Prilosec 40mg
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Prilosec 40mg: Clinical Developments and Efficacy
Introduction to Prilosec 40mg
Prilosec (omeprazole) is a widely used proton pump inhibitor (PPI) that reduces stomach acid production. It is commonly prescribed for conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. The 40mg dosage is often used for more severe cases or specific clinical scenarios.
Development of Omeprazole/Antacid Powder Suspension
Santarus Inc. has been developing an immediate-release formulation of omeprazole combined with an antacid (sodium bicarbonate) known as Acitrel or Rapinex powder for oral suspension. This formulation aims to provide rapid relief from upper gastrointestinal (GI) conditions by leveraging the quick action of the antacid and the sustained effect of omeprazole1 3. The technology for this formulation is licensed from the University of Missouri, with additional licenses from Tulane and North Carolina Universities for potential GI treatments1 3.
Clinical Trials and Efficacy of Rapinex 40mg
Phase III Trial Results
In a phase III clinical trial, Rapinex 40mg was compared to intravenous cimetidine for preventing upper GI bleeding in critically ill patients. The trial included 359 adult patients and demonstrated positive results, indicating that Rapinex 40mg is effective in this setting1 3. This suggests that the immediate-release formulation can be a viable alternative to intravenous treatments, offering ease of administration and potentially better patient compliance.
Safety and Tolerability
An open-label clinical trial involving 243 patients, including 97 with gastric ulcers, evaluated the safety of Rapinex 40mg over an 8-week period. The results confirmed that the formulation is safe for use, with no significant adverse effects reported1 3. This trial supports the long-term use of Rapinex 40mg in managing upper GI conditions.
Regulatory and Patent Considerations
Santarus has been proactive in addressing regulatory and patent issues related to Rapinex 40mg. The company has provided notice to the NDA holder for Prilosec delayed-release capsules, asserting that Rapinex 40mg does not infringe on existing patents or that those patents are invalid1 3. This step is crucial for ensuring the smooth market entry and distribution of the new formulation.
Conclusion
Prilosec 40mg, particularly in the form of the immediate-release Rapinex powder, shows promise for treating upper GI conditions effectively and safely. Clinical trials have demonstrated its efficacy in preventing GI bleeding and managing gastric ulcers, with a favorable safety profile. As Santarus navigates regulatory and patent landscapes, Rapinex 40mg could become a significant addition to the therapeutic options available for GI diseases.
Sources and full results
Most relevant research papers on this topic
Omeprazole/antacid-powder suspension--Santarus: Acitrel, Rapinex Powder for oral suspension, SAN 05.
Santarus's omeprazole/antacid powder suspension, Acitrel, shows potential in preventing upper GI bleeding and has shown no patent infringement or invalidity.
A Prospective, Double-Blinded, Randomized, Clinical Trial Comparing the Efficacy of 40 Mg and 60 Mg Hyperbaric 2% Prilocaine Versus 60 Mg Plain 2% Prilocaine for Intrathecal Anesthesia in Ambulatory Surgery
Hyperbaric 2% prilocaine is comparable to plain prilocaine for sensory block onset, but shows faster motor block onset and shorter surgical block duration in ambulatory surgery.
RCTOmeprazole/Antacid-Powder Suspension — Santarus
Santarus Inc. is developing an immediate-release formulation of omeprazole in combination with an antacid (sodium bicarbonate) as a powder for suspension, known as AcitrelTM, and is considering alternative names for the product with the FDA.
Omeprazole/Antacid-powder suspension-Santarus: omeprazole/sodium bicarbonate powder-Santarus, SAN 05.
Santarus Inc. is developing an immediate-release omeprazole powder suspension (Acitrel) to treat gastrointestinal diseases, including gastrointestinal haemorrhage, gastro-oesophageal reflux disease, heartburn, and peptic ulcers.
Acid reduction in peptic ulcer disease. Choosing therapy according to drug interactions, individual response, and cost.
Omeprazole is an effective acid reducer, but cost and long-term safety concerns may prevent its widespread use.
American heart association scientific sessions 2012 american association for the study of liver disease: american college of rheumatology/association of rheumatology health professionals.
PA32540 effectively reduces treatment discontinuation due to gastrointestinal side effects, improving cardiovascular disease prevention in patients at risk of aspirin-associated gastric ulcers.
RCT
Large Human TrialAsthma and gastroesophageal reflux: acid suppressive therapy improves asthma outcome.
Acid suppressive therapy with omeprazole improves asthma symptoms and/or peak expiratory flow rates by >20% and pulmonary function in 73% of asthmatics with gastroesophageal reflux after 3 months of therapy.
Non-RCT
Highly CitedComparison of Prilosec OTCTM (omeprazole magnesium 20·6 mg) to placebo for 14 days in the treatment of frequent heartburn
Prilosec OTC (omeprazole magnesium 20-6 mg) is a safe and effective over-the-counter treatment for frequent heartburn when administered as a 14-day regimen.
RCTA Multicentre Randomized Controlled Trial of the Efficacy and Safety of Single-Dose Praziquantel at 40 mg/kg vs. 60 mg/kg for Treating Intestinal Schistosomiasis in the Philippines, Mauritania, Tanzania and Brazil
A higher dose of 60 mg/kg of praziquantel offers no significant efficacy advantage over standard 40 mg/kg for treating intestinal schistosomiasis caused by S. mansoni or S. japonicum.
RCTLarge Human Trial
Rigorous JournalHighly CitedThe curative of prilosec joint Mosapride on treating senile reflux esophagitis
Prilosec joint Mosapride effectively reduces stomach content of reflux in elderly patients, with a distinct curative effect and safe drug use.
RCT