Amoxicillin

Generic Name: Amoxicillin

Brand Names: Amoxil, Augmentin, Clavulin, Moxatag, Omeclamox, Prevpac, Talicia, Voquezna 14 Day Dualpak 20;500, Voquezna 14 Day Triplepak 20;500;500

Drug Type: Small Molecule

Chemical Formula: C_₁₆H_₁₉N_₃O_₅S

CAS Number: 26787-78-0

Unique Ingredient Identifier: 9EM05410Q9

Background: Amoxicillin, or BRL-2333, is a penicillin G derivative first described in the literature in 1972. Amoxicillin has similar activity to penicillin and ampicillin, but leads to higher serum concentrations than ampicillin.

Amoxicillin was granted FDA approval on 18 January 1974.

Indication: Amoxicillin alone is indicated to treat susceptible bacterial infections of the ear, nose, throat, genitourinary tract, skin, skin structure, and lower respiratory tract. Amoxicillin is given with calvulanic acid to treat acute bacterial sinusitis, community acquired pneumonia, lower respiratory tract infections, acute bacterial otitis media, skin and skin structure infections, and urinary tract infections. Amoxicillin is given with omeprazole in the treatment of Helicobacter pylori (H. pylori) infection.

Amoxicillin is used in combination with vonoprazan and clarithromycin as co-packaged triple therapy or in combination with vonoprazan as co-packaged dual therapy to treat H. pylori infection in adults.

Associated Conditions: Acute Bacterial Sinusitis (ABS), Acute Otitis Media (AOM), Bacterial Infections, Community Acquired Pneumonia (CAP), Duodenal ulcer caused by helicobacter pylori, Genitourinary tract infection, Helicobacter Pylori Infection, Lower Respiratory Tract Infection (LRTI), Peptic Ulcer With H. Pylori Infection, Sinusitis, Skin and Subcutaneous Tissue Bacterial Infections, Urinary Tract Infection, Acute, uncomplicated Gonorrhea, Ear, nose, and throat infections

Clinical Trials

FDA Approves Sulopenem Etzadroxil/Probenecid (Orlynvah) for Uncomplicated UTIs

7 months ago

• The FDA has approved sulopenem etzadroxil and probenecid (Orlynvah) for uncomplicated urinary tract infections (uUTIs) in adult women with limited oral treatment options. • Backed by Phase 3 SURE 1 and REASSURE trials, Orlynvah demonstrated efficacy against _E. coli, K. pneumoniae_, and _P. mirabilis_, including antibiotic-resistant strains. • As the first oral penem approved in the US, Orlynvah offers a novel alternative in the underserved uUTI market, addressing a critical need for new treatment options. • The drug is administered orally twice daily for 5 days but is not indicated for complicated UTIs or intra-abdominal infections.

Drug Development Updates

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