Sucralfate (Ulsanic, Carafate) - Dose, Side effects

Sucralfate (Ulsanic, Carafate) is an orally available medicine used in the treatment of gastroesophageal reflux disease, prevention, and treatment of stomach ulcers.

Sucralfate Uses:

  • Duodenal ulcer:

    • Short-term (≤8 weeks) treatment of active duodenal ulcers;
    • As a maintenance therapy for duodenal ulcers (tablets only)

Sucralfate Dose in Adults

Sucralfate Dose in the treatment of Duodenal ulcer:

  • Active duodenal ulcer:

    • Suspension, tablet: Initial: 1 g 4 times a day for 4 to 8 weeks
    • Maintenance therapy: Tablet: 1 g twice a day

Sucralfate Dose in Childrens

Sucralfate dose as an adjunctive therapy in the treatment of Peptic ulcer disease:

  • Infants, Children, and Adolescents:

    • Oral: at 40 to 80 mg/kg/day divided every 6 hours.
    • Maximum dose: 1,000 mg/dose.

Sucralfate dose in the treatment of Esophagitis:

  • Infants ≥3 months and Children <6 years:

    • Oral: 500 mg/dose four times daily
  • Children ≥6 years:

    • Oral: 1,000 mg/dose four times daily.

Sucralfate Pregnancy Category B

  • After oral administration, it is only minimally absorbed.
  • According to available data, sucralfate doesn't appear to increase the risk for adverse fetal outcomes when it is used in the first trimester.
  • It can be used to treat reflux or duodenal ulcers in pregnancy.

Sucralfate use during breastfeeding:

  • It is unknown if the drug is found in breast milk.
  • Ulsanic can only be absorbed minimally after oral administration.
  • The manufacturer suggests that breastfeeding mothers exercise caution when administering the drug, but the manufacturer considers it acceptable to use.

Dose in Kidney Disease:

  • There are no dosage adjustments provided in the manufacturer's labeling.
  • Aluminum salt is minimally absorbed; however, it may accumulate in renal impairment;
  • use with caution in patients with chronic renal failure or on dialysis.

Dose in Liver disease:

  • There are no dosage adjustments provided in the manufacturer's labeling.

Side Effects of Sucralfate (Ulsanic):

  • Gastrointestinal:

    • Constipation

Contraindications to Sucralfate (Ulsanic):

  • Hypersensitivity/ hyperresponsiveness of any drug component or drug ingredient

Warnings and precautions

  • Diabetes:

    • Patients with diabetes have reported hyperglycemia and the suspension of their insulin. It is important to monitor glycemia closely.
    • Adjustment of anti-diabetic medication may be required.
  • Duodenal ulceration

    • Suprafate acts at the ulcer and should not be used to treat it.
  • Renal impairment

    • Patients with chronic renal disease should be cautious
    • This is an aluminum complex. Small amounts of aluminum can be absorbed after oral administration.
    • Patients with chronic renal failure and dialysis may have lower aluminum excretion, which can increase the risk of aluminum accumulation or toxicity (eg aluminum osteodystrophy and osteomalacia).

Sucralfate: Drug Interaction

Risk Factor C (Monitor therapy)

Ketoconazole (Systemic)

Sucralfate may decrease the serum concentration of Ketoconazole (Systemic).

Levothyroxine

Sucralfate may decrease the serum concentration of Levothyroxine.

Risk Factor D (Consider therapy modification)

Bictegravir

Polyvalent Cation Containing Products may decrease the serum concentration of Bictegravir. Management: Administer bictegravir under fasting conditions at least 2 hours before or 6 hours after polyvalent cation containing products. Coadministration of bictegravir with or 2 hours after most polyvalent cation products is not recommended.

Bisphosphonate Derivatives

Polyvalent Cation Containing Products may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Exceptions: Pamidronate; Zoledronic Acid.

Cholic Acid

Sucralfate may decrease the absorption of Cholic Acid.

Deferiprone

Polyvalent Cation Containing Products may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours.

Digoxin

Sucralfate may decrease the serum concentration of Digoxin. Specifically, sucralfate may decrease the absorption of digoxin. Management: Administer digoxin at least 2 hours before or at least 6 hours after sucralfate.

Dolutegravir

Sucralfate may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after sucralfate. Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after sucralfate.

Eltrombopag

Polyvalent Cation Containing Products may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any polyvalent cation containing product.

Furosemide

Sucralfate may decrease the serum concentration of Furosemide. Sucralfate may impair the absorption of furosemide. Management: Avoid concomitant oral administration of furosemide and sucralfate. Separate administration by at least 2 hours. Does not apply to parenterally administered furosemide.

Multivitamins/Fluoride (with ADE)

May increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum may be increased. Sucralfate may decrease the serum concentration of Multivitamins/Fluoride (with ADE). More specifically, sucralfate may impair the absorption of fluoride. Management: Avoid administration of aluminum-containing products, such as sucralfate, within at least 1-2 hours of fluoride administration. In patients with severe renal dysfunction, consider avoiding this combination altogether.

