vitamin k1
Pharmaranks rates Vitamin K1 3.0/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Vitamin K1 (Phytonadione) is a vitamin k used to treat Drug-Induced Abnormalities, Hypoprothrombinemias, Diseases Premature Infant.
Phytonadione · by Hospira
Generic of Aquamephyton
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Phytonadione
- Drug class
- Vitamin K
- Form
- Injectable, Emulsion
- Strength
- Phytonadione 1MG/0.5ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Hospira
- What the pharmacy pays
- ~$340.49 for 30 — not your price
- FDA application
- ANDA087954
- FDA boxed warning
- Yes — see the boxed warning
What is Vitamin K1?
From the FDA label: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. STRUCTURE
How to use
Vitamin K1 is sold in more than one form (Injectable and Emulsion), and each is dosed differently. The instructions below come from the FDA label for application ANDA087954 — follow the label that came with the product you were actually prescribed.
Whenever possible, Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) should be given by the subcutaneous route (See BOX WARNING ). When intravenous administration is considered unavoidable, the drug should be injected very slowly, not exceeding 1 mg per minute. 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 Vitamin K1 Injection may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Benzyl alcohol as a preservative has been associated with toxicity in newborns. Therefore, all of the above diluents should be preservative-free (See WARNINGS ). 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, as well as unused contents of the ampul. Prophylaxis of Hemorrhagic Disease of the Newborn The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of Vitamin K1 Injection 0.5 to 1 mg within one hour of birth is recommended. Treatment of Hemorrhagic Disease of the Newborn Empiric administration of vitamin K1 should not replace proper laboratory…
Side effects
Deaths have occurred after intravenous and intramuscular administration. (See BOX WARNING .) 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. Pain, swelling, and tenderness at the injection site may occur. 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 (See PRECAUTIONS , PEDIATRIC USE).
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
BOXED WARNING
Warnings
Important safety information
Benzyl alcohol as a preservative in Bacteriostatic Sodium Chloride Injection has been associated with toxicity in newborns. Data are unavailable on the toxicity of other preservatives in this age group. There is no evidence to suggest that the small amount of benzyl alcohol contained in Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP), when used as recommended, is associated with toxicity. An immediate coagulant effect should not be expected after administration of phytonadione. It takes a minimum of 1 to 2 hours 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. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they required large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Who should not take Vitamin K1
Hypersensitivity to any component of this medication.
Overdose — what happens if you take too much
The intravenous LD50 of Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) in the mouse is 41.5 and 52 mL/kg for the 0.2% and 1% concentrations, respectively.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
- Vitamin K
- Warfarin Reversal Agent
May treat (source: NIH RxClass)
See how Vitamin K1 ranks — best-rated vitamin k for:
Dosage forms
Injectable and Emulsion
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Vitamin K1 treat?
- Vitamin K1 (Phytonadione) may be used to treat drug-induced abnormalities, hypoprothrombinemias, diseases premature infant, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Vitamin K1 rated?
- pharmaranks gives Vitamin K1 a composite score of 3.0 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Vitamin K1 cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $340.49 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Vitamin K1?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Vitamin K1. To pay less, Vitamin K1 is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Vitamin K1?
- Vitamin K1 is marketed by Hospira. You can see Hospira's full profile, rating, and other products on pharmaranks.
- Is Vitamin K1 a brand-name or generic drug?
- Vitamin K1 is a generic medication; its active ingredient is Phytonadione. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Vitamin K1 available over the counter?
- No. Vitamin K1 is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Vitamin K1 come in?
- Vitamin K1 is currently marketed as injectable and emulsion, per the FDA's National Drug Code Directory.
- What class of drug is Vitamin K1?
- Vitamin K1 is classified as vitamin k, warfarin reversal agent, per the FDA's Established Pharmacologic Class.
- Is Vitamin K1 FDA-registered?
- Vitamin K1 is on record with the U.S. FDA under application number ANDA087954. You can verify this on its official FDA label.
- Has Vitamin K1 been recalled by the FDA?
- Vitamin K1 has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Vitamin K1 safe?
- There's no single safe-or-not verdict. pharmaranks gives Vitamin K1 a recall-safety score of 60/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Vitamin K1?
- Vitamin K1's side effects are taken directly from its FDA label. From the label: Deaths have occurred after intravenous and intramuscular administration. (See BOX WARNING .) 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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vitamin k1
60/100