Tergynan Pregnancy

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Consists of Metronidazole, Neomycin, Nystatin

Pregnancy of Metronidazole (Tergynan) in details

infoPregnancy is always a special situation where every action or side effect of the drug varies when compared to a situation of a non-pregnant patient. It is not only because the pregnant woman's metabolism differs due to the hormonal and other changes happened to her, but also because every medicine or its metabolite passes to the baby and shows its action there. The only thing is, be cautious, attentive and well supervised when you take any single drug in pregnancy. The interactions can vary in pregnancy, and the dosage may differ as well. Strict supervision of the Physician is mandatory.
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Animal studies have failed to reveal evidence of fetal harm, except when the drug was administered intraperitoneally. There are no controlled data in human pregnancy. Metronidazole (Tergynan) crosses the placental barrier; effects on human fetal organogenesis are not known. Published data from case-control studies, cohort studies, and 2 meta-analyses included more than 5000 pregnant women who used Metronidazole (Tergynan) during pregnancy. Many studies included first trimester exposures. In 1 study, an increased risk of cleft lip (with or without cleft palate) was seen in infants exposed to Metronidazole (Tergynan) in utero; however, findings were not confirmed. More than 10 randomized placebo-controlled clinical studies enrolled more than 5000 pregnant women to assess use of antibiotics (including Metronidazole (Tergynan)) for bacterial vaginosis on rate of preterm delivery. Most studies did not show increased risk for congenital anomalies or other adverse fetal outcomes after Metronidazole (Tergynan) exposure during pregnancy. Increased risk of infant cancer after Metronidazole (Tergynan) exposure during pregnancy was not found in 3 studies conducted to assess this risk; however, limited ability to detect such a signal. The CDC recommends use of Metronidazole (Tergynan) for vaginal trichomoniasis during any stage of pregnancy. Multiple studies and meta-analyses have not established an association between Metronidazole (Tergynan) use during pregnancy and teratogenic or mutagenic effects in infants. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

FDA pregnancy category: B Use of Metronidazole (Tergynan) for trichomoniasis is contraindicated during the first trimester; the manufacturer makes no further recommendations regarding use during pregnancy.

See references

Metronidazole (Tergynan) breastfeeding

infoWhen a drug is taken when the patient is breast feeding, a part of the drug is secreted in her breast milk and is passed to the baby. The dosage of the medicine to mother and baby are different, and many drugs actions are side effects when you take them without a disease, and what if you the baby takes them without a disease? What if the drug is contraindicated in newborns, infants or children? So, breastfeeding is a very alarming situation when the mother is on medications. Ask your Physician or Pediatrician about the effect of the drug on the baby and how much is excreted in breast milk and if it harms the baby!
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Metronidazole (Tergynan) is present in human milk at levels similar to maternal serum levels, and infant serum levels can be similar to infant therapeutic levels. Due to the potential for tumorigenicity shown for Metronidazole (Tergynan) in mouse and rat studies, discontinuation of the drug or nursing is recommended. Alternatively, nursing mothers may pump and discard their milk during and for 24 hours after Metronidazole (Tergynan) therapy and feed their infants stored human milk or formula.

