MedPath
HSA Approval

AUGMEX TABLET 375 mg

SIN11639P

AUGMEX TABLET 375 mg

AUGMEX TABLET 375 mg

August 20, 2001

ZIWELL MEDICAL (S) PTE LTD

ZIWELL MEDICAL (S) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantZIWELL MEDICAL (S) PTE LTD
Licence HolderZIWELL MEDICAL (S) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

CLAVULANATE POTASSIUM

125 mg

Clavulanic acid

AMOXICILLIN

250 mg

Amoxicillin

Documents

Package Inserts

Augmex Tabs. 375 mg proposed PI 25 Feb 2022.pdf

Approved: April 7, 2022

Download

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

AUGMEX TABLET 375 mg - HSA Approval | MedPath