Country-wise Listing - Israel

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S.NO Title & Authors Name page
1
Treating Symptoms of Morning Sickness: The First Dual Release Combination of Doxylamine-Pyridoxine
Gideon Koren*, Manon Vrandrick
 Abstract                  View                 Download                 XML

Modified release tablet preparations are sought when there is a need to provide clinical solutions which are not achieved optimally with the standard release products. Nausea and vomiting of pregnancy (NVP) affect most pregnancies. Symptomatic treatment aims to improve woman’s quality of life, and counteract dehydration, electrolyte imbalance, need for hospitalization and attendant risk of maternal and fetal complications. Until recently, the only agent approved by Canada, USA, South Korea. Israel and Singapore has been the delayed release combination of doxylamine and pyridoxine (Diclectin®/ Diclegis®).
All other countries worldwide do not presently have a pregnancy- approved anti emetic drug.
Due to its delayed release properties, Diclectin®/ Diclegis® begins to exert its antiemetic effect 6-8 hours after ingestion, and hence symptom relief may be delayed and necessitate the use of an immediate release medication. In November 2016 the FDA approved Bonjesta®, a novel, dual- release combination of doxylamine and pyridoxine, whereby a rapid release phase is followed by a delayed release phase, thus overcoming the time delay in action of the delayed release combination of doxylamine and pyridoxine.

In this article we review the unique properties of this new drug in the context of other medications where modified- release forms have been effective.

51-58
2
Preventing Inappropriate Hydroxyurea Dosing in Children by Introducing a Child-Appropriate Preparation
Gideon Koren*, Michael Lishner, Ami Ballin
 Abstract                  View                 Download                 XML

Hydroxyurea (HU) is the only FDA- approved disease- modifying drug for sickle cell disease, by inducing the production of fetal hemoglobin and thus decreasing the sickling of red blood cells. Till recently HU was available only in adult doses of 1000 mg. This meant that to aim at the standard dose of 20 mg/kg/d, most young children had to be overdosed, or the doses had to be fluctuated daily to achieve the aimed mean dose. Because adherence improves with unchanged daily dose, and due to the more than 10 fold variability in HU pharmacokinetics in children, there was an urgent need for a pediatric formulation of HU.
This issue has been solved with FDA approval of the French-originated orphan HU, Siklos, a preparation of 50 and 100 mg, which prevents the risk of inappropriate dosing in children.

23-27