Theophylline Elixir Pregnancy

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• Pregnancy of Theophylline Elixir in details
• Theophylline Elixir breastfeeding
• Theophylline Elixir reviews

Pregnancy of Theophylline Elixir in details

The Collaborative Perinatal Project monitored 193 women with first trimester exposure to Theophylline Elixir or aminophylline and found no increased risk of malformations. Cord serum concentrations and infant serum concentrations have been reported to approximate the mother's serum concentrations immediately following birth. In 12 mothers receiving Theophylline Elixir, at the time of delivery, maternal serum, cord serum, and infant serum Theophylline Elixir concentrations averaged 10 mcg/mL. Cases of jitteriness, irritability, and vomiting have been reported in infants of mothers maintained on Theophylline Elixir prior to delivery. Apnea has been reported in an infant born after 37.5 weeks gestation to a mother who had been maintained on Theophylline Elixir throughout pregnancy for asthma. At approximately 48 hours after birth, the infants serum Theophylline Elixir level was 15 mcg/mL. The infant was placed on Theophylline Elixir when the concentration measured 2 mcg/mL. Apnea resolved when the Theophylline Elixir concentration reached 17 mcg/mL. The pharmacokinetics of Theophylline Elixir have been studied in women during pregnancy. Studies throughout pregnancy have noted a significant decrease in the clearance of Theophylline Elixir during the third trimester. The clearance was only slightly decreased during the first and second trimester. The plasma protein binding of Theophylline Elixir also has been shown to decrease in the later stages of pregnancy. It is important to closely monitor the Theophylline Elixir serum concentration and the patient for signs of toxicity during pregnancy. One study has shown an increase in fetal breathing movements when Theophylline Elixir was ingested by pregnant women at 33 to 38 weeks gestation. Since fetal breathing movements are routinely used to assess fetal status in late gestation, maternal Theophylline Elixir intake should be taken into account.

Theophylline Elixir has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryolethality and teratogenicity. There are no controlled data in human pregnancy. Theophylline Elixir is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

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Theophylline Elixir breastfeeding

Theophylline Elixir is excreted into human milk and may cause irritability or other signs of mild toxicity. The concentration of Theophylline Elixir in breast milk is approximately equivalent to the maternal serum concentration. The manufacturer states that serious adverse effects in the infant are unlikely unless the mother has toxic serum Theophylline Elixir concentrations. The American Academy of Pediatrics considers Theophylline Elixir to be compatible with breast-feeding.

In a study of five women given aminophylline, Theophylline Elixir was detected in milk with a milk:serum ratio of 0.61 to 0.87. The peak milk concentration occurred between one and three hours after ingestion of the dose. Irritability was reported in one infant whose mother took aminophylline. Adverse effects were not reported in the infants of the other women participating in this study. Exposure to the infant can be minimized by administering nursing prior to administration of Theophylline Elixir to avoid peak milk concentrations.

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References for pregnancy information

1. Hernandez E, Angell CS, Johnson JW "Asthma in pregnancy: current concepts." Obstet Gynecol 55 (1980): 739-43
2. Gardner MJ, Schatz M, Cousins L, Zeiger R, Middleton E, Jusko WJ "Longitudinal effects of pregnancy on the pharmacokinetics of Theophylline Elixir." Eur J Clin Pharmacol 32 (1987): 289-95
3. Dombrowski MP "Pharmacologic therapy of asthma during pregnancy." Obstet Gynecol Clin North Am 24 (1997): 559
4. Ishikawa M, Yoneyama Y, Power GG, Araki T "Maternal Theophylline Elixir administration and breathing movements in late-gestation human fetuses." Obstet Gynecol 88 (1996): 973-8
5. Pratt WR "Allergic diseases in pregnancy and breast feeding." Ann Allergy 47 (1981): 355-60
6. Frederiksen MC, Ruo TI, Chow MJ, Atkinson AJ, Jr "Theophylline Elixir pharmacokinetics in pregnancy." Clin Pharmacol Ther 40 (1986): 321-8
7. Schatz M, Zeiger RS, Harden K, Hoffman CC, Chilingar L, Petitti D "The safety of asthma and allergy medications during pregnancy." J Allergy Clin Immunol 100 (1997): 301-6
8. Stenius-aarniala B, Riikonen S, Teramo K "Slow-release Theophylline Elixir in pregnant asthmatics." Chest 109 (1996): 1668
9. Weinstein AM, Dubin BD, Podleski WK, Spector SL, Farr RS "Asthma and pregnancy." JAMA 241 (1979): 1161-5
10. Yeh TF, Pildes RS "Transplacental aminophylline toxicity in a neonate." Lancet 1 (1977): 910
11. Stenius-Aarniala B, Riikonen S, Teramo K "Slow-release Theophylline Elixir in pregnant asthmatics." Chest 107 (1995): 42-7
12. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
13. Carter BL, Driscoll CE, Smith GD "Theophylline Elixir clearance during pregnancy." Obstet Gynecol 68 (1986): 555-9
14. Steniusaarniala B, Riikonen S, Teramo K "Slow-release Theophylline Elixir in pregnant asthmatics." Chest 107 (1995): 642-7
15. Turner ES, Greenberger PA, Patterson R "Management of the pregnant asthmatic patient." Ann Intern Med 6 (1980): 905-10
16. Labovitz E, Spector S "Placental Theophylline Elixir transfer in pregnant asthmatics." JAMA 247 (1982): 786-8
17. Horowitz DA, Jablonski W, Mehta KA "Apnea associated with Theophylline Elixir withdrawal in a term neonate." Am J Dis Child 136 (1982): 73-4
18. Mcdonald CF, Burdon JGW "Asthma in pregnancy and lactation - a position paper for the thoracic society of australia and new zealand." Med J Aust 165 (1996): 485-8
19. Arwood LL, Dasta JF, Friedman C "Placental transfer of Theophylline Elixir: two case reports." Pediatrics 63 (1979): 844-6
20. "Product Information. Theo-Dur (Theophylline Elixir)." Schering Laboratories, Kenilworth, NJ.

References for breastfeeding information

1. Yurchak AM, Jusko WJ "Theophylline Elixir secretion into breast milk." Pediatrics 57 (1976): 518-20
2. Pratt WR "Allergic diseases in pregnancy and breast feeding." Ann Allergy 47 (1981): 355-60
3. "Product Information. Theo-Dur (Theophylline Elixir)." Schering Laboratories, Kenilworth, NJ.
4. Stec GP, Greenberger P, Ruo TI, et al "Kinetics of Theophylline Elixir transfer to breast milk." Clin Pharmacol Ther 28 (1980): 404-8
5. Mcdonald CF, Burdon JGW "Asthma in pregnancy and lactation - a position paper for the thoracic society of australia and new zealand." Med J Aust 165 (1996): 485-8
6. Bailey DN "Lidocaine, quinidine, and Theophylline Elixir binding to human milk." Ann Clin Lab Sci 28 (1998): 289-92
7. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50

References

1. DailyMed. "THEOPHYLLINE: 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. "Theophylline (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).
3. Human Metabolome Database (HMDB). "Theophylline: 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