1 INDICATIONS AND USAGE Vitamin K 1 Injection 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 it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.

( 1.1 ) Vitamin K 1 Injection is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.

( 1.2 ) 1.1 Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Vitamin K 1 Injection 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.

1.2 Prophylaxis and Treatment of Vitamin K-Deficiency Bleeding in Neonates Vitamin K 1 Injection is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.

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 Pfizer Inc.

at 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials 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.

6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Vitamin K 1 Injection.

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.