Epinephrine ophthalmic Pregnancy and Breastfeeding Warnings
Epinephrine ophthalmic is also known as: Epifrin, Epinal, Eppy/N, Glaucon
Epinephrine ophthalmic Pregnancy Warnings
Epinephrine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity when epinephrine was given in doses approximately 25 times the usual recommended human dose (on a per kg basis). There are no reports of teratogenicity in humans. There are no controlled data from human pregnancy. Epinephrine ophthalmic is only recommended for use during pregnancy when benefit outweighs risk.
Because epinephrine is an endogenous catecholamine its relationship to adverse pregnancy outcomes is difficult to determine. Moreover, it is usually only used in dire situations that may otherwise portend fetal risk, such as shock, allergic reactions, and severe bronchial asthma.
Epinephrine crosses the human placenta and may, in high concentrations, cause both maternal and fetal glycogenolysis and elevated blood glucose concentrations. Animal data indicate that epinephrine may cause decreased placental blood flow, increasing the risk of fetal hypoxemia. There has been an interesting debate in the medical literature as to whether endogenous epinephrine and other vasoactive substances play an etiologic role in placental insufficiency, preeclampsia or toxemia of pregnancy.
Data from the Collaborative Perinatal Project (CPP), in which 50,282 mother-child pairs were retrospectively examined, reveal a survival- and race-standardized relative risk for any malformation associated with epinephrine and any sympathomimetic agent of 1.99 and 1.30, respectively. These data are based on an incidence of 22 malformed children from 189 cases (of the 50,282 pairs) where there was first trimester exposures to epinephrine. These data reveal evidence of an association between the use of epinephrine and congenital malformations, although underlying diseases were not accounted for in the analysis.
Data from the Michigan Medicaid Birth Defects Study (MMBDS) reveal no evidence of an association between the use of epinephrine and congenital malformations (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). The MMBDS is a retrospective study of 229,101 deliveries between 1985 and 1992. Of the 229,101 deliveries, 35 were exposed to epinephrine during the first trimester. No defects were observed.
Epinephrine has been extensively and safely used to prolong the analgesic effect of epidurally administered local anesthetics during human pregnancy.
In vitro data have shown that epinephrine increases placental lactate production and increases placental glycogenolysis. While some in vitro data have shown that epinephrine stimulates the spontaneous contractile activity of the nonpregnant uterus, in vivo data have shown that the drug may inhibit uterine contractions and prolong the first stage of labor.
Epinephrine ophthalmic Breastfeeding Warnings
There are no data on the excretion of epinephrine ophthalmic into human milk.
References for pregnancy information
- Holdcroft A "Use of adrenaline in obstetric analgesia." Anaesthesia 47 (1992): 987-90
- Levinson G, Shnider SM "Vasopressors in obstetrics." Clin Anesth 10 (1973): 77-109
- Ginsburg J "The effect of adrenaline on placental metabolism." Proc R Soc Med 59 (1966): 748-50
- Peleg D, Munsick RA, Diker D, Goldman JA, Ben-Jonathan N "Distribution of catecholamines between fetal and maternal compartments during human pregnancy with emphasis on L-dopa and dopamine." J Clin Endocrinol Metab 62 (1986): 911-4
- Davies J, Robson JM, Sullivan FM "Effects of drugs on placental function and their relation to congenital abnormalities." Proc R Soc Med 62 (1969): 317-8
- Altura BM, Malaviya D, Reich CF, Orkin LR "Effects of vasoactive agents on isolated human umbilical arteries and veins." Am J Physiol 222 (1972): 345-55
- Levinson G, Shnider SM "Placental transfer of local anesthetics: clinical implications." Clin Anesth 10 (1973): 173-85
- Okamura K, Watanabe T, Tanigawara S, Endo H, Iwamoto M, Murotsuki J, Yajima A "Catecholamine levels and their correlation to blood gases in umbilical venous blood obtained by cordocentesis." Fetal Diagn Ther 5 (1990): 147-52
- Van Nimwegen D, Dyer DC "The action of vasopressors on isolated uterine arteries." Am J Obstet Gynecol 118 (1974): 1099-103
- Costin M, Milliken RA "Epinephrine is unsafe in the preeclamptic patient." Anesthesiology 66 (1987): 99-100
- Reynolds F, Laishley R, Morgan B, Lee A "Effect of time and adrenaline on the feto-maternal distribution of bupivacaine." Br J Anaesth 62 (1989): 509-14
- Zuspan FP, Whaley WH, Nelson GH, Ahlquist RP "Placental transfer of epinephrine. I. Maternal-fetal metabolic alterations of glucose and nonesterified fatty acids." Am J Obstet Gynecol 95 (1966): 284-9
- Alahuhta S, Rasanen J, Jouppila R, Jouppila P, Hollmen AI "Effects of extradural bupivacaine with adrenaline for caesarean section on uteroplacental and fetal circulation." Br J Anaesth 67 (1991): 678-82
- Goodall M, Diddle AW "Epinephrine and norepinephrine in pregnancy. A comparative study of the adrenal gland and catechol output in different species of animals and man." Am J Obstet Gynecol 111 (1971): 896-904
- Zuspan FP "Catecholamines. Their role in pregnancy and the development of pregnancy-induced hypertension." J Reprod Med 23 (1979): 143-50
- Yurth DA "Placental transfer of local anesthetics." Clin Perinatol 9 (1982): 13-28
- Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
- Gomel V, Hardwick DF "Search for a pressor substance in toxemia of pregnancy." Am J Obstet Gynecol 94 (1966): 308-9
- Martin JE, Pauerstein CJ "The initiation of labor." Clin Anesth 10 (1973): 51-69
- Pinto RM, Lerner U, Pontelli H, Rabow W "Action of epinephrine and norepinephrine on contractile activity of the three separate layers of the human uterus." Am J Obstet Gynecol 102 (1968): 333-9
- Blouquit MF, Sturbois G, Breart G, Grill C, Sureau C, Roffi J "Catecholamine levels in newborn human plasma in normal and abnormal conditions and in maternal plasma at delivery." Experientia 35 (1979): 618-9
- Barden TP, Stander RW "Effects of adrenergic blocking agents and catecholamines in human pregnancy." Am J Obstet Gynecol 102 (1968): 226-35
References for breastfeeding information
- "Product Information. Epifrin Sterile Ophthalmic Solution (epinephrine)." Allergan Inc, Irvine, CA.