Mef PROXYVON 10MG/250MG TABLET Pregnancy

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Consists of Dicyclomine, Mefenamic Acid

Pregnancy of Dicyclomine (Mef PROXYVON 10MG/250MG TABLET) in details

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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 Dicyclomine (Mef PROXYVON 10MG/250MG TABLET) may be preferred for the treatment of irritable bowel syndrome in pregnant women (Enck 2016).

Dicyclomine (Mef PROXYVON 10MG/250MG TABLET) 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 Dicyclomine (Mef PROXYVON 10MG/250MG TABLET). A causal relationship between Dicyclomine (Mef PROXYVON 10MG/250MG TABLET) and apnea could not be confirmed. Similar adverse reactions have occurred with direct administration of Dicyclomine (Mef PROXYVON 10MG/250MG TABLET) to infants.

See references

References for pregnancy information

  1. Williams J, Watkins-Jones R "Dicyclomine (Mef PROXYVON 10MG/250MG TABLET): 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 Altman PM "Debendox withdrawn."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 Correy JF, Newman NM "Debendox withdrawn."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 (Dicyclomine (Mef PROXYVON 10MG/250MG TABLET))." 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 Dicyclomine (Mef PROXYVON 10MG/250MG TABLET) 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/Dicyclomine (Mef PROXYVON 10MG/250MG TABLET) 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 (Dicyclomine (Mef PROXYVON 10MG/250MG TABLET))." 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):

Pregnancy of Mefenamic Acid (Mef PROXYVON 10MG/250MG TABLET) in details

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Mefenamic Acid (Mef PROXYVON 10MG/250MG TABLET) crosses the placenta (Mackenzie 1985). Birth defects have been observed following in utero NSAID exposure in some studies; however, data is conflicting (Bloor 2013). Nonteratogenic effects, including prenatal constriction of the ductus arteriosus, persistent pulmonary hypertension of the newborn, oligohydramnios, necrotizing enterocolitis, renal dysfunction or failure, and intracranial hemorrhage have been observed in the fetus/neonate following in utero NSAID exposure. In addition, nonclosure of the ductus arteriosus postnatally may occur and be resistant to medical management (Bermas 2014; Bloor 2013). Because NSAIDs may cause premature closure of the ductus arteriosus, product labeling for Mefenamic Acid (Mef PROXYVON 10MG/250MG TABLET) specifically states use should be avoided starting at 30 weeks' gestation.

The use of NSAIDs close to conception may be associated with an increased risk of miscarriage (Bloor 2013; Bermas 2014).

Mefenamic Acid (Mef PROXYVON 10MG/250MG TABLET) breastfeeding

Due to lack of published clinical experience in nursing mothers and the potential for toxicity, other agents may be preferred.

Use is not recommended. Excreted into human milk: Yes (in trace amounts) Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."
  3. "Product Information. Ponstel (Mefenamic Acid (Mef PROXYVON 10MG/250MG TABLET))." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. 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 -]):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Ponstel (Mefenamic Acid (Mef PROXYVON 10MG/250MG TABLET))." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."


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References

  1. DailyMed. "MEFENAMIC ACID: 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. "Mefenamic Acid (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. 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).

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