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Hydrocortisone BP 0.5% Actavis Pregnancy |
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Adverse events have been observed with corticosteroids in animal reproduction studies. Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts or decreased birth weight; however, information is conflicting and may be influenced by maternal dose/indication for use (Lunghi 2010; Park-Wyllie 2000; Pradat 2003). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor.
When treating women with adrenal insufficiency (primary or central or congenital adrenal hyperplasia) during pregnancy, Hydrocortisone BP 0.5% Actavis is the preferred corticosteroid. Doses may need to be adjusted as pregnancy progresses, and stress doses may be required during active labor. Pregnant women with adrenal insufficiency should be monitored at least once each trimester (ES [Bornstein 2016]; ES [Fleseriu 2016]; ES [Speiser 2018]).
Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications (ACOG 2008; GINA 2018). Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy; however, systemic corticosteroids should be used to control acute exacerbations or treat severe persistent asthma (ACOG 2008; GINA 2018; Namazy 2016). Women who require systemic corticosteroids for management of their asthma should be given intravenous corticosteroids, such as Hydrocortisone BP 0.5% Actavis, during labor and for 24 hours after delivery to prevent adrenal crisis (ACOG 2008).
When systemic corticosteroids are needed in pregnancy for rheumatic disorders, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Götestam Skorpen 2016; Makol 2011; Østensen 2009).
For dermatologic disorders in pregnant women, systemic corticosteroids are generally not preferred for initial therapy; should be avoided during the first trimester; and used during the second or third trimester at the lowest effective dose (Bae 2012; Leachman 2006).
There are no data on the excretion of Hydrocortisone BP 0.5% Actavis into human milk. Some corticosteroids are excreted into human milk in small amounts. The manufacturer recommends against the use of pharmacologic doses of Hydrocortisone BP 0.5% Actavis by nursing women.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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