API

Sucralfate (7% w/w)

Drug classification

Gastrointestinal agent; specific subclass: mucosal protectant (topical formulation for wound healing).

Dosage form

Topical cream containing 7% w/w sucralfate for external use.

API strength per dosage

Dose

Sucral Cream (sucralfate 7% w/w) is typically applied topically to affected areas 2–4 times daily. Safety and efficacy in children have not been established. Use with caution in patients with renal impairment due to potential aluminum accumulation. No specific hepatic dosing adjustments are documented. Avoid contact with eyes and mucous membranes.

Mechanism of action

Sucralfate forms a viscous, adhesive barrier by binding to positively charged proteins in ulcerated tissue, primarily albumin and fibrinogen, at the site of epithelial injury. This protective layer shields the area from acid, pepsin, and bile salts, promoting healing without significant systemic absorption or direct action on gastric acid secretion.

Indications

Treatment of Skin conditions with inflammation & itchingTreatment of Intestinal ulcersTreatment of Stomach ulcers

Side effects

Application site reactions burning irritation itching and redness

Pregnancy category

Limited human data; animal studies show no harm. Use in pregnancy only if clearly needed and benefits outweigh potential risks. Consult healthcare provider.

Precautions

Avoid use on infected or deep wounds, mucous membranes, or eyes, monitor for local hypersensitivity reactions, discontinue if irritation or rash develops, use caution in patients with known allergy to sucralfate or excipients, not for systemic use, safety in pregnancy and lactation not established.

Contraindications

Hypersensitivity to sucralfate or any component of the formulation, severe renal impairment due to risk of aluminum accumulation.