Orecil NF Pregnancy

• Pregnancy of Hydrocortisone (Orecil NF) in details
• Hydrocortisone (Orecil NF) breastfeeding
• Pregnancy of Lidocaine (Orecil NF) in details
• Lidocaine (Orecil NF) breastfeeding
• Pregnancy of Ofloxacin (Orecil NF) in details
• Ofloxacin (Orecil NF) breastfeeding
• Orecil NF reviews

Consists of Hydrocortisone, Lidocaine, Ofloxacin

Pregnancy of Hydrocortisone (Orecil NF) in details

Adverse events have been observed with corticosteroids in animal reproduction studies. 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.

When treating women with adrenal insufficiency (primary or central or congenital adrenal hyperplasia) during pregnancy, Hydrocortisone (Orecil NF) is the preferred corticosteroid. Doses may need to be adjusted as pregnancy progresses, and stress doses may be required during active labor. Pregnant women with adrenal insufficiency should be monitored at least once each trimester (ES [Bornstein 2016]; ES [Fleseriu 2016]; ES [Speiser 2018]).

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 (ACOG 2008; GINA 2018). 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). Women who require systemic corticosteroids for management of their asthma should be given intravenous corticosteroids, such as Hydrocortisone (Orecil NF), during labor and for 24 hours after delivery to prevent adrenal crisis (ACOG 2008).

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 women, 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).

Hydrocortisone (Orecil NF) breastfeeding

There are no data on the excretion of Hydrocortisone (Orecil NF) into human milk. Some corticosteroids are excreted into human milk in small amounts. The manufacturer recommends against the use of pharmacologic doses of Hydrocortisone (Orecil NF) by nursing women.

See references

References for pregnancy information

1. Zuspan FR, Cordero L, Semchyshyn S "Effects of Hydrocortisone (Orecil NF) on lecithin-sphingomyelin ratio." Am J Obstet Gynecol 128 (1977): 571-4
2. "Product Information. Hydrocortone (Hydrocortisone (Orecil NF))." Merck & Co, Inc, West Point, PA.
3. Houlihan CM, Knuppel RA, Vintzileos AM, Guo JZ, Hahn DW "The effect of specific hormones on fibrinolysis in pregnancy." Am J Obstet Gynecol 175 (1996): 168-72
4. Wilson EA, Jawad MJ "Stimulation of human chorionic gonadotropin secretion by glucocorticoids." Am J Obstet Gynecol 142 (1982): 344-9
5. Whitt GG, Buster JE, Killam AP, Scragg WH "A comparison of two glucocorticoid regimens for acceleration of fetal lung maturation in premature labor." Am J Obstet Gynecol 124 (1976): 479-82
6. Tan SL, Balen A, el Hussein E, Campbell S, Jacobs HS "The administration of glucocorticoids for the prevention of ovarian hyperstimulation syndrome in in vitro fertilization: a prospectiv randomized study." Fertil Steril 58 (1992): 378-83

References for breastfeeding information

1. "Product Information. Hydrocortone (Hydrocortisone (Orecil NF))." Merck & Co, Inc, West Point, PA.

Pregnancy of Lidocaine (Orecil NF) in details

Lidocaine (Orecil NF) 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. Lidocaine (Orecil NF) should only be given during pregnancy and in labor and delivery when need has been clearly established.

Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF) after prolonged continuous maternal IV administration has been described. After 14.1 g of Lidocaine (Orecil NF) (50 mg/hr for 282 hours), the umbilical vein/maternal vein Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF) during labor. The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of whom 293 received Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF) and birth defects.

See references

Lidocaine (Orecil NF) breastfeeding

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

Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF) to nursing women.

See references

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 (Lidocaine (Orecil NF))." Astra USA, Westborough, MA.
4. Kuhnert BR, Philipson EH, Pimental R, et al "Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF)." 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 Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF): does it matter?" Anesth Analg 80 (1995): 1063
9. Alakokko TI, Pienimaki P, Herva R, Hollmen AI, Pelkonen O, Vahakangas K "Transfer of Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF) 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 Lidocaine (Orecil NF) (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 "Lidocaine (Orecil NF) 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 (Lidocaine (Orecil NF))." Astra USA, Westborough, MA.

Pregnancy of Ofloxacin (Orecil NF) in details

Ofloxacin (Orecil NF) has been assigned to pregnancy category C by the FDA. Animal studies using high doses have revealed evidence of fetotoxicity and teratogenicity. There are no controlled data in human pregnancy. Surveillance studies have not reported an increased risk of major birth defects. However, cartilage damage and arthropathy are reported in immature animals giving rise to concern over effects on bone formation in the developing fetus. Because safer alternatives are available, some experts consider Ofloxacin (Orecil NF) contraindicated during pregnancy, especially during the first trimester. The manufacturer only recommends use of Ofloxacin (Orecil NF) during pregnancy when benefit outweighs risk.

Of 549 cases reported by the European Network of Teratology Information Services involving fluoroquinolone exposure (including Ofloxacin (Orecil NF)), congenital malformations were reported in 4.8%; however, this was not higher than the background rate.

See references

Ofloxacin (Orecil NF) breastfeeding

Ofloxacin (Orecil NF) is excreted into human milk. Breast milk concentrations approximate maternal serum concentrations. Quinolone-induced cartilage erosion and arthropathies that have been observed in juvenile animals render some concern over its possible toxic effects on the developing joints of nursing infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

1. Ramakrishnan K, Scheid DC "Diagnosis and management of acute pyelonephritis in adults." Am Fam Physician 71 (2005): 933-42
2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
3. "Product Information. Floxin (Ofloxacin (Orecil NF))." Ortho Pharmaceutical Corporation, Raritan, NJ.
4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

1. Giamarellou H, Kolokythas E, Petrikkos G, Gazis J, Aravantinos D, Sfikakis P "Pharmacokinetics of three newer quinolones in pregnant and lactating women." Am J Med 87 (1989): s49-51
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
4. "Product Information. Floxin (Ofloxacin (Orecil NF))." Ortho Pharmaceutical Corporation, Raritan, NJ.
5. 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 -]):

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. DailyMed. "OFLOXACIN: 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. DailyMed. "CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE: 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).

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Information checked by Dr. Sachin Kumar, MD Pharmacology