DRUGS & SUPPLEMENTS
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Regel-SO (Sucralfate) is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis(hydrogen sulfate), aluminum complex.
R = SO Al(OH) 3 2
Tablets for oral administration contain 1 g of Regel-SO (Sucralfate).
Regel-SO (Sucralfate) is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine.
Although the mechanism of sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent:
These observations suggest that sucralfate’s antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1 g dose of Regel-SO (Sucralfate).
Regel-SO (Sucralfate) is indicated in:
There are no known contraindications to the use of Regel-SO (Sucralfate).
Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with Regel-SO can result in complete healing of the ulcer, a successful course of treatment with Regel-SO (Sucralfate) should not be expected to alter the posthealing frequency or severity of duodenal ulceration.
Some studies have shown that simultaneous Regel-SO administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and Regel-SO (Sucralfate) therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of Regel-SO (Sucralfate) to chronic warfarin therapy.
The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from Regel-SO (Sucralfate) binding to the concomitant agent in the gastrointestinal tract. In all case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before Regel-SO (Sucralfate) eliminated the interaction. Because of the potential of Regel-SO (Sucralfate) to alter the absorption of some drugs, Regel-SO (Sucralfate) should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.
Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose).
There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Regel-SO is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Regel-SO (Sucralfate) tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. DOSAGE AND ADMINISTRATION
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. PRECAUTIONS Special Populations Chronic Renal Failure and Dialysis Patients
Adverse reactions to Regel-SO (Sucralfate) in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with Regel-SO (Sucralfate) tablets, 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 the patients are listed below by body system:
Due to limited experience in humans with overdosage of Regel-SO (Sucralfate), no specific treatment recommendations can be given. Acute oral toxicity studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Regel-SO (Sucralfate) is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing Regel-SO (Sucralfate) overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.
Depending on the reaction of the Regel-SO after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Regel-SO not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Regel-SO addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology