INTRODUCTION

MACRALFATE 1000MG SUSPENSION contains Sucralfate, which belongs to the group of medicines called Anti-ulcer agents. It is used for the short-term (up to 8 weeks) treatment of active duodenal ulcers (part of the small intestine), prophylaxis of gastrointestinal haemorrhage due to stress ulceration in critically ill patients, gastric and benign ulcers.

MACRALFATE 1000MG SUSPENSION should be used with caution in patients with chronic renal failure, dialysis patients and diabetes. MACRALFATE 1000MG SUSPENSION should be used with caution in pregnant and breastfeeding women. The safety and effectiveness of MACRALFATE 1000MG SUSPENSION for use in children have not been established.

MACRALFATE 1000MG SUSPENSION should be used with caution in elderly patients above 65 years of age. The most common side effect of taking MACRALFATE 1000MG SUSPENSION is constipation. Consult your doctor if any of your symptoms get worse or persist.

USES OF MACRALFATE 1000MG SUSPENSION

• Treatment of active duodenal ulcer, benign and gastric ulcers
• Prophylaxis management of gastrointestinal haemorrhage

HOW MACRALFATE 1000MG SUSPENSION WORKS

MACRALFATE 1000MG SUSPENSION works by forming a protective layer around the ulcer saving it from the further attack of acid, pepsin or bile. It increases growth factor production, promoting tissue growth, regeneration, thereby facilitating repair.

DIRECTIONS FOR USE

Take MACRALFATE 1000MG SUSPENSION as advised by your physician. Shake well before each use. Take MACRALFATE 1000MG SUSPENSIONon an empty stomach at least 1 hour before or 2 hours after a meal for best results. Your doctor will determine the correct dose and duration for you based on your age, body weight and disease condition.

SIDE EFFECTS OF MACRALFATE 1000MG SUSPENSION

HOW TO MANAGE SIDE EFFECTS

Constipation:

Consume fiber-rich foods such as fresh fruits, vegetables and cereals. Consume lots of water and exercise more regularly. Contact your doctor if your symptom doesn’t improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking MACRALFATE 1000MG SUSPENSION, inform your doctor if you are taking any of the following medicine:

• ranitidine, cimetidine (medicine used to treat stomach acidity and peptic ulcer)
• digoxin (a medicine used to treat heart failure), quinidine (a medicine used to treat irregular heart rate)
• antibiotics like fluoroquinolone, ciprofloxacin, norfloxacin, ofloxacin, ketoconazole and tetracycline (medicines used to treat bacterial infections)
• l-thyroxine (a medicine used to treat low thyroid hormone)
• phenytoin (a medicine used to treat epilepsy)
• theophylline (medicine used to treat wheezing, shortness of breath and chest tightness)
• warfarin (to prevent blood clots)

Overdosage:

If you or anyone else accidentally take too much of MACRALFATE 1000MG SUSPENSION, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are nausea, vomiting, indigestion and abdominal pain.

SYNOPSIS

MORE INFORMATION

• Keep MACRALFATE 1000MG SUSPENSION out of reach from children
• Store MACRALFATE 1000MG SUSPENSION below 30°C

FAQs ABOUT MACRALFATE 1000MG SUSPENSION

What is MACRALFATE 1000MG SUSPENSION used for?

MACRALFATE 1000MG SUSPENSION is used for the short-term (up to 8 weeks) treatment of active duodenal ulcer (part of the small intestine), prophylaxis of gastrointestinal haemorrhage due to stress ulceration in critically ill patients, gastric and benign ulcers.

Is MACRALFATE 1000MG SUSPENSION safe in pregnancy?

MACRALFATE 1000MG SUSPENSION should be used with caution in pregnant women or women planning to have a baby. It will be given to you by the doctor only if clearly needed. Contact your doctor before taking MACRALFATE 1000MG SUSPENSION.

Can MACRALFATE 1000MG SUSPENSION be used in elderly patients?

MACRALFATE 1000MG SUSPENSION should be used with caution in elderly patients aged 65 years or above, especially with decreased liver, kidney and cardiac function or other diseases. Contact your doctor before taking MACRALFATE 1000MG SUSPENSION.

How MACRALFATE 1000MG SUSPENSION work?

MACRALFATE 1000MG SUSPENSION works by forming a protective layer around the ulcer, saving it from further attack by acid, pepsin or bile. It increases growth factor production, promoting tissue growth, regeneration, thereby facilitating repair.

Can MACRALFATE 1000MG SUSPENSION be used in patients with kidney problems?

MACRALFATE 1000MG SUSPENSION should be used with caution in patients with chronic kidney failure and patients undergoing dialysis. Contact your doctor for more information before taking it.

REFERENCES

1. KD Tripathi. Drugs for Peptic Ulcer and Gastroesophageal Reflux Disease. Essentials of Medical Pharmacology. Seventh Edition, 2013. Page - 656.

2. Wallace JL, Sharkey KA. Pharmacotherapy of Gastric Acidity, Peptic Ulcers and Gastroesophageal Reflux Disease. In: Brunton LL, Chabner BA, Knollmann BC, editors. Goodman & Gilman’s: The Pharmacological Basis of Therapeutics. 12th ed. New York, New York: McGraw-Hill Medical; 2011. Page - 1315.

3. Kudaravalli P, John S. Sucralfate. StatPearls [Internet]. NIH National Library of Medicine. National Center for Biotechnology Information. [Revised in February 2022] [Accessed on 18th October 2022] https://www.ncbi.nlm.nih.gov/books/NBK551527/

4. R N Brogden, R C Heel, T M Speight, G S Avery. Sucralfate. A review of its pharmacodynamic properties and therapeutic use in peptic ulcer disease. NIH National Library of Medicine. National Center for Biotechnology Information. Pubmed.gov 1984. [Accessed on 18th October 2022] https://pubmed.ncbi.nlm.nih.gov/6368184/#:~:text=Sucralfate%20is%20a%20basic%20aluminium%20salt%20of%20sulphated,effects%20of%20pepsin%2C%20acid%20and%20possibly%20bile%20salts.

5. Aptalis Pharma US, Inc. U.S. Food & Drug Administration. [Revised in March 2013] [Accessed on 18th October 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf

6. Sucralfate. Pharmaceutical Associates, Inc. [Revised in January 2022] [Accessed on 18th October 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=fa6e4661-1bee-4a64-b982-9d44dbdb8498&type=display

7. Sucralfate. Amneal Pharmaceuticals LLC. [Revised in February 2021] [Accessed on 18th October 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4350b771-76a9-4e00-93f0-a18c71288f83

8. Sucralfate. Aptalis Pharma Canada Inc. [Revised in September 2013] [Accessed on 18th October 2022] https://allerganwebcdnprod.azureedge.net/allergancanadaspecialty/allergancanadaspecialty/media/actavis-canada-specialty/en/products/pms/sulcrate_pm_12sep2013_eng.pdf

9. Zuventus Healthcare Ltd. Ancool SF (Sucralfate 500mg). [Accessed on 18th October 2022] http://www.zuventus.co.in/patient_wise_products_selected.aspx?Medi_Id=256

10. Fourrts India Laboratories Pvt Ltd. Sucralfate. [Accessed on 18th October 2022] https://www.fourrts.com/sucrafil/

11. Wellona Pharma. Sucralfate. [Accessed on 18th October 2022] https://wellonapharma.com/product/finished/sucralfate-suspension

USEFUL DIAGNOSTIC TESTS

• Kidney function test