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Amoclan (Amoxicillin / Clavulanate Potassium) - Summary

 
 



AMOCLAN SUMMARY

Amoxicillin and clavulanate potassium for oral suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the "ß-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a ß-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of ß-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated ß-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins.

Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors:

  • antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:
      –age ≤2 years
    • –daycare attendance

[See CLINICAL PHARMACOLOGY, Microbiology.]

NOTE: Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium for oral suspension, 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥4 mcg/mL.

Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC ≤2 mcg/mL) and the β-lactamase–producing organisms listed above.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.


See all Amoclan indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Amoclan (Amoxicillin / Clavulanic Acid)

Study finds steroid therapy benefits patients with pneumonia
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Source: MedicineNet Adenoids and Tonsils Specialty [2015.05.04]
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New research offers the potential of new treatments for Toxoplasma-induced pneumonia and cystic fibrosis
Source: Cystic Fibrosis News From Medical News Today [2015.05.01]
The research has discovered a link between a vital pumping system that does not function correctly in people with cystic fibrosis and the parasite Toxoplasma.

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Published Studies Related to Amoclan (Amoxicillin / Clavulanic Acid)

Amoxicillin/clavulanic acid-warfarin drug interaction: a randomized controlled trial. [2011.02]
AIMS: To investigate whether an interaction exists between amoxicillin/clavulanic acid (amoxiclav) and warfarin in patients treated with stable oral anticoagulant therapy... CONCLUSION: Amoxiclav did not modify anticoagulation in patients treated with stable warfarin therapy and without infection. (c) 2011 The Authors. British Journal of Clinical Pharmacology (c) 2011 The British Pharmacological Society.

Clinical and microbiological efficacy of moxifloxacin versus amoxicillin/clavulanic acid in severe odontogenic abscesses: a pilot study. [2009.01]
The aim of this study targeted the evaluation of the in vivo effect of moxifloxacin in the treatment of patients with severe odontogenic abscesses. This was a prospective, two-armed, randomised, unblinded, monocentric pilot study, which enrolled 21 hospitalized patients with severe odontogenic abscesses.

Prophylaxis versus pre-emptive treatment for infective and inflammatory complications of surgical third molar removal: a randomized, double-blind, placebo-controlled, clinical trial with sustained release amoxicillin/clavulanic acid (1000/62.5 mg). [2007.04]
The most common complications after surgical extraction of the third mandibular molar are trismus, oedema or swelling, local pain, dysphagia and infection. The aim of this comparative, double-blind, randomized clinical trial was to evaluate the efficacy of two sustained release amoxicillin/clavulanate regimens in the reduction of infection after third molar extractive surgery...

Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections: results of the RELIEF study. [2013]
regimens in patients with diabetic foot infections (DFIs)... CONCLUSION: Moxifloxacin has shown favorable safety and efficacy profiles in DFI

Moxifloxacin vs amoxicillin/clavulanic acid in outpatient AECOPD: maestral results. [2011.12.01]
Bacterial infections causing acute COPD exacerbations (AECOPD) frequently require antibacterial treatment. More evidence is needed to guide antibiotic choice.MAESTRAL was a multiregional, randomised, double-blind non-inferiority outpatient study... Both therapies were well tolerated.

more studies >>

Clinical Trials Related to Amoclan (Amoxicillin / Clavulanic Acid)

Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry [Completed]
The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.

A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults [Terminated]
The primary outcome measure is to compare efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults in clinical and biological cure. The cure rate will be evaluated at the second visit (14 days after the inclusion visit)

Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media) [Completed]
This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the information on proper use, such as safety and efficacy, under actual use conditions, targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media. ("CLAVAMOX" is a trademark of the GlaxoSmithKline group of companies.)

Amoxicillin-Clavulanic Acid 400 mg-57 mg Chewable Tablets Under Fasting Conditions [Completed]
The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under fasting conditions.

Amoxicillin-Clavulanic Acid 400 mg-57 mg Chewable Tablets Under Non-Fasting Conditions [Completed]
The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under fed conditions.

more trials >>


Page last updated: 2015-08-11

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