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Basic Drug Info
Drug Name:Amoxicillin
Manufacturer:Aurobindo Pharma Limited
Other Info:

An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects.

Of the 1,811 subjects treated with capsules of amoxicillin, 85% were <60 years old, 15%  were ?61 years old and 7% were ?71 years old.

This analysis and other reported clinical experience 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.



Clinical Trials:


Indications and 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 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. 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), S.

pneumoniae, Staphylococcus spp., or H.

influenzae.Infections of the genitourinary tract – due to E.

coli, P.

mirabilis, or E.

faecalis.Infections of the skin and skin structure – due to Streptococcus spp.

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

coli.Infections of the lower respiratory tract – due to Streptococcus spp.

(?- and ?-hemolytic strains only), S.

pneumoniae, Staphylococcus spp., or H.

influenzae.Gonorrhea, acute uncomplicated (ano-genital and urethral infections) – due to N.

gonorrhoeae (males and females).H.

pylori eradication to reduce the risk of duodenal ulcer recurrenceTriple TherapyAmoxicillin/clarithromycin/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.

(See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)Dual TherapyAmoxicillin/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.

(See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.) Indicated surgical procedures should be performed.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Gonorrhea -- Acute infectious disease characterized by primary invasion of the urogenital tract. The etiologic agent, NEISSERIA GONORRHOEAE, was isolated by Neisser in 1879.

Gonorrhea male --

Helicobacter Pylori Infection --

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

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

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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