Phytonadione 1 mg/.5mL Injection, Emulsion, 10 syringes
Other active recalls for Phytonadione (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Warfarin Reversal Agent class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Phytonadione is simply vitamin K1 — the same vitamin K your body uses to make clotting proteins in the liver. Your doctor has prescribed it because your blood isn't clotting proper...
- What exactly is phytonadione, and why has my doctor prescribed it?
- Phytonadione is not instant. If you're receiving it by injection into a vein, you may start to see improvement in your clotting levels within one to two hours, and bleeding is usua...
- Yes — and this is important to understand. Phytonadione directly counteracts warfarin's blood-thinning effect, which is exactly why it's used when your INR is dangerously high. How...
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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UNII ZT934N0X4W
A naturally occurring amino acid salt used as a reducing agent and antioxidant in medications. It helps prevent ingredient breakdown and may improve product stability during storage.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII NVG71ZZ7P0
A salt derived from acetic acid, sodium acetate anhydrous is used in medicines as a buffer to help maintain stable pH levels and sometimes as a preservative or bulking agent in solid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.0805 | $0.40 / 5 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J3430 | $3.253 / J3430 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Phytonadione 1 mg/.5mL 00404-9935-05 | Henry | 1 syringe | — | AB1 | FDA listed | — |
| Phytonadione 1 mg/.5mL 25021-0505-70 | Sagent | 10 syringes | — | AB1 | FDA listed | — |
| Phytonadione 1 mg/.5mL 46708-0826-05 | Alembic | 1 syringe | — | AB1 | FDA listed | — |
| Phytonadione 1 mg/.5mL 62332-0826-05 | Alembic | 1 syringe | — | AB1 | FDA listed | — |
| Phytonadione 1 mg/.5mLthis 69097-0003-96 | Cipla | 10 syringes | — | AB1 | FDA listed | — |
| Phytonadione 1 mg/.5mL 70095-0154-02 | Sun | 1 syringe | — | AB1 | FDA listed | — |
| phytonadione 1 mg/.5mL 70121-1682-07 | Amneal | 1 syringe | — | AB1 | FDA listed | — |
| Phytonadione 1 mg/.5mL 76329-1240-01 | International | 1 syringe | — | AB1 | FDA listed | — |
| Phytonadione 1 mg/.5mL 81607-0020-02 | Orbicular | 1 syringe | — | AB1 | FDA listed | — |
| Phytonadione 1 mg/.5mL 69097-0709-96 | Cipla | 10 vials | — | AB2 | FDA listed | — |
| Phytonadione 1 mg/.5mL 43066-0132-10 | Baxter | 10 vials | — | AB2 | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69097-0003-96 You're viewing this | 10 SYRINGE in 1 CARTON (69097-003-96) / .5 mL in 1 SYRINGE (69097-003-67) | 2025-01-15 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING - HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Phytonadione Injectable Emulsion. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see Warnings and Precautions ( 5.1 )].
WARNING – HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE See full prescribing information for complete boxed warning . Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of Phytonadione Injectable Emulsion. Reactions have occurred despite dilution to avoid rapid infusion and upon first and subsequent doses.
Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified ( 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Phytonadione Injectable Emulsion is a vitamin K replacement indicated for the treatment of the following 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. Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives; ( 1.1 ) Hypoprothrombinemia due to antibacterial therapy; ( 1.1 ) Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; ( 1.1 ) Other drug-induced hypoprothrombinemia where is it definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.
( 1.1 ) Phytonadione Injectable Emulsion is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. ( 1.2 )
1.1Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Phytonadione Injectable Emulsion is indicated for the treatment of the following 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: anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; hypoprothrombinemia due to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.
1.2Prophylaxis and Treatment of Vitamin K-Deficiency Bleeding in Neonates Phytonadione Injectable Emulsion is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer Phytonadione Injectable Emulsion 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 )
2.1Dosing Considerations Whenever possible, administer Phytonadione Injectable Emulsion 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 Phytonadione Injectable Emulsion. The coagulant effects of Phytonadione Injectable Emulsion are not immediate; improvement of INR may take 1-8 hours. Interim use of whole blood or component therapy may also be necessary if bleeding is severe.
When Phytonadione Injectable Emulsion 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 Injectable Emulsion is not a clotting agent, but overzealous therapy with Phytonadione Injectable Emulsion may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and INR should be checked regularly as clinical conditions indicate.
2.2Recommended Dosage for Coagulation Disorders from Vitamin K Deficiency or Interference The recommended dosage of Phytonadione Injectable Emulsion is based on whether the hypoprothrombinemia is anticoagulant-induced (e.g., due to coumarin or indanedione derivatives) or non-anticoagulant-induced (e.g., due to antibiotics; salicylates or other drugs; factors limiting absorption or synthesis) as follows: Anticoagulant-Induced Hypoprothrombinemia: Phytonadione Injectable Emulsion 2.5 mg to 10 mg or more subcutaneously, intramuscularly, or intravenously.
