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)
Response of feline eosinophilic plaques and lip ulcers to amoxicillin
trihydrate-clavulanate potassium therapy: a randomized, double-blind
placebo-controlled prospective study. [2012] In this study, we evaluated the treatment of feline eosinophilic plaques and lip
ulcers with amoxicillin trihydrate-potassium clavulanate (Clavamox(®); Pfizer
Animal Health). Nineteen cats with clinical and cytological findings consistent
with eosinophilic plaques and/or lip ulcers were enrolled...
Clinical and microbiological benefits of metronidazole alone or with amoxicillin as adjuncts in the treatment of chronic periodontitis: a randomized placebo-controlled clinical trial. [2011.09] AIM: To evaluate the effects of the adjunctive use of metronidazole (MTZ) or MTZ+amoxicillin (AMX) in the treatment of generalized chronic periodontitis (ChP)... CONCLUSION: The adjunctive use of MTZ+AMX offers short-term clinical and microbiological benefits, over SRP alone, in the treatment of non-smokers subjects with generalized ChP. The added benefits of MTZ were less evident. (c) 2011 John Wiley & Sons A/S.
Efficacy of amoxicillin treatment in preventing postoperative complications in patients undergoing third molar surgery: a prospective, randomized, double-blind controlled study. [2011.06] PURPOSE: The aim of the present study was to evaluate and compare the occurrence of postoperative complications in patients receiving either pre- or postoperative amoxicillin versus placebo after third molar surgery... CONCLUSION: Amoxicillin administered pre- or postoperatively demonstrated greater efficacy than placebo in preventing postoperative complications in patients undergoing third molar surgery. The best results were obtained using the postoperative protocol. Copyright (c) 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.
Treatment of streptococcal pharyngitis with once-daily amoxicillin versus intramuscular benzathine penicillin G in low-resource settings: a randomized controlled trial. [2011.06] BACKGROUND: Primary prevention of acute rheumatic fever is achieved by proper antibiotic treatment of group A beta -hemolytic streptococcal (GAS) pharyngitis... CONCLUSION: If compliance is a major issue, a single dose of IM BPG may be preferable for treatment of GAS pharyngitis.
Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. [2011.05.07] BACKGROUND: Researchers have suggested that antibiotics could cure acute appendicitis. We assessed the efficacy of amoxicillin plus clavulanic acid by comparison with emergency appendicectomy for treatment of patients with uncomplicated acute appendicitis... INTERPRETATION: Amoxicillin plus clavulanic acid was not non-inferior to emergency appendicectomy for treatment of acute appendicitis. Identification of predictive markers on CT scans might enable improved targeting of antibiotic treatment. FUNDING: French Ministry of Health, Programme Hospitalier de Recherche Clinique 2002. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Clinical Trials Related to Amoxil (Amoxicillin)
Bioequivalence of Two Commercial Amoxicillin Suspensions [Completed]
The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the
bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian
volunteers.
The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children [Recruiting]
The goal of this study is to determine whether amoxicillin (AMX) alone has an appreciable
effect on upper gastrointestinal motility compared to placebo. In particular, induction of
phase III of the interdigestive migrating motor complex (MMC) by AMX will be the primary
outcome of the study. MMCs are periodic waves of electrical activity resulting in muscular
contractions that pass through the walls of the stomach and intestinal tract during the
fasting state. It is characterized by an initial period where there is a minimal electrical
activity and muscular contraction (phase I), followed by a gradual increase in the frequency
of contractions (phase III) that often leads to a characteristic cluster of contractions
(phase III). This cycle occurs only in the fasting state in normal individuals and the
frequency of phase III is quite varied, dependent on age and the presence of any underlying
abnormalities in gastrointestinal motility. Secondary outcomes will include characteristics
of the MMC, patient demographics in responders and non-responders, and the safety profile of
AMX at the intervention dose.
Clarithromycin, Amoxicillin, and Metronidazole Based Regimens to Treat Helicobacter Pylori Infections in Colombia [Completed]
More than half of the world's population is infected with Helicobacter pylori, a bacterium
that colonizes the human stomach. Although most infected subjects live free of symptoms and
disease outcomes (except superficial gastritis), only a few develop peptic ulcers or gastric
cancer, while some others may develop non-ulcer dyspepsia. Current clinical practice for the
management of peptic ulcer disease includes testing for and treating H. pylori, if present.