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

See references

References for pregnancy information

  1. Morales WJ, Schorr S, Albritton J "Effect of Metronidazole (Tergynan) in patients with preterm birth in preceding pregnancy and bacterial vaginosis: a placebo-controlled, double-blind study." Am J Obstet Gynecol 171 (1994): 345-9
  2. Mcdonald HM, Oloughlin JA, Vigneswaran R, Jolley PT, Mcdonald PJ "Bacterial vaginosis in pregnancy and efficacy of short-course oral Metronidazole (Tergynan) treatment: a randomized controlled trial." Obstet Gynecol 84 (1994): 343-8
  3. Sorensen HT, Larsen H, Jensen ES, Thulstrup AM, Schonheyder HC, Nielsen GL, Czeizel A "Safety of Metronidazole (Tergynan) during pregnancy: a cohort study of risk of congenital abnormalities, preterm delivery and low birth weight in 124 women." J Antimicrob Chemother 44 (1999): 854-5
  4. Thapa PB, Whitlock JA, Worrell KGB, Gideon P, Mitchel EF, Roberson P, Pais R, Ray WA "Prenatal exposure to Metronidazole (Tergynan) and risk of childhood cancer: A retrospective cohort study of children younger than 5 years." Cancer 83 (1998): 1461-8
  5. "Product Information. Flagyl (Metronidazole (Tergynan))." Searle, Skokie, IL.
  6. CDC. Centers for Disease Control and Prevention "Sexually transmitted diseases treatment guidelines, 2010. Available from: URL: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5912a1.htm?s_cid=rr5912a1_e." ([2010 Dec 17]):
  7. Donders GGG "Treatment of sexually transmitted bacterial diseases in pregnant women." Drugs 59 (2000): 477-85
  8. Carvajal A, Sanchez A, Hurtarte G "Metronidazole (Tergynan) during pregnancy." Int J Gynaecol Obstet 48 (1995): 323-4
  9. Burtin P, Taddio A, Ariburnu O, Einarson TR, Koren G "Safety of Metronidazole (Tergynan) in pregnancy: a meta-analysis." Am J Obstet Gynecol 172 (1995): 525-9

References for breastfeeding information

  1. "Product Information. Flagyl (Metronidazole (Tergynan))." Searle, Skokie, IL.
  2. Moore B, Collier J "Drugs and breast feeding." Br Med J 2 (1979): 211
  3. Erickson SH, Oppenheim GL, Smith GH "Metronidazole (Tergynan) in breast milk." Obstet Gynecol 57 (1981): 48-50
  4. Passmore CM, McElnay JC, Rainey EA, D'Arcy PF "Metronidazole (Tergynan) excretion in human milk and its effect on the suckling infant." Br J Clin Pharmacol 26 (1988): 45-51
  5. Heisterberg L, Branebjerg PE "Blood and milk concentrations of Metronidazole (Tergynan) in mothers and infants." J Perinat Med 11 (1983): 114-20
  6. 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
  7. Gray MS, Kane PO, Squires S "Further observations on Metronidazole (Tergynan) (flagyl)." Br J Vener Dis 37 (1961): 278-9
  8. Clements CJ "Metronidazole (Tergynan) and breast feeding." N Z Med J 92 (1980): 329

Pregnancy of Neomycin (Tergynan) in details

infoPregnancy is always a special situation where every action or side effect of the drug varies when compared to a situation of a non-pregnant patient. It is not only because the pregnant woman's metabolism differs due to the hormonal and other changes happened to her, but also because every medicine or its metabolite passes to the baby and shows its action there. The only thing is, be cautious, attentive and well supervised when you take any single drug in pregnancy. The interactions can vary in pregnancy, and the dosage may differ as well. Strict supervision of the Physician is mandatory.
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Neomycin (Tergynan) has been assigned to pregnancy category D by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy; however, other aminoglycoside antibiotics cross the placenta. Streptomycin use in pregnancy has been associated with irreversible bilateral deafness in children. Serious fetal side effects have not been reported with other aminoglycosides. Patients should be warned of potential hazards to the fetus if they if take Neomycin (Tergynan) during pregnancy or become pregnant while taking this drug.

See references

Neomycin (Tergynan) breastfeeding

infoWhen a drug is taken when the patient is breast feeding, a part of the drug is secreted in her breast milk and is passed to the baby. The dosage of the medicine to mother and baby are different, and many drugs actions are side effects when you take them without a disease, and what if you the baby takes them without a disease? What if the drug is contraindicated in newborns, infants or children? So, breastfeeding is a very alarming situation when the mother is on medications. Ask your Physician or Pediatrician about the effect of the drug on the baby and how much is excreted in breast milk and if it harms the baby!

There are no data on the excretion of Neomycin (Tergynan) into human milk. Other aminoglycosides are excreted into human milk. The manufacturer recommends that due to the potential for adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Neomycin (Tergynan) was excreted into cow milk after intramuscular injection.

See references

References for pregnancy information

  1. "Product Information. Neomycin (Tergynan) (Neomycin (Tergynan))" Pharma-Tek, Huntington, NY.

References for breastfeeding information

  1. "Product Information. Neomycin (Tergynan) (Neomycin (Tergynan))" Pharma-Tek, Huntington, NY.