Up to 25 mg to 50 mg may be administered as a single dose. Repeated large doses of Phytonadione Injectable Emulsion are not warranted in liver disease if the initial response is unsatisfactory. Failure to respond to Phytonadione Injectable Emulsion may indicate that the condition being treated is inherently unresponsive to Phytonadione Injectable Emulsion.
Hypoprothrombinemia Due to Other Causes (Non-Anticoagulation-Induced Hypoprothrombinemia): Phytonadione Injectable Emulsion 2.5 mg to 25 mg or more intravenously, intramuscularly, or subcutaneously. Up to 50 mg may be administered as a single dose. Evaluate INR after 6-8 hours, and repeat dose if INR remains prolonged.
Modify subsequent dosage (amount and frequency) based on the INR or clinical condition.
2.3Recommended Dosage for Prophylaxis and Treatment of Vitamin K Deficiency Bleeding in Neonates Prophylaxis of Vitamin K-Deficiency Bleeding in Neonates The recommended dosage of Phytonadione Injectable Emulsion is 0.5 mg to 1 mg within one hour of birth for a single dose. Treatment of Vitamin K-Deficiency Bleeding in Neonates The recommended dosage of Phytonadione Injectable Emulsion is 1 mg given either subcutaneously or intramuscularly. Consider higher doses if the mother has been receiving oral anticoagulants.
A failure to respond (shortening of the INR in 2 to 4 hours) may indicate another diagnosis or coagulation disorder.
2.4Directions for Dilution Dilute Phytonadione Injectable Emulsion with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. When diluted, start administration of Phytonadione Injectable Emulsion immediately after dilution. Discard unused portions of diluted solution as well as unused contents of the prefilled syringe.
Protect Phytonadione Injectable Emulsion from light at all times. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solu…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 1 mg/0.5 mL single-dose pre-filled syringe. Injection: 1 mg/0.5 mL single-dose pre-filled syringe. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity to phytonadione or any other component of this medication [see Warnings and Precautions (5.1)]. Hypersensitivity to any component of this medication. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Cutaneous Reactions: May occur with parenteral use. Discontinue drug and manage medically. ( 5.3 )
5.1Hypersensitivity Reactions Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of Phytonadione Injectable Emulsion. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. These reactions have included shock, cardiorespiratory arrest, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea.
Administer Phytonadione Injectable Emulsion subcutaneously whenever feasible. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see Dosage and Administration ( 2.1 )] .
5.3Cutaneous Reactions Parenteral administration of vitamin K replacements (including Phytonadione Injectable Emulsion) may cause cutaneous reactions. Reactions have included eczematous reactions, scleroderma-like patches, urticaria, and delayed-type hypersensitivity reactions. Time of onset ranged from 1 day to a year after parenteral administration. Discontinue Phytonadione Injectable Emulsion for skin reactions and institute medical management.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 Cipla Ltd. at 1-866-604-3268, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials and Post-Marketing 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. The following adverse reactions have been identified during post-approval use of Phytonadione Injectable Emulsion. 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.
Neurologic: Dysgeusia, dizziness. Pulmonary: Dyspnea. Skin and Subcutaneous Tissue Disorders: Erythema, pruritic plaques, scleroderma-like lesions, erythema perstans.
Vascular: Cyanosis.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Anticoagulants Phytonadione Injectable Emulsion may induce temporary resistance to prothrombin-depressing anticoagulants, especially when larger doses of Phytonadione Injectable Emulsion 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). Phytonadione Injectable Emulsion does not affect the anticoagulant action of heparin.
Anticoagulants: May induce temporary resistance to prothrombin-depressing anticoagulants. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: If available, use the preservative-free formulation in pregnant women. ( 8.1 ) Lactation: If available, use the preservative-free formulation in lactating women. ( 8.2 ) Pediatric Use: The safety and effectiveness of Phytonadione Injectable Emulsion in pediatric patients from 6 months to 17 years have not been established. ( 8.4 )
8.1Pregnancy Risk Summary If Phytonadione is needed during pregnancy, consider using a preservative-free formulation. Published studies with the use of phytonadione during pregnancy have not reported a clear association with phytonadione and adverse developmental outcomes (see Data) . There are maternal and fetal risks associated with vitamin K deficiency during pregnancy (see Clinical Considerations) .
Animal reproduction studies have not been conducted with phytonadione. The estimated background risk for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnant women with vitamin K deficiency hypoprothrombinemia may be at an increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery. Subclinical maternal vitamin K deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage.
Data Human Data Phytonadione has been measured in cord blood of infants whose mothers were treated with phytonadione during pregnancy in concentrations lower than seen in maternal plasma. Administration of vitamin K 1 to pregnant women shortly before delivery increased both maternal and cord blood concentrations. Published data do not report a clear association with phytonadione and adverse maternal or fetal outcomes when used during pregnancy.
However, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding. Animal Data In pregnant rats receiving vitamin K 1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer.
8.2Lactation Risk Summary If available, preservative-free Phytonadione is recommended when Phytonadione is needed during lactation [see Use in Specific Populations ( 8.4 )] . Phytonadione is present in breastmilk. There are no data on the effects of Phytonadione Injectable Emulsion on the breastfed child or on milk production.
The developmental and health benefits of breastfeeding should be considered along with the clinical need for Phytonadione Injectable Emulsion and any potential adverse effects on the breastfed child from Phytonadione Injectable Emulsion or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of Phytonadione Injectable Emulsion for prophylaxis and treatment of vitamin K deficiency have been established in neonates. Use of phytonadione injection for prophylaxis and treatment of vitamin K deficiency is based on published clinical studies.
🆘 Overdosage ▾
10 OVERDOSAGE Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, may result from Phytonadione Injectable Emulsion overdose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Phytonadione Injectable Emulsion aqueous colloidal solution of vitamin K 1 for parenteral injection, possesses the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the post-translational carboxylation of multiple, specific, peptide-bound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X.
The resulting gamma-carboxy-glutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood. In normal animals and humans, phytonadione is virtually devoid of activity. However, in animals and humans deficient in vitamin K, the pharmacological action of vitamin K is related to its normal physiological function, that is, to promote the hepatic biosynthesis of vitamin K dependent clotting factors.
12.2Pharmacodynamics The action of the aqueous dispersion, when administered intravenously, is generally detectable within an hour or two and hemorrhage is usually controlled within 3 to 6 hours. A normal INR may often be obtained in 12 to 14 hours.
12.3Pharmacokinetics Absorption : Phytonadione is readily absorbed following intramuscular administration. Distribution : After absorption, phytonadione is initially concentrated in the liver, but the concentration declines rapidly. Very little vitamin K accumulates in tissues. Elimination : Little is known about the metabolic fate of vitamin K. Almost no free unmetabolized vitamin K appears in bile or urine.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Phytonadione Injectable Emulsion, USP 1 mg in 0.5 mL is a yellow, sterile, aqueous colloidal solution and is supplied in unit use packages containing one single-dose pre-filled syringe with 27 G. x ½” needle. NDC 69097-003-67. Phytonadione Injectable Emulsion, USP 1 mg in 0.5 mL available in a carton of 10 mono-cartons; each mono-carton contains one single-dose, prefilled syringe and 27 G. x 1/2” needle.
NDC 69097-003-96. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect Phytonadione Injectable Emulsion, USP from light.
Store container in closed original carton until contents have been used. Prefilled Syringe Assembly Directions: See User Guide USE ASEPTIC TECHNIQUE Do not remove from carton or assemble until ready to use. 1) a.
Peel the safety needle pouch half way open. b . Ensure Shield is in the UP position (see inset), then remove protective luer lock cap from prefilled syringe by twisting cap in anti-clockwise direction. 2) Grasp the needle sheath using the plastic peel pouch.
Keep Needle and syringe in UP position. Attach the safety needle to the luer connection of the syringe using aseptic technique and twist the syringe clockwise. 3) a.
Flip shield down. b. Remove needle cover PULLING STRAIGHT UP (DO NOT TWIST). Expel air.
4) a. After injection, push tab forward with thumb to flip shield toward needle. b. With a FIRM, QUICK motion, press down against a flat surface until an audible "click" is heard.
This sound indicates shield activation. Note: Audible click may not be heard on small needle size: visual confirmation is required. figure-1 figure-2 figure-3 figure-4a figure-4b
📋 Description ▾
11 DESCRIPTION Phytonadione is a vitamin K replacement, 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 C 31 H 46 O 2 and its molecular structure is: Phytonadione Injectable Emulsion, USP injection is a yellow, sterile, aqueous colloidal solution of vitamin K 1 , with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose pre-filled syringe.
Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains the following inactive ingredients: 0.125 mg L-cysteine hydrochloride monohydrate, 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0. The air above the liquid in the individual containers has been displaced by flushing with nitrogen during the filling operation. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform the patient of the following important risks of Phytonadione Injectable Emulsion: Serious Hypersensitivity Reactions Advise the patient and caregivers to immediately report signs of hypersensitivity after receiving Phytonadione Injectable Emulsion [see Warnings and Precautions (5.1)]. Cutaneous Reactions Advise the patient and caregivers to report the occurrence of new rashes after receiving Phytonadione Injectable Emulsion.
These reactions may be delayed for up to a year after treatment [see Warnings and Precautions (5.3)] . Rx Only Manufactured by: Cipla Ltd., India At M/s. Gland Pharma Limited, India Manufactured for: Cipla USA, Inc.
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