Trade Name: Sucralfate

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: VistaPharm, Inc.

Presentation: SUSPENSION, HUMAN PRESCRIPTION DRUG

Strength: 1 g/10mL

Storage and handling

SUCRALFATE Aluminum Complex [EPC],Organometallic Compounds [CS]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Rx only
  • Sucralfate Oral Suspension contains sucralfate and sucralfate is an u03b1-D-glucopyranoside, u03b2-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
  • SucralfateOral Suspension for oral administration contains 1 g of sucralfate per 10 mL.
  • SucralfateOral Suspension also contains: colloidal silicon dioxide NF, FD&C Red #40, flavor, glycerin USP, methylcellulose USP, methylparaben NF, microcrystalline cellulose NF, purified water USP, simethicone USP, and sorbitol solution USP.n
  • Therapeutic category: antiulcer.n
  • Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine.
  • Although the mechanism of sucralfate's ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent:n
  • In vitro
  • These observations suggest that sucralfate's antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1 g dose of sucralfate.
  • In a multicenter, double-blind, placebo-controlled study of Sucralfate Oral Suspension, a dosage regimen of 1 gram (10 mL) four times daily was demonstrated to be superior to placebo in ulcer healing.
  • Equivalence of sucralfate oral suspension to sucralfate tablets has not been demonstrated.n
  • Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
  • Sucralfate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.
  • Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of Sucralfate Oral Suspension. Administer Sucralfate Oral Suspension only by the oral route. Do not administer intravenously.
  • The physician should read the u201cu201d section when considering the use of Sucralfate Oral Suspension in pregnant or pediatric patients, or patients of childbearing potential.
  • Duodenal ulcer is a chronic, recurrent disease. 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.n
  • Episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated with Sucralfate Oral Suspension is recommended. Adjustment of the anti-diabetic treatment dose during the use of Sucralfate Oral Suspension might be necessary.n
  • Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%).
  • Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:n
  • Gastrointestinal
  • Dermatological
  • Nervous System
  • Other
  • Post-marketing
  • Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate.n
  • Cases of hyperglycemia have been reported with sucralfate.n
  • Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.
  • Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.
  • Active Duodenal Ulcer.
  • Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after Sucralfate Oral Suspension.n
  • While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.n
  • Elderly.n- Array
  • Call your doctor for medical advice about side effects. You may report side effects to VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or .
  • Sucralfate Oral Suspension, 1 g/10 mL is a pink suspension supplied as follows:
  • NDC 66689-790-01: 10 mL unit-dose cupn
  • NDC 66689-790-30: Case contains 30 unit-dose cups of 10 mL
  • (NDC 66689-790-01), packaged in 3 trays of 10 unit-dose cups each.
  • NDC 66689-790-40: Case contains 40 unit-dose cups of 10 mLn
  • (NDC 66689-790-01), packaged in 4 trays of 10 unit-dose cups each.
  • NDC 66689-790-50: Case contains 50 unit-dose cups of 10 mL
  • (NDC 66689-790-01), packaged in 5 trays of 10 unit-dose cups each.
  • NDC 66689-790-99: Case contains 100 unit-dose cups of 10 mLn
  • (NDC 66689-790-01), packaged in 10 trays of 10 unit-dose cups each.
  • SHAKE WELL BEFORE USING. AVOID FREEZING.
  • Store at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). [See USP Controlled Room Temperature].n
  • Rx Only
  • Distributed by:
  • VistaPharm, Inc.n
  • Largo, FL 33771, USA
  • VP1059R10n
  • 02/2020
  • Sucralfaten
  • 1 g / 10 mL
  • Shake Well
  • Delivers 10 mL
  • Store at 20u00b0u201325u00b0C (68u00b0u2013 77u00b0F)
  • Rx Only
  • VP1060R6
  • 01/18
  • XACTDOSE
  • Distributed by:
  • VistaPharm, Inc.
  • Largo, FL 33771, USA
  • NDC 66689-790-01

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Sucralfate (Sucralfate) which is also known as Sucralfate and Manufactured by VistaPharm, Inc.. It is available in strength of 1 g/10mL.

Sucralfate (Sucralfate) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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