SUCRALFATE
Drugs in Pregnancy and Lactation.
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Name: SUCRALFATE
Class: Gastrointestinal Agent (Antisecretory)
Risk Factor: BM
Fetal Risk Summary
Sucralfate is an aluminum salt of a sulfated disaccharide that inhibits pepsin activity and protects against ulceration. The drug is a highly polar anion when solubilized in strong acid solutions, which probably accounts for its poor gastrointestinal absorption. Its ulcer protectant and healing effects are exerted through local, rather than systemic, action (1). The small amounts that are absorbed, up to 2.2% of a dose in one study using healthy males (2), are excreted in the urine (1,2).
In mice, rats, and rabbits, sucralfate had no effect on fertility and was not teratogenic with doses up to 50 times those used in humans (1). Sucralfate is a source of bioavailable aluminum (3,4). Each 1-g tablet of sucralfate contains 207 mg of aluminum (3). The potential fetal toxicity of this drug relates to its aluminum content.
When administered parenterally to pregnant animals, aluminum accumulates in the fetus causing an increased perinatal mortality and impaired learning and memory (5,6). Teratogenic effects, however, were not observed (6). Prolonged exposure to the metal causes neurobehavioral and skeletal toxicity (7). A 1985 review of aluminum described these toxic effects on the brain and bone tissue as dialysis encephalopathy in patients with renal failure and a unique form of osteodystrophy in uremic patients (3). Aluminum received from IV fluids may also be related to osteopenia in premature infants (8). A 1991 report described the results of a study of 88 pregnancies in women exposed to high amounts of aluminum sulfate that had been accidentally added to the city's water supply (9). Except for an increased rate of talipes (club foot) (four cases, one control; p=0.01), there was no evidence that the exposure was harmful to the fetuses. Several theoretical explanations for the four cases of club foot were offered by the investigators, including the possibility that the observed incidence occurred by chance (9).
In patients with end-stage chronic renal failure, the use of sucralfate to bind phosphate resulted in serum aluminum levels comparable to those obtained from the antacid aluminum hydroxide (4). Administration of sucralfate to normal subjects did not increase plasma aluminum concentrations, but evidence of tissue aluminum loading was found in experiments with animals (3).
Analysis of 97 amniotic fluid samples, mostly from women undergoing amniocentesis for advanced maternal age, found a mean aluminum concentration of 93.4 µg/L (range 37–149 µg/L) (10). The authors of this study did not mention whether the women were consuming aluminum-containing medications, and the measured levels are apparently the normal baseline for the patient population studied.
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 183 newborns had been exposed to sucralfate during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of five (2.7%) major birth defects were observed (eight expected). Specific data were available for six defect categories, including (observed/expected) 1/2 cardiovascular defects, 1/0 oral clefts, 0/0 spina bifida, 1/0.5 polydactyly, 0/0.5 limb-reduction defects, and 1/0.5 hypospadias. These data do not support an association between the drug and congenital defects.
Although the toxicity of aluminum has been well documented, there is no evidence that normal doses of aluminum-containing medications, such as sucralfate, present a risk to the fetuses of pregnant women with normal renal function. Oral absorption of aluminum is poor with only an average of 12% retained in one study of six normal subjects ingesting 1–3 g of aluminum per day (3). Moreover, no evidence has been found to suggest that aluminum is actively absorbed from the gastrointestinal tract (3). Because of these characteristics and the lack of reports of adverse fetal effects in humans or animals attributable to sucralfate, the risk to the fetus is probably nil. A 1985 review on the use of gastrointestinal drugs during pregnancy and lactation by the American College of Gastroenterology classified sucralfate as an agent whose potential benefits outweighed any potential risks (11).
Breast Feeding Summary
Minimal, if any, excretion of sucralfate into milk should be expected, because only small amounts of this drug are absorbed systemically.
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References
- Product information. Carafate. Hoechst Marion Roussel, 2000.
- Giesing D, Lanman R, Runser D. Absorption of sucralfate in man (abstract). Gastroenterology 1982;82:1066.
- Lione A. Aluminum toxicology and the aluminum-containing medications. Pharmacol Ther 1985;29:255–85.
- Leung ACT, Henderson IS, Halls DJ, Dobbie JW. Aluminum hydroxide versus sucralfate as a phosphate binder in uraemia. Br Med J 1983;286:1379–81.
- Yokel RA. Toxicity of gestational aluminum exposure to the maternal rabbit and offspring. Toxicol Appl Pharmacol 1985;79:121–33.
- McCormack KM, Ottosen LD, Sanger VL, Sprague S, Major GH, Hook JB. Effect of prenatal administration of aluminum and parathyroid hormone on fetal development in the rat (40493). Proc Soc Exp Biol Med 1979;161:74–7.
- Yokel RA, McNamara PJ. Aluminum bioavailability and disposition in adult and immature rabbits. Toxicol Appl Pharmacol 1985;77:344–52.
- Sedman AB, Klein GL, Merritt RJ, Miller NL, Weber KO, Gill WL, Anand H, Alfrey AC. Evidence of aluminum loading in infants receiving intravenous therapy. N Engl J Med 1985;312:1337–43.
- Golding J, Rowland A, Greenwood R, Lunt P. Aluminum sulphate in water in north Cornwall and outcome of pregnancy. Br Med J 1991;302:1175–7.
- Hall GS, Carr MJ, Cummings E, Lee M. Aluminum, barium, silicon, and strontium in amniotic fluid by emission spectrometry. Clin Chem 1983;29:1318.
- Lewis JH, Weingold AB. The use of gastrointestinal drugs during pregnancy and lactation. Am J Gastroenterol 1985;80:912–23.
Q&A about Sucralfate
This is for a dog with reoccuring stomach issues. Looking to find a more affordable alternative than going to the vets everytime for a prescription.
ing results. sucralfate is for ulcers. please help
Together, they should last for a day - after the first day you take them. So if today is your first day, don't expect too much. Tomorrow though, expect a radical change in the way you feel.
Hope i helped.
T
I am on it for esophageal spams, only been a couple of days, I've read that it could cause weight gain, anyone have some input?
I suppose you could use sucralfate (Splenda) for sweetener, but how would you preserve consistency and taste as much as possible ? Presumably there has to be some fat or it is more like a muffin than a donut.
I have a seizure disorder I take topamax and depakote sucralfate and eyoscyamine and levothyroxine would these medication harm the baby? But without it might kill me and the unborn baby.
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http://www.safefetus.com/DrugDetail.asp?...
Generic Name Topimasate (Topiramate)
Trade Name Topamax
Manufacturer
Risk Category
* Risk classification not available
FDA Pregnancy Risk Categories
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Indication
* Antiepileptic.
Fetal Risk
* Crosses the placenta in animals.
* Teratogenic in animals causing limb, digital and vertebral malformations.
* Fetotoxic in animals causing reduced fetal weight and skeletal ossification.
* No human data, should be used if potential benefit of the mother outweighs risk to the fetus.
depakote
http://www.epilepsy.com/medications/b_de...
In the United States, the Food and Drug Administration (FDA) assigns each medication to a Pregnancy Category according to whether it has been proven to be harmful in pregnancy. Depakote is listed in Pregnancy Category D. This means that there is a risk to the baby, but the benefits may outweigh the risk for some women.
In fact, a large majority of women who use Depakote during pregnancy have normal, healthy babies. Certain types of defects are increased (especially if Depakote is taken during the first 3 months of pregnancy) but they are still relatively uncommon. The risk of defects is higher for women who take more than one seizure medicine. Women with a family history of birth defects also have a higher risk.
Women with epilepsy who are pregnant or thinking about becoming pregnant should talk to their doctor about their seizure medicines. Taking more than one seizure medicine may increase the risk of birth defects, so doctors sometimes gradually reduce the number or amount of seizure medicines taken by women planning for pregnancy. This is not done routinely, however, because it increases the risk of seizures. Some kinds of seizures can injure the baby, so do not stop using seizure medicines or reduce the amount without the doctor’s OK.
Exposure To Epilepsy Drug Depakote During Pregnancy Can Increase Risk Of Mental Defects In Newborns, Study Says
http://www.medicalnewstoday.com/articles...
Q: Pregnancy and Depakote
http://bipolarworld.net/Phelps/ph_2001/p...
http://www.safefetus.com/DrugDetail.asp?...
Generic Name Levothyroxine
Trade Name PMS-Levothyroxine Sodium
Manufacturer
Risk Category
A
* Adequate and well-controlled studies have failed to demonstrate risk on fetus.
* Possibility of fetal harm seems appears remote.
FDA Pregnancy Risk Categories
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Indication
* Thyroid hormone for treatment of hypothyroidism.
Fetal Risk
* Crosses the placenta in minimal amounts.
* No adequate human data but suggested possible association with cardiovascular defects, down's syndrome and polydactyly in first trimester exposure.
* The number of exposure was too small to make a conclusion.
gerd dr gave me this medicine, it's been 5 days, I'm nauseas, no appetite and sooo tired, anyone have this?
Tiredness is an unusual side effect. You should let your doctor know.
I believe I discovered what they ate within 2 hours of ingestion, I called the vet and she had be induce vomiting, I inspected their throw up and found the poison pretty much intact, some bright green was mixed, but their food was still intact and the same color as it was when it went in, I was instructed to induce vomiting one more time until they threw up clear fluids. They never appeared sick at all and still don't and it's been almost a week but have been on the vitamin K1 since, along with pepcid AC and sucralfate. Their appetites don't seem to be affected, although my larger dog hasn't been able to tolerate her milk bones like she used to, now she throw it up, but she tolerates her regular food just fine.
You did great by calling your DVM and following instructions ASAP. Have they been back for a followup hematocrit and blood clot time? If not, it's time to double check and make sure those are okay.
Keep on the vitamin K1. Rodenticides can have effects in the system for up to 4-8 weeks, depending on the active ingredient (the newer ones that have been out for the past several years are the worst.) It only takes a tiny bit to have been absorbed to affect the clotting ability of the blood for that long. But since you caught it and began treatment so quick, their chances of surviving are excellent. :-)
(And you shouldn't be feeding milk bones anyway.....)
Am suffering from esophageal ulcers and hiatus hernia.The doc has prescribed "sucralfate and rabeprozale sodium".I have been on this medication for two weeks now.How long does it take for the ulcers to go away and how do I get to know if the medicines are working.I was also operated for head and neck cancer twice in the past and have also undergone radio therapy twice in the past,the last one recently.Would be grateful if someone with a similiar condition could enlighten me.
She used SUCRALFATE 1GM TAB 4 OR 3 TABS a day she suffers ANXIETY sleepness serious chest pain . The medicine was stopped Thanks these symtoms are very much relief My request Please suggest simple medicine which may not have side effects thanks She is allergy to Penicillin
