PSEUDOEPHEDRINE
Drugs in Pregnancy and Lactation.
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Name: PSEUDOEPHEDRINE
Class: Sympathomimetic (Adrenergic)
Risk Factor: C
Fetal Risk Summary
Pseudoephedrine is a sympathomimetic used to alleviate the symptoms of allergic disorders or upper respiratory infections. It is a common component of proprietary mixtures containing antihistamines and other ingredients. Thus, it is difficult to separate the effects of pseudoephedrine on the fetus from those of other drugs, disease states, and viruses.
Sympathomimetic amines are teratogenic in some animal species, but human teratogenicity has not been suspected (1). The Collaborative Perinatal Project monitored 50,282 mother-child pairs, 3,082 of which had 1st trimester exposure to sympathomimetic drugs (2, pp. 345356). For use anytime during pregnancy, 9,719 exposures were recorded (2, p. 439). An association in the 1st trimester was found between the sympathomimetic class of drugs as a whole and minor malformations (not life-threatening or major cosmetic defects), inguinal hernia, and clubfoot (2, pp. 345356). However, independent confirmation of these results is required (2, pp. 345356).
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 940 newborns had been exposed to pseudoephedrine during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 37 (3.9%) major birth defects were observed (40 expected). Specific data were available for six defect categories, including (observed/expected) 3/9 cardiovascular defects, 2/2 oral clefts, 0/0 spina bifida, 3/3 polydactyly, 0/2 limb reduction defects, and 0/2 hypospadias. These data do not support an association between the drug and congenital defects.
A case-controlled surveillance study published in 1992 reported a significantly elevated relative risk of 3.2 (95% confidence interval, 1.37.7) for the use of pseudoephedrine during the 1st trimester and 76 exposed cases with gastroschisis (3). A total of 2142 infants with other malformations formed a control group. Relative risks for other drugs were salicylates 1.6, acetaminophen 1.7, ibuprofen 1.3, and phenylpropanolamine 1.5. Because some of these drugs are vasoactive substances, and because the cause of gastroschisis is thought to involve vascular disruption of the omphalomesenteric artery (3), the investigators compared the use of 1st trimester pseudoephedrine and other drugs in relation to a heterogeneous group of malformations, other than gastroschisis, suspected of also having a vascular origin. In this case, however, the relative risk for the drugs approximated unity. These data suggested that the association between pseudoephedrine and the other drugs and gastroschisis may have been caused by an underlying maternal illness (3).
A 1981 report described a woman who consumed, throughout pregnancy, 480840 mL/day of a cough syrup (4). The potential maximum daily doses based on 840 mL of syrup were 5.0 g of pseudoephedrine, 16.8 g of guaifenesin, 1.68 g of dextromethorphan, and 79.8 mL of ethanol. The infant had features of the fetal alcohol syndrome (see Ethanol) and displayed irritability, tremors, and hypertonicity. It is not known whether the ingredients, other than the ethanol, were associated with the adverse effects observed in the infant.
Breast Feeding Summary
Pseudoephedrine is excreted into breast milk (5). Three mothers, who were nursing healthy infants, were given an antihistamine-decongestant preparation containing 60 mg of pseudoephedrine and 2.5 mg of triprolidine as the hydrochloride salts. Two of the mothers had been nursing for 14 weeks, and one had been nursing for 18 months. Milk concentrations of pseudoephedrine were higher than plasma levels in all three patients, with peak milk concentrations occurring at 1.01.5 hours. The milk:plasma ratios at 1, 3, and 12 hours in one subject were 3.3, 3.9, and 2.6, respectively. The investigators calculated that 1000 mL of milk produced during 24 hours would contain 0.250.33 mg of pseudoephedrine base, approximately 0.50.7% of the maternal dose (5). The American Academy of Pediatrics considers the drug to be compatible with breast feeding (6).
References
- Nishimura H, Tanimura T. Clinical Aspects of the Teratogenicity of Drugs. Amsterdam: Excerpta Medica, 1976:231.
- Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977.
- Werler MM, Mitchell AA, Shapiro S. First trimester maternal medication use in relation to gastroschisis. Teratology 1992;45:3617.
- Chasnoff IJ, Diggs G. Fetal alcohol effects and maternal cough syrup abuse. Am J Dis Child 1981;135:968.
- Findlay JWA, Butz RF, Sailstad JM, Warren JT, Welch RM. Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers. Br J Clin Pharmacol 1984;18:9016.
- Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
Q&A about Pseudoephedrine
I'm taking demazin and cold&flu tablets and both contain pseudoephedrine (I'm sick with a cold or the flu at the moment)
Anyway, they tend to make me drowsy but I've just noticed that they also relax me and help me focus a lot more. Normally, I find it extremely difficult to study, even for 5 minutes because I can't focus and in turn I get stressed out.
However, I'm suddenly in a very focused, relaxed mood and am having no troubles studying at all :S Is this an effect of the pseudoephedrine?
Also what are the effects of combining pseudoephedrine and codeine-ibuprofen pills (such as nurofen plus) because I took them last night and found myself in a bit of a delerius and confused state? Is it dangerous to combine the two?
I don't care how it is made. But isn't it a pain to buy allgery medicine nowadays. The Patriot Act signed by President Bush on March 9, 2006, prohibits the sale of more than 9 grams of pseudoephedrine in a month. Plus you have to sign and show picture ID. Is anybody else finding this a royal pain in the a$$. I have respiratory allergies, so does my girlfriend and her two children. We have to alternate buying the allergy medicine so we do not go over the 9 gram limit. Now the meth problem in the United States is affecting normal every day people who just have allgeries. Your Thoughts?? Can you really make Methamphetamine from one box of Claritin D?
People buying this stuff and cooking meth is happening everywhere. The by-products are dumped and can cause serious health problems. Like leaking into the soil and then into streams and wells. And cops who bust the lab, have developed serious health problems.
Its sad, that some people will try to abuse anything. And to try to prevent this abuse, the rest of us have to change our lifestyles.
And yes, you can make a small batch with a box.
I've never taken this Sudafed before. It has 240mg of Pseudoephedrine HCI. Had to sign some book for it. Just curious as to what level is considered dangerous. Thanks.
The amount it wil ltake to overdose, like anythign else, will vary from person to person as well as day to day, depending on how much activity they have had, the types and amount of food they have consumed, etc.
Seek emergency medical attention if you think you have taken too much pseudoephedrine.
Symptoms of a pseudoephedrine overdose may include feeling restless or nervous.
Now that my state (the whole country too??) has limited sales of medicines containing pseudoephedrine due to meth lab activity, I have not been able to get my trusty, non-drowsy sudafed. I have to go to the store when the pharmacist is in and get it from behind the counter. Since the pharmacist was not there when I went today, I bought phenyephedrine. What are the major differences?
I took a pseudoephedrine 60mg today at noon and yesterday at noon. I swear I can still feel it in me right now (11 hours later). Am I dreaming?
I wasn't getting the answers I wanted on the last question. I understand that meth is bad and the government wanted to make it harder to get a lot of Sudafed or what have you, to help the fight to reduce meth production (you can argue if this would even help, but that is not important to me).
Basically, I know that the common way to make Meth is a combination of pseudoephedrine and red phosphorus (usually from red phosphorus matches) and iodine (ok this one you have to keep, I guess). They were all Class-1 chemicals before the Patriot Act which means that you had to control the production and distrubution of the chemical in the process of making it, and show caution when selling the product in large quantities. So why target Sudafed and not the matches, we have better matches today than the red phosphorus matches, but there are people who borderline need Sudafed for nasal congestion issues.
So I ask you, does anyone know why they targeted pseudoephedrine?
associated with the use of products containing ephedrine.
O.K., I have been taking pseudoephedrine to remove the congestoun in my nose caused by allergies, I get allergie shots, but it gets rid of all the symptoms except some nose congestion, runny nose and sneezing. So, I have been taking pseudoephedrine to relieve the congestion, but it is causing my nose to run like CRAZY, I have to have a kleenex at my nose all the time, is this normal? Is there a better drug I should be taking?
I am writing a thesis for my effective writing college course and I need to know when pseudoephedrine was first put in cold remedies and introduced as a legal over the counter drug. I think it was some time in the 60's or 70's, but I am not sure.
like 2. (this was not intentional) my other medicine looks exactly the same and im supposed to take 1 of the pseudoephedrine and 2 of the other stuff.
I have bad Eustachian Tube congestion (ear congestion) during allergy season. A combination of Pseudoephedrine and Diphenhydramine always gets rid of my allergies in a pinch.
Problem is I can't find Pseudoephedrine OTC anymore...?!?!? Where can I find an OTC medication that has both of these meds in it? Do they make such a thing?