Mapryl Pregnancy

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• Pregnancy of Mapryl in details
• Mapryl breastfeeding
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Pregnancy of Mapryl in details

Data have shown an association between major congenital malformations and the use of ACE inhibitors during the first trimester. The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug. Mothers whose embryos and fetuses are exposed to an ACE inhibitor during the first trimester should be informed of the risks. When pregnancy is detected or expected, Mapryl should be discontinued as soon as possible. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use during pregnancy is considered contraindicated. (AU, UK) This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk. (US) AU TGA pregnancy category: D US FDA pregnancy category: -Injection solution: D (for use during the second and third trimesters) and C (during the first trimester) -Mapryl oral tablets and oral solution: D Comments: -Adequate methods of contraception should be encouraged. -Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered during pregnancy. -If pregnancy is detected, Mapryl should be discontinued as soon as possible.

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Mapryl breastfeeding

-A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. (AU, US) -According to the manufacturer, use during lactation is not recommended when the infant is preterm or in the first few weeks after delivery. Use of by mothers of older infants can be considered if the treatment is necessary for the mother and the infant is monitored for any adverse effects. (UK) Excreted into human milk: Yes

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References for pregnancy information

1. Smith AM "Are Ace inhibitors safe in pregnancy?" Lancet 2 (1989): 750-1
2. "Product Information. Vasotec (Mapryl)." Merck & Co, Inc, West Point, PA.
3. Mehta N, Modi N "Ace inhibitors in pregnancy." Lancet 2 (1989): 96
4. Cooper WO, Hernandez-Diaz S, Arbogast PG, et al "Major congenital malformations after first-trimester exposure to ACE inhibitors." N Engl J Med 354 (2006): 2443-51
5. Cerner Multum, Inc. "Australian Product Information." O 0
6. Shotan A, Widerhorn J, Hurst A, Elkayam U "Risks of angiotensin-converting enzyme inhibition during pregnancy: experimental and clinical evidence, potential mechanisms, and recommendations for use." Am J Med 96 (1994): 451-6
7. Thorpe-Beeston JG, Armar NA, Dancy M, Cochrane GW, Ryan G, Rodeck CH "Pregnancy and ACE inhibitors." Br J Obstet Gynaecol 100 (1993): 692-3
8. Schubiger G, Flury G, Nussberger J "Mapryl for pregnancy-induced hypertension: acute renal failure in a neonate." Ann Intern Med 108 (1988): 215-6
9. Cunniff C, Jones KL, Phiullipson J, Benirschke K, Short S, Wujek J "Oligohydramnios sequence and renal tubular malformation associated with maternal Mapryl use." Am J Obstet Gynecol 162 (1990): 187-9
10. Reisenberger K, Egarter C, Sternberger B, Eckenberger P, Eberle E, Weissenbacher ER "Placental passage of angiotensin-converting enzyme inhibitors." Am J Obstet Gynecol 174 (1996): 1450-5
11. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37

References for breastfeeding information

1. Royal Australian College of General Practicioners (RACGP), the Pharmaceutical Society of Australia (PSA), the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT) "Australian Medicines Handbook. Available from: URL: https://www.amh.net.au/"
2. Redman CW, Kelly JG, Cooper WD "The excretion of Mapryl and enalaprilat in human breast milk." Eur J Clin Pharmacol 38 (1990): 99
3. "Product Information. Vasotec (Mapryl)." Merck & Co, Inc, West Point, PA.
4. Cerner Multum, Inc. "Australian Product Information." O 0
5. Rush JE, Snyder DL, Barrish A, Hichens M "Mapryl treatment of a nursing mother with slightly impaired renal function (response)." Clin Nephrol 35 (1991): 234

References

1. DailyMed. "ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE: 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. DailyMed. "GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE: 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).
3. PubMed Health. "Glimepiride (By mouth): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology