Indications
Prophylaxis and treatment of haemorrhagic disease in the newborn.
Haemorrhage or risk of haemorrhage as a result of severe hypoprothrombinemia (i.e. deficiency of clotting factors II, VII, IX and X) of various etiologies, including overdosage of courmarin-type anticoagulants, their combination with phenylbutazone, and other forms of hypovitaminosis K (e.g. in obstructive jaundice as well as liver and intestinal disorders, and after prolonged treatment with antibiotics, sulphonamides or salicylates).
Prevention and treatment of bleeding due to vitamin K deficiency.
Therapeutic Class
Pharmacology
Dosage & Administration
Prophylaxis: Mild Hemorrhage or hemorrhagic tendency: The usual dose for Neonates is 2 mg orally at or just after birth. Then 2 mg on 4 th-5 th day and another 2 mg on 28 th – 30 th day orally. If the oral route is unsuitable then 2 mg of drug can be administered by IM or IV route. Children over 1 year of age are could be given 5-10 mg orally.
A single 1 mg (0.1 ml) dose IM is recommended in children who are not assured of receiving a second oral dose or, in the case of breast-fed children, who are not assured of receiving a third oral dose.
Therapy: Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical picture and coagulation status. Neonates with special risk factors
[Pre-maturity, birth asphyxia (inadequate intake of oxygen by the baby during birth process), obstructive jaundice, inability to swallow, maternal use of anticoagulants or anti-epileptics]:
- 1 mg intramuscularly or intravenously at birth or shortly after birth if the oral route is unsuitable.
- Intramuscular and intravenous doses should not exceed 0.4 mg/kg in premature infants weighing less than 2.5 kg.
- The size and frequency of further doses should be based on coagulation status
To ensure a total protection of the newborns, 3 prophylactic doses of Vitamin K should be administered orally following the dosing schedule mentioned above.
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