Ulsicral

Ulsicral

sucralfate

Manufacturer:

Ikapharmindo
Full Prescribing Info
Contents
Sucralfate.
Description
Each 5 ml suspension contains Sucralfate 500 mg.
Action
Drug Action: Sucralfate is a complex formed by sucrose octasulfate and polyaluminium hydroxide. Sucralfate's antiulcer activity is the result of formation of an ulcer-adherent complex with proteinaceous exudates, that covers the ulcer site and protects it against further attack by gastric acid, pepsin, and bile salts. Laboratory as well as clinical studies showed that sucralfate accelerates healing of ulcers in three ways: Sucralfate forms an ulcer-adherent chemical complex with proteinaceous exudate at the ulcer site forming a protective layer; Sucralfate inhibits the activity of gastric acid, pepsin and bile salts; The sucralfate-albumin film provides a barrier to diffusion of gastric acid hydrogen ions.
Studies showed that sucralfate may remain for long periods of time in the digestive tract producing a long lasting drug effect.
Sucralfate is only minimally absorbed from the gastrointestinal tract, so that systemic effects are minimal.
Indications/Uses
ULSICRAL Suspension is indicated in the short-term (up to 8 weeks) treatment of duodenal ulcer.
Dosage/Direction for Use
The recommended adult dosage is 2 measuring spoons (10 ml) four times per day, on an empty stomach (1 hour before meals and bedtime).
Treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by X-ray or endoscopic examination.
Contraindications
There are no known contraindications to the use of sucralfate.
Special Precautions
ULSICRAL should be used with caution in patients with chronic renal failure and dialysis patients.
This drug should be used during pregnancy only if clearly needed. Caution should be exercised when ULSICRAL is administered to a lactating woman. Antacids may be prescribed if needed, but should not be taken within one-half hour before or after ULSICRAL.
Safety and effectiveness in pediatric patients have not been established.
Use In Pregnancy & Lactation
This drug should be used during pregnancy only if clearly needed. Caution should be exercised when ULSICRAL is administered to a lactating woman. Antacids may be prescribed if needed, but should not be taken within one-half hour before or after ULSICRAL.
Adverse Reactions
Side effects are rare. Constipation and dry mouth were the most frequent complaint reported. Other complaints include diarrhea, nausea, vomiting, gastric discomfort, flatulence, pruritus, rash, sleepiness, dizziness, back pain, and headache.
Drug Interactions
ULSICRAL administration may reduce the extent of absorption (bioavailability) of the following drugs: cimetidine, fluoroquinolone antibiotics (ciprofloxacin, norfloxacin), digoxin, ketoconazole, phenytoin, ranitidine, tetracycline, quinidine, L-thyroxine and theophylline, so that these medications should be given 2 hours before the administration of ULSICRAL.
Storage
Store in a dry place below 25°C.
ATC Classification
A02BX02 - sucralfate ; Belongs to the class of other drugs used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Oral susp 500 mg/5 mL x 100 mL x 1's, 200 mL x 1's.
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