Since the publication of Golding’s report(1), many
studies have been undertaken to study the efficacy of oral vitamin K
preparations. Some of these studies have compared 1 mg of oral vitamin
K with 1 mg of intramuscular vitamin K given in a single dose on the
first day(2). In oral group, serum vitamin K levels were found to be
less than in intramuscular group at two weeks, one month and three
months postnatally. Some studies have compared 2 mg of vitamin K in
single dose on first day(3). This dose was found to provide equal
protection vis-à-vis IM vitamin K in first week but the study does not
continue beyond the first week. In other studies 2 mg of oral vitamin
K was given on 1,7 and 28th day of neonatal period(4). This dose was
found to provide equal protection vis-à-vis IM vitamin K against
classical as well as late hemorrhagic bleeding and is most promising.
Very interesting results have been shown in one study conducted in
Netherlands. In this study low doses of vitamin K drops (25 micrograms
per day) were given daily for a period of three months(5). The results
were comparable to IM vitamin K.
A word about oral vitamin K preparations. Konakion
MM® is one preparation most commonly available internationally,
marketed by Roche. This is a mixed micellar preparation of vitamin K (phytomenadione)
which is used for both injections as well as suspended in medium chain
triglycerides to provide oral vitamin K. In UK there is a commercial
preparation known as Orokay® marketed by Smith Kline Beecham. In this
preparation parenteral form of vitamin K (phytomena-dione) is
suspended in oil to make it suitable for oral use. So, oral form of
Vitamin K is available internationally.
Oral vitamin K is efficacious(4) and safe. No
untoward reactions have been reported so far. It can be conveniently
transported and stored in vial or ampoule forms. Cost factor will be
important in deciding the feasibility of oral vitamin K. If it is
manufactured indigenously by an Indian Company or still better, by
many companies, the cost can be considerably reduced but imported oral
form is going to be costlier than injectable vitamin K at this stage.
Multidose vials will be more cost effective. Parental compliance is
another factor, which will decide the feasibility of oral vitamin K.
The doctors or trained paramedical staff can deliver the first dose in
the Hospital. Future doses can be given at home by well informed
mothers or mothers can carry the newborns to nearby health centers or
hospitals as the case may be. In field area dais, ANMs and
other health workers can deliver the first dose as well as the future
doses. The regimen administering doses on first, seventh and twenty
eighth day seems most effective and useful(4).
In most of the developed world oral vitamin K is
now being offered as an alternative to injectable form. Hence, taking
cue from global scenario there is need to license and develop oral
vitamin K preparations in our country. Indian Academy of Pediatrics
should outline its official policy and recommendations for use of
vitamin K at birth.
Mukul Tiwari,
Consultant Pediatrician
Apex Hospital, University Road,
Gwalior 474 011, M.P.,
India.
E-mail:
[email protected]
