1.AUGMENTIN HISTORY
(How was Augmentin discovered?)

Augmentin is a product of GlaxoSmithKline.

The US FDA approved Augmentin in April 2002. 

Augmentin is an antibiotic, which is utilized to fight bacteria in the body. In general, it is being used to treat various forms of bacterial infections such as infections of the skin, bronchitis, sinusitis or urinary tract infections.

Augmentin belongs to the medical class of the penicillins.

Note: World-drugs.net sells generic version of Augmentin

2.AUGMENTIN FACTS

GlaxoSmithKline (GSK) is a premier research-based pharmaceutical company with a powerful combination of skills and resources that provides a platform for delivering strong growth in today's rapidly changing healthcare environment.

GSK's aim is to improve the quality of human life by helping people to do more, feel better and live longer.

GlaxoSmithKline is headquartered in the UK and has operations based in the US ; the new company is one of the industry leaders, with an estimated seven per cent of the world's pharmaceutical market.

GSK also has leadership in four major therapeutic areas - anti-infectives, central nervous system (CNS), respiratory and gastro-intestinal/metabolic. In addition, it is a leader in the important area of vaccines and has a growing portfolio of oncology products.

GSK also has a Consumer Healthcare portfolio comprising over-the-counter (OTC) medicines; oral care products and nutritional healthcare drinks, all of which are among the market leaders. 

3.ABOUT AUGMENTIN MEDICATION

What are antibiotics?

An antibiotic is a drug that kills or slows the growth of bacteria. Antibiotics are one class of "antimicrobials", a larger group, which also includes anti-viral, anti-fungal, and anti-parasitic drugs. They are relatively harmless to the host, and therefore can be used to treat infections. The term originally described only those formulations derived from living organisms, in contradistinction to "chemotherapeutic agents", which were purely synthetic. Nowadays the term "antibiotic" is also applied also to synthetic antimicrobials, such as the sulfonamides.

Antibiotics are labeled as "magic bullets": drugs, which target disease without harming the host. Antibiotics are not effective in viral, fungal and other nonbacterial infections, and individual antibiotics vary widely in their effectiveness on various types of bacteria. Some specific antibiotics target either gram-negative or gram-positive bacteria, and others are more wide-spectrum antibiotics.

The effectiveness of individual antibiotics varies with the location of the infection, the ability of the antibiotic to reach the site of infection, and the ability of the bacteria to resist or inactivate the antibiotic. Some antibiotics actually kill the bacteria (bactericidal), whereas others merely prevent the bacteria from multiplying (bacteriostatic) so that the host's immune system can overcome them.

Classes of Antibiotics?
There are many ways to classify antibiotics.

One such classification is by chemical structure:

Aminoglycosides

• Amikacin
• Dibekacin
• Gentamicin
• Kanamycin
• Neomycin
• Netilmicin
• Paromomycin
• Sisomycin
• Streptomycin
• Tobramycin

Beta-lactam ring antibiotics

Carbapenems

• Ertapenem
• Imipenem
• Meropenem

Cephalosporins and cephamycins

• Cephalexin
• Cefazolin
• Cefuroxime
• Cefadroxil
• Ceftazidime

Penicillins

• Amoxicillin
• Augmentin

Monocyclic beta-lactams

Glycopeptide antibiotics

• Vancomycin
• Teicoplanin
• Ramoplanin
• Decaplanin

Oxazolidinones

• Linezolid
• Quinupristin/dalfopristin

Polyketides

Macrolides

• Erythromycin
• Azithromycin
• Clarithromycin
• Roxithromycin

Ketolides

• Telithromycin

Tetracyclines

• Doxycycline
• Oxytetracycline
• Chlortetracycline

Polymyxins

• Polymyxin B
• Colistin  

Quinolones (fluoroquinolones)

• Nalidixic acid
• Ciprofloxacin (Cipro)
• Ofloxacin
• Norfloxacin (Norflox)
• Levofloxacin (Levaquin)
• Trovafloxacin (Trovan)

Streptogramins

Sulfonamides

• Prontosil  

Other important antibiotics:

• Chloramphenicol
• Clindamycin
• Fusidic acid
• Trimethoprim

Another such classification is by their mechanism of action

Antibiotics, which interfere with cell-wall synthesis

Beta-lactams, including penicillins like Amoxicillin and cephalosporins; mono-lactams, such as Imipenem; vancomycin, bacitracin

Antibiotics that interfere with bacterial protein synthesis

Antibiotics that bind to the 50S ribosomal unit

Lincosamides/lincosides including clindamycin and lincomycin; chloramphenicol, macrolides

Antibiotics, which interfere the 30S ribosomal unit

Tetracyclines; aminoglycosides including gentamicin

Drugs that inhibit folate synthesis

Sulfonamides and trimethoprim

Drugs that interfere with DNA synthesis

Metronidazole, quinolones, novobiocin

Drugs that interfere with RNA synthesis

Rifampin (rifampicin)

Drugs that interfere with cell membrane function

Polymyxin B, gramicidin

Antibiotics can also be classified by the organisms against which they are effective, and by the type of infection in which they are useful, which depends on the sensitivities of the organisms that most commonly cause the infection and the concentration of antibiotic obtainable in the affected tissue.

How does Augmentin work?

Augmentin is an antibiotic that is a combination of a penicillin (Amoxicillin) and a substance called clavulanic acid. Augmentin kills bacteria, by interfering with their ability to form cell walls. The bacteria therefore break up and die.

clavulanic acid is an antibiotic used for its ability to enhance the effectiveness of other Antibiotics, such as the penicillins. It achieves this by blocking the chemical defences some bacteria have against some penicillins, known as beta-lactamase.

The addition of clavulanic acid to