PenicillAMINE

Polyvalent Cation Containing Products may decrease the serum concentration of PenicillAMINE. Management: Separate the administration of penicillamine and oral polyvalent cation containing products by at least 1 hour.

Phosphate Supplements

Sucralfate may decrease the absorption of Phosphate Supplements. Management: This applies only to oral phosphate administration. Administering oral phosphate supplements at least 1 hour before or 2 hours after administration of sucralfate may reduce the significance of the interaction. Exceptions: Sodium Glycerophosphate Pentahydrate.

QuiNIDine

Sucralfate may decrease the serum concentration of QuiNIDine. Specifically, sucralfate may decrease the absorption of quinidine. Management: Administer quinidine at least 2 hours before or at least 6 hours after sucralfate.

Quinolones

Sucralfate may decrease the serum concentration of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after the sucralfate dose. Greater separation of doses may further lessen the risk for a significant interaction. Exceptions: LevoFLOXacin (Oral Inhalation).

Raltegravir

Polyvalent Cation Containing Products may decrease the serum concentration of Raltegravir. Management: Administer raltegravir 2 hours before or 6 hours after administration of the polyvalent cations. Dose separation may not adequately minimize the significance of this interaction.

Sulpiride

Sucralfate may decrease the serum concentration of Sulpiride. Management: Separate administration of sucralfate and sulpiride by at least 2 hours in order to minimize the impact of sucralfate on sulpiride absorption.

Tetracyclines

Sucralfate may decrease the absorption of Tetracyclines. Management: Administer the tetracycline derivative at least 2 hours prior to sucralfate in order to minimize the impact of this interaction. Exceptions: Eravacycline.

Trientine

Polyvalent Cation Containing Products may decrease the serum concentration of Trientine. Management: Avoid concomitant administration of trientine and oral products that contain polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. If other oral polyvalent cations are needed, separate administration by 1 hour.

Vitamin K Antagonists (eg, warfarin)

Sucralfate may diminish the anticoagulant effect of Vitamin K Antagonists. Sucralfate may decrease the serum concentration of Vitamin K Antagonists. Specifically, sucralfate may decrease the absorption of Vitamin K Antagonists. Management: Administer vitamin K antagonists at least 2 hours before or at least 6 hours after sucralfate.

Risk Factor X (Avoid combination)

Baloxavir Marboxil

Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil.

Multivitamins/Minerals (with ADEK, Folate, Iron)

May increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum from sucralfate may be increased, leading to an increase in the serum aluminum concentration.

Vitamin D Analogs

May increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum from sucralfate may be increased, leading to an increase in the serum aluminum concentration.

Monitoring parameters:

  • Blood glucose levels (in diabetic patients receiving oral suspension).

How to administer Sucralfate (Ulsanic)?

  • Administer on an empty stomach.
  • Shake suspension well before use.
  • Do not administer antacids within 30 minutes of administration of sucralfate.

Mechanism of action of Sucralfate (Ulsanic):

  • This complex is formed by binding positively charged proteins to exudates. It forms a viscous paste-like adhesive substance.
  • This creates a protective coating which acts locally to protect the gastric membrane against bile salts, pepsin and peptic acid.

The onset of action:

  • Paste formation and ulcer adhesion: 1 to 2 hours;
  • acid neutralizing capacity: ~14 to 16 mEq/1 g dose of sucralfate

Absorption:

  • Minimal from GI tract

Distribution:

  • Acts locally at ulcer sites; unbound in the GI tract to aluminum and sucrose octa-sulfate

Metabolism:

  • None

Excretion:

  • Primarily urine (small amounts of sulfated disaccharide)

International Brands of Sucralfate:

  • Carafate
  • APO-Sucralfate
  • Cytogard
  • DOM-Sucralfate
  • PMS-Sucralfate
  • Sucralfate-1
  • Sulcrate
  • Sulcrate Plus
  • TEVA-Sucralfate
  • Alivoato
  • Alsucral
  • Alusac
  • Alusulin
  • Andapsin
  • Antepsin
  • Calfate
  • Carafate
  • Ciprid
  • Dip
  • Discral
  • Dolisec
  • Episan
  • Eradict
  • Exinol
  • Gasmezol
  • Gastril
  • Gastrofait
  • Gastronic
  • Inpepsa
  • Iselpin
  • Keal
  • Lanpepsa
  • Metixane
  • Mucifat
  • Neciblok
  • Peptonorm
  • Profat
  • Serat
  • Sucrabest
  • Sucrafil
  • Sucrafilm
  • Sucral
  • Sucralfin
  • Sucralose
  • Sucramal
  • Sucrate
  • Sucrate Gel
  • Sude
  • Sulcran
  • Sulcrate
  • Taxilan
  • Ulcafate
  • Ulcar
  • Ulcera
  • Ulcerfate
  • Ulcerlmin
  • Ulcermin
  • Ulcertec
  • Ulcetab
  • Ulcicure
  • Ulcogant
  • Ulcumaag
  • Ulsaheal
  • Ulsanic
  • Ulsec
  • Ulsicral
  • Unival
  • Urbal
  • Vanter
  • Venter

Sucralfate Brand Names in Pakistan:

Sucralfate Suspension 1 gm/5ml

Cayfate Caylex Pharmaceuticals (Pvt) Ltd.
Cidifen Libra Pharmaceuticals (Pvt) Ltd
Crafate Multinational Buisness Link
Crafilm Pacific Pharmaceuticals Ltd.
Crafilm Pacific Pharmaceuticals Ltd.
Cytozole Safe Pharmaceutical (Pvt) Ltd.
Dyfate Dyson Research Laboratories
Epigard Zinta Pharmaceuticals Industries
Macsufate Mac & Rans Pharmaceuticals (Pvt) Ltd
Mallar Jafson Pharmaceuticals (Pvt) Ltd.
Masfate Masfa Industries (Pvt) Ltd
Medgel Medicraft Pharmaceuticals (Pvt) Ltd.
Orafate Orta Labs. (Pvt) Ltd.
Pro-Fit Synchro Pharmaceuticals
Rafate Rakaposhi Pharmaceutical (Pvt) Ltd.
Ralfate Rakaposhi Pharmaceutical (Pvt) Ltd.
Sucfate Siza International (Pvt) Ltd.
Suclive Olive Laboratories
Sucmed Mediceena Pharma (Pvt) Ltd.
Sucrafate Medicaids Pakistan (Pvt) Ltd.
Sucragray Gray`S Pharmaceuticals
Sucral-Heim Unipharma (Pvt) Ltd.
Sucralan Paramount Pharmaceuticals
Sucralgem Delux Chemical Industries
Sucralif Alliance Pharmaceuticals (Pvt) Ltd.
Sucralix Neo Medix
Sucranic Unison Chemical Works
Sucraz Miracle Pharmaceuticals(Pvt) Ltd
Sucrosun Hisun Pharmaceuticals
Sulcrate Harmann Pharmaceutical Laboratories (Pvt) Ltd.
Surlka Searle Pakistan (Pvt.) Ltd.
Ulcafate Star Laboratories (Pvt) Ltd.
Ulceley Medley Pharmaceuticals
Ulcerate Helix Pharma (Private) Limited
Ulcercure Eros Pharmaceuticals
Ulcernil Lisko Pakistan (Pvt) Ltd
Ulcertec Polyfine Chempharma (Pvt) Ltd.
Ulcocid Don Valley Pharmaceuticals (Pvt) Ltd.
Ulfate Obsons Pharmaceuticals
Ulsanic Highnoon Laboratories Ltd.
Ulsanic Highnoon Laboratories Ltd.
Ulsuc Mediate Pharmaceuticals (Pvt) Ltd
Winsanic Zanctok Pharmaceuticals

 

Sucralfate 1 gm Tablets

Biofate Biorex Pharmaceuticals
Cidifen Libra Pharmaceuticals (Pvt) Ltd
Cytozole Safe Pharmaceutical (Pvt) Ltd.
Epigard Zinta Pharmaceuticals Industries
Mallar Jafson Pharmaceuticals (Pvt) Ltd.
Marifate Miracle Pharmaceuticals(Pvt) Ltd
Medgel Medicraft Pharmaceuticals (Pvt) Ltd.
Sucfate Siza International (Pvt) Ltd.
Sucmed Mediceena Pharma (Pvt) Ltd.
Sucrafate Medicaids Pakistan (Pvt) Ltd.
Sucral Reko Pharmacal (Pvt) Ltd.
Sucralif Alliance Pharmaceuticals (Pvt) Ltd.
Ulcafate Star Laboratories (Pvt) Ltd.
Ulcerate Helix Pharma (Private) Limited
Ulcercure Forte Eros Pharmaceuticals
Ulcernil Lisko Pakistan (Pvt) Ltd
Ulcocid Don Valley Pharmaceuticals (Pvt) Ltd.
Ulsanic Highnoon Laboratories Ltd.

 

Sucralfate 500 Mg Tablets

Biofate Biorex Pharmaceuticals
Cidifen Libra Pharmaceuticals (Pvt) Ltd
Cytozole Safe Pharmaceutical (Pvt) Ltd.
Rafate Rakaposhi Pharmaceutical (Pvt) Ltd.
Ralfate Rakaposhi Pharmaceutical (Pvt) Ltd.
Sucfate Siza International (Pvt) Ltd.
Sucrafate Medicaids Pakistan (Pvt) Ltd.
Sucralif Alliance Pharmaceuticals (Pvt) Ltd.
Ulcafate Star Laboratories (Pvt) Ltd.
Ulcerate Helix Pharma (Private) Limited
Ulcocid Don Valley Pharmaceuticals (Pvt) Ltd.
Ulsanic Highnoon Laboratories Ltd.

 

Sucralfate 1 gm Capsules

Ulcoat Akhai Pharmaceuticals.

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