Ulfate Suspension

Indications

Ulfate is prescribed for adults and adolescents aged 14 and older for the management of:

• Duodenal Ulcer
• Gastric Ulcer
• Chronic Gastritis
• Prophylaxis of gastrointestinal hemorrhage due to stress ulceration in critically ill patients.

Always use this medication as directed by a registered healthcare professional.

Pharmacology

Sucralfate, the active ingredient in Ulfate, is classified as a non-systemic medication, as it is only minimally absorbed by the gastrointestinal tract. The small quantity that is absorbed is primarily eliminated through urine. Sucralfate aids in the healing of gastric and duodenal ulcers by forming a chemical complex that adheres to the ulcer site, creating a protective barrier. Additionally, it inhibits the effects of pepsin and bile.

Dosage

For Duodenal Ulcer, Gastric Ulcer, and Chronic Gastritis:

• Adults: The standard dosage is Sucralfate 2 grams taken twice daily—once in the morning and once at bedtime—or 1 gram taken four times daily, one hour before meals and at bedtime. The maximum recommended daily dose is 8 grams, but in resistant cases, treatment may extend up to twelve weeks.
• Pediatric Population: The safety and effectiveness of Sucralfate in children under 14 have not been established.
• Elderly: No special dosage adjustments are required for elderly patients; however, the lowest effective dose should always be utilized.

For Prophylaxis of Gastrointestinal Hemorrhage from Stress Ulceration:

• Adults: The usual dose is Sucralfate 1 gram, administered orally or via a nasogastric tube, 4 to 6 times daily. To avoid clogging of the nasogastric tube, flush with 10 ml of water after each dose. The duration of prophylactic treatment should be individualized and continued as long as the risk factors for stress ulceration are present, but generally not exceeding 14 days.

Always use this medication as directed by a registered healthcare professional.

Administration

Sucralfate should be taken on an empty stomach. Antacids should not be taken within 30 minutes of administering Sucralfate.

Always use this medication as directed by a registered healthcare professional.

Interaction

Co-administration of Ulfate may decrease the bioavailability of certain medications, including fluoroquinolones (Ciprofloxacin and Norfloxacin), tetracycline, ketoconazole, sulpiride, digoxin, warfarin, phenytoin, theophylline, levothyroxine, quinidine, and H2 antagonists. To restore the bioavailability of these agents, separate their administration from Ulfate by at least two hours. This interaction is believed to be non-systemic, likely due to Ulfate binding with these agents in the gastrointestinal tract. Ulfate should not be taken alongside citrate preparations, as this can increase aluminum blood concentrations due to chelation, enhancing absorption. When using Ulfate 1 gram with enteral feeds via nasogastric tube, a one-hour separation is recommended to prevent bezoar formation, which can occur when Ulfate and enteral feeds are administered too closely together.

Contraindications

Ulfate is contraindicated in individuals with a known hypersensitivity to sucralfate.

Side Effects

Common adverse reactions include headache (3.4%), nausea (2.3%), abdominal pain (2.3%), constipation (1.1%), diarrhea (1.1%), and urticaria (1.1%). Patients reporting bezoars often have underlying medical conditions predisposing them to this complication, such as delayed gastric emptying, or are receiving concurrent enteral tube feedings. Episodes of hyperglycemia have been observed in diabetic patients.

Pregnancy & Lactation

The safety of Sucralfate during pregnancy has not been established; it should only be used if clearly needed. It is also unknown whether Sucralfate is excreted in human milk. Caution is advised when administering this medication to breastfeeding women.

Precautions & Warnings

Ulfate should be used with caution in patients with renal dysfunction due to the risk of increased aluminum absorption. It is not recommended for individuals undergoing dialysis. For patients with severe or chronic renal impairment, Ulfate should be administered with extreme caution and only for short-term use. Small amounts of aluminum may be absorbed through the gastrointestinal tract, potentially leading to accumulation and associated conditions such as aluminum osteodystrophy, osteomalacia, encephalopathy, and anemia. Regular laboratory monitoring of aluminum, phosphate, calcium, and alkaline phosphatase levels is advised for patients with renal function impairment. Concurrent use of other aluminum-containing medications is not recommended due to the enhanced risk of aluminum absorption and toxicity. Bezoars have been reported mainly in severely ill patients, particularly in intensive care units.

Use in Special Populations

Pediatric Population: Ulfate is not recommended for children under 14 years due to insufficient safety and efficacy data.

Elderly Patients: No dose adjustments are necessary.

Renal Impairment: Use Ulfate cautiously in patients with renal insufficiency.

Effects on Driving and Operating Machinery: Patients should refrain from driving or operating machinery if experiencing dizziness or drowsiness.

Overdose Effects

In clinical trials involving healthy adults, most overdose cases of Ulfate were asymptomatic. However, some cases reported symptoms such as abdominal pain, nausea, and vomiting. Animal studies have not identified a lethal dose, even at doses as high as 12 gm/kg body weight, indicating minimal risk associated with overdose.

Therapeutic Class

Chelating Complex

Storage Conditions

Store Ulfate in a cool, dry place, away from light.