Consists of Acetaminophen, Aspirin, Caffeine
Pregnancy of Acetaminophen (Coficil-Plus) in details
Acetaminophen (Coficil-Plus) crosses the placenta (Naga Rani 1989).
Based on epidemiological data, an increased risk of major congenital malformations has not been observed following maternal use of Acetaminophen (Coficil-Plus) during pregnancy. Although not considered a major birth defect, an association between maternal Acetaminophen (Coficil-Plus) use and cryptorchidism (undescended testis) has been observed (Fisher 2016; Jensen 2010; Kristensen 2011; Snijder 2012). The use of Acetaminophen (Coficil-Plus) in normal doses during pregnancy is not associated with an increased risk of miscarriage or still birth; however, an increase in fetal death or spontaneous abortion may be seen following maternal overdose if treatment is delayed (Li 2003; Rebordosa 2009; Riggs 1989). Prenatal constriction of the ductus arteriosus has been noted in case reports following maternal use during the third trimester (Allegaert 2019); although this association was not confirmed in a large observational study (Dathe 2019), Acetaminophen (Coficil-Plus) has been evaluated for the treatment of a persistent patent ductus arteriosus in preterm neonates (Terrin 2016). Additional adverse events such as wheezing and asthma in early childhood and adverse neurodevelopmental effects such as ADHD following in utero Acetaminophen (Coficil-Plus) exposure have been evaluated in multiple studies; outcome information is inconclusive, and a causal association has not been established (Cheelo 2014; Fan 2017; Lourido-Cebreiro 2017; Scialli 2010; SMFM 2017). It should be noted that maternal fever is also associated with adverse fetal outcomes, including neural tube defects, oral clefts, and congenital heart defects. Treatment of maternal fever with an antipyretic may reduce these risks (Drier 2014).
Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of Acetaminophen (Coficil-Plus) may be altered. Dose adjustments are not recommended (Kulo 2014). Acetaminophen (Coficil-Plus) is considered appropriate for the treatment of pain and fever in pregnancy (SMFM 2017). Acetaminophen (Coficil-Plus) may be used as part of a multimodal approach to pain relief following cesarean delivery (ACOG 209 2019), for the treatment of acute migraine in pregnant patients (Burch 2019; Hamilton 2019a; Marmura 2015) and is recommended for the treatment of fever in pregnant women diagnosed with influenza (ACOG 753 2018). Acetaminophen (Coficil-Plus) is recommended to be used at the lowest effective dose for the shortest duration of time to effectively treat the mother and protect the health of the fetus (Kilcoyne 2017).
Acetaminophen (Coficil-Plus) breastfeeding
One small study has reported that following a 1000 mg dose of Acetaminophen (Coficil-Plus) to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose.
Aspirin is excreted into human milk in small amounts. Peak milk salicylate levels have been reported at nine hours after maternal dosing (and measured at 1.1 mg/dL). Use of large doses of aspirin can result in rashes, platelet abnormalities, and bleeding in nursing infants. Because of a single case report of metabolic acidosis, the American Academy of Pediatrics characterizes aspirin as a drug that has been "associated with significant effects on some nursing infants and should be given to nursing mothers with caution." Acetaminophen (Coficil-Plus) is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen (Coficil-Plus) is considered compatible with breast-feeding by the American Academy of Pediatrics. Caffeine is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely. However, irritability and poor sleep patterns have been reported in nursing infants. The amount of caffeine generally found in caffeinated beverages is considered to usually be compatible with breast-feeding by the American Academy of Pediatrics. Because caffeine is excreted into human milk and because caffeine is metabolized slowly by nursing infants, consumption of more than moderate levels of caffeine by nursing mothers is not recommended.
Pregnancy of Aspirin (Coficil-Plus) in details
Aspirin (Coficil-Plus) has not been formally assigned to pregnancy category by the FDA. However, Aspirin (Coficil-Plus) is considered to be in pregnancy category D by the FDA if full dose Aspirin (Coficil-Plus) is taken in the third trimester. Use of nonsteroidal anti-inflammatory drugs during the third trimester of pregnancy should be avoided due to effects on the fetal cardiovascular system (closure of the ductus arteriosus). Aspirin (Coficil-Plus) use in pregnancy has been associated with alterations in both maternal and fetal hemostasis. In addition, high doses have been associated with increased perinatal mortality, intrauterine growth retardation, and teratogenic effects. During the first two trimesters of pregnancy, Aspirin (Coficil-Plus) should only be given during pregnancy when clearly needed and when benefit outweighs risk. In 1990, the FDA issued a warning that it is especially important not to use Aspirin (Coficil-Plus) during the last trimester of pregnancy unless specifically directed to do so by a physician because it may cause problems in the unborn child or complications during delivery.
Increased maternal bleeding can occur during delivery when Aspirin (Coficil-Plus) is used 1 week prior to and/or during labor and delivery. Prolonged gestation and labor have been reported due to Aspirin (Coficil-Plus)'s inhibition of prostaglandin. A study of the use of low-dose Aspirin (Coficil-Plus) (60 mg per day) to prevent and treat preeclampsia in 9364 pregnant women (the Collaborative Low-dose Aspirin (Coficil-Plus) Study in Pregnancy--CLASP) did "not support routine prophylactic or therapeutic administration of antiplatelet therapy in pregnancy to all women at increased risk of preeclampsia or IUGR." In that study, no excess of intraventricular hemorrhage, neonatal bleeds, or mortality attributable to bleeding were observed. The investigators did identify a possible role for low-dose Aspirin (Coficil-Plus) in the treatment of early-onset preeclampsia severe enough to need very preterm delivery. Another study of low-dose Aspirin (Coficil-Plus) (follow-up from the Italian Study of Aspirin (Coficil-Plus) in Pregnancy) has suggested that "low dose Aspirin (Coficil-Plus) in pregnancy is safe with respect to the risks of malformation and of major impairment in development at 18 months of age." High-dose Aspirin (Coficil-Plus) (2 g per day) has been associated with stillbirths, cerebral hemorrhage, oculoauriculovertebral dysplasia, neonatal salicylate toxicity, constricted ductus arteriosus, cyclopia, and neonatal acidosis. Some cases of congenital heart defects have been reported. However, a case control study of Aspirin (Coficil-Plus) use in the first trimester concluded that Aspirin (Coficil-Plus) "does not increase the risk of congenital heart defects in relation to that of other structural malformations."
See references
Aspirin (Coficil-Plus) breastfeeding
Aspirin (Coficil-Plus) is excreted into human milk in small amounts. Peak milk salicylate levels have been reported at nine hours after maternal dosing (and measured at 1.1 mg/dL). Use of large doses of Aspirin (Coficil-Plus) can result in rashes, platelet abnormalities, and bleeding in nursing infants. Because of a single case report of metabolic acidosis, the American Academy of Pediatrics characterizes Aspirin (Coficil-Plus) as a drug that has been "associated with significant effects on some nursing infants and should be given to nursing mothers with caution."
See references
References for pregnancy information
- Karlowicz MG, White LE "Severe intracranial hemorrhage in a term neonate associated with maternal acetylsalicylic acid ingestion." Clin Pediatr (Phila) 32 (1993): 740-3
- Subtil D, Deruelle P, Trillot N, Jude B "Preclinical phase of polycythemia vera in pregnancy." Obstet Gynecol 98(5 Pt 2) (2001): 945-7
- Leonhardt A, Bernert S, Watzer B, Schmitz-Ziegler G, Seyberth HW "Low-dose Aspirin (Coficil-Plus) in pregnancy: maternal and neonatal Aspirin (Coficil-Plus) concentrations and neonatal prostanoid formation." Pediatrics 111 (2003): e77-81
- Kozer E, Nikfar S, Costei A, Boskovic R, Nulman I, Koren G "Aspirin (Coficil-Plus) consumption during the first trimester of pregnancy and congenital anomalies: A meta-analysis." Am J Obstet Gynecol 187 (2002): 1623-30
- Li DK, Liu L, Odouli R "Exposure to non-steroidal anti-inflammatory drugs during pregnancy and risk of miscarriage: population based cohort study." BMJ 327 (2003): 368
- Parazzini F, Bortolus R, Chatenoud L, Restelli S, Benedetto C "Follow-up of children in the italian study of Aspirin (Coficil-Plus) in pregnancy." Lancet 343 (1994): 1235
- "Product Information. Bayer Aspirin (Coficil-Plus)." Bayer, West Haven, CT.
- Schoenfeld A, Bar Y, Merlob P, Ovadia Y "NSAIDs: maternal and fetal considerations." Am J Reprod Immunol 28 (1992): 141-7
- "Clasp: a randomised trial lf low-dose Aspirin (Coficil-Plus) for the prevention and treatment of pre-eclampsia among 9364 pregnant women." Lancet 343 (1994): 619-29
References for breastfeeding information
- Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
- "Product Information. Bayer Aspirin (Coficil-Plus)." Bayer, West Haven, CT.
- Erickson SH, Oppenheim GL "Aspirin (Coficil-Plus) in breast milk." J Fam Pract 8 (1979): 189-90
Pregnancy of Caffeine (Coficil-Plus) in details
Caffeine (Coficil-Plus) 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 (Coficil-Plus) is unlikely to cause congenital malformations (Brent 2011). However, available data show conflicting results related to maternal Caffeine (Coficil-Plus) 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 (Coficil-Plus) during pregnancy may lead to neonatal withdrawal at delivery (eg, apnea, irritability, jitteriness, vomiting) (Martin 2007).
The half-life of Caffeine (Coficil-Plus) 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 (Coficil-Plus) intake from all sources to ≤200 mg/day during pregnancy (ACOG 2010).
Caffeine (Coficil-Plus) breastfeeding
Caffeine (Coficil-Plus) citrate is not indicated for use in adult patients. Excreted into human milk: Yes Comments: -Caffeine (Coficil-Plus) readily crosses the placenta into the fetal circulation. -Breastfeeding mothers of infants receiving Caffeine (Coficil-Plus) citrate should not ingest Caffeine (Coficil-Plus)-containing foods, beverages, and medicinal products.
See references
References for pregnancy information
- "Product Information. Cafcit (Caffeine (Coficil-Plus))" Roxane Laboratories Inc, Columbus, OH.
References for breastfeeding information
- "Product Information. Cafcit (Caffeine (Coficil-Plus))" Roxane Laboratories Inc, Columbus, OH.
References
- 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).
- DailyMed. "ASPIRIN; DIPYRIDAMOLE: 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. "ACETAMINOPHEN; ASPIRIN; CAFFEINE: 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
