Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - amoxicillin trihydrate 0,5741 g - eq. amoxicillin 500 mg - powder for oral suspension - 500 mg/5 ml - amoxicillin trihydrate - amoxicillin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

aurobindo sa-nv - amoxicillin trihydrate 573,892 mg - eq. amoxicillin 500 mg - film-coated tablet - 500 mg - amoxicillin trihydrate 573.892 mg - amoxicillin

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - amoxicillin trihydrate,potassium clavulanate -

Canada - English - Health Canada

4349121 canada inc - amoxicillin (amoxicillin trihydrate) - capsule - 500mg - amoxicillin (amoxicillin trihydrate) 500mg - aminopenicillins

New Zealand - English - Medsafe (Medicines Safety Authority)

miro healthcare limited - amoxicillin trihydrate 575mg equivalent to amoxicillin 500 mg;  ;   - capsule - 500 mg - active: amoxicillin trihydrate 575mg equivalent to amoxicillin 500 mg     excipient: brilliant blue fcf carmoisine croscarmellose sodium gelatin ink magnesium stearate methyl hydroxybenzoate propyl hydroxybenzoate purified water quinoline yellow sodium laurilsulfate sunset yellow fcf   titanium dioxide   - amoxicillin is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: upper respiratory infections: otitis media, pharyngitis, sinusitis and tonsillitis. lower respiratory infections: bronchitis, bronchopneumonia and lobar pneumonia. urinary tract infections: cystitis, cysto-pyelitis, urethritis, and gonococcal urethritis. prophylaxis: against ?-haemolytic (viridans group) and ?-haemolytic streptococci before dental, oral or upper respiratory tract surgery or instrumentation. prophylaxis: of bacterial endocarditis in patients with any of the following conditions: congenital cardiac malformations, rheumatic and other acquired valvular lesions, prosthetic heart valves, previous history of bacterial endocarditis, hypertrophic cardiomyopathy, surgically constructed systemic-pulmonary shunts, mitral valve prolapse with valvular regurgitation or mitral valve prolapse without valvular regurgitation but associated with thickening and/or redundancy of the valve

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - amoxicillin trihydrate, quantity: 574 mg (equivalent: amoxicillin, qty 500 mg); potassium clavulanate, quantity: 149 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose; sodium lauryl sulfate; cetyl alcohol - short-term treatment of bacterial infections at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms: skin and skin structure infections. urinary tract infections (complicated and uncomplicated). upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxycillin/clavulanic acid tablet preparations. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptible studies. once these results are known, therapy should be adjusted if appropriate. the treatment of mixed infections cause by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxycillin/clavulanic acid tablet preparations should not require the addition of another antibiotic due to the amoxycillin content of these products.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

noumed life sciences ltd - amoxicillin trihydrate - oral capsule - 500mg

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

industrial veterinaria s.a. - amoxicillin trihydrate 500 mg/g - eq. amoxicillin 435,6 mg/g - powder for use in drinking water - 500 mg/g - amoxicillin trihydrate 500 mg/g - amoxicillin - pig; poultry

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 250 mg - adults and pediatric patients - upper respiratory tract infections of the ear, nose, and throat: amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (only β-lactamase-negative) isolates of streptococcus species. (α- and β-hemolytic isolates only), streptococcus pneumoniae , staphylococcus spp., or haemophilus influenzae . - infections of the genitourinary tract: amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (only β-lactamase-negative) isolates of escherichia coli , proteus mirabilis , or enterococcus faecalis . - infections of the skin and skin structure: amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (only β-lactamase-negative) isolates of streptococcus spp. (α- and β-hemolytic isolates only), staphylococcus spp., or e. coli . - infections of the lower respiratory tract: amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (only β-lactamase-negative) isolates of streptococcus spp. (α- and β-hemolytic isolates only), s. pneumoniae , staphylococcus spp., or h. influenzae . adult patients only - helicobacter pylori infection and duodenal ulcer disease: triple therapy for helicobacter pylori (h. pylori) with clarithromycin and lansoprazole: amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate h. pylori . eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. dual therapy for h. pylori with lansoprazole: amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (see the clarithromycin package insert, microbiology.) eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. usage to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by 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. amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or stevens-johnson syndrome) to amoxicillin or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). there was no evidence of harm to the fetus due to amoxicillin. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed. oral ampicillin is poorly absorbed during labor. it is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention. penicillins have been shown to be excreted in human milk. amoxicillin use by nursing mothers may lead to sensitization of infants. caution should be exercised when amoxicillin is administered to a nursing woman. the safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients. the safety and effectiveness of amoxicillin for the treatment of h. pylori infection have not been established in pediatric patients. because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (3 months or younger) [see dosage and administration (2.3)] . an analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. these analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (gfr less than 30 ml/min). see dosing in renal impairment (2.5) for specific recommendations in patients with renal impairment.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - amoxicillin trihydrate, quantity: 1005 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; silicon dioxide; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose - short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. skin and skin structure infections. urinary tract infections (uncomplicated and complicated). upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to apx-amoxicillin/clavulanic acid 875/125 tablets. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. once these results are known, therapy should be adjusted if appropriate. the treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to apx-amoxicillin/clavulanic acid 875/125 tablets should not require the addition of another antibiotic due to the amoxycillin content of apx-amoxicillin/clavulanic acid 875/125 tablets. short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. skin and skin structure infections. urinary tract infections (uncomplicated and complicated). upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to curam/muric tablets. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. once these results are known, therapy should be adjusted if appropriate. the treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to curam/muric tablets should not require the addition of another antibiotic due to the amoxycillin content of curam/muric tablets.