pharmacopeia
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/api/v1/drug/vitamin-k1

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

Indications

Sourced from openFDA
  • INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.

Contraindications

Sourced from openFDA
  • INFUVITE PEDIATRIC is contraindicated in patients who have: • An existing hypervitaminosis, or • A history of hypersensitivity to any vitamins or excipients contained in this formulation.contraindicated

Dosage & administration

Sourced from openFDA

• INFUVITE PEDIATRIC is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12 ( 2.1 ) • INFUVITE PEDIATRIC is for administration by intravenous infusion after dilution ( 2.1 ) • Recommended daily dosage is based on patient’s actual weight ( 2.2 ): • INFUVITE PEDIATRIC Single Dose: o Weight less than 1 kg: 1.2 mL of Vial 1 and 0.3 mL of Vial 2 o Weight 1 kg to less than 3 kg: 2.6 mL of Vial 1 and 0.65 mL Vial 2 o Weight 3 kg or greater: 4 mL of Vial 1 and 1 mL of Vial 2 • INFUVITE PEDIATRIC Pharmacy Bulk Package : o Weight less than 1 kg: 1.5 mL of combined content of Vials 1 and 2 o Weight 1 kg to less than 3 kg: 3.25 mL of combined content of Vials 1 and 2 o Weight 3 kg or greater: 5 mL of combined content of Vials 1 and 2. • Supplemental vitamin A may be required for low-birth weight infants ( 2.2 ) • INFUVITE PEDIATRIC is supplied as a single dose and as a pharmacy bulk package: • Single Dose consists of two vials labeled Vial 1 and Vial 2. Add one daily dose of Vial 1 and one daily dose of Vial 2 directly to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use ( 2.3 ) • Pharmacy Bulk Package consists of two vials labeled Vial 1 and Vial 2. Transfer contents of Vial 2 to contents of Vial 1.

Warnings & precautions

Sourced from openFDA

• Risk of Aluminum Toxicity: For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels ( 5.1 ) • Allergic Reactions: To thiamine may occur ( 5.2 ) • Hypervitaminosis A : Patients with renal failure or liver disease may be at higher risk ( 5.3 ) • Decreased Anticoagulant Effect of Warfarin: Monitor INR ( 5.4 , 7.1 ) • Interferes with Megaloblastic Anemia Diagnosis: Avoid during testing for this disorder ( 5.5 ) • Risk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations ( 5.6 ) • False Negative Urine Glucose Tests: Due to vitamin C ( 5.7 ) • Risk of Vitamin E Toxicity: Additional oral and parenteral vitamin E may result in elevated vitamin E blood concentrations in infants ( 5.8 ) • Low Vitamin A Levels: Monitor vitamin A levels ( 5.9 ) • Risk of E-Ferol Syndrome: Due to polysorbates ( 5.10 ) 5.1 Aluminum Toxicity INFUVITE PEDIATRIC contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration in pediatric patients with renal impairment. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, 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.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed in greater detail in other sections of the labeling. • Allergic reactions to thiamine [ see Warnings and Precautions ( 5.2 ) ]. • Hypervitaminosis A [ see Warnings and Precautions ( 5.3 ) ] The following adverse reactions have been identified during postapproval use of INFUVITE PEDIATRIC. Because these reactions are 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. Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

• Renal Impairment: Monitor renal function, calcium, phosphorus and vitamin A levels ( 8.6 ) • Hepatic Impairment: Monitor vitamin A levels ( 8.7 ) 8.1 Pregnancy Pregnancy Category C. INFUVITE PEDIATRIC has not been studied in pregnant women. Pregnant women should follow the U.S. recommended daily allowances for pregnancy because their vitamin requirements may exceed those of non-pregnant women. Animal reproduction studies have not been conducted with INFUVITE PEDIATRIC (multiple vitamins injection). 8.3 Nursing Mothers INFUVITE PEDIATRIC has not been studied in nursing mothers. Lactating women may have vitamin requirements that exceed those of non-lactating women. Caution should be exercised when INFUVITE PEDIATRIC is administered to nursing mothers. 8.4 Pediatric Use INFUVITE PEDIATRIC is approved for the prevention of vitamin deficiency in pediatric patients up to 11 years old receiving parenteral nutrition. INFUVITE PEDIATRIC has not been studied in pediatric patients older than 11 years. INFUVITE PEDIATRIC contains aluminum that may be toxic for premature neonates. Aluminum levels should be monitored periodically during administration of INFUVITE PEDIATRIC to premature neonates [ see Warnings and Precautions ( 5.1 ) ].

Overdosage

Sourced from openFDA

Signs and symptoms of acute or chronic overdosage may be those of individual INFUVITE PEDIATRIC component toxicity. There is no clinical experience with INFUVITE PEDIATRIC overdosage.

Approval history

Sourced from openFDA
  • Feb 21, 2001NDANDA021265Sandoz Canada Inc
  • Apr 9, 2026ANDAANDA210273Apotex

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
11 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1No Adverse Event982%
  2. 2Product Compounding Quality Issue436%
  3. 3Incorrect Dose Administered327%
  4. 4Product Preparation Error218%
  5. 5Blood Sodium Increased19.1%
  6. 6Drug Dispensing Error19.1%
  7. 7Incorrect Drug Administration Rate19.1%
  8. 8Product Selection Error19.1%

Literature

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Recent PubMed references pinned to Vitamin K1 as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 63 ClinicalTrials.gov registrations naming Vitamin K1 as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Vitamin K1 work?
Mechanism-of-action class: Unknown Cellular or Molecular Interaction.
What is Vitamin K1 used for?
According to FDA labeling, Vitamin K1 carries indications including: INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Vitamin K1?
Vitamin K1 is classified as Vitamin K, Vitamin K, Warfarin Reversal Agent, Unknown Cellular or Molecular Interaction, Increased Prothrombin Activity, Reversed Anticoagulation Activity.
What are the brand names for Vitamin K1?
Vitamin K1 is marketed under brand names including Infuvite, Infuvite Pediatric, Mephyton, Veta-K1.
What are the contraindications for Vitamin K1?
Vitamin K1 labeling lists contraindications including: INFUVITE PEDIATRIC is contraindicated in patients who have: • An existing hypervitaminosis, or • A history of hypersensitivity to any vitamins or excipients contained in this formulation.. Always consult the full prescribing information and a clinician.
Note. Data for vitamin-k1 is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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