Eab Lactation subsection Risk summary Statement of compatibility with breast feeding o2.Clinical considerations Options to minimize exposure Dose adjustments during lactation 0E-Medication effects and monitoring parameters in an exposed child Supporting data 2 &-Synopsis of data used to derive summary of risk and clinical considerations KENTUCKY http://www.regulations.gov/#!documentdetail;D=fda-2006-n-0515-0001 College of Pharmacy
Lactation Subsection • Risk summary – Statement of compatibility with breast feeding • Clinical considerations – Options to minimize exposure – Dose adjustments during lactation – Medication effects and monitoring parameters in an exposed child • Supporting data – Synopsis of data used to derive summary of risk and clinical considerations http://www.regulations.gov/#!documentDetail;D=FDA-2006-N-0515-0001
Database review r. Review of 8 insurance databases o:. Study period from Jan 1, 1996-Dec. 31, 2000 g8. Average of 2.7 medications dispensed and 1.7 medications other than vitamins and minerals o000oc0= In the 270 days prior to delivery 37.8% received a medicine from category c 4.8%received a medicine from category d 4.6% received a medicine from category X KENTUCKY 0: Andrade S,et al. Am Jour Obst Gyne 2004: 191:398-407 College of Pharmacy
Database Review • Review of 8 insurance databases • Study period from Jan. 1, 1996- Dec. 31, 2000 • Average of 2.7 medications dispensed and 1.7 medications other than vitamins and minerals • In the 270 days prior to delivery – 37.8% received a medicine from category C – 4.8% received a medicine from category D – 4.6% received a medicine from category X Andrade S, et. al. Am Jour Obst Gyne 2004;191:398-407
Common Medical Issues during Pregnancy oi.Constipation% Non-pharmacologic treatment 00 Fiber or stool softener Osmotic laxatives-occasional use Senna and biscodyl -occasional use o000oc0= Gastroesophageal reflux disease% Non-pharmacologic treatment Aluminum, calcium, or magnesium antacids or sucralfate Ranitidine or cimetidine (famotidine, nizatidine KENTUCKY College of Pharmacy
Common Medical Issues during Pregnancy • Constipation - 25-40% – Non-pharmacologic treatment – Fiber or stool softener – Osmotic laxatives – occasional use – Senna and biscodyl – occasional use • Gastroesophageal reflux disease – 80% – Non-pharmacologic treatment – Aluminum, calcium, or magnesium antacids or sucralfate – Ranitidine or cimetidine (famotidine, nizatidine)
Eab Common Medical Issues during Pregnancy Nausea and vomiting% 00 Most common weeks 5-13; 15% throughout whole pregnancy; 1-3% hyperemesis gravidarum Non-pharmacological treatment o000oc0= Multivitamins, pyridoxine 10-25 mg 3-4 times/ day, doxylamine 12.5 mg 3-4 times/day, gInger Phenothiazines (promethazine 12.5-25 mg every 6 hours) and metoclopramide 12.5-25 mg 2-3 times/ day Ondansetron if other treatments fail KENTUCKY College of Pharmacy
Common Medical Issues during Pregnancy • Nausea and vomiting – 90% – Most common weeks 5-13; 15% throughout whole pregnancy; 1-3% hyperemesis gravidarum – Non-pharmacological treatment – Multivitamins, pyridoxine 10-25 mg 3-4 times/day, doxylamine 12.5 mg 3-4 times/day, ginger – Phenothiazines (promethazine 12.5-25 mg every 6 hours) and metoclopramide 12.5-25 mg 2-3 times/day – Ondansetron if other treatments fail
Eab Common Medical Issues during Pregnancy Gestational diabetes% 00 Non-pharmacological treatment Insulin Glyburide is occasionally used o000oc0= Need to monitor blood glucoses aik. Thromboembolism.06-0.13% LoW-molecular weight or unfractionated heparin Continue until 6 weeks after delivery KENTUCKY College of Pharmacy
Common Medical Issues during Pregnancy • Gestational diabetes – 1-14% – Non-pharmacological treatment – Insulin – Glyburide is occasionally used – Need to monitor blood glucoses • Thromboembolism – 0.06-0.13% – Low-molecular weight or unfractionated heparin – Continue until 6 weeks after delivery