Elica-M Pregnancy

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Consists of Miconazole, Mometasone

Pregnancy of Miconazole (Elica-M) 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. Miconazole (Elica-M) has been used in several clinical trials for the treatment of vaginal candidiasis, generally during the second and third trimester, without evidence of fetal harm. In a review of 229,101 deliveries to Michigan Medicaid patients, 7266 first-trimester exposures to Miconazole (Elica-M) and 31,503 exposures any time during pregnancy were recorded. A total of 304 birth defects were reported with first trimester exposure (273 expected) and included (observed/expected) 77/73 cardiovascular defects, 14/13 clefts, 3 spina bifida, 4/4 oral clefts, 22/15 polydactyly, 12/9 limb reductions, and 20/17 hypospadias (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). These data do not support an association between first-trimester Miconazole (Elica-M) use and birth defects.

Miconazole (Elica-M) has not officially been assigned to a pregnancy category by the FDA. In clinical trials, Miconazole (Elica-M) treatment of vaginal candidiasis has not been associated with fetal harm. Miconazole (Elica-M) is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Miconazole (Elica-M) 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 Miconazole (Elica-M) into human milk. The manufacturer recommends that caution be used when administering Miconazole (Elica-M) to nursing women.

See references

References for pregnancy information

  1. Weisberg M "Treatment of vaginal candidiasis in pregnant women." Clin Ther 8 (1986): 563-7
  2. "Product Information. Monistat (Miconazole (Elica-M))." Ortho Pharmaceutical Corporation, Raritan, NJ.
  3. Rosa FW, Baum C, Shaw M "Pregnancy outcomes after first-trimester vaginitis drug therapy." Obstet Gynecol 69 (1987): 751-5
  4. Wallenburg HCS, Wladimiroff JW "Recurrence of vulvovaginal candidosis during pregnancy." Obstet Gynecol 48 (1976): 491-4
  5. "Product Information. ORAVIG (Miconazole (Elica-M))." Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc., Woodcliff Lake, NJ.
  6. McNellis D, Facog, McLeod M, Lawson J, Pasquale SA "Treatment of vulvovaginal candidiasis in pregnancy." Obstet Gynecol 50 (1977): 674-8

References for breastfeeding information

  1. "Product Information. Monistat (Miconazole (Elica-M))." Ortho Pharmaceutical Corporation, Raritan, NJ.
  2. "Product Information. ORAVIG (Miconazole (Elica-M))." Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc., Woodcliff Lake, NJ.

Pregnancy of Mometasone (Elica-M) 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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Animal reproduction studies in mice, rats, and rabbits revealed evidence of teratogenicity, such as increased fetal malformations and decreased fetal growth (measured by lower fetal weights and/or delayed ossification). Dystocia and related complications were also observed when administered in late gestation. In mice, subcutaneous administration produced cleft palate at approximately one-third of the maximum recommended daily human dose (MRHD). In rats, topical administration produced umbilical hernia at doses approximately 6 times the MRHD. Subcutaneous administration in rats, throughout pregnancy or late in gestation, had caused prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at doses approximately 8 times the MRHD. In rabbits, topical administration caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 3 times the MRHD. There are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. US FDA pregnancy category: C Comments: -Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. -Monitor signs of hypoadrenalism in infants born to mothers taking substantial corticosteroid doses during pregnancy.

See references

Mometasone (Elica-M) 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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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: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Asmanex HFA (Mometasone (Elica-M))." Merck & Company Inc, Whitehouse Station, NJ.
  3. "Product Information. Asmanex Twisthaler (Mometasone (Elica-M))." Schering-Plough Corporation, Kenilworth, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Asmanex Twisthaler (Mometasone (Elica-M))." Schering-Plough Corporation, Kenilworth, NJ.
  3. "Product Information. Asmanex HFA (Mometasone (Elica-M))." Merck & Company Inc, Whitehouse Station, NJ.

References

  1. DailyMed. "MICONAZOLE: 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. "Mometasone (Into the nose): 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. "Miconazole (Topical route): 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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