Phytonadione is a vitamin k sold in the U.S. under 4 brand and generic names, for drug-induced abnormalities, hypoprothrombinemias and diseases premature infant. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Vitamin K1 (application ANDA087954). Other phytonadione products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer Vitamin K 1 Injection by the subcutaneous route, whenever possible. ( 2.1 ) • When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute. ( 2.1 ) 2.1 Dosing Considerations Whenever possible, administer Vitamin K 1 Injection by the subcutaneous route [see Boxed Warning ] . When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute [see Warnings and Precautions (5.1) ] . Monitor international normalized ratio (INR) regularly and as clinical conditions indicate. Use the lowest effective dose of Vitamin K 1 Injection. The coagulant effects of Vitamin K 1 Injection are not immediate; improvement of INR may take 1 to 8 hours. Interim use of whole blood or component therapy may also be necessary if bleeding is severe. Whenever possible, administer benzyl alcohol-free phytonadione formulations in pediatric patients [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] . When Vitamin K 1 Injection 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. Vitamin K 1 Injection is not a clotting agent, but overzealous therapy with Vitamin K 1 Injection may restore…
The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Cutaneous Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Vitamin K 1 Injection. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders: Tachycardia, hypotension. General Disorders and Administration Site Conditions: Generalized flushing; pain, swelling, and tenderness at injection site. Hepatobiliary Disorders: Hyperbilirubinemia. Immune System Disorders: Fatal hypersensitivity reactions, anaphylactic reactions.…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 54/100 | Prescription | Injectable | Generic | $354 | View → | |
| 2 |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Hypersensitivity to phytonadione or any other component of this medication [see Warnings and Precautions (5.1) ] . Hypersensitivity to any component of this medication. ( 4 )
Anticoagulants Vitamin K 1 Injection may induce temporary resistance to prothrombin-depressing anticoagulants, especially when larger doses of Vitamin K 1 Injection are used. Should this occur, higher doses of anticoagulant therapy may be needed when resuming anticoagulant therapy, or a change in therapy to a different class of anticoagulant may be necessary (i.e., heparin sodium). Vitamin K 1 Injection does not affect the anticoagulant action of heparin. Anticoagulants: May induce temporary resistance to prothrombin-depressing anticoagulants. ( 7 )
| Not yet rated |
| Prescription |
| Injectable |
| Generic |
| $354 |
| View → |
| 3 | Not yet rated | Prescription | Injectable | Generic | $354 | View → |
| 4 | Not yet rated | Prescription | Injectable | Generic | $354 | View → |