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Basic Drug Info
Drug Name:Amoxicillin
Manufacturer:Sandoz Inc.
Other Info:CLINITEST is a registered trademark of Miles, Inc.CLINISTIX is a registered trademark of Bayer Corporation.CLOtest is a registered trademark of Kimberly-Clark Corporation.Manufactured by:Bristol-Myers Squibb CompanyPrinceton, NJ 08543Manufactured for:Sandoz, Inc.Broomfield, CO 80020Product of ItalyRev December 2007



Clinical Trials:


Indications and Usage

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY ?-lactamase-negative) strains of the designated microorganisms in the conditions listed below:Infections of the ear, nose, and throat due to Streptococcus spp.

(?- and ?-hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp., or H.

influenzaeInfections of the genitourinary tract due to E.

coli, P.

mirabilis, or E.

faecalisInfections of the skin and skin structure due to Streptococcus spp.

(?- and ?-hemolytic strains only), Staphylococcus spp., or E.

coliInfections of the lower respiratory tract due to Streptococcus spp.

(?- and ?-hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp.

or H.

influenzaeGonorrhea, acute uncomplicated (ano-genital and urethral infections) due to N.

gonorrhoeae (males and females)H.

pylori eradication to reduce the risk of duodenal ulcer recurrence
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Gonorrhea male --

Duodenal Ulcer -- A PEPTIC ULCER located in the DUODENUM.

Contraindications
A history of allergic reaction to any of the penicillins is a contraindication.
Allergic Reaction --

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY.

ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS.

THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.

THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS.

BEFORE INITIATING THERAPY WITH AMOXICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS.

IF AN ALLERGIC REACTION OCCURS, AMOXICILLIN SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED.

SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE.

OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.

difficile.C.

difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin-producing strains of C.

difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.

difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.

difficile, and surgical evaluation should be instituted as clinically indicated.
Branded Drugs
The following US Branded drugs contain Amoxicillin


AMOXIL -- GLAXOSMITHKLINE

TRIMOX -- APOTHECON INC DIV BRISTOL MYERS SQUIBB

TRIMOX -- APOTHECON SUB BRISTOL MYERS SQUIBB CO

UTIMOX -- PARKE DAVIS DIV WARNER LAMBERT CO

WYMOX -- WYETH AYERST LABORATORIES

AMOXICILLIN PEDIATRIC -- TEVA PHARMACEUTICALS USA INC

LAROTID -- GLAXOSMITHKLINE

POLYMOX -- APOTHECON INC DIV BRISTOL MYERS SQUIBB

MOXATAG -- MIDDLEBROOK PHARMACEUTICALS INC

DISPERMOX -- RANBAXY LABORATORIES LTD

PREVPAC -- TAKEDA PHARMACEUTICALS NORTH AMERICA INC

AMOXICILLIN AND CLAVULANATE POTASSIUM -- HIKMA PHARMACEUTICALS

AMOXICILLIN AND CLAVULANATE POTASSIUM -- LEK PHARMACEUTICALS D D

AMOXICILLIN AND CLAVULANATE POTASSIUM -- LEK PHARMACEUTICALS DD

AMOXICILLIN AND CLAVULANATE POTASSIUM -- MORTON GROVE PHARMACEUTICALS

AMOXICILLIN AND CLAVULANATE POTASSIUM -- RANBAXY LABORATORIES LTD

AMOXICILLIN AND CLAVULANATE POTASSIUM -- SANDOZ INC

AMOXICILLIN AND CLAVULANATE POTASSIUM -- TEVA PHARMACEUTICALS USA INC

AUGMENTIN '125' -- GLAXOSMITHKLINE

AUGMENTIN '200' -- GLAXOSMITHKLINE

AUGMENTIN '250' -- GLAXOSMITHKLINE

AUGMENTIN '400' -- GLAXOSMITHKLINE

AUGMENTIN ES-600 -- SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE

AUGMENTIN XR -- GLAXOSMITHKLINE

AMOXICILLIN AND CLAVULANATE POTASSIUM -- APOTEX INC

AMOXICILLIN AND CLAVULANATE POTASSIUM -- APOTEX INC ETOBICOKE SITE

AMOXICILLIN AND CLAVULANATE POTASSIUM -- RANBAXY PHARMACEUTICALS INC

AUGMENTIN '500' -- GLAXOSMITHKLINE

AUGMENTIN '875' -- GLAXOSMITHKLINE


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