Pregnancy of Nystatin (Tergynan) in details

infoPregnancy is always a special situation where every action or side effect of the drug varies when compared to a situation of a non-pregnant patient. It is not only because the pregnant woman's metabolism differs due to the hormonal and other changes happened to her, but also because every medicine or its metabolite passes to the baby and shows its action there. The only thing is, be cautious, attentive and well supervised when you take any single drug in pregnancy. The interactions can vary in pregnancy, and the dosage may differ as well. Strict supervision of the Physician is mandatory.
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In a review of 229,101 deliveries to Michigan Medicaid patients, 489 first-trimester exposures to Nystatin (Tergynan) and 1881 exposures any time during pregnancy were recorded. Both systemic and nonsystemic exposures were included. A total of 20 birth defects were reported with first trimester exposure (21 expected) and included (observed/expected) 3/5 cardiovascular defects, 1 cleft palate, 1 polydactyly, and 1 limb reduction. (Written communication, Franz Rosa, MD, Food and Drug Administration, 1994). These data do not support an association with birth defects. Nystatin (Tergynan) has been used for the treatment of vaginal candidiasis in several studies, generally during the second and third trimester, without association with adverse fetal outcome. In one study, Nystatin (Tergynan) was administered to 244 women in all stages of pregnancy. One infant was born with congenital heart disease, one infant was born with hip "clicks" on abduction, and one infant was born premature with hyaline membrane disease.

Nystatin (Tergynan) has been assigned to pregnancy category A by the FDA when administered as a vaginal suppository and to category C when administered as an oral troche. Nystatin (Tergynan) has not been associated with adverse fetal outcome, however Nystatin (Tergynan) is only recommended for use during pregnancy when benefit outweighs risk.

See references

Nystatin (Tergynan) breastfeeding

infoWhen a drug is taken when the patient is breast feeding, a part of the drug is secreted in her breast milk and is passed to the baby. The dosage of the medicine to mother and baby are different, and many drugs actions are side effects when you take them without a disease, and what if you the baby takes them without a disease? What if the drug is contraindicated in newborns, infants or children? So, breastfeeding is a very alarming situation when the mother is on medications. Ask your Physician or Pediatrician about the effect of the drug on the baby and how much is excreted in breast milk and if it harms the baby!

There are no data on the excretion of Nystatin (Tergynan) into human milk. However, Nystatin (Tergynan) is not thought to be absorbed after application to skin or mucous membranes.

See references

References for pregnancy information

  1. Wallenburg HC, Wladimiroff JW "Recurrence of vulvovaginal candidosis during pregnancy. Comparison of miconazole vs Nystatin (Tergynan) treatment." Obstet Gynecol 48 (1976): 491-4
  2. Tan CG, Good CS, Milne LJ, Loudon JD "A comparative trial of six day therapy with clotrimazole and Nystatin (Tergynan) in pregnant patients with vaginal candidiasis." Postgrad Med J 50 Suppl 1 (1974): 102-5
  3. "Product Information. Mycostatin Pastilles (Nystatin (Tergynan))." Ernest Jackson & Co., Ltd., Crediton, Devon, England,.
  4. Milne LJ, Brown AD "Comparison of Nystatin (Tergynan) ('Nystan') and hydrargaphen ('Penotrane') in the treatment of vaginal candidosis in pregnancy." Curr Med Res Opin 1 (1973): 524-7
  5. McNellis D, McLeod M, Lawson J, Pasquale SA "Treatment of vulvovaginal candidiasis in pregnancy. A comparative study." Obstet Gynecol 50 (1977): 674-8
  6. Higton BK "A trial of clotrimazole and Nystatin (Tergynan) in vaginal candidiasis." Postgrad Med J 50 Suppl 1 (1974): 95-8

References for breastfeeding information

  1. "Product Information. Nystatin (Tergynan), USP from Extemporaneous Preparation of

    Oral Suspension (Nystatin (Tergynan))." Paddock Laboratories Inc, Minneapolis, MN.

  2. "Product Information. Mycostatin Pastilles (Nystatin (Tergynan))." Ernest Jackson & Co., Ltd., Crediton, Devon, England,.



References

  1. DailyMed. "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE: 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. "PREDNISOLONE: 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. "HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE: 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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