Consists of caffeine, chlorpheniramine maleate, paracetamol, pseudoephedrine hydrochloride
Pregnancy of Caffeine in details
Caffeine crosses the placenta; serum concentrations in the fetus are similar to those in the mother (Grosso 2005).
Based on current studies, usual dietary exposure to caffeine is unlikely to cause congenital malformations (Brent 2011). However, available data show conflicting results related to maternal caffeine use and the risk of other adverse events, such as spontaneous abortion or growth retardation (Brent 2011; Jahanfar 2013; Nehlig 1994). Chronic maternal consumption of high amounts of caffeine during pregnancy may lead to neonatal withdrawal at delivery (eg, apnea, irritability, jitteriness, vomiting) (Martin 2007).
The half-life of caffeine is prolonged during the second and third trimesters of pregnancy and maternal and fetal exposure is also influenced by maternal tobacco or alcohol consumption (Brent 2011; Koren 2000). Current guidelines recommend limiting caffeine intake from all sources to ≤200 mg/day during pregnancy (ACOG 2010).
Caffeine breastfeeding
Caffeine citrate is not indicated for use in adult patients. Excreted into human milk: Yes Comments: -Caffeine readily crosses the placenta into the fetal circulation. -Breastfeeding mothers of infants receiving caffeine citrate should not ingest caffeine-containing foods, beverages, and medicinal products.
See references
References for pregnancy information
- "Product Information. Cafcit (caffeine)" Roxane Laboratories Inc, Columbus, OH.
References for breastfeeding information
- "Product Information. Cafcit (caffeine)" Roxane Laboratories Inc, Columbus, OH.
Pregnancy of Chlorpheniramine maleate 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 breastfeeding
There are no data on the excretion of Chlorpheniramine maleate 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 to nursing women.
See references
References for pregnancy information
- "Product Information. Chlortrimeton (Chlorpheniramine maleate)." 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)." Schering-Plough, Liberty Corner, NJ.
Pregnancy of Paracetamol in details
During pregnancy patients should avoid prolonged use of Paracetamol Zodley Pharmaceuticals because the risk of addiction in the fetus and the occurrence of withdrawal in the neonatal period.
If necessary using in lactation (breastfeeding) should be aware that tramadol in small amounts excreted in breast milk. In the case of long-term treatment can not been excluded the possibility of drug dependence.
Paracetamol Zodley Pharmaceuticals is not recommended for treatment of withdrawal syndrome drugs.
Patients need to avoid combination with MAO inhibitors.
During the period of treatment with Paracetamol Zodley Pharmaceuticals you should avoid to take alcohol.
Tramadol in the form of long-acting formulations should not be used in children under the age of 14 years.
During the period of tramadol using is not recommended to engage in activities that require special attention, speed of psychomotor reactions.
Pregnancy of Pseudoephedrine hydrochloride in details
Use of Pseudoephedrine hydrochloride during the first trimester may be associated with a possible risk of gastroschisis, small intestinal atresia, and hemifacial microsomia due to Pseudoephedrine hydrochloride's vasoconstrictive effects; additional studies are needed to define the magnitude of risk. Single doses of Pseudoephedrine hydrochloride were not found to adversely affect the fetus during the third trimester of pregnancy (limited data); however, fetal tachycardia was noted in a case report following maternal use of an extended release product for multiple days. Decongestants are not the preferred agents for the treatment of rhinitis during pregnancy.
Oral Pseudoephedrine hydrochloride should be avoided during the first trimester.
Pseudoephedrine hydrochloride 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 hydrochloride 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).
- DailyMed. "CAFFEINE; ERGOTAMINE TARTRATE: 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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Information checked by Dr. Sachin Kumar, MD Pharmacology
