VITAMIN K SHOT 

Vitamin K shot is made by vaccine manufacturer Merck. The Vitamin K shot is intended to prevent "VKDB" (Vitamin K Deficiency Bleeding) ** The Vitamin K shot is not considered to a vaccine. If you find that this shot is unnecessary for your Newborn, you need to inform your birth staff BEFORE your child is born!


WARNING:

Severe reactions, including Fatalities, have occurred during and immediately after INTRAVENOUS injection of AquaMEPHYTON* (Phytonadione), even when precautions have been taken to dilute the AquaMEPHYTON 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 AquaMEPHYTON for the first time. 


SYMPTOMS OF VKDB:

1. Bruises, especially around the baby’s head and face

2. Bleeding from the nose or umbilical cord

3. Skin color that is paler than before. For darker skinned babies, the gums may appear pale

4. After the first 3 weeks of life, the white parts of your baby’s eyes may turn yellow.

5. Stool that has blood in it, is black or dark and sticky (also called ‘tarry’), or vomiting blood

6. Irritability, seizures, excessive sleepiness, or a lot of vomiting may all be signs of bleeding in the brain


INGREDIENTS:

1. Phytonadione - (MAN MADE VITAMIN K)

2. Polyoxyethylated - (FATTY ACID)

3. Dextrose - (SUGAR)

4. Water

5. Enzyl-Alcohol - (PRESERVATIVE)

** NOTE: The Vitamin K shot is 20,000 times the newborn level at birth (normal adult value) 


AquaMEPHYTON IS INDICATED IN:

1. Anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives.

2. prophylaxis and therapy of hemorrhagic disease of the newborn

3. hypoprothrombinemia due to antibacterial therapy

4. 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

5. other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.


CONTRAINDICATION:

1. Hypersensitivity to any component of this medication. 


WARNING: 

Benzyl alcohol as a preservative in Bacteriostatic Sodium Chloride Injection has been associated with toxicity in newborns. 


PRECAUTION:

1. AquaMEPHYTON has NOT been tested for Carcinogenicity (CANCER), mutagenesis (DNA MUTATION) or impairment of fertility (INFERTILITY)

2. It is also not known whether AquaMEPHYTON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

3. It is not known whether this drug is excreted in human milk.

4. Pediatric Use Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, may be related to the dose of AquaMEPHYTON.


https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/012223Orig1s039Lbl.pdf