KONAKION MM PAEDIATRIC Solution (ampoules) Ref.[7154] Active ingredients: Vitamin K1

Pharmacotherapeutic group: Antihaemorrhagics (vitamins)
ATC code: B02BA01

Konakion MM is a preparation of synthetic phytomenadione (vitamin K₁). The presence of vitamin K₁ is essential for the formation within the body of prothrombin, factor VII, factor IX and factor X, and of the coagulation inhibitors, protein C and protein S.

Vitamin K₁ does not readily cross the placental barrier from mother to child and is poorly excreted in breast milk.

Lack of vitamin K₁ leads to an increased tendency to haemorrhagic disease in the newborn. Vitamin K₁ administration, which promotes synthesis of the above-mentioned coagulation factors by the liver, can reverse an abnormal coagulation status due to vitamin K₁ deficiency.

Paediatric population

A prospective randomised controlled study included 44 infants (1-26 weeks of age) with conjugated hyperbilirubinaemia (idiopathic neonatal hepatitis – 17 patients, biliary atresia – 13, total parenteral nutrition cholestasis – 3, Alagille’s syndrome – 2, alpha 1 antitrypsin deficiency – 2, inspissated bile syndrome – 2, and 5 miscellaneous diagnoses (fructosaemia, galactosaemia, choledochal cyst, necrotising enterocolitis, cytomegalovirus hepatitis). The pharmacokinetics and efficacy of oral versus intravenous mixed micellar vitamin K prophylaxis in infants with cholestatic liver disease was compared.

Main outcome measures were serum concentrations of vitamin K₁ and undercarboxylated prothrombin (PIVKA-II) before and for up to 4 days after a single dose of mixed micellar K₁ 1 mg intravenously or 2 mg orally. A comparison was also made between K₁ levels 24 hours after oral K₁ administration with those of 14 healthy newborns given the same dose.

Results: At admission, 18 infants (41%) had elevated levels of serum PIVKA-II and eight (18%) had low K₁ concentrations, indicative of subclinical vitamin K deficiency. Median serum K₁ concentrations were similar in the oral and intravenous groups at baseline (0.92 v 1.15 ng/ml), rising to 139 ng/ml six hours after intravenous K₁ but to only 1.4 ng/ml after oral administration. In the latter group, the low median value (0.95 ng/ml) and wide range (<0.15–111 ng/ml) of serum K₁ compared unfavourably with the much higher levels (median 77, range 11–263 ng/ml) observed in healthy infants given the same oral dose, and suggested impaired and erratic intestinal absorption in cholestatic infants. The severity of malabsorption was such that only 4/24 (17%) achieved an incremental rise in serum K₁ >10 ng/ml.

The data from a retrospective study indicate that weekly oral prophylaxis was effective in the prevention of VKDB. A total of 507 850 live babies were born during the study period, November 1992 to June 2000. Of these infants, 78% and 22% received oral and intra-muscular prophylaxis, respectively; i.e. about 396000 neonates received oral prophylaxis at birth. Weekly oral prophylaxis was recommended for all infants as long as they were mainly breastfed. Oral vitamin K prophylaxis at birth 2 mg phytomenadione, followed by weekly oral vitamin K prophylaxis; 1 mg was administered by the parents until 3 months of age. No cases of VKDB were revealed, i.e. the incidence was 0–0.9:100000 (95% CI).