Bismuth Subsalicylate
Risk Factor: C
Class: GASTROINTESTINAL AGENTS
/ Antidiarrheals
Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers
Fetal Risk Summary
Bismuth subsalicylate (bismuth salicylate) is hydrolyzed in the gastrointestinal tract to bismuth salts and sodium salicylate (1,2). Two tablets or 30 mL suspen sion of the compound yields 204 mg and 258 mg, respectively, of salicylate. Inorganic bismuth salts, in contrast to organic complexes of bismuth, are relatively water-insoluble and poorly absorbed systemically, but significant absorption of salicylate does occur (1,2). A brief 1992 study found minimal absorption of bismuth (exact serum concentrations not specified) from bismuth subsalicylate in 12 healthy subjects as opposed to a peak serum level of 0.050 g/mL after a dose of 216 mg of colloidal bismuth subcitrate in a single patient (3). Some bismuth absorption was documented across the normal gastric mucosa, but the primary absorption occurred from the duodenum (3). Others believe, however, that the design of the study produced the observed results, and that bismuth absorption occurs only in the gastric antrum, not in the gastric body or duodenum (4).
Although absorption of inorganic bismuth salts is negligible, in a study of chronic administration of bismuth tartrate 5 mg/kg/day, one of four lambs born of treated ewes was stunted, hairless, and exophthalmic, and a second was aborted (5). Moreover, in one case report, the use of an extemporaneously compounded antidiarrheal mixture containing bismuth subsalicylate was associated with bismuth encephalopathy in a 60-year-old man who took an unknown amount of the preparation for a period of 1 month (6). Encephalopathy was diagnosed by an electroencephalogram characteristic of bismuth toxicity and a blood bismuth level of 72 ng/mL (upper limit of normal is 5 ng/mL).
No reports of adverse fetal outcome after the use of commercially available bismuth subsalicylate have been located for humans. The Collaborative Perinatal Project recorded 15 1st trimester exposures to bismuth salts (bismuth subgallate N= 13, bismuth subcarbonate N=1, and milk of bismuth N=1), but none to bismuth subsalicylate (7, pp. 3847). These numbers are small, but no evidence was found to suggest any association with congenital abnormalities. For use anytime during pregnancy, 144 mother-child pairs were exposed to bismuth subgallate and 5 of the in utero exposed infants had inguinal hernia, a hospital standardized relative risk (SRR) of 2.6 (7, pp. 442,497). A causal relationship, however, cannot be determined from these data.
In contrast to bismuth, salicylate is rapidly absorbed with more than 90% of the dose recovered in the urine. Data on the use of salicylates in human pregnancy, primarily acetylsalicylic acid (aspirin), is extensive. The main concerns from exposure to this drug during pregnancy include congenital defects, increased perinatal mortality from premature closure of the ductus arteriosus in utero, intrauterine growth retardation, and salicylate intoxication (see Aspirin). An increased risk of intracranial hemorrhage in premature or low-birth-weight infants is a potential complication of aspirin exposure near delivery, but other salicylates, including sodium salicylate, probably do not present a risk because the presence of the acetyl moiety seems to be required to suppress platelet function (8,9 and 10).
In summary, inorganic bismuth salts, formed from metabolism of bismuth subsalicylate in the gastrointestinal tract, apparently present little or no risk to the fetus from normal therapeutic doses, but the data available for bismuth in pregnancy are poor and the actual fetal risk cannot be determined (11). On the other hand, the potential actions of salicylates on the fetus are complex. Although the risk for toxicity may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates. Because of this, the use of bismuth subsalicylate during gestation should be restricted to the first half of pregnancy, and then only in amounts that do not exceed the recommended doses.
Breast Feeding Summary
The excretion of large amounts of bismuth obtained from bismuth subsalicylate into breast milk is not expected because of the poor absorption of bismuth into the systemic circulation. Salicylates, however, are excreted in milk and are eliminated more slowly from milk than from plasma with milk:plasma ratios rising from 0.030.08 at 3 hours to 0.34 at 12 hours (12). Because of the potential for adverse effects in the nursing infant, the American Academy of Pediatrics recommends that salicylates should be used cautiously during breast feeding (13). A recent review also states that bismuth subsalicylate should be avoided during lactation because of systemic salicylate absorption (14).
References
- Pickering LK, Feldman S, Ericsson CD, Cleary TG. Absorption of salicylate and bismuth from a bismuth subsalicylate-containing compound (Pepto-Bismol). J Pediatr 1981;99:6546.
- Feldman S, Chen S-L, Pickering LK, Cleary TG, Ericsson CD, Hulse M. Salicylate absorption from a bismuth subsalicylate preparation. Clin Pharmacol Ther 1981;29:78892.
- Menge H, Brosius B, Lang A, Gregor M. Bismuth absorption from the stomach and small intestine. Gastroenterology 1992;102:2192.
- Nwokolo CU, Pounder RE. Bismuth absorption from the stomach and small intestine. Reply. Gastroenterology 1992;102:21923.
- James LF, Lazar VA, Binns W. Effects of sublethal doses of certain minerals on pregnant ewes and fetal development. Am J Vet Res 1966;27:1325.
- Hasking GJ, Duggan JM. Encephalopathy from bismuth subsalicylate. Med J Aust 1982;2:167.
- Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA:Publishing Sciences Group, 1977.
- O'Brien JR. Effects of salicylates on human platelets. Lancet 1968;1:77983.
- Weiss HJ, Aledort ML, Shaul I. The effect of salicylates on the haemostatic properties of platelets in man. J Clin Invest 1968;47:216980.
