Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**DOSAGE AND ADMINISTRATION** _Adults:_ The usual adult oral dose is 1 tablet every 8 hours. Dosage may be adjusted according to the patient's age or symptoms.
ORAL
Medical Information
**INDICATIONS** _Susceptible organisms:_ \* _Staphylococcus aureus,_\* _Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, viridans_ group _Streptococcus, Enterococcus faecalis, Corynebacterium_ species, _Bacillus anthracis, Listeria monocytogenes, Clostridium_ species, _Peptococcus_ species, _Peptostreptococcus_ species \* _Escherichia coli,_ \* _Proteus mirabilis,_ \* _Proteus vulgaris,_ \* _Klebsiella_ species, \* _Salmonella_ species, \* _Shigella_ species, _Bordetella pertussis,_ \* _Yersinia enterocolitica, Gardnerella vaginalis, Brucella_ species, _Neisseria meningitidis,_ \* _Neisseria gonorrhoeae,_ \* _Moraxella catarrhalirococcus,_ \* _Haemophilus influenzae,_ \* _Haemophilus ducreyi, Pasteurella multocida, Campylobacter jejuni, Vibrio cholerae,_ \* _Bacteroides_ species ( \\* : Including _β_-lactamase producing organisms which are resistant to ampicillin and amoxicillin) _Indications:_ Acute & chronic bronchitis, lobar- & broncho-pneumonia, empyema, lung abscess, tonsillitis, sinusitis, otitis media Cystitis, urethritis, nephropyelitis Septic abortion, puerperal septicemia, pelvic cellulitis, chancroid, gonorrhea Furuncle & abscess, cellulitis, wound infection, intra-abdominal sepsis Peritonitis Osteomyelitis Septicemia Post-operative infection
**CONTRAINDICATIONS** Patients with hypersensitivity to penicillins Patients with contagious mononucleosis Patients with a history of penicillin-associated jaundice/hepatic dysfunction
J01CR02
amoxicillin and beta-lactamase inhibitor
Manufacturer Information
ZIWELL MEDICAL (S) PTE LTD
KOREA UNITED PHARMACEUTICAL INC
Active Ingredients
Documents
Package Inserts
Augmex Tabs. 375 mg proposed PI 25 Feb 2022.pdf
Approved: April 7, 2022