Cvs amoxicillin over the counter

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AUGMENTIN™ in Dental Infections (AUGDENT) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S.

Study Details Tabular View Study Results Disclaimer How to Read a Study Record.

Condition or disease Intervention/treatment Phase Focal Infection, Dental Drug: Amoxicillin/clavulanate Drug: Clindamycin Phase 4.

This two-arm, parallel, comparative, observer blind, randomised study will be performed in adult subjects both male and female ?18 years of age who present with acute odontogenic infection with or without abscess. A total of 472 subjects will be randomised in 1:1 ratio to get 205 evaluable subjects in each study arm.

After obtaining informed consent, subject will undergo surgical intervention including surgical incisions, drainages, removal of the involved tooth, debridement, puncture lavage or trephination, if deemed necessary by the Investigator.

These surgical interventions will be performed before the start of study treatment.

On Day 0 after confirming the eligibility, subjects will be randomised to either of the study arms.

The treatment duration of the study will be at least 5 days which may increase to 7 days, if Investigator feels the need of continuing the treatment at Day 5.

In such cases clinical assessment will be done again at Day 7.

Thus the efficacy evaluation will be performed at baseline (Day 0) prior to study drug administration and on Day 5 and/ or 7.

Safety laboratory evaluations will be performed at Screening Visit and will be repeated at end of study treatment i.e.

On Baseline, Day 2, Day 5 and/ or Day 7, Visual Analogue Scale buy amoxicillin 250mg (VAS) will be used to measure amount of pain and swelling that a subject will experience. Zero would mean "No pain" and 10 would mean "Worst possible pain".

The subject will be asked to choose the most appropriate score on VAS which best describes his/her pain status over last 24 hours.

While using VAS for swelling, zero would mean "No swelling" and 10 would mean "Maximum possible swelling".

The Investigator will choose the most appropriate score on VAS which best describes subject's swelling.

Sample for microbiological culture will be obtained at the discretion of Investigator while performing the surgical procedure. When microbiological culture is indicated and feasible, two sets (each consisting of aerobic and anaerobic media) will be obtained. This sampling will be done in approximately 80 subjects randomly who will provide consent at Screening.

The sample will be collected and dispatched in appropriate transport medium to the central laboratory for culture and antibiotic susceptibility.

Protocol waivers or

exemptions

The total duration of each subject's participation will be 6-9 days including Screening period of 0-1 day (Day -1 to Day 0) and Treatment period of 5-7 days (Day 0 to Day 5-7).

The primary objective of the study is to compare clinical efficacy (cure and improvement) of both the treatment arms which uses VAS for assessment of pain and swelling.

Since the clinical efficacy parameters are subjective, it is mandatory to keep the observer/Investigator blinded during the study assessment.

In addition, designing blinded study is challenging owing to different dosage regimen and formulation of study drugs.

The study design of double blind double dummy is not recommended in view of increased pill burden which in turn can have an impact on treatment compliance.

The possibility of over-encapsulation is ruled out due to large pill size of amoxicillin + clavulanic acid. Therefore to maintain blinding of Investigators, the study is designed as observer blind with Investigator remaining blinded throughout the study

period

An unblinded study team member will be appointed for each site who will be involved in dispensing of the study drugs to subjects.

The unblinded study team member will remain present during subject assessment for all study visits and will ensure that Investigator remains blinded to treatment assignment. Study treatment includes amoxicillin + clavulanic acid (875mg/125mg) two times daily or clindamycin (150mg) four times daily for 5-7 days both administered orally with meal. Augmentin™ (amoxicillin + clavulanic acid) from GSK and Dalacin-C (clindamycin) from Pfizer will be used as study treatments.

The contents of the label will be in accordance with all applicable regulatory requirements.

Patients can receive additional medical penicillin and amoxicillin together therapy such as analgesics or anti-inflammatory drugs. However, opioid analgesics and any other antibiotic apart from study drugs will not be permitted during entire study period.

This study will be conducted in accordance with ICH GCP, all applicable subject privacy requirements, and the ethical principles that are outlined in the Declaration of Helsinki 2008, including IRB/ IEC review and approval of study protocol and any subsequent amendments, subject informed consent and Investigator reporting requirements.

Maria Tereza Ferreira Duenhas Monreal I ; Paulo Camara Marques Pereira II ; Carlos Alberto de Magalhaes Lopes II.

I Federal University of Mato Grosso do Sul (UFMS), Campo Grande, MS II State University of Sao Paulo (UNESP); Botucatu, SP, Brazil.

The intestinal tract harbors a huge diversity of metabolically-active aerobic and anaerobic bacteria that interact, forming a complex ecosystem. This microbiota has an important role in human metabolism, nutrition, immunity, and protection against colonization by pathogenic microorganisms.

Several factors can influence the intestinal microbiota; these include age, diet, inflammatory and infectious processes, and the use of antimicrobials.

We investigated the influence of bacterial infection of the respiratory tract and of amoxicillin therapy on the normal intestinal microbiota of patients.

Bacterial infectious processes affecting the respiratory tract were found to influence the intestinal microbiota, significantly decreasing the number of colony-forming units (CFUs) of Bacteroides spp. The use of amoxicillin also influenced the intestinal microbiota, significantly decreasing the CFU of Bifidobacterium spp. Changes in the composition of the intestinal microbiota need to be observed, since a decrease in the normal microorganisms can pose a number of hazards for hosts, including decreased resistance to colonization. With proper follow-up, health-care teams can minimize such hazards by implementing suitable therapy- and diet-related measures, thus reducing the occurrence of detrimental effects on the gastrointestinal ecosystem. Key Words: Intestinal microbiota, bifidobacterium, bacteroides, lactobacillus. The gastrointestinal tract harbors a huge diversity of aerobic and anaerobic bacteria that interact in a complex ecosystem [1]. This microflora comprises 400 to 500 metabolically-active bacterial species, which have a pronounced impact on the host's intestinal function and health [2,3]. There is evidence that the dominant profile of anaerobic bacteria usually found in adults is established in the first four years of life [4].

Overall, intestinal bacteria can be grouped into species that have detrimental effects on the host and species that have

beneficial

The detrimental effects include diarrhea, infections, liver damage, carcinogenesis, and intestinal putrefaction.

Inhibition of harmful bacteria (a mechanism known as 'resistance to colonization') [5], stimulation of the immune system, improvements in the digestion and absorption of essential nutrients, and vitamin synthesis are examples of the protective effects brought about by the intestinal microbiota [6]. The normal microbiota acts as a barrier, preventing colonization by potentially pathogenic microorganisms and an overgrowth of microorganisms that are already present, such as yeasts, which can cause systemic infections in immunodepressed patients, and Clostridium difficile , which can be a cause of diarrhea and pseudomembranous colitis [7,8]. Microorganisms of the genera Bifidobacterium and Lactobacillus perform a variety of functions important for the host's health.

Whereas microorganisms of the genus Bacteroides have beneficial as well as detrimental effects [9], those of the genus Lactobacillus contribute to sustaining resistance to colonization, possibly by producing acetic and lactic acids, which lower intestinal pH, thus preventing overgrowth of many potentially pathogenic microorganisms, whose spread is curbed by intestinal acidity. also produce hydrogen peroxide, which prevents the development of yeasts ( Candida albicans ) [10].