- Bleyer WA. Maternal ingested salicylates as a cause of neonatal hemorrhage. J Pediatr 1974;85:7367.
- Friedman JM, Little BB, Brent RL, Cordero JF, Hanson JW, Shepard TH. Potential human teratogenicity of frequently prescribed drugs. Obstet Gynecol 1990;75:5949.
- Findlay JWA, DeAngelis RL, Kearney MF, Welch RM, Findley JM. Analgesic drugs in breast milk and plasma. Clin Pharmacol Ther 1981;29:62533.
- Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
-
Anderson PO. Drug use during breast feeding. Clin Pharm 1991;10:594624.
Questions and Answers
Is there any harm in taking bismuth subsalicylate (Pepto Bismol) 262 mg. tablet a few times a week?, I am kind of addicted to them, because I hate having diarrhea so much that at the first sign of a very loose stool, I take Pepto. My bf is worried that this may be bad for me or cause bad side effects. Does anyone know?
first of all do you know the cause of your disarrah if so attack that cause first. eat healthy. if you follow the package directions you should be ok but through time it can affect your organs as do all medications they can affect your filtering organs such as your liver. so be cautious and don't over do it. any thing you do too much of is not too good especially medications if you go to your doctor he can take a stool and blood sample and then give you something specific for your problem. so i caution you. good luck coping with your annoying symptom.
Why can't I take Bismuth Subsalicylate (Generic Pepto Bismol) with an ulcer?, I've been having some stomach problems so I bought same good ol' Pepto but i'm broke and I got the generic kind. Well I looked at the warnings and it said I cant take it with an ulcer. So I looked onlineand everything I said says it helps ulcers. Does anyone know why?
Any aspirin derivative (salicylate) has the potential to increase bleeding, which you do not want if you have an ulcer. Salicylate weakens the membranes in the lining of your stomach, making it easier for the acid in your stomach to cause damage. THAT is why the label cautions against use of this product if you have an ulcer.
what is the dosage schedule for bismuth subsalicylate?,
the dosage will be on the side of bottle, also it say not to have more tha a certain % each day ,if symtoms get worst or they are frequent go see your dr .
does lomotil and bismuth subsalicylate have aspirin?, do they contain aspirin?
yes they both do,...
can this product cause darking of the stools,,bismuth subsalicylate ?,,thank you?,
yes, the ingredients will turn your stool. it is normal.
is it safe for me to use peptobismol(bismuth subsalicylate).......?, im about 20 years and 4 months old......i am in the final stages of recovering from a bacterial throat infection......and i ate something yesterday which caused me to have loose motions...i have pepto bismol....but it says to be safe from reyes syndrome kids and teenagers should avoid pepto while flu....im not sure if i had flu or a strep throat....nyways im above 20 and i think im not a teenager anymore so can i take pepto.....thanks
It would be alright for you to take petobismol. You are not a teenager anymore.
Is it alright to give 10 day old kittens Kaopectate? What about adult cats?, I'm raising a litter of orphaned kittens. A retired vet told me to give the kittens Kaopectate for their runny stool. Research on the internet said the new formula with Bismuth Subsalicylate is highly toxic for adult cats. Why would it be alright for kittens?
No!! It used to be alright (which is why the retired vet thought it was okay) but the formula changed a few years ago. The current Kaopectate has bismuth subsalicylate, which is closely related to aspirin. Cats do not metabolism aspirin very well, and it is extremely easy to give them a toxic dose. Please do not use Kaopectate on your kittens or adult cats unless you can find the old type that contains kaolin/pectin rather than bismuth subsalicylate.
Are they the same even with different names?, Is Bismuth subsalicylate the same as just Bismuth?
(Bismuth being element 83)
I'm not sure if it is or not.
Thank you SO much for your help:)
I realllllllllly appreciate it.
no, bismuth is an element, but bismuth subsalicylate is a compound, with the element bismuth in it.
C7H5BiO4 is the chemical formula for this compound.
Pamprin and Pepto Bismol?, I always get really nauseated when I take Pamprin, but it calms be down, so, would it be alright if I took some Pepto?
The Pamprin I'm taking is:
acetaminophen 500mg
pamabrom 25mg
pyrilamine maleate 15mg
And I take two.
and the Pepto is:
bismuth subsalicylate 525mg
Can I take them together? And also, is it normal for Pamprin to make you nauseated?
It is fine to take them together they won't hurt you. You period is probably what is making you nausiated not the pill, it just seems that way because you only take it on your period. If you are still unsure you might ask your physician to make sure you are not having an allergic reaction but I am sure it is not that because you would have different symptoms not nausia. I hope this helps
Does Pepto-Bismol affect breast milk? should we dispose of it?, My wife recently took an adult dose, 2 tablespoons, of Pepto-Bismol MAX Strength (active ingredient Bismuth Subsalicylate 525 mg per tablespoon).
Ten hours later she pumped 6 ounces of breast milk which she can't decide whether to keep or dispose of.
She's concerned because the allergy warning on the bottle includes the following line:
* Do not take if you are allergic to salicylates (including ASPIRIN)
Yes, Anything you put into your body (just like pregnancy) is in Breast Milk. On the up side depending on your baby's age it may not affect them enough to dispose of the milk, but I would definatly contact your Peditrician or Ob before feeding it to your child as they may not approve. All it warents is a quick Phone call that may even be answered by your Nurse Practitioner or P.A. Also be sure to tell them that the milk was pumped 10 hours after consumption, this may be long enough for it to be out of her system. Good Luck... and Don't Worry Baby's are very Resiliant
Heather
