Vitamin K1

Phytonadione is relatively nontoxic. However, severe reactions have occurred rarely and only during or immediately after the administration of the drug by the IV route. These reactions, which may occur in patients receiving phytonadione for the first time, resemble hypersensitivity or anaphylaxis.

Symptoms include cramp-like pains, convulsive movements, cardiac irregularities, chest pains, cyanosis, dulled consciousness, flushing of the face, a sense of chest constriction, circulatory collapse, bronchospasm, hyperhydrosis, dyspnea, alteration of taste, dizziness, rapid and weak pulse, brief hypotension, shock, cardiac and/or respiratory arrest, and death.

It is not known whether these adverse reactions are caused by the drug or the injection vehicle. Dilution and slow infusion ma y not prevent severe reactions; therefore, the IV route should be restricted to emergency use only. The possibility of allergic reactions, including anaphylaxis, should also be considered when phytonadione injection is given by the IM or SC routes.

2 ml is indicated for the prophylaxis and treatment of vitamin K deficiency bleeding (VKDB) in neonates and infants. 2 ml can be used, following specialist advice from a haematologist, as an antidote to anticoagulant drugs of the coumarin type in infants and children.

For use as an antidote to anticoagulant drugs of the coumarin type in adolescents and adults, refer to Konakion MM Ampoules 10 mg/ml solution for injection or Phytomenadione 10 mg/1 ml solution for injection.