Amoxil (Amoxicillin) - Summary

AMOXIL SUMMARY

Dual Therapy

Formulations of AMOXIL contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms.

AMOXIL is indicated in the treatment of infections due to susceptible (ONLY (beta)-lactamase-negative) strains of the designated microorganisms in the conditions listed below:

Infections of the ear, nose, and throat --due to Streptococcus spp. ((alpha)- and (beta)-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. ((alpha)- and (beta)-hemolytic strains only), Staphylococcus spp., or E. coli.

Infections of the lower respiratory tract --due to Streptococcus spp. ((alpha)- and (beta)-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 recurrence

Triple Therapy:    AMOXIL/clarithromycin/lansoprazole

AMOXIL, 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 Therapy:    AMOXIL/lansoprazole

AMOXIL, 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.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXIL and other antibacterial drugs, AMOXIL 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. Indicated surgical procedures should be performed.

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NEWS HIGHLIGHTS

Published Studies Related to Amoxil (Amoxicillin)

Randomized controlled trial comparing oral amoxicillin-clavulanate and ofloxacin with intravenous ceftriaxone and amikacin as outpatient therapy in pediatric low-risk febrile neutropenia. [2009.09]
BACKGROUND: Outpatient oral therapy is infrequently used in pediatric low-risk febrile neutropenia (LRFN) as there is insufficient data regarding its equivalence as compared with parenteral therapy... CONCLUSIONS: Outpatient therapy is efficacious and safe in pediatric LRFN. There was no difference in outcome in oral versus IV outpatient therapy. Amoxycillin-clavulanate and ofloxacin may be the oral regimen of choice.

Reduced susceptibility to amoxicillin of oral streptococci following amoxicillin exposure. [2009.08]
As antibiotic pressure often triggers bacterial resistance, the use of short-duration therapies is increasingly recommended. The objective of the present study was to evaluate both the clinical efficiency and the impact on oral streptococci of a 3 day versus a 7 day amoxicillin therapy for odontogenic infection requiring tooth extraction...

Efficacy of the standard quadruple therapy versus triple therapies containing proton pump inhibitor plus amoxicillin and clarithromycin or amoxicillin-clavulanic acid and metronidazole for Helicobacter pylori eradication in children. [2009.08]
CONCLUSION: Considering these data we suggest quadruple therapy as the first line of therapy for eradication of H. pylori infection in children in our geographic area (Iran).

Effectiveness of amoxicillin/clavulanate potassium in the treatment of acute bacterial sinusitis in children. [2009.07]
OBJECTIVE: The role of antibiotic therapy in managing acute bacterial sinusitis (ABS) in children is controversial. The purpose of this study was to determine the effectiveness of high-dose amoxicillin/potassium clavulanate in the treatment of children diagnosed with ABS... CONCLUSIONS: ABS is a common complication of viral upper respiratory infections. Amoxicillin/potassium clavulanate results in significantly more cures and fewer failures than placebo, according to parental report of time to resolution of clinical symptoms.

Intravenous amoxicillin-sulbactam against Escherichia coli: optimizing the dose, component ratio and infusion time using a human pharmacodynamic model. [2009.06]
Amoxicillin-sulbactam (AMX-SUL) is an aminopenicillin/beta-lactamase inhibitor combination currently available in 29 countries which may be a suitable option for treating intra-abdominal infections. the aim of this study was to identify the optimal dose and ratio between components of this formulation through an ex-vivo human pharmacodynamic model against Escherichia coli...

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Clinical Trials Related to Amoxil (Amoxicillin)

Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications [Completed]
To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It was designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.

A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications [Completed]
To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It is designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.

Efficacy of Single Versus Double Dose of Oral Amoxicillin for Non-Severe Pneumonia in Children [Completed]
The World Health Organization’s (WHO) standard case management strategy for reducing acute respiratory infection (ARI) related mortality recommends oral cotrimoxazole and oral amoxicillin as first line drugs for the treatment of pneumonia. In 1989, the Pakistan Ministry of Health (MOH) adopted this strategy to control ARI mortality and recommended cotrimoxazole for treatment of outpatients pneumonia due to lower costs. A number of studies subsequently performed have shown significant in vivo and in vitro resistance of H. influenzae and S. pneumoniae, the commonest bacteria causing childhood pneumonia, to cotrimoxazole.

Although on a case by case basis for pneumonia, in vitro resistance does not correlate very well with in vivo failures, nevertheless, clinical failure rate for pneumonia therapy has increased in Pakistan over the years. One can hypothesize that if bacterial pneumonia is a certain proportion of all pneumonia cases, the rise in clinical failures may be related to increasing antimicrobial resistance. Therefore, it is probable that this rising clinical failure rate could be a reflection of increasing resistance. There may be an increase in antimicrobial resistance of S. pneumoniae and H. influenzae to amoxicillin over the period of years and the rising treatment failure could be a reflection of the rising minimum inhibitory concentrations (MIC’s) (> 2 mcg/ml for H. influenzae, 1993-94), thereby, resulting in this increasing failure rate.

For the current study the researchers propose a multicentre, randomized, controlled double blind trial in which standard versus double dose oral amoxicillin for three days for the treatment of non-severe pneumonia in children less than five years of age will be compared.

Primary Objective:

To compare the proportion of children 2 – 59 months of age presenting with non-severe pneumonia, who achieve clinical resolution on day 5 with standard (15 mg/kg/8hrly) versus double dose (30 mg/kg/8hrly) of oral amoxicillin therapy given for 3 days.

Secondary Objective:

To follow the clinical course of non-severe pneumonia with the alternative criteria of treatment failure (signs of deterioration i. e. lower chest indrawing and appearance of danger signs) on or before day 3 and compare them with other children who have persistent fast breathing (respiratory rate above the cut off for age) on day 3.

Hypothesis:

Therapy outcome with double dose of oral amoxicillin is not different than the standard dose of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2–59 months old children.

Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients [Completed]
Clinical research study to test amoxicillin and clavulanate tablet formulation for use in Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR in the body after it has been swallowed by children.

Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis [Completed]
To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).

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PATIENT REVIEWS / RATINGS / COMMENTS

Amoxil review by care giver of 46 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		strep throat
Dosage & duration:		500 mg 3 times/daily taken by mouth for the period of 10 days
Other conditions:		fever
Other drugs taken:		none
		Reported Results
Benefits:		the drug worked usually by the second dose. My daughter was up and around and feeling better immediatley it seemed. It had no side effects that she ever had. She could either take it on a full tomach or empty one.
Side effects:		There were no side effects that she ever had.
Comments:		I woudl give her a pill 3 times daily. She would take it right before school, right afterschool and then right before bedtime. It was easy to swallow and didn't amke her tired or sleepy, so she was able to function at school. It seemed to work tight away usually within the first day of treatment. It was great!!

Amoxil review by 19 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		a boil
Dosage & duration:		500mg 1 tablet after 8 hours taken as prescribed for the period of 5 days
Other conditions:		none other
Other drugs taken:		later given an anti acid
		Reported Results
Benefits:		the instructed me that by taking the antibiotic, it would surround the bacterias thus preventing further spread if the infections to other body parts.it really worked except that a nodule was left at the site of the boil. however, the drug gave me severe stomach aches due to gastritis before i went back to the physician to get some antiacids.
Side effects:		anti acids
Comments:		i was required to take drug for seven days. i only took it for 5 days and it still worked

Amoxil review by 17 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Glandular Fever
Dosage & duration:		250mg taken 3 times daily for the period of 7 days
Other conditions:		Swollen Glands, Mild Fever, Sore Throat, Headaches and Fatigue
Other drugs taken:		Nurofen
		Reported Results
Benefits:		Very little affects were felt on my throat
Side effects:		9 days after first taking Amoxil, full body hives appeared. Never before been allergic to Amoxil, or anything else. Itching was severe and uncontrollable.
Comments:		Was given the Amoxil without a blood test by not my usual doctor. After seeing my usual doctor he ordered a blood test, which found Glandular Fever was positive, and ordered me off the drugs. I had already, however taken the lot under the direction of first doctor.