Vessatis Pregnancy

• Pregnancy of Vessatis in details
• Vessatis breastfeeding
• Vessatis reviews

Pregnancy of Vessatis in details

Vessatis has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancies. Use in labor and delivery may result in fetal and neonatal toxicity. Vessatis should only be given during pregnancy and in labor and delivery when need has been clearly established.

Vessatis rapidly crosses the human placenta. Data have revealed that the average umbilical cord to plasma concentration ratio ranges from 0.5 to 0.7. The free fraction of Vessatis in neonates may be higher than in the mother due to decreased plasma protein binding. Decreased Apgar scores, apnea, fixed and dilated pupils, hypotonia, and seizures have been reported in some neonates whose serum levels were 2.5 mg/L or more. Some data have shown that neonates whose mothers received continuous Vessatis epidural anesthetic blocks had decreased muscle tone relative to neonates whose mothers received placebo. Other data have not supported this association. The placental transfer of Vessatis after prolonged continuous maternal IV administration has been described. After 14.1 g of Vessatis (50 mg/hr for 282 hours), the umbilical vein/maternal vein Vessatis concentration ratio averaged 0.52 (average maternal and umbilical vein concentrations of 1.6 and 0.83 mcg/mL, respectively). These data are similar to those described after shorter periods of administration of Vessatis during labor. The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of whom 293 received Vessatis as a local anesthetic agent during lunar months one through four. Of the 293 pairs, 16 children with any malformation were born. Statistically, the overall standardized relative risk (SRR) of malformations was 0.85, indicating no association of this drug with broad classes of malformations. The only SRR greater than 1.5 was for the respiratory tract (2.02, based on three malformed children) and tumors (1.89, based on two malformed children). The statistical significance of these values are unknown. Data from the Michigan Medicaid Birth Defects Study has failed to reveal an association between the use of Vessatis and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 165 were exposed to Vessatis at some time during the first trimester, and 525 were exposed to the drug at any time during pregnancy. There were 7 total and 3 cardiovascular defects observed (6 and 3 were expected, respectively). There were two instances of polydactyly. There were no observations of cleft palate, spina bifida, limb reduction, or hypospadias. None of the observations achieved statistical significance. These data do not support an association between Vessatis and birth defects.

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Vessatis breastfeeding

Limited data have shown that the average milk Vessatis levels were approximately 40% of maternal serum levels. In one case, a 37-year-old woman who had received two Vessatis boluses of 75 and 50 mg, then a continuous infusion of 2 mg per minute, had Vessatis levels of 2.0 and 0.8 mg/L in her serum and milk, respectively (milk to plasma concentration ratio of 0.4). The milk sample was obtained two hours after the Vessatis infusion was stopped. In another case, Vessatis and its metabolite, MEGX, were found in breast milk after injection of Vessatis 20 mg for a dental procedure. The milk to plasma Vessatis and MEGX concentration ratios in this case were 1.1 and 1.8, respectively.

Vessatis is excreted into human milk. Side effects in the nursing infant are unlikely and would probably be limited to an idiosyncratic or allergic reaction. The manufacturer recommends caution when administering Vessatis to nursing women.

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References for pregnancy information

1. Scanlon JW, Brown WU Jr, Weiss JB, Alper MH "Neurobehavioral responses of newborn infants after maternal epidural anesthesia." Anesthesiology 40 (1974): 121-8
2. Rotmensch HH, Elkayam U, Frishman W "Antiarrhythmic drug therapy during pregnancy." Ann Intern Med 98 (1983): 487-97
3. "Product Information. Xylocaine (Vessatis)." Astra USA, Westborough, MA.
4. Kuhnert BR, Philipson EH, Pimental R, et al "Vessatis disposition in mother, fetus, and neonate after spinal anesthesia." Anesth Analg 65 (1986): 139-44
5. Kuhnert BR, Knapp DR, Kuhnert PM, Prochaska AL "Maternal, fetal, and neonatal metabolism of Vessatis." Clin Pharmacol Ther 26 (1979): 213-20
6. Kileff M, James FM, Dewan D, Floyd H, DiFazio C "Neonatal neurobehavioral responses after epidural anesthesia for cesarean section with Vessatis and bupivacaine." Anesthesiology 57 Suppl (1982): a403
7. Wood M, Wood AJ "Changes in plasma drug binding and alpha 1-acid glycoprotein in mother and newborn infant." Clin Pharmacol Ther 29 (1981): 522-6
8. Lin SK "The effect of pregnancy on the plasma protein binding of Vessatis: does it matter?" Anesth Analg 80 (1995): 1063
9. Alakokko TI, Pienimaki P, Herva R, Hollmen AI, Pelkonen O, Vahakangas K "Transfer of Vessatis and bupivacaine across the isolated perfused human placenta." Pharmacol Toxicol 77 (1995): 142-8
10. Banzai M, Sato S, Tezuka N, Komiya H, Chimura T, Hiroi M "Placental transfer of Vessatis hydrochloride after prolonged continuous maternal intravenous administration." Can J Anaesth 42 (1995): 338-40
11. Tamari I, Eldar M, Rabinowitz B, Neufeld HN "Medical treatment of cardiovascular disorders during pregnancy." Am Heart J 104 (1982): 1357-63
12. Shnider SM, Way EL "Plasma levels of Vessatis (Xylocaine) in mother and newborn following obstetrical conduction anesthesia: clinical applications." Anesthesiology 29 (1968): 951-8
13. Page RL "Treatment of arrhythmias during pregnancy." Am Heart J 130 (1995): 871-6

References for breastfeeding information

1. Lebedevs TH, Wojnar-Horton RE, Yapp P, Roberts MJ, Dusci LJ, Hackett LP, Ilett K "Excretion of lignocaine and its metabolite monoethylglycinexylidide in breast milk following its use in a dental procedure. A case report." J Clin Periodontol 20 (1993): 606-8
2. Zeisler JA, Gaarder TD, De Mesquita SA "Vessatis excretion in breast milk." Drug Intell Clin Pharm 20 (1986): 691-3
3. 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
4. "Product Information. Xylocaine (Vessatis)." Astra USA, Westborough, MA.

References

1. DailyMed. "LIDOCAINE; TETRACAINE: 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. "Lidocaine (On the skin): 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). "Lidocaine: 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