Although there are triple therapies that contain 2 antibiotics plus a bismuth compound, a
proton-pump inhibitor, or a H2-receptor antagonist which are effective at eliminating H.
pylori in Europe and North America, these treatments are dramatically less effective in
developing countries. Our recent meta-analysis showed quadruple therapies containing
clarithromycin, amoxicillin, metronidazole and a proton pump inhibitor to be effective in
the presence of clarithromycin or metronidazole resistance. However, this regimen has yet to
be tested in a developing country. Therefore, in the current randomized clinical trial in
Pasto, Colombia, we aim to examine the effectiveness of clarithromycin, amoxicillin,
metronidazole with and without a proton pump inhibitor compared to the Food and Drug
Administration approved 10-day regimen containing clarithromycin, amoxicillin and
omeprazole. Since antibiotic therapy is most effective within a specific gastric pH range,
and since mutifocal atrophy results in damage and loss of the acid producing parietal cells,
we will test the efficacy of our modified therapy stratified by diagnosis of multifocal
atrophic gastritis.
Cotrimoxazole Versus Amoxicillin in the Treatment of Community Acquired Pneumonia in Children Aged 2-59 Months [Completed]
The investigators hypothesized that Oral amoxicillin (25mg/kg/dose bid) given to children
aged 2-59 months with pneumonia, would lead to better clinical outcome on day three in
89. 9% of the children compared to 77. 0% of children receiving oral cotrimoxazole (8
mg/kg/dose trimethoprim, 40 mg/kg/dose sulphamethoxazole). A double blind randomized
controlled trial was conducted in the Assessment Center of Mulago Hospital. Children with
non-severe pneumonia were randomized to receive either oral amoxicillin (25 mg/kg/dose) or
cotrimoxazole (trimethoprim 8 mg/kg and sulphamethoxazole 40 mg/kg) and followed up on day 3
and 5 of treatment. The primary outcome measures were normalization of respiratory rate by
day 3 of treatment. Secondary outcome measures were antimicrobial susceptibility to
cotrimoxazole and amoxicillin.
Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59 Months [Completed]
Many children with "non-severe pneumonia" (cough and fast breathing) have neither clinical
pneumonia as assessed by physicians nor pneumonia on chest radiographs. Inappropriate use of
antibiotics for these cases is leading to resistant strains of bacteria in the community.
Evidence shows that almost 50% of antibiotic prescription is unnecessary. As over half of
antibiotic prescription for ARI are not necessary since most of these infections are viral
and do not respond to antibiotic therapy which will be source of resistance in the
community.
To address this issue the investigators conducted this randomized, double blind placebo
controlled clinical trial of oral Amoxicillin versus placebo in children with non-severe
pneumonia taking into account all the necessary safety precautions for their well being.
The study hypothesis was that the clinical outcome of children 2 to 59 months of age with
cough and fast breathing (WHO defined non-severe pneumonia) with or without wheezing is
equivalent, whether they are treated with amoxicillin or placebo.
Reports of Suspected Amoxil (Amoxicillin) Side Effects
Nasopharyngitis (2),
Respiratory Disorder (2),
Malaise (2),
Blood Pressure Increased (2),
Angioedema (2),
Asthenia (2),
Skin Exfoliation (1),
Dermatitis Bullous (1),
Drug Dispensing Error (1),
Vomiting (1), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 23 ratings/reviews, Amoxil has an overall score of 6.83. The effectiveness score is 7.57 and the side effect score is 7.22. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| 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!! |
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| Amoxil review by care giver of 77 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Considerably Effective |
Side effects: | | Mild Side Effects | | Treatment Info |
Condition / reason: | | Throat infection and cough |
Dosage & duration: | | 250mg taken 3 times a day for the period of 5 days |
Other conditions: | | Fever |
Other drugs taken: | | Cophadyl-e cough lintus and serratiopeptidase (tolpa) | | Reported Results |
Benefits: | | It cleared the throat infection (painful throat when swallowing or even touching the neck) and cough significantly after 5 days, and totally cleared symptoms after 2 weeks. My 78-year-old mother could not tolerate many antibiotics. This is 1 of the few that she could take fortunately. |
Side effects: | | There was dry mouth, which was easily solved by taking lime juice or sour drinks. |
Comments: | | The treatment was easy as it involved swallowing tablets and drinking cough mixture. |
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| Amoxil review by 27 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Ineffective |
Side effects: | | Severe Side Effects | | Treatment Info |
Condition / reason: | | persistent chest infection symptoms |
Dosage & duration: | | unknown (dosage frequency: 1/day) for the period of 2 wks req'd but quit in 3 days b/c react |
Other conditions: | | none |
Other drugs taken: | | none | | Reported Results |
Benefits: | | None, presum,ably b/c I had to quit taking the drug before the prescription was completed due to side effects/ possible allergic reaction. |
Side effects: | | None - could not continue treatment |
Comments: | | Was supposed to take the drug for 2 weeks but had to stop after 3 days because of itchy rash and difiiculty breathing. |
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Page last updated: 2013-02-10
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