AUGMENTIN FOR ORAL SUSPENSION 457mg/5ml

Product Information

Registration Status: Active

AUGMENTIN FOR ORAL SUSPENSION 457mg/5ml is approved to be sold in Singapore with effective from 1998-06-19. It is marketed by GLAXOSMITHKLINE PTE LTD, with the registration number of SIN09832P.

This product contains Amoxycillin 400mg/5ml, and Clavulanic Acid 57mg/5ml in the form of POWDER, FOR SUSPENSION. It is approved for ORAL use.

This product is manufactured by SmithKline Beecham Limited trading as SmithKline Beecham Pharmaceuticals in FRANCE, andGlaxo Wellcome Production in UNITED KINGDOM.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Amoxycillin
Clavulanic Acid

Description

A broad-spectrum semisynthetic antibiotic similar to ampicillin except that its resistance to gastric acid permits higher serum levels with oral administration. Amoxicillin is commonly prescribed with clauvanic acid (a beta lactamase inhibitor) as it is susceptible to beta-lacatamase degradation.

Indication

For the treatment of infections of the ear, nose, and throat, the genitourinary tract, the skin and skin structure, and the lower respiratory tract due to susceptible (only b-lactamase-negative) strains of Streptococcus spp. (a- and b-hemolytic strains only), S. pneumoniae, Staphylococcus spp., H. influenzae, E. coli, P. mirabilis, or E. faecalis. Also for the treatment of acute, uncomplicated gonorrhea (ano-genital and urethral infections) due to N. gonorrhoeae (males and females).

Mechanism of Action

Amoxicillin binds to penicillin-binding protein 1A (PBP-1A) located inside the bacterial cell well. Penicillins acylate the penicillin-sensitive transpeptidase C-terminal domain by opening the lactam ring. This inactivation of the enzyme prevents the formation of a cross-link of two linear peptidoglycan strands, inhibiting the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that amoxicllin interferes with an autolysin inhibitor.

Pharmacokinetics

Absorption
Rapidly absorbed after oral administration.
Distribution
Metabolism
Hepatic metabolism accounts for less than 30% of the biotransformation of most penicillins
Elimination

Toxicity

Serious toxicity is unlikely following large doses of amoxicillin. Acute ingestion of large doses of amoxicillin may cause nausea, vomiting, diarrhea and abdominal pain. Acute oliguric renal failure and hematuria may occur following large doses.

Active Ingredient/Synonyms

(2S,5R,6R)-6-{[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid | 6-(p-hydroxy-α-aminophenylacetamido)penicillanic acid | Amox | Amoxicilina | Amoxicillin (anhydrous) | Amoxicillin anhydrous | Amoxicilline | Amoxicillinum | Amoxycillin | AX | p-Hydroxyampicillin | α-amino-p-hydroxybenzylpenicillin | Amoxicillin |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.


Description

Clavulanic acid and its salts and esters. The acid is a suicide inhibitor of bacterial beta-lactamase enzymes from Streptomyces clavuligerus. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with beta-lactam antibiotics prevents antibiotic inactivation by microbial lactamase. [PubChem]

Indication

For use with Amoxicillin, clavulanic acid is suitable for the treatment of infections with Staph. aureus and Bacteroides fragilis, or with beta-lactamase producing H. influenzae and E. coli.

Mechanism of Action

Clavulanic acid competitively and irreversibly inhibits a wide variety of beta-lactamases, commonly found in microorganisms resistant to penicillins and cephalosporins. Binding and irreversibly inhibiting the beta-lactamase results in a restauration of the antimicrobial activity of beta-lactam antibiotics against lactamase-secreting-resistant bacteria. By inactivating beta-lactamase (the bacterial resistance protein), the accompanying penicillin/cephalosporin drugs may be made more potent as well.

Pharmacokinetics

Absorption
75%
Distribution
Metabolism
Hepatic
Elimination

Toxicity

Gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients

Active Ingredient/Synonyms

(2R,3Z,5R)-3-(2-HYDROXYETHYLIDENE)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid | (Z)-(2R,5R)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic acid | acide clavulanique | ácido clavulánico | Acidum clavulanicum | Antibiotic MM 14151 | Clavulanic Acid | Clavulansäure | MM 14151 | Clavulanate |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank