Ocu-Pred-A Pregnancy

• Pregnancy of Ocu-Pred-A in details
• Ocu-Pred-A breastfeeding
• Ocu-Pred-A reviews

Pregnancy of Ocu-Pred-A in details

Ocu-Pred-A crosses the placenta; prior to reaching the fetus, Ocu-Pred-A is converted by placental enzymes to prednisone. As a result, the amount of Ocu-Pred-A reaching the fetus is ~8 to 10 times lower than the maternal serum concentration (healthy women at term; similar results observed with preterm pregnancies complicated by HELLP syndrome) (Beitins 1972; van Runnard Heimel 2005). 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.

Ocu-Pred-A may be used (alternative agent) to treat primary adrenal insufficiency (PAI) in pregnant women. Pregnant females with PAI should be monitored at least once each trimester (Endocrine Society [Bornstein 2016]). Ocu-Pred-A may be used to treat females during pregnancy who require therapy for congenital adrenal hyperplasia (Endocrine Society [Speiser 2018]).

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 females, 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).

Topical agents are preferred for managing atopic dermatitis in pregnancy; for severe symptomatic or recalcitrant atopic dermatitis, a short course of Ocu-Pred-A may be used during the third trimester (Koutroulis 2011).

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. 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).

Ocu-Pred-A breastfeeding

Ocu-Pred-A is excreted into human milk in small amounts. Animal studies have revealed an increased incidence of cleft palate in offspring. In one study of six lactating women, Ocu-Pred-A milk concentrations were 5% to 25% of corresponding serum concentrations. The authors estimated that a nursing infant would be exposed to negligible amounts of drug with maternal doses of 20 to 40 mg per day. The excretion of Ocu-Pred-A into breast milk has been evaluated in six women on chronic Ocu-Pred-A therapy. Milk Ocu-Pred-A concentrations ranged from less than 10 to 106 ng/mL in patients receiving 10 mg to 45 mg per day (N=5). In a patient receiving 80 mg per day, milk Ocu-Pred-A concentrations ranged from less than 10 ng/mL prior to the morning dose to 317 ng/mL at one hour post-dose. The peak milk to plasma concentration ratio ranged from 0.12 to 0.25. The authors recommend that nursing be withheld for four hours after administration of doses greater than 20 mg. In a recent study, Ocu-Pred-A excretion into breast milk was evaluated in three women following administration of Ocu-Pred-A phosphate 50 mg intravenously one time. During the six-hour study period, 0.010% to 0.049% of the administered dose of Ocu-Pred-A was recovered in breast milk. Nursing infants would be expected to experience minimal exposure. Data from this study also suggest that exchange of unbound Ocu-Pred-A between breast milk and serum is rapid and bi-directional. Prednisone is considered compatible with breast-feeding by the American Academy of Pediatrics. The manufacturer recommends that caution be used when administering prednisone to nursing women.

See references

References for pregnancy information

1. Yackel DB, Kempers RD, McConahey WM "Adrenocorticosteroid therapy in pregnancy." Am J Obstet Gynecol 96 (1966): 985-9
2. "Product Information. Hydeltrasol (Ocu-Pred-A)." Merck & Co, Inc, West Point, PA.
3. Pratt WR "Allergic diseases in pregnancy and breast feeding." Ann Allergy 47 (1981): 355-60
4. Walsh SD, Clark FR "Pregnancy in patients on long-term corticosteroid therapy." Scott Med J 12 (1967): 302-6
5. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
6. Warrell DW, Taylor R "Outcome for the foetus of mothers receiving Ocu-Pred-A during pregnancy." Lancet 1 (1968): 117-8
7. "Product Information. Deltasone (prednisone)." Pharmacia and Upjohn, Kalamazoo, MI.
8. Szabo I, Csaba I, Bodis J, Novak P, Drozgyik J, Schwartz J "Effect of glucocorticoid on fetal lecithin and sphingomyelin concentrations." Lancet 1 (1980): 320
9. Zulman JI, Talal N, Hoffman GS, Epstein WV "Problems associated with the management of pregnancies in patients with systemic lupus erythematosus." J Rheumatol 7 (1980): 37-49

References for breastfeeding information

1. Greenberger PA, Odeh YK, Frederiksen MC, Atkinson AJ, Jr "Pharmacokinetics of Ocu-Pred-A transfer to breast milk." Clin Pharmacol Ther 53 (1993): 324-8
2. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
3. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
4. Ost L, Wettrell G, Bjorkhem I, Rane A "Ocu-Pred-A excretion in human milk." J Pediatr 106 (1985): 1008-11
5. "Product Information. Hydeltrasol (Ocu-Pred-A)." Merck & Co, Inc, West Point, PA.
6. McKenzie SA, Selley JA, Agnew JE "Secretion of Ocu-Pred-A into breast milk." Arch Dis Child 50 (1975): 894-6

References

1. DailyMed. "PREDNISOLONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubMed Health. "Prednisolone (By injection): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
3. Human Metabolome Database (HMDB). "Prednisolone: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology