The Meals and Drug Management (FDA) has authorized Endoâs Abbreviated New Drug Software (ANDA) for the primary generic edition of PyleraÂ® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) tablets.
Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride tablets are indicated to be used, together with omeprazole, for the remedy of sufferers with Helicobacter pylori (H. pylori) an infection and duodenal ulcer illness (energetic or historical past of inside the previous 5 years) to get rid of H. pylori.Â
Each and every pill incorporates 140mg of bismuth subcitrate potassium, 125mg of metronidazole, a nitroimidazole antimicrobial, and 125mg of tetracycline hydrochloride, a tetracycline magnificence antimicrobial. The product is equipped as a ten day treatment pack containing 10 blister playing cards, with every card containing 12 tablets for a complete of 120 tablets.
Par Prescription drugs introduced that transport of the generic product has commenced.
- Endo launches first generic edition of PyleraÂ® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) tablets. Information free up. Endo World %. Accessed March 10, 2023. https://www.prnewswire.com/news-releases/endo-launches-first-generic-version-of-pylera-bismuth-subcitrate-potassium-metronidazole-tetracycline-hydrochloride-capsules-301768573.html.
- Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride tablets. Bundle insert. Endo World %; 2023. Accessed March 10, 2023. https://www.endodocuments.com/paperwork/Bismuth/Bismuth_PI.pdf.
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