Neosartan Plus Pregnancy

• Pregnancy of Neosartan Plus in details
• Neosartan Plus breastfeeding
• Neosartan Plus reviews

Pregnancy of Neosartan Plus in details

Animal studies have failed to reveal evidence of fetal harm. There are no data from controlled human studies, but retrospective reviews have shown an increased risk of malformations associated with thiazide diuretics. In addition, use of thiazide diuretics during pregnancy has been associated with fetal or neonatal electrolyte abnormalities, jaundice, and/or thrombocytopenia. The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of whom 233 were exposed to thiazide or related diuretics during the first trimester. An increased risk of malformations was found for thiazide diuretics. Use of thiazides after the first trimester does not seem to carry this risk. Thiazide diuretics may, however pose metabolic risks to the mother and fetus (hyponatremia, hypokalemia, thrombocytopenia, hyperglycemia), and may have a direct effect on smooth muscle, resulting in inhibition of labour. Data from the U.S. Michigan Medicaid Birth Defects Study has revealed an association between the use of Neosartan Plus and congenital abnormalities. This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 567 were exposed to Neosartan Plus at some time during the first trimester, and 1,173 were exposed to the drug at any time during pregnancy. Of the 567 pregnancies, there were 24 total and 7 cardiovascular birth defects (22 and 6 were expected, respectively). There were no observations of cleft palate, spina bifida, limb reduction, or hypospadias. The one instance of polydactyly did not achieve statistical significance. These data are consistent with an association between the use of Neosartan Plus and birth defects, although other factors, including underlying disease(s) of the mother are not accounted for. Cases of neonatal thrombocytopenia associated with antepartum administration of thiazide diuretics have been reported. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US 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.

The manufacturer recommends that Neosartan Plus should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: B The routine use of diuretics during pregnancy is not indicated or recommended.

See references

Neosartan Plus breastfeeding

Manufacturer recommendation: Use is not recommended and 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 According to LactMed this drug has been used without apparent harmful effects in the nursing infant at doses of 50 mg daily or less. Large doses may cause intense diuresis resulting in a decrease in breastmilk production.

See references

References for pregnancy information

1. Lindheimer MD, Katz AI "Sodiuim and diuretics in pregnancy." N Engl J Med 288 (1973): 891-4
2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ():
3. Cerner Multum, Inc. "Australian Product Information." O 0
4. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
5. Rodriguez SU, Sanford LL, Hiller MC "Neonatal thrombocytopenia associated with ante-partum administration of thiazide drugs." N Engl J Med 270 (1964): 881-4
6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

1. Cerner Multum, Inc. "Australian Product Information." O 0
2. "Product Information. HydroDIURIL (Neosartan Plus)." Merck & Co, Inc, West Point, PA.
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 -]):

References

1. DailyMed. "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL: 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. "Hydrochlorothiazide (By mouth): 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). "Hydrochlorothiazide: 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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Information checked by Dr. Sachin Kumar, MD Pharmacology