Consists of CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL
Pregnancy of Chlorpheniramine MALEATE (D-Congestamine) in details
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).
Chlorpheniramine MALEATE (D-Congestamine) breastfeeding
There are no data on the excretion of Chlorpheniramine MALEATE (D-Congestamine) into human milk. However, because other antihistamines are excreted into human milk in low concentrations, the manufacturer recommends that caution be used when administering Chlorpheniramine MALEATE (D-Congestamine) to nursing women.
See references
References for pregnancy information
- "Product Information. Chlortrimeton (Chlorpheniramine MALEATE (D-Congestamine))." Schering-Plough, Liberty Corner, NJ.
- Black RA, Hill DA "Over-the-counter medications in pregnancy." Am Fam Physician 67 (2003): 2517-24
- Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
- Nelson MA, Forfar JO "Associations between drugs administered during pregnancy and congenital abnormalities of the fetus." Br Med J 1 (1971): 523-7
References for breastfeeding information
- "Product Information. Chlortrimeton (Chlorpheniramine MALEATE (D-Congestamine))." Schering-Plough, Liberty Corner, NJ.
Pregnancy of Pseudoephedrine HCL (D-Congestamine) in details
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Pseudoephedrine HCL (D-Congestamine) breastfeeding
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
- Werler MM, Mitchell AA, Shapiro S "First trimester maternal medication use in relation to gastroschisis." Teratology 45 (1992): 361-7
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
- Cerner Multum, Inc. "Australian Product Information." O 0
- Smith CV, Rayburn WF, Anderson JC, Duckworth AF, Appel LL "Effect of a single dose of oral Pseudoephedrine HCL (D-Congestamine) on uterine and fetal Doppler blood flow." Obstet Gynecol 76 (1990): 803-6
References for breastfeeding information
- Cerner Multum, Inc. "Australian Product Information." O 0
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- 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
- 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).
- 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).
- PubMed Health. "Pseudoephedrine (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).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
