Iyafin Junior Pregnancy

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Consists of Chlorpheniramine, Dextromethorphan, Guaifenesin, Pseudoephedrine, Sodium Citrate

Pregnancy of Chlorpheniramine (Iyafin Junior) 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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Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Pregnancy of Dextromethorphan (Iyafin Junior) 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.

Dextromethorphan (Iyafin Junior) has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Dextromethorphan (Iyafin Junior) is only recommended for use during pregnancy when benefit outweighs risk.

See references

Dextromethorphan (Iyafin Junior) 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 Dextromethorphan (Iyafin Junior) into human milk.

Based on the low molecular weight of Dextromethorphan (Iyafin Junior) some passage into breast milk probably occurs. However, maternal use of Dextromethorphan (Iyafin Junior) products that do not contain alcohol are probably safe to use during breast-feeding.

See references

References for pregnancy information

  1. Debus O, Kurlemann G, Gehrmann J, Krasemann T "Dextromethorphan (Iyafin Junior) in pregnancy." Chest 120 (2001): 1038-40
  2. Andaloro VJ, Monaghan DT, Rosenquist TH "Dextromethorphan (Iyafin Junior) and other N-methyl-D-aspartate receptor antagonists are teratogenic in the avian embryo model." Pediatr Res 43 (1998): 1-7
  3. Einarson A, Lyszkiewicz D, Koren G "The safety of Dextromethorphan (Iyafin Junior) in pregnancy - Results of a controlled study." Chest 119 (2001): 466-9
  4. "Product Information. Benylin DM (Dextromethorphan (Iyafin Junior))." Warner Lambert Laboratories, Morris Plains, NJ.
  5. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

References for breastfeeding information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. "Product Information. Benylin DM (Dextromethorphan (Iyafin Junior))." Warner Lambert Laboratories, Morris Plains, NJ.

Pregnancy of Guaifenesin (Iyafin Junior) 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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The Collaborative Perinatal Project reported 197 first-trimester exposures to Guaifenesin (Iyafin Junior). Fourteen malformations were reported for a relative risk not significantly different from 1.0. In a review of 229,101 deliveries to Michigan Medicaid patients, 141 first-trimester exposures to Guaifenesin (Iyafin Junior) and 349 exposures anytime during pregnancy were recorded. A total of 9 birth defects were reported with first trimester exposure (6 expected) and included 2 cardiovascular defects. These data do not support an association between Guaifenesin (Iyafin Junior) and birth defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)

Guaifenesin (Iyafin Junior) has been assigned to pregnancy category C. by the FDA. There are no controlled data in human pregnancy. Guaifenesin (Iyafin Junior) is only recommend for use during pregnancy when benefit outweighs risk.

See references

Guaifenesin (Iyafin Junior) 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 Guaifenesin (Iyafin Junior) into human milk. The manufacturer recommends that due to the potential for serious 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.

See references

References for pregnancy information

  1. "Product Information. Humabid (Guaifenesin (Iyafin Junior))." Medeva Pharmaceuticals, Rochester, NY.
  2. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297

References for breastfeeding information

  1. Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):

Pregnancy of Pseudoephedrine (Iyafin Junior) 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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Doses of 35 to 50 times the human daily dose to rabbits and rats, respectively, have not produced teratogenic effects. A case-controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester use in 76 cases. The authors hypothesized vascular disruption as the etiology of gastroschisis. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to this drug were recorded and 1919 exposures anytime during pregnancy. A total of 37 birth defects were reported with first trimester exposure (40 expected) and included (observed/expected) 3/9 cardiovascular defects, 2 oral clefts, and 3/2 polydactyly. These researchers reviewed nine cases of abdominal wall defects in the 1980 through 1983 Medicaid data. Seven of the nine cases occurred in 3752 woman who had taken Pseudoephedrine (Iyafin Junior) for a relative risk of 1.8. There are no adequate and well controlled studies in pregnant women. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B2 US FDA pregnancy category: Not formally assigned

See references

Pseudoephedrine (Iyafin Junior) 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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Based on limited data, it has been estimated that 0.5% to 0.7% of the mother's dose is excreted into breast milk over 24 hours. In 1 study, irritability was reported in up to 20% of infants. A 24% mean decrease in milk production was observed after a single 60 mg dose in 8 nursing mothers.

Caution is recommended Excreted into human milk: Yes Comments: -Single doses are unlikely to harm a nursing infant, but may cause irritability or disturbed sleep. -Repeated doses may interfere with lactation in mothers who are having difficulties producing sufficient milk or in those whose lactation is not well established.

See references

References for pregnancy information

  1. Werler MM, Mitchell AA, Shapiro S "First trimester maternal medication use in relation to gastroschisis." Teratology 45 (1992): 361-7
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Smith CV, Rayburn WF, Anderson JC, Duckworth AF, Appel LL "Effect of a single dose of oral Pseudoephedrine (Iyafin Junior) on uterine and fetal Doppler blood flow." Obstet Gynecol 76 (1990): 803-6

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. 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 -]):

Pregnancy of Sodium Citrate (Iyafin Junior) 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.

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

References

  1. DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: 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. "SODIUM CITRATE: 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. "PSEUDOEPHEDRINE 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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