Moxyvit Forte 500 Pregnancy

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Pregnancy of Moxyvit Forte 500 in details

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Moxyvit Forte 500 has been assigned to pregnancy category B by the FDA. Animal studies using 10 times the human dose have failed to reveal any evidence of teratogenicity. Although no controlled data in human pregnancy are available, literature reports of adverse fetal effects are lacking. Moxyvit Forte 500 is only recommended during pregnancy when benefit outweighs risk.

In the Collaborative Perinatal Project involving 50,282 mother-child pairs, there were 3,546 mother-child pairs exposed to penicillin derivatives in the first trimester. As a group, there was no significant increase in the risk of malformations. In the Michigan Medicaid Birth Defects Study involving 229,101 pregnancies from 1985 to 1992, there were 8,538 first trimester exposures to Moxyvit Forte 500. Overall, 317 cases of birth defects were observed (363 expected). There was no evidence of an association between first trimester use of Moxyvit Forte 500 and major groups of malformations. A Danish study of 401 women exposed to Moxyvit Forte 500 during pregnancy from 1991 to 2000 did not find an increased risk of birth defects or adverse outcomes compared to women who had taken no medication. Transient decreases in total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol plasma concentrations have been reported in pregnant women who received ampicillin and this may also occur with Moxyvit Forte 500.

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Moxyvit Forte 500 breastfeeding

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In one study, six women were administered a single 1000 mg dose of Moxyvit Forte 500 on the third postpartum day. Moxyvit Forte 500 milk concentrations ranged from 0.10 to 0.81 mcg/mL, with a peak concentration measured at 5 hours post-dose. The milk to maternal serum concentration ratio ranged from 0.013 to 0.043.

Moxyvit Forte 500 is excreted into human milk in small amounts. Sensitization of the infant may occur. The American Academy of Pediatrics considers the use of Moxyvit Forte 500 to be compatible with breast-feeding. The manufacturer recommends that caution be used when administering Moxyvit Forte 500 to nursing women.

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References for pregnancy information

  1. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  2. Jepsen P, Skriver MV, Floyd A, Lipworth L, Schonheyder HC, Sorensen HT "A population-based study of maternal use of Moxyvit Forte 500 and pregnancy outcome in Denmark." Br J Clin Pharmacol 55 (2003): 216-221
  3. "Product Information. Amoxil (Moxyvit Forte 500)." SmithKline Beecham, Philadelphia, PA.
  4. Marinoff DN, Chinn A "Preventing recurrent second trimester group B streptococcus chorioamnionitis by intermittent prophylactic ampicillin." Obstet Gynecol 98(5 Pt 2) (2001): 918-9
  5. Heikkila A, Erkkola R "Review of beta-lactam antibiotics in pregnancy - the need for adjustment of dosage schedules." Clin Pharmacokinet 27 (1994): 49-62
  6. "Product Information. Polymox (Moxyvit Forte 500)." Bristol-Myers Squibb, Princeton, NJ.
  7. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

References for breastfeeding information

  1. 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
  2. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  3. Kafetzi D, Siafas C, Georgakopoulos P, Papdatos C "Passage of cephalosporins and Moxyvit Forte 500 into the breast milk." Acta Paediatr Scand 70 (1981): 285-8
  4. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  5. "Product Information. Amoxil (Moxyvit Forte 500)." SmithKline Beecham, Philadelphia, PA.
  6. "Product Information. Polymox (Moxyvit Forte 500)." Bristol-Myers Squibb, Princeton, NJ.


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References

  1. DailyMed. "AMOXICILLIN; CLAVULANATE POTASSIUM: 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. "DisperMox: 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). "Amoxicillin: 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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