vitamin K1 Overview including Precautions
- Vitamin K1 FDA Approved Prescribing Information including Dosage
Vitamin K1 - User Reviews
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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