Sulcrate Suspension Plus; Descriptions. The tablets are available as 1 g tablets. May reduce absorption of tetracyclines, quinidine, levothyroxine, phenytoin, cimetidine, digoxin, ciprofloxacin, norfloxacin, ketoconazole, ranitidine, theophylline; dose concomitant drugs 2hrs before sucralfate. . Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland. Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate. Arzneimittel-Forschung. If any of these effects last or get worse, notify your doctor or pharmacist promptly. By providing your mobile phone number, you agree and acknowledge that Allergan may text you information about CARAFATE and the /CreationDate (D:20160429093924-04'00') The American journal of gastroenterology. Tell your doctor if you are pregnant or breastfeeding. This /AIS false *P=0.016 P=0.001 P=0.0001. Do not allow the liquid medicine to freeze. When given orally, it disintegrates in the stomach in the presence of acid and binds to normal and damaged mucosa forming a protective layer. Safety and effectiveness in pediatric patients have not been established. Depending on your insurance coverage, most eligible patients may pay as little as $30 per 30day supply for each of up to six (6) prescription fills. being able to get an erection sometimes, but not every time you want to have sex. Indications Sucralfate is a unique anti-ulcer drug. Allergan reserves the right to rescind, revoke, or amend this offer without notice. CARAFATE (sucralfate) Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. Offer good only in the USA, including Puerto Rico, at participating retail pharmacies. US residents can call their local poison control center at 1-800-222-1222. Long-term users of sucralfate are shown to retain negligible levels of aluminum, except when a patient has renal insufficiency. This card has no cash value and may not be used in combination with any other discount, coupon, rebate, free trial, or similar offer for the specified prescription. /SMask /None>> /AIS false Sucralfate forms a coating over ulcers, protecting the area from further injury. /Title ( C A R A F A T E \( s u c r a l f a t e \) S u s p e n s i o n) Inaddition,aluminum doesnotcrossdialysismembranesbecauseitisboundtoalbuminandtransferrinplasmaproteins. Warnings Administer CARAFATE only by the oral route. Sucral Suspension is taken one hour before meals preferably at bedtime in the dose and duration advised by the . Compare . Active Duodenal Ulcer:The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL)fourtimesperday. This offer is good for use only with a valid prescription for CARAFATE (sucralfate) at the time the prescription is filled by the pharmacist and dispensed to the patient. being able to get an erection, but not having it last long enough for sex. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Carafate only for the indication prescribed. << -Each dose should be taken on an empty stomach. [/Pattern /DeviceRGB] Before taking sucralfate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Does Carafate Suspension, (Final Dose Form) interact with other drugs you are taking? /SM 0.02 Enter your medication into the WebMD interaction checker, IBD and People of Color: Diet and Wellness Tips. Take your next dose at the regular time. Do not administer intravenously as fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration. Carafate Manufacturer: AbbVie Inc: Country of Origin: Unknown: Alternate Manufacturer Number . Equivalence of sucralfate suspension to sucralfate tablets has not been demonstrated.1. This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Tell your doctor about all your current medicines and any medicine you start or stop using. EVALUATION OF ENEMAS CONTAINING SUCRALFATE IN TISSUE CONTENT OF MUC-2 PROTEIN IN EXPERIMENTAL MODEL OF DIVERSION COLITIS. Amneal has immediately initiated commercialization activities, the company said in a press release. CARAFATE Oral Suspension for oral administration contains 1 g of sucralfate per 10 mL. PRECAUTIONS Duodenal ulcer is a chronic, recurrent disease. Epub [PubMed PMID: 29257850], Driks MR, Craven DE, Celli BR, Manning M, Burke RA, Garvin GM, Kunches LM, Farber HW, Wedel SA, McCabe WR. 4 0 obj Clinical studies of CARAFATE Oral Suspensiondidnot include sufficient numbers of subjects aged 65 andover to determine whether they responddifferently from younger subjects. Print; Email; . Carafate pregnancy and breastfeeding warnings. The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract. Shake the bottle well before each dose. No therapeutic monitoring has been recommended for this medication as it undergoes minimal absorption from the enteral system. 1991 Oct 3:325(14):1017-25 [PubMed PMID: 1886624], Masuelli L, Tumino G, Turriziani M, Modesti A, Bei R. Topical use of sucralfate in epithelial wound healing: clinical evidences and molecular mechanisms of action. The approval for the first generic sucralfate oral suspension is 1 of the 15 complex products the manufacturer expects to launch over an 18- to 24-month period. Equivalenceof sucralfateoral suspension to sucralfate tablets has not been demonstrated. Sucralfate is a medication used to treat duodenal ulcers, epithelial wounds, chemotherapy-induced mucositis, radiation proctitis, ulcers in Behcet disease, and burn wounds. Post-marketingcasesof hypersensitivityhavebeenreported withtheuse ofsucralfateoral suspension,includinganaphylacticreactions,dyspnea,lip swelling,edemaofthemouth, pharyngeal edema, pruritus, rash, swelling of the faceand urticaria. Depending on your insurance coverage, most eligible patients may pay as little as $30 per 30day supply for each of up to six (6) prescription fills. Sucralfateisonlyminimallyabsorbedfromthegastrointestinaltract. Instudiesinvolvingover2700patientstreatedwithsucralfate,adverseeffects were reported in 129 (4.7%). Close more info about CARAFATE SUSPENSION. Sucralfate can make it harder for your body to absorb other medications you take by mouth. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Tablet; Oral Suspension; Dosage 1 G. 1 G; Quantity 120 tablets. If you miss a dose, take it as soon as you remember. 1 0 obj The incidence of peptic ulcer disease is also on the rise, with population migration from regions endemic to Helicobacter pylori, lifestyle changes, and overuse of pain medications like NSAIDs, particularly with the move away from opioids. Store at room temperature away from moisture and heat. Store at controlled room temperature 20-25C (68-77F)[see USP]. Active: 1g 4 times daily on an empty stomach for 48 weeks. Because animalreproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. 1 g orally 4 times a day In all cases studied todate (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing theconcomitant medication 2 hours before sucralfate eliminated the interaction. It is not known if this medication passes into breast milk. European journal of drug metabolism and pharmacokinetics. By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. Elimination Diet for Eosinophilic Esophagitis, Challenges of Living With Eosinophilic Esophagitis. This protects the ulcer from the acid of the stomach, allowing it to heal. /Creator () /Length 9 0 R Do not take two doses at one time. Do not stop taking this medication without consulting your doctor. Radiation-induced proctosigmoiditis. Learn about sucralfate (Carafate) usage and dosing. We will continue to honor any Allergan-provided privacy notices for personal information previously collected, used, and maintained by Allergan. Constipation, dry mouth, upset stomach, gas, and nausea may occur. The pharmacist is tasked with checking the dosing and frequency of administration, providing additional patient counseling regarding how to use the medication, watching for potential adverse events, and contacting the prescriber with any concerns. Tell your doctor right away if you have any serious side effects, including: an unusual feeling of fullness in the stomach that doesn't go away, nausea/vomiting/stomach pain especially after meals. It works mainly in the lining of the stomach by sticking to ulcer sites and protecting them from acids, enzymes, and bile salts. Feel free to get in touch with us and send a message. Managing the side effects of chemotherapy and radiation has become a challenge and is encountered more often by clinicians with new treatment regimens and prolonged survival of oncology patients. Documented hypersensitivity to sucralfate is an absolute contraindication as it can cause an anaphylactic reaction. A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. Amazon Prime members get additional benefits including FREE 2-Day Delivery and low prices on medications. A few medications like antacids administered within 15 minutes of sucralfate can reduce its efficacy by decreasing the binding ability of sucralfate to gastric ulcers.[10]. Do not administer intravenously as fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration. Carafate. Ask your doctor before using an antacid, and use only the type your doctor recommends. Chronic renal failure. Patients were treated with 1g (10mL) of CARAFATE Suspension or placebo four times daily. The liquid form of Carafate should never be injected through a needle into the body, or death may occur. /Creator () If you are pregnant, tell your doctor before using sucralfate. Identify the mechanism of action of sucralfate. Madison, NJ: Allergan USA, Inc.; June 2018. Areproductionstudyinratsatdoses upto38timesthehumandosedidnotrevealanyindicationoffertilityimpairment. Nursing mothers. /CA 1.0 Sucralfate contains an aluminum salt. 2014 Apr; [PubMed PMID: 24299100], Kochhar R, Patel F, Dhar A, Sharma SC, Ayyagari S, Aggarwal R, Goenka MK, Gupta BD, Mehta SK. You can purchase Carafate for only $17.29 for 120, 1gm Tablet of generic Carafate when you use a SingleCare Carafate copay card. 6 sucralfate interactions to know about. Please note that if FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for a Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine,digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. The medication has a relatively safe profile as there is negligible absorption from the enteral system. We comply with the HONcode standard for trustworthy health information. For questions about the program, including savings on mail-order prescriptions, please call 1.877.823.9481. Carafate is not greatly absorbed into the body through the digestive tract. Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administrationofCARAFATEOralSuspension. The dosage is based on your medical condition and response to treatment. << You should not use Carafate if you are allergic to sucralfate. How much does SUCRALFATE or CARAFATE cost near you? Sucralfate is used to treat and prevent duodenal ulcers and other conditions as determined by your doctor. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The drug may also be used during breastfeeding, although no human data is available. Carafate is a brand name of sucralfate, approved by the FDA in the following formulation(s): Yes. Sucralfateisonlyminimallyabsorbedfromthe gastrointestinaltract. Products meeting necessary bioequivalence requirements. Carafate oral suspension is to be taken only by mouth. Studiesinhumansubjectsandwithanimalmodelsofulcerdiseasehaveshownthatsucralfate forms an ulcer-adherent complex with proteinaceousexudate at the ulcer site. Allergan, Inc. CARAFATEOralSuspensioncontainssucralfateandsucralfateisan-D-glucopyranoside,-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminumcomplex. Sucralfate is not systemically metabolized and is primarily excreted unchanged in the feces. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. Recommended adult dosing for CARAFATE Suspension is 1g (10mL) four times per day, CARAFATE Suspension should be administered on an empty stomach, Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate, While healing with CARAFATE Suspension may occur during the first week or two, treatment should be continued for four to eight weeks unless healing has been demonstrated by x-ray or endoscopic examination. [Level 5], Interprofessional team coordination can take on several forms. It contains the active ingredient sucralfate which promotes the healing of ulcers by forming a coating over them which acts as a physical barrier. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. ",#(7),01444'9=82. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. stream Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. Dueto limited experienceinhumans withoverdosage ofsucralfate,no specifictreatment recommendationscanbegiven. Nephron. Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after CARAFATE Oral Suspension. Prescribing Information 1 0 obj It is a basic aluminum salt of sucrose octasulfate. >> Allergan and its design are trademarks of Allergan, Inc. CARAFATE is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate. Follow all directions on your prescription label and read all medication guides or instruction sheets. /SA true Store at room temperature away from light and moisture. Sucralfate can heal an active ulcer, but it will not prevent future ulcers from occurring. Do not double the dose to catch up. Manufacturer # 00254101196: Manufacturer: Par Pharmaceuticals: Country of Origin: United States: Alternate Manufacturer Number: 1508654: Application: GI Protectant: Void if prohibited by law, taxed, or restricted. All rights reserved. << Use this medication regularly in order to get the most benefit from it. Comments: Version: 10.01. Consult your pharmacist or local waste disposal company. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. The average cost of Carafate without insurance may be around $293.00 for 1, 420ML of 1GM/10ML Suspension. Your doctor may recommend some lifestyle changes such as stress-reducing programs, diet changes and exercise to assist in treatment and prevention of ulcers. Digestive diseases and sciences. /ca 1.0 It works by forming a barrier or coat over the ulcer. Patients may not Additive aluminum load with aluminum-containing antacids. Carafate is used to treat an active duodenal ulcer. By redeeming this card, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer. (BRAND) CARAFATE; Form Tablet. /CreationDate (D:20230119183122-05'00') Otheradverseeffectsreportedinlessthan0.5% of the patients are listed below by body system: Gastrointestinal:diarrhea,drymouth,flatulence,gastricdiscomfort,indigestion,nausea,vomiting, Nervous System: dizziness, insomnia, sleepiness, vertigo. Offer applies only to prescriptions filled before the program expires on 12/31/20. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. There are two oral forms of sucralfate tablets and an oral suspension. Inadvertent IV use of sucralfate has caused fatal complications such as pulmonary emboli and cerebral edema. Whensucralfateisadministeredorally,smallamountsofaluminumareabsorbedfrom the gastrointestinaltract. This medicine is a pink, cherry, suspension, Select a condition to view a list of medication options. understand that the frequency of these recurring messages depends on user preferences/activity and that message and data rates may The product's dosage form is suspension and is administered via oral form. The following products are equivalent to Carafate: Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Carafate. /Filter /DCTDecode /Width 393 Sucralfate--alternative therapy for peptic-ulcer disease. Many people using this medication do not have serious side effects. In Canada - Call your doctor for medical advice about side effects. Treatments Duodenal Ulcer Carafate Print Save Carafate Generic name: sucralfate (oral) [ soo-KRAL-fate ] Drug class: Miscellaneous GI agents Medically reviewed by Kaci Durbin, MD. stream Please ensure your email address is in the correct format: This site is intended for U.S. consumers only. 120 tablets; 60 tablets; 90 tablets; 30 tablets; 360 tablets; Custom Qty . Use: Maintenance therapy for patients after healing of acute duodenal ulcers. While short-term treatment with sucralfate can result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to alter the post-healing frequency or severity of duodenal ulceration. Drug interactions may change how your medications work or increase your risk for serious side effects. Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Acuteoralstudiesinanimals,however,usingdosesupto12 g/kgbodyweight,couldnotfindalethaldose. This card is not transferable. It binds to positively charged proteins in exudates, locally forming a thick viscous substance. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate. CARAFATE is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients. Copyright 1996-2023 Cerner Multum, Inc. Do not administer intravenously. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. You may report side effects to FDA at 1-800-FDA-1088. Episodes of hyperglycemia have been reported in diabetic patients treated with sucralfate suspension. /BitsPerComponent 8 /SM 0.02 Drug class: Miscellaneous GI agents. 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Standard for trustworthy health information sucralfateoral Suspension to sucralfate tablets and an oral Suspension stress-reducing programs, changes.