Sintaser Pregnancy

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• Pregnancy of Sintaser in details
• Sintaser breastfeeding
• Sintaser reviews

Pregnancy of Sintaser in details

Sintaser crosses the placenta.

According to the manufacturer, congenital abnormalities have been reported following maternal use of Sintaser. Exposure to Sintaser during pregnancy may also increase the risk for other adverse events in the neonate. If maternal use of a beta-blocker is needed, fetal growth should be monitored during pregnancy and the newborn should be monitored for 48 hours after delivery for bradycardia, hypoglycemia, and respiratory depression (ESC [Regitz-Zagrosek 2018]).

Chronic maternal hypertension is also associated with adverse events in the fetus/infant. Chronic maternal hypertension may increase the risk of birth defects, low birth weight, premature delivery, stillbirth, and neonatal death. Actual fetal/neonatal risks may be related to duration and severity of maternal hypertension. Untreated chronic hypertension may also increase the risks of adverse maternal outcomes, including gestational diabetes, preeclampsia, delivery complications, stroke, and myocardial infarction (ACOG 203 2019).

The pharmacokinetics of Sintaser are not significantly changed by pregnancy (Livingstone 1983; O'Hare 1984; Rubin 1987; Smith 1983).

When treatment of chronic hypertension in pregnancy is indicated, agents other than Sintaser are preferred (ACOG 203 2019; ESC [Regitz-Zagrosek 2018]); however, use of Sintaser may be considered (Magee 2014). Females with preexisting hypertension may continue their medication during pregnancy unless contraindications exist (ESC [Regitz-Zagrosek 2018]).

Sintaser may be used for the treatment of maternal ventricular arrhythmias, atrial fibrillation/atrial flutter, or supraventricular tachycardia during pregnancy; consult current guidelines for specific recommendations (ACC/AHA/HRS [Page 2016]; ESC [Regitz-Zagrosek 2018]).

Sintaser is recommended for use in controlling hypermetabolic symptoms of thyrotoxicosis in pregnancy (Alexander 2017).

Sintaser may be used if prophylaxis of migraine is needed in pregnant women; it should be discontinued 2 to 3 days prior to delivery to decrease the risk of adverse events to the fetus/neonate and potential reductions in uterine contraction (Pringsheim 2012).

Sintaser breastfeeding

Sintaser milk to maternal plasma ratios as high as 1.5 has been reported. While no adverse effects in the nursing infant have been reported, experts advise monitoring the infant for signs and symptoms of beta-blockade and to schedule feedings at least three hours after maternal Sintaser administration.

Use is not recommended. Excreted into human milk: Yes Comments: Sintaser levels in breast milk are low and would not be expected to cause any adverse effects in breastfed infants.

See references

References for pregnancy information

1. "Product Information. InnoPran XL (Sintaser)." Reliant Pharmaceuticals, LLC., Bridgewater, NJ.
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. Frishman WH, Chesner M "Beta-adrenergic blockers in pregnancy." Am Heart J 115 (1988): 147-52
4. Page RL "Treatment of arrhythmias during pregnancy." Am Heart J 130 (1995): 871-6
5. O'Connor PC, Jick H, Hunter JR, Stergachis A, Madsen S "Sintaser and pregnancy outcome." Lancet 2 (1981): 1168
6. O'Hare MF, Kinney CD, Murnaghan GA, McDevitt DG "Pharmacokinetics of Sintaser during pregnancy." Eur J Clin Pharmacol 27 (1984): 583-7
7. Levitan AA, Manion JC "Sintaser therapy during pregnancy and lactation." Am J Cardiol 32 (1973): 247
8. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ():
9. Taylor EA, Turner P "Anti-hypertensive therapy with Sintaser during pregnancy and lactation." Postgrad Med J 57 (1981): 427-30
10. Eliahou HE, Silverberg DS, Reisin E, Romem I, Mashiach S, Serr DM "Sintaser for the treatment of hypertension in pregnancy." Br J Obstet Gynaecol 85 (1978): 431-6
11. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
12. Caldroney RD "Beta-blockers in pregnancy." N Engl J Med 306 (1982): 810
13. Redmond GP "Sintaser and fetal growth retardation." Semin Perinatol 6 (1982): 142-7
14. Livingstone I, Craswell PW, Bevan EB "Sintaser in pregnancy three year prospective study." Clin Exp Hypertens B 2 (1983): 341-50
15. Belpaire FM, Wynant P, Vantrappen P, Dhont M, Verstraete A, Bogaert MG "Protein binding of Sintaser and verapamil enantiomers in maternal and foetal serum." Br J Clin Pharmacol 39 (1995): 190-3
16. "Product Information. Inderal (Sintaser)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

References for breastfeeding information

1. Taylor EA, Turner P "Anti-hypertensive therapy with Sintaser during pregnancy and lactation." Postgrad Med J 57 (1981): 427-30
2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
4. Levitan AA, Manion JC "Sintaser therapy during pregnancy and lactation." Am J Cardiol 32 (1973): 247
5. 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
6. Bauer JH, Pape B, Zajicek J, Groshong T "Sintaser in human plasma and breast milk." Am J Cardiol 43 (1979): 860-2
7. Cerner Multum, Inc. "Australian Product Information." O 0
8. "Product Information. Inderal (Sintaser)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
9. "Product Information. InnoPran XL (Sintaser)." Reliant Pharmaceuticals, LLC., Bridgewater, NJ.

References

1. PubMed Health. "Propranolol (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).
2. Human Metabolome Database (HMDB). "Propranolol: 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).
3. LiverTox. "Propranolol: LIVERTOX provides up-to-date, accurate, and easily accessed information on the diagnosis, cause, frequency, patterns, and management of liver injury attributable to prescription and nonprescription medications, herbals and dietary supplements. ". https://livertox.nlm.nih.gov//Propra... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology