phytonadione
Phytonadione is a vitamin k used to treat Drug-Induced Abnormalities, Hypoprothrombinemias, Diseases Premature Infant.
Vitamin K · by Gland
Generic of Aquamephyton
Key facts
- Active ingredient
- Phytonadione
- Drug class
- Vitamin K
- Form
- Injectable, Emulsion, Tablet
- Strength
- Phytonadione 10MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Gland
- What the pharmacy pays
- ~$340.49 for 30 — not your price
- FDA application
- ANDA217386
- FDA boxed warning
- Yes — see the boxed warning
What is Phytonadione?
From the FDA label:Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is practically insoluble in water, sparingly soluble in ethanol and miscible with fatty oils. It has a molecular weight of 450.70. Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-en-1-yl-naphthalene-1,4 dione. Its empirical formula is C 31 H 46 O 2 and its structural formula is: 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, USP 10 mg, polyoxyl 35 castor oil 70 mg, dextrose monohydrate 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. phytonadione-structure
How to use
Phytonadione is sold in more than one form (Injectable, Emulsion and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA217386 — follow the label that came with the product you were actually prescribed.
Whenever possible, 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 Phytonadione injectable emulsion, USP 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 Phytonadione be given to the newborn. A single intramuscular dose of phytonadione injectable emulsion, USP 0.5 to 1 mg within one hour of birth is recommended. Treatment of Hemorrhagic Disease of the Newborn Empiric administration of Phytonadione should not replace…
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
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.
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 Phytonadione Injectable Emulsion, 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 Phytonadione 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 Phytonadione 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 Phytonadione
Hypersensitivity to any component of this medication.
Overdose — what happens if you take too much
The intravenous LD 50 of Phytonadione Injectable Emulsion 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 Phytonadione ranks — best-rated vitamin k for:
Dosage forms
Injectable, Emulsion and Tablet
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 Phytonadione treat?
- Phytonadione (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 much does Phytonadione 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 Phytonadione?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Phytonadione. To pay less, Phytonadione 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 Phytonadione?
- Phytonadione is marketed by Gland. You can see Gland's full profile, rating, and other products on pharmaranks.
- Is Phytonadione a brand-name or generic drug?
- Phytonadione 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 Phytonadione available over the counter?
- No. Phytonadione 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 Phytonadione come in?
- Phytonadione is currently marketed as injectable, emulsion and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Phytonadione?
- Phytonadione is classified as vitamin k, warfarin reversal agent, per the FDA's Established Pharmacologic Class.
- Is Phytonadione FDA-registered?
- Phytonadione is on record with the U.S. FDA under application number ANDA217386. You can verify this on its official FDA label.
- Is Phytonadione safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Phytonadione. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Phytonadione?
- Phytonadione'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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