Clomaz/Clomaz-Forte Pregnancy

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Pregnancy of Clomaz/Clomaz-Forte in details

Pregnancy 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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Pregnancy predisposes patients to the development of vaginal candidiasis due to changes in the vaginal tract. Clomaz/Clomaz-Forte has been used in several clinical trials for the treatment of vaginal candidiasis during the second and third trimester without evidence of fetal harm. One trial included 57 patients in their first trimester. Again no adverse effects were attributed to Clomaz/Clomaz-Forte. In a review of 229,101 deliveries to Michigan Medicaid patients, 2624 first-trimester exposures to Clomaz/Clomaz-Forte and 8590 exposures any time during pregnancy were recorded. A total of 118 birth defects were reported with first trimester exposure (112 expected) and included (observed/expected) 27/26 cardiovascular defects, 3/1 spina bifida, 4/4 oral clefts, 9/6 polydactyly, 1 limb reduction, and 6/6 hypospadias. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association between first-trimester Clomaz/Clomaz-Forte use and birth defects.

Clomaz/Clomaz-Forte has been assigned to pregnancy category C by the FDA when given as oral troches, and pregnancy category B when used intravaginally or topically. Animals given high doses intravaginally and orally have not shown evidence of teratogenicity. In clinical trials involving women in their second and third trimester, Clomaz/Clomaz-Forte treatment of vaginal candidiasis has not been associated with fetal harm. Clomaz/Clomaz-Forte use has not been well studied during the first trimester. Clomaz/Clomaz-Forte is only recommended for use during pregnancy when benefit outweighs risk.

See references

Clomaz/Clomaz-Forte breastfeeding

When 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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There are no data on the excretion of Clomaz/Clomaz-Forte into human milk.

See references

References for pregnancy information

  1. "Product Information. Mycelex (Clomaz/Clomaz-Forte)." Bayer, West Haven, CT.
  2. Haram K, Digranes A "Vulvovaginal candidiasis in pregnancy treated with Clomaz/Clomaz-Forte." Acta Obstet Gynecol Scand 57 (1978): 453-5
  3. Frerich W, Gad A "The frequency of Candida infections in pregnancy and their treatment with Clomaz/Clomaz-Forte." Curr Med Res Opin 4 (1977): 640-4
  4. Tan CG, Good CS, Milne LJ, Loudon JD "A comparative trial of six day therapy with Clomaz/Clomaz-Forte and nystatin in pregnant patients with vaginal candidiasis." Postgrad Med J 50 Suppl 1 (1974): 102-5
  5. Lindeque BG, van Niekerk WA "Treatment of vaginal candidiasis in pregnancy with a single Clomaz/Clomaz-Forte 500 mg vaginal pessary." S Afr Med J 65 (1984): 123-4

References for breastfeeding information

  1. "Product Information. Mycelex (Clomaz/Clomaz-Forte)." Bayer, West Haven, CT.


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References

  1. DailyMed. "BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE: 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. "Mycelex: 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). "Clotrimazole: 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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