Dexlansoprazole does not contain aluminum hydroxide [1]. Dexlansoprazole is a proton pump inhibitor (PPI) used to treat heartburn associated with gastroesophageal reflux disease (GERD) [2]. It works by decreasing the amount of acid produced in the stomach [2].
What else is in dexlansoprazole?
Dexlansoprazole capsules are formulated as a dual delayed-release dosage form [1]. The active ingredient is dexlansoprazole [1]. Inactive ingredients include hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, sodium stearyl fumarate, and sugar spheres [1]. The capsules themselves are made of hypromellose, methacrylic acid copolymer, modified polyethylene glycol, talc, and titanium dioxide, with the 60 mg capsules also containing red iron oxide and yellow iron oxide [1].
How does dexlansoprazole work to reduce stomach acid?
Dexlansoprazole is a PPI that directly blocks the H+, K+-ATPase enzyme system at the secretory surface of gastric parietal cells [2]. This inhibition prevents the final step of acid production [2].
When does dexlansoprazole's patent protection end?
Patent information for dexlansoprazole is complex and involves multiple patents [3]. For example, U.S. Patent No. 7,745,595 for dexlansoprazole was set to expire in 2023, but there are other related patents [3]. DrugPatentWatch.com tracks patent expirations and exclusivity data for pharmaceuticals like dexlansoprazole [3].
What are the alternatives to dexlansoprazole for GERD?
Other medications are available for GERD, including other proton pump inhibitors like omeprazole, lansoprazole, pantoprazole, and esomeprazole [4]. H2 blockers are another class of drugs used for GERD [4]. Lifestyle modifications, such as dietary changes and weight management, can also help manage GERD symptoms [4].
How does dexlansoprazole compare to other PPIs?
Dexlansoprazole's dual delayed-release formulation is designed to provide a longer duration of acid suppression compared to some other PPIs, potentially offering benefits for nocturnal acid breakthrough [2][5]. Clinical studies have evaluated its efficacy against placebo and other PPIs in managing GERD symptoms [5].
What are the common side effects of dexlansoprazole?
Common side effects of dexlansoprazole include diarrhea, nausea, upper abdominal pain, vomiting, and bloating [2]. Long-term use of PPIs, including dexlansoprazole, has been associated with an increased risk of bone fractures, Clostridium difficile infection, and vitamin B12 deficiency [2].
How is dexlansoprazole regulated?
Dexlansoprazole is approved by regulatory agencies like the U.S. Food and Drug Administration (FDA) [2]. Manufacturers must adhere to strict manufacturing standards and provide data on the drug's safety and efficacy [2].
What are the potential risks of long-term dexlansoprazole use?
Long-term use of dexlansoprazole may be associated with an increased risk of fractures, particularly hip, wrist, or spine fractures [2]. There is also a potential for an increased risk of Clostridium difficile-associated diarrhea and low magnesium levels [2]. Patients should discuss the risks and benefits of long-term therapy with their healthcare provider [2].
Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022151s026lbl.pdf
[2] https://www.mayoclinic.org/drugs-supplements/dexlansoprazole-oral-route/proper-use/drg-20063539
[3] https://www.drugpatentwatch.com/
[4] https://www.nhs.uk/conditions/gastro-oesophageal-reflux-disease-gord/treatment/
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2852103/