Sucralfate
Risk Factor: BM
Class: GASTROINTESTINAL AGENTS
/ Antisecretory Agents
Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers
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 g/L (range 37149 g/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 13 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.
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;29:25585.
- Leung ACT, Henderson IS, Halls DJ, Dobbie JW. Aluminum hydroxide versus sucralfate as a phosphate binder in uraemia. Br Med J 1983;286:137981.
- Yokel RA. Toxicity of gestational aluminum exposure to the maternal rabbit and offspring. Toxicol Appl Pharmacol 1985;79:12133.
- 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;161:747.
- Yokel RA, McNamara PJ. Aluminum bioavailability and disposition in adult and immature rabbits. Toxicol Appl Pharmacol 1985;77:34452.
- 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;312:133743.
- Golding J, Rowland A, Greenwood R, Lunt P. Aluminum sulphate in water in north Cornwall and outcome of pregnancy. Br Med J 1991;302:11757.
- Hall GS, Carr MJ, Cummings E, Lee M. Aluminum, barium, silicon, and strontium in amniotic fluid by emission spectrometry. Clin Chem 1983;29:1318.
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Lewis JH, Weingold AB. The use of gastrointestinal drugs during pregnancy and lactation. Am J Gastroenterol 1985;80:91223.
Questions and Answers
Does anyone know if there is an OTC version of Sucralfate or Carafate?, 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.
No. They're both Rx
i am taking prevacid and sucralfate. prevacid once daily and the other 4 times daily. when would i start feeli, ing results. sucralfate is for ulcers. please help
Well sucralfate is basically a polymer containing alumiunium hydroxide and sucrose octa sulphate. Basically when it enters an acidic area i.e. your stomach, it will become very negative, and bind to positive proteins, therefore forming a protective covering over your ulcer; preventing further damage from acid/ possible perforation. Prevacid is a proton pump inhibitor - i.e. it will prevent too much acid being formed [mechanism of action: it accumulates in your parietal cells - which are the cells that secrete the acid. It will inhibit a transport protein which the cells need to release the acid into the stomach].
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
did you gain weight on sucralfate?, 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 take those tablets constantly but had no symptoms of gainin weight....
How do you make a low or lower calorie donut?, 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.
just make doughnuts and only eat half .....simple
i accidentlly took a sucralfate?, i need to know the adverse effects since i don't have an ulcer or anything.
please don't say "call your doctor or pharmacist" because im a pharmacy student, and its proper embarrassing. im also a bit droonk, and my PDR doesnt have any information about it
You shouldn't have any problems, alcohol is not necessarily contraindicated unless you actually have an ulcer. Just make sure you drink some water to prevent headache or dehydration. Xerostomia is a side-effect of sucralfate.
Just curious, you're a pharmacy student? What school are you attending in what country? I got my pharmacy degree at UGA (University of Georgia) here in the US. Anyway, good luck with your studies, it's a killer profession!
I was wonder is it safe to become pregrent if you take precreble medicne?, 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.
Get the prescribing doctor (not sure if you would be seeing a specialist) to call Motherisk and discuss appropriate treatment options during pregnancy. They have all the most up-to-date information about safety during pregnancy and lactation. If your doctor won't call then you make the call. It is usually easier if your doctor calls though, particularly when taking many medications.
(416) 813-6780 - Motherisk Info Line -Ask about the risk or safety of prescription and over-the-counter drugs, herbal products, chemicals, x-rays, chronic disease and infections during pregnancy and while nursing 9-5 EST
Call from anywhere in the world.
http://www.safefetus.com/DrugDetail.asp?...
Generic Name Topimasate (Topiramate)
Trade Name Topamax
Manufacturer
Risk Category
* Risk classification not available
FDA Pregnancy Risk Categories
Place (not click) your mouse cursor over the bold words in the text below to receive description
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
Place (not click) your mouse cursor over the bold words in the text below to receive description
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.
does sucralfate get you high?,
No it does not under proper dosage.
It's used to treat:
* Active duodenal ulcer not related to NSAID use -- 1 g PO four times a day given 1 hr before meals and at bedtime for 4-8 weeks
* Maintenance therapy for resolved duodenal ulcers -- 1 g PO bid on empty stomach
* Gastric ulcer not related to NSAID use and gastritis due to GERD -- 1 g PO four times a day 1 hr before meals and at bedtime. Triple combination therapy with lansoprazole + cisapride + sucralfate can significantly improve symptoms and quality of life and was more cost-effective than ranitidine combination group. [Journal of Zhejiang University 2003 Sep-Oct; 4(5): 602-6]
* Aphthous ulcer and stomatitis due to radiation or chemotherapy -- 5-10 mL PO suspension swish and spit/swallow four times a day.
* Proctitis from radiation or ulcerative colitis -- 3 g/15 mL rectal suspension once or twice daily.
* Gastro-esophageal reflux disease during pregnancy -- first-line drug therapy combined with lifestyle and diet modification.[3]
* Stress ulcer prophylaxis -- The use of sucralfate rather than H2 antagonists for stress ulcer prophylaxis, and measures to prevent aspiration, such as semirecumbent positioning or continuous subglottic suctioning, have all been shown to reduce the risk of ventilator-associated pneumonia (VAP).[4]
* Prevention of stricture formation -- Sucralfate has an inhibitory effect on stricture formation in experimental corrosive burns and can be used in the treatment of corrosive esophageal burns to enhance mucosal healing and suppress stricture formation[5]
* Rectal bleeding and its management after irradiation for uterine cervical cancer
carafate sucralfate?,
Check the following link:
sucralfate sleeping???, gerd dr gave me this medicine, it's been 5 days, I'm nauseas, no appetite and sooo tired, anyone have this?
SIDE EFFECTS: Indigestion, dizziness, dry mouth, back pain, or itching may occur as your body adjusts to the medication. If these effects persist or worsen, inform your doctor. If you notice other effects not listed above, contact your doctor or pharmacist.
Tiredness is an unusual side effect. You should let your doctor know.
