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Penicillin V potassium is a slow-onset antibiotic that is used to treat many types of mild to moderate infections caused by bacteria, including scarlet fever, pneumonia, skin infections, and infections affecting the nose, mouth, or throat.

Penicillin V potassium is also used to prevent the symptoms of rheumatic fever. Penicillin V potassium is also used to prevent infections of the heart valves in people with certain heart conditions who need to have dental work or surgery. Penicillin V potassium may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking penicillin V potassium? You should not be treated with this medicine if you are allergic to penicillin.

Tell your doctor if you have ever had: an allergic reaction to a cephalosporin antibiotic (Keflex, Omnicef, and others); any type of allergy; asthma or breathing problems; a stomach or intestinal disorder; heart pms amoxicillin disease; or kidney disease. If you have stomach problems or are sick with severe vomiting or diarrhea, your medication may not be as effective. Penicillin V potassium oral liquid may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU). Tell your doctor if you are pregnant or breastfeeding.

Do not give this medicine to a child without medical advice. Follow all directions on your prescription label and read all medication guides or instruction sheets. You may take penicillin V potassium with or without food.

Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). When given before surgery or dental work, penicillin V potassium is usually taken 1 hour before and 6 hours after the procedure.

Follow your doctor's dosing instructions very carefully. Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Skipping doses can increase your risk of infection that is resistant to medication.

Penicillin V potassium will not treat a viral infection such as the flu or a common cold.

After you have finished all doses, your doctor may want to do tests to make sure your infection has completely cleared up. Store the tablets at room temperature away from moisture, heat, and light.

Take the medicine as

soon

as you can, but skip the missed dose if it is almost time for your next dose. Seek emergency medical attention or call

the

Poison Help line at 1-800-222-1222.

What should I avoid while taking penicillin V potassium?

Do not share this medicine with another person , even if they have the same symptoms you have. Antibiotic medicines can cause diarrhea, which may be a sign of a new infection.

If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine. What are the possible side effects of penicillin V potassium? Get emergency medical help if you have signs of an allergic reaction: hives; fever, chills, joint pain; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: severe

stomach

pain, diarrhea that is watery or bloody (even if it occurs months after your last dose); easy bruising or bleeding; pale or yellowed skin, dark colored urine; numbness, tingling, or burning pain; urination problems; or fever, swollen glands, itching, joint pain, or not feeling well.

Common side effects may include: nausea, vomiting, upset stomach; diarrhea; swollen, black, or "hairy" tongue; rash; or vaginal itching or discharge.

This is not a complete list of side effects and others may occur.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect penicillin V potassium?

Penicillin V potassium can make birth control pills less effective.

Ask

your

doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy. Other drugs may affect penicillin V potassium, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using. Your doctor or pharmacist can provide more information about penicillin V potassium. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc.

('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.

Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to,

and

not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate

for

any given patient.

Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. 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 (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 will not be allowed.

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 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 antibiotics after tooth extraction amoxicillin 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 effects.

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]. In addition, they can stimulate cells of the immune system, inducing the production of IL-12 by mononuclear cells of the peripheral blood [11]. They are also capable of converting cholesterol into coprostanol, which, being less soluble, can be excreted; this mechanism precludes its absorption and consequential increase in plasma [12]. and Bifidobacterium spp., when administered in food items known as probiotics [13-15], can survive the transit through the gastrointestinal tract and temporarily settle in the intestine [6], with a number of desirable effects on the immune system, such as stimulation of phagocytic function [16] and control of the balance of pro- and antiinflammatory cytokines [15]. Bifidobacteria constitute a numerically-important group that is capable of a wide variety of biological activities important for host health. One of these activities is an inhibitory effect against other species, often preventing colonization by invasive pathogens [17,18]. It has been suggested that the inhibitory mechanism is related to the production of acetic and lactic acids and other wide-spectrum antimicrobial compounds [19].

In fact, microorganisms of the genus Bacteroides are nutritionally versatile, being able to use a wide range of carbon sources. They are responsible for most of the digestion of polysaccharides that takes place in the large intestine [20,21].

play an important function in the mechanism of resistance to colonization by C. difficile [22]; they are found in large numbers in the large intestine [23].

Although the intestinal microflora remains relatively stable throughout life [8], factors such as disease and certain drugs can affect this balance [17]. This ecosystem can also be influenced by diet, geographical location, and gastrointestinal surgery [24]. Over the past years, studies have revealed the importance and participation of the intestinal microbiota in pathological processes, such as rheumatoid arthritis and atopic diseases [25-30]. Infections in the respiratory tract have also attracted the attention of investigators, as these infections are commonly seen in general clinical practice. Although antibiotics are routinely prescribed to treat such episodes, one result of antimicrobial therapy may be a reduction in the number of microorganisms that normally live in the gastrointestinal tract, which allows for an overgrowth of bacterial species that are already present and consequent colonization by potentially-pathogenic microorganisms [31].



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