Guaifenesin/pseudoephedrine Pregnancy and Breast Feeding Warnings
Guaifenesin/pseudoephedrine is also known as: Abletex-PSE, Altarussin PE, Ambifed, Ambifed-G, Ami-Tex PSE, Anatuss LA, Biotuss PE, Coldmist, Coldmist Jr, Coldmist LA, Congestac, D-Feda II, Deco-D, Decongest II, Deconsal LA, Defen-LA, Degen II, Demibid II, Desal II, Despec-SR, Drituss GP, Durasal II, Dynex, Entex PSE, Eudal SR, ExeFen, Fenex-PSE, G-Phed, G-Phed- PD, GP 500, Guai Sudo, Guai-Vent/PSE, Guaibid D, Guaibid D Pediatric, Guaifed, Guaifed-PD, Guaifed-PSE, Guaifenex GP, Guaifenex PSE 120, Guaifenex PSE 60, Guaifenex PSE 80, Guaifenex PSE 85, Guaifenex RX, Guaimax-D, Guaipax PSE, Guaitab, Guaivent (Ethex), Guaivent PD, Guiadrine II, Guiadrine II SR, Guiadrine PSE, Guiadrine PSE 120, Guiatex II, Guiatex II SR, Guiatex PSE, Guiatuss PE, H 9600 SR, Hi Tex PSE, Humibid GC, Iosal II, Iotex PSE, Levall G, Mardrops-EX, Mastussin PE, Maxifed, Maxifed-G, Med-RX, Medent-LDI, Miraphen PSE, Mucinex D, Mytussin PE, Nalex, Nalex CR, Nalex Jr, Nasabid, Nasabid SR, Nasatab LA, Nomuc-PE, Pan-Mist LA, Panmist JR, Panmist LA, Panmist-S, Poly-Vent, Poly-Vent IR, Poly-Vent, Jr., Profen Forte, Profen II, Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Pseudo-G/PSI, Pseudocot-G, Pseudovent, Pseudovent 400, Pseudovent Ped, Q-Tussin PE, Respaire-120 SR, Respaire-30, Respaire-60 SR, Robafen PE, Robichem PE, Robitussin PE, Robitussin Severe Congestion, Ru Tuss DE, Ru-Tuss Jr., Rymed, S-Pack, Sinufed, Sinufed Timecelles, Sinutab Non Drying, Stamoist E, Sudafed Non Drying Sinus, Sudal 60/500, Sudal SR, SudaTex-G, Syn-Rx, T-Tussin PE, Tenar PSE, Touro LA, Touro LA-LD, Tuss-LA, Tusscidin PE, Tussin PE, Uni Tussin PE, V-Dec-M, Venbid TR, Versacaps, We Mist II LA, We Mist LA, Zaptec PSE, Zephrex, Zephrex LA
Overview
If you become pregnant while taking Guaifenesin/Pseudoephedrine , contact your doctor. You will need to discuss the benefits and risks of using Guaifenesin/Pseudoephedrine while pregnant. It is not known if Guaifenesin/Pseudoephedrine is found in breast milk. Do not breast-feed while taking Guaifenesin/Pseudoephedrine .
Guaifenesin/pseudoephedrine Pregnancy Warnings
Guaifenesin-pseudoephedrine has been assigned to a pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Guaifenesin-pseudoephedrine is only recommended for use during pregnancy when benefit outweighs risk.
Pseudoephedrine: A case-controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester pseudoephedrine use in 76 cases. Relative risks for other drugs were 1.6 for salicylates, 1.7 for acetaminophen, 1.3 for ibuprofen, and 1.5 for phenylpropanolamine (not significant). The authors hypothesized vascular disruption was the etiology of gastroschisis. A second group of 416 infants with heterogenous defects suspected to have a vascular etiology was studied. There was no increased risk associate with salicylates, ibuprofen, pseudoephedrine, phenylpropanolamine and other decongestants. These data require independent confirmation. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to pseudoephedrine and 1919 exposures any time during pregnancy were recorded. 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 1980-1983 Medicaid data compared to 3752 pseudoephedrine-exposed pregnancies. Seven of the nine cases had been exposed to pseudoephedrine providing a relative risk of 1.8. Only one case was a surgically treated abdominal wall defect. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) The Collaborative Perinatal Project monitored 50,282 mother-child pairs. Only 39 first-trimester exposures to pseudoephedrine were recorded, with one birth defect observed. For use any time during pregnancy, 194 exposures were recorded with 3 birth defects observed (3.22 expected). The effect of pseudoephedrine on uterine and fetal blood was studied in 12 healthy pregnant women between 26 and 40 weeks gestation. Following a single 60-mg dose of pseudoephedrine, no significant effect was seen on fetal heart rate, uterine blood flow, or fetal aortic blood flow. Guaifenesin: The Collaborative Perinatal Project reported 197 first-trimester exposures to guaifenesin. 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 and 349 exposures any time 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 and birth defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)
Guaifenesin/pseudoephedrine Lactation Warnings
There are no data on the excretion of guaifenesin into human milk. Pseudoephedrine is excreted 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.
Three mothers given pseudoephedrine demonstrated milk concentrations consistently higher than plasma concentrations. Maximum milk concentrations were reached at 1 to 1.5 hours after dosing. In one woman, the milk:plasma concentration ratio at 1, 3, and 12 hours was 3.3, 3.9, and 2.6, respectively. The authors calculated that 1000 mL of breast milk consumed over 24 hours would provide an infant with 0.25 to 0.33 mg of pseudoephedrine, or 0.5% to 0.7% of the dose ingested by the mother.
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