Oxityl-P Pregnancy

• Pregnancy of Oxityl-P in details
• Oxityl-P breastfeeding
• Oxityl-P reviews

Pregnancy of Oxityl-P in details

In epidemiologic studies, birth defects were not observed following maternal doses up to 40 mg daily throughout the first trimester; information has not been located when used in pregnant women at recommended doses (80 to 160 mg daily). Agents other than Oxityl-P may be preferred for the treatment of irritable bowel syndrome in pregnant women (Enck 2016).

Oxityl-P breastfeeding

Use should be avoided. Excreted into human milk: Yes Excreted into animal milk: Data not available Comments: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

A single case has been reported of a breast-fed 12 day old infant who developed apnea whose mother was receiving Oxityl-P. A causal relationship between Oxityl-P and apnea could not be confirmed. Similar adverse reactions have occurred with direct administration of Oxityl-P to infants.

See references

References for pregnancy information

1. Williams J, Watkins-Jones R "Oxityl-P: worrying symptoms associated with its use in some small babies." Br Med J (Clin Res Ed) 288 (1984): 901
2. Huff PS "Safety of drug therapy for nausea and vomiting of pregnancy." J Fam Pract 11 (1980): 969-70
3. Altman PM "Debendox withdrawn." Med J Aust 140 (1984): 119
4. Congenital Abnormalities Sub-Committee of the Australian Drug Evaluation Committtee "Debendox in pregnancy." Med J Aust 1 (1980): 197
5. Miklovich L, van den Berg BJ "An evaluation of the teratogenicity of certain antinauseant drugs." Am J Obstet Gynecol 125 (1976): 244-8
6. Correy JF, Newman NM "Debendox and limb reduction deformities." Med J Aust 1 (1981): 417-8
7. Correy JF, Newman NM "Debendox withdrawn." Med J Aust 140 (1984): 796-7
8. Sheffield LJ, Batagol R "The creation of therapeutic orphans--or, what have we learnt from the Debendox fiasco?" Med J Aust 143 (1985): 143-7
9. DonnaiD, Harris R "Unusual fetal malformations after antiemetics in early pregnancy." Br Med J 1 (1978): 691-2
10. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
11. Gordon I "Debendox." Med J Aust 144 (1986): 51-2
12. Fleming DM, Knox JD, Crombie DL "Debendox in early pregnancy and fetal malformation." Br Med J (Clin Res Ed) 283 (1981): 99-101
13. Mellor S "Fetal malformation after debendox treatment in early pregnancy." Br Med J 1 (1978): 1055
14. Wheatley D "Treatment of pregnancy sickness." Br J Obstet Gynaecol 84 (1977): 444-7
15. Patterson DC "Congenital deformities associated with Benedectin." Can Med Assoc J 116 (1977): 1348
16. Cordero JF, Oakley GP Jr "Drug exposure during pregnancy: some epidemiologic considerations." Clin Obstet Gynecol 26 (1983): 418-28
17. "Product Information. Bentyl (Oxityl-P)." Aventis Pharmaceuticals, Kansas City, MO.
18. Dickson JH "Congenital deformities associated with bendectin." Can Med Assoc J 117 (1977): 721-2
19. Smithells RW, Sheppard S "Fetal malformation after debendox treatment in early pregnancy." Br Med J 1 (1978): 1055-6
20. Harris R, Donnai D "Debendox and the media." Br Med J 280 (1980): 480-1
21. Morelock S, Hingson R, Kayne H, Dooling E, Zuckerman B, Day N, Alpert JJ, Flowerdew G "Bendectin and fetal development. A study of Boston City Hospital." Am J Obstet Gynecol 142 (1982): 209-13
22. Harron DW, Griffiths K, Shanks RG "Debendox and congenital malformations in Northern Ireland." Br Med J 281 (1980): 1379-81
23. Shapiro S, Heinonen OP, Siskind V, Kaufman DW, Monson RR, Slone D "Antenatal exposure to doxylamine succinate and Oxityl-P hydrochloride (Benedectin) in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score." Am J Obstet Gynecol 128 (1977): 480-5
24. Golden SM, Perman KI "Bilateral clinical anophthalmia: drugs as potential factors." South Med J 73 (1980): 1404-7
25. Gibson GT, Colley DP, McMichael AJ, Hartshorne JM "Congenital anomalies in relation to the use of doxylamine/Oxityl-P and other antenatal factors: an ongoing prospective study." Med J Aust 1 (1981): 410-4
26. Mitchell AA "Debendox." Med J Aust 144 (1986): 52
27. Maling TJ "Debendox: a statement from the New Zealand Adverse Drug Reactions Committee." N Z Med J 97 (1984): 203-4

References for breastfeeding information

1. "Product Information. Bentyl (Oxityl-P)." Aventis Pharmaceuticals, Kansas City, MO.
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):

References

1. PubMed Health. "Dicyclomine (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). "Dicyclomine: 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. FDA Pharm Classes. "FDA Pharmacological Classification: FDA published a final rule that amended the requirements for the content and format of approved labeling (prescribing information) for human prescription drug and biological products in January 2006.". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology