Index
It is used to treat and prevent duodenal ulcers. As determined by your doctor, Ulcogant may also be used to treat other conditions.
This medicine works by forming a barrier or lining over the ulcer. This protects the ulcer from stomach acid, allowing the ulcer to heal. Ulcogant contains an aluminum salt.
Ulcogant is available only with a prescription from your doctor.
Once a drug has been approved for marketing for a particular use, experience may show that it is useful for other medical problems as well. Although these uses are not listed on the product labeling, Ulcogant is used in certain patients with the following medical conditions:
- Gastric ulcers
- Gastroesophageal reflux disease (a condition in which acid from the stomach is reintroduced into the esophagus).
- Stomach or intestinal ulcers resulting from stress or trauma damage or from damage caused by medications used to treat rheumatoid arthritis.
Ulcogant indications
Ulcogant Tablets, USP are indicated in:
- Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with Ulcogant can occur during the first week or two, treatment should be continued for 4 to 8 weeks, unless healing has been demonstrated by X-ray or endoscopic examination.
- Maintenance therapy for duodenal ulcer patients at reduced doses after acute ulcer healing.
How should the Ulcogant be used?
Use Ulcogant as directed by your doctor. Check the drug label for exact dosing instructions:
- Take Ulcogant by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
- Before each use, shake well.
- Use a marked measuring device for medication dosing. If you are not sure how to measure your dose, ask your doctor or pharmacist for help.
- Ulcogant should only be taken orally. DO NOT inject the Ulcogant.
- Do not take an antacid for at least 30 minutes before or after taking Ulcogant.
- It may take 4 to 8 weeks for your ulcer to heal completely. Keep taking Ulcogant for the full treatment, even if you feel better.
- Do not take Ulcogant at the same time as other medicines. Take Ulcogant at least 2 hours after other medications. If you are unsure of the best time to take Ulcogant, ask your doctor or pharmacist.
- If you miss a dose of Ulcogant, take it as soon as possible. If it is almost time for your next dose, go back to your regular dosing schedule. Do not take 2 doses at the same time.
Ulcogant is used to treat stomach ulcers, intestinal ulcers, and inflammation of the stomach.
Description of the Ulcogant
Each tablet contains 1g of Ulcogant.
- Ulcogant (Iselpin) is a white amorphous powder that is soluble in strong acids and alkalis but practically insoluble in water and alcohol. It is a basic aluminum complex of sucrose octasulfate.
- Ulcogant is α-D-glucopyranoside, β-D-fructofuranosyl, octakis (hydrogen sulfate), aluminum complex. Its molecular formula is C 12 H m Al 16 O N S 8 ( m and n are approximately 54 and 75, respectively, resulting in an average molecular weight of approximately 2,086 daltons).
Ulcogant dosage
Usual Adult Dose for Duodenal Ulcer
- 1 g orally on an empty stomach 4 times a day or alternatively.
- 2 g orally on an empty stomach 2 times a day.
Usual Adult Dose for Duodenal Ulcer Prophylaxis
- 1 g orally on an empty stomach twice a day.
Usual Adult Dose for Gastric Ulcer
- 1 g orally on an empty stomach 4 times a day.
Usual Adult Dose for Gastroesophageal Reflux Disease
- 1 g orally on an empty stomach 4 times a day.
Usual Adult Dose for Stress Ulcer Prophylaxis
- 1 g orally on an empty stomach every 4 to 6 hours.
Usual Adult Dose for Stomatitis
- 1 g (10 ml) topically as a suspension 4 times a day.
Usual Adult Dose for Hyperphosphatemia in Renal Failure
- 1 g orally on an empty stomach twice a day.
This dose can be titrated based on serum phosphate levels.
Usual pediatric dose for stomatitis
The safety and efficacy of this medicine in pediatric patients have not been established. However, the use of Ulcogant may be appropriate in some situations.
- More than 1 year: 250 to 500 mg (2.5 to 5 mL) topically as a suspension 4 times a day for the treatment of stomatitis.
Precautions
While short-term therapy with Ulcogant may result in complete healing of a duodenal ulcer, a successful course of treatment with Ulcogant should not be expected to alter the frequency or severity of duodenal ulceration after healing.
When Ulcogant is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of Ulcogant with other aluminum-containing products, such as aluminum-containing antacids, may increase the total body burden of aluminum in the body.
Patients with normal kidney function receiving the recommended doses of Ulcogant and concomitant medications excrete aluminum adequately in the urine.
Patients receiving dialysis or those with chronic renal failure have impaired excretion of absorbed aluminum. Furthermore, aluminum does not pass through dialysis membranes because it is bound to albumin and transfers plasma proteins.
Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal failure. Ulcogant should be used with caution in patients with chronic renal failure.
In general, dose selection for elderly patients should be cautious, generally starting at the lower end of the dosage range, reflecting the greater frequency of decreased liver, kidney, or heart function, and concomitant disease or other treatment. pharmacological.
Ulcogant is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be higher in patients with kidney failure.
Because the elderly are more likely to have decreased kidney function, care must be taken in dose selection, and monitoring of kidney function may be helpful.
Other comments on the drug
Treatment with this medication should be continued for approximately 4 to 8 weeks, depending on the disease and severity.
Interactions with other medications
Some studies have shown that the simultaneous administration of Ulcogant in healthy volunteers reduces the degree of absorption (bioavailability) of single doses of the following:
- Cimetidine.
- Digoxin.
- Fluoroquinolone antibiotics.
- Ketoconazole.
- Thyroxine.
- Phenytoin
- Quinidina.
- Ranitidine.
- Tetracycline
- Theophylline
Subtherapeutic prothrombin times with concomitant warfarin and Ulcogant therapy have been reported in published and spontaneous case reports.
However, two clinical studies have shown no changes in serum warfarin concentration or prothrombin time with the addition of Ulcogant to chronic warfarin therapy.
The mechanism of these interactions appears to be non-systemic in nature, presumably as a result of the binding of Ulcogant to the concomitant agent in the gastrointestinal tract.
In all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dose the concomitant medication 2 hours before Ulcogant eliminated the interaction.
Due to the potential of Ulcogant to alter the absorption of some drugs, Ulcogant should be administered separately from other drugs when alterations in bioavailability are considered critical. In these cases, patients must be properly monitored.
Ucolgant side effects
Adverse reactions to Ulcogant tablets in clinical trials were minor and rarely led to drug discontinuation. In studies involving more than 2,700 patients treated with Ulcogant, adverse effects were reported in 129 (4.7%). Constipation was the most frequent complaint (2%).
Other adverse effects reported in less than 0.5% of patients are listed below by body system:
- Gastrointestinal: diarrhea, dry mouth, flatulence, gastric upset, indigestion, nausea, vomiting.
- Dermatological: itching, rash.
- Nervous system: dizziness, insomnia, drowsiness, vertigo.
- Other: back pain, headache.
Post-marketing reports of hypersensitivity reactions, including urticaria (urticaria), angioedema, respiratory distress, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving Ulcogant tablets.
Similar events were reported with Ulcogant. However, a causal relationship has not been established. Cases of hyperglycemia have been reported with Ulcogant.
Bezoars have been reported in patients treated with Ulcogant. Most of the patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feeding.
Inadvertent injection of insoluble Ulcogant and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Ulcogant is not designed for intravenous administration.
Ulcogant contraindications
- Known hypersensitivity to Ulcogant or to any of the excipients in Ulcogant.
- Dialysis patients (long-term administration of Ulcogant may cause aluminum accumulation and toxicity. Aluminum toxicity has been implicated in encephalopathy and osteomalacia).
