Registered Rwanda · Rwanda FDA

LUMECOAT

Sucralfate Oral Suspension

Rwanda FDA-HMP-MA-1992 SUSPENSION 1g/10mL INN generic

What it does

Sucralfate is a medicine used to treat stomach and intestinal problems by forming a protective layer over sores and ulcers.

Commonly used for: stomach ulcers (peptic ulcers), gastroesophageal reflux disease (GERD), intestinal ulcers

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
Rwanda FDA-HMP-MA-1992
Registration date
17/08/2024
Expiry date
16/08/2029
Status
Registered
Active ingredient
Sucralfate Oral Suspension
Dosage form
SUSPENSION
Strength
1g/10mL
Pack size
1
Therapeutic class
-
Manufacturer / MAH
Annora Pharma
Applicant / LTR
Hetero Labs Limited
Country of origin
INDIA
Manufacturer location
Sy. no. 261 Plot no. 13 to 14 Annaram Village, Jinnaram Mandal, dist, Hyderabad, Annaram, Telangana 502319, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:04 · updated 2026-09-17 02:30:43

Drug Interactions

13
Check interactions

Severe (1)

Sucralfate - increases risk of adverse effects

Sodium citrate is predicted to increase the risk of adverse effects when given with sucralfate. Avoid. Theoretical Sodium glucose co-transporter 2 inhibitors → see TABLE 14 p. 1520 (antidiabetic drugs

Severe Theoretical

Unknown (12)

Bictegravir - decreases exposure

Sucralfateispredictedtodecreasetheexposuretobictegravir. Avoid.oTheoretical

Unknown Theoretical

Coumarins - decreases effects

Sucralfate potentially decreases the effects of coumarins (warfarin). Separate administration by 2 hours.

Unknown Anecdotal

Digoxin - decreases absorption

Sucralfate decreases the absorption of digoxin. Separate administration by 2 hours.

Unknown Anecdotal

Dolutegravir - decreases absorption

Sucralfate decreases the absorption of dolutegravir. Domperidone → see TABLE 9 p. 1519 (QT-interval prolongation)

Unknown Study

Enteralfeeds - increases risk of blocked enteral or nasogastric tubes

Sucralfate increases the risk of blocked enteral or nasogastric tubes when given with enteral feeds. Separate administration by 1 hour.

Unknown Study

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Sucralfate is a medicine used to treat stomach and intestinal problems by forming a protective layer over sores and ulcers.

What it treats

  • stomach ulcers (peptic ulcers)
  • gastroesophageal reflux disease (GERD)
  • intestinal ulcers

How it works

It works by coating the lining of the stomach and intestines, helping to protect them from acid and allowing healing.

Who it's for

It is for adults and children who have ulcers or other stomach lining issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Sucralfate

BNF-referenced

Sucralfate is a gastroprotective agent primarily used in the treatment of gastric and duodenal ulcers. It is a complex of aluminum hydroxide and sulfated sucrose that forms a protective barrier over ulcerated mucosa, shielding it from gastric acid, pepsin, and bile. Sucralfate is often administered to promote healing in ulcerative conditions and prevent stress-related mucosal disease.

Indications

  • Gastric ulcers
  • Duodenal ulcers
  • Prophylaxis of stress ulceration
  • NSAID-associated ulcers

Dosage

Children: Refer to the BNF for Children for specific dosing information as it varies based on age and weight.

Adults: Adult: 1 g four times daily, taken on an empty stomach, or 2 g twice daily, depending on the clinical scenario. Maximum dosage is 8 g per day.

Mechanism of action

Sucralfate acts locally in the gastrointestinal tract. When it comes into contact with gastric acid, it undergoes a process of polymerization, forming a viscous gel that adheres to the ulcer site. This gel creates a physical barrier against further irritation and promotes healing by providing a conducive environment for repair. Additionally, sucralfate may stimulate mucosal defense mechanisms, including increased secretion of mucus and bicarbonate.

Pharmacodynamics

Sucralfate does not have systemic absorption; its effects are primarily localized within the gastrointestinal tract. The protective barrier it forms is effective against both acid and pepsin, reducing the damage to the mucosa and promoting ulcer healing. Its action is dose-dependent and requires administration on an empty stomach for optimal efficacy.

Pharmacokinetics

Sucralfate is minimally absorbed in the gastrointestinal tract, with over 90% of the administered dose remaining locally at the site of action. It has a half-life of approximately 6 to 12 hours, depending on the formulation and the individual patient's gastrointestinal transit time. It is excreted mainly in the feces and does not undergo significant hepatic metabolism.

Contra-indications

  • Hypersensitivity to sucralfate or any of its components
  • Patients with renal impairment (risk of aluminium accumulation)
  • Children under 16 years (risk of Reye's syndrome)

Adverse effects

  • Constipation
  • Dry mouth
  • Nausea
  • Headache
  • Vertigo
  • Gastrointestinal disturbances
  • Skin reactions
  • Discoloration of mucous membranes

Interactions

  • Sodium citrate: Severe interaction increasing risk of adverse effects
  • Bictegravir: Unknown interaction decreasing exposure
  • Warfarin: Unknown interaction decreasing effects
  • Digoxin: Unknown interaction decreasing absorption
  • Dolutegravir: Unknown interaction decreasing absorption
  • Enteral feeds: Unknown interaction increasing risk of blocked enteral or nasogastric tubes
  • Quinolones: Unknown interaction decreasing exposure
  • Coumarins: Unknown interaction decreasing effects
  • Sulpiride: Unknown interaction decreasing absorption
  • Theophylline: Unknown interaction decreasing absorption

Precautions

  • Caution in patients with renal impairment due to risk of aluminium accumulation
  • Caution in patients receiving enteral feeds due to risk of bezoar formation
  • Caution with concurrent use of other medications that may affect gastric pH

Pregnancy

Manufacturer advises to avoid unless essential; no information available regarding safety.

Breast-feeding

Amount probably too small to be harmful; limited information available.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets
  • Oral suspension
BNF 85 (British National Formulary) p.98 BNF for Children 2019-2020 p.77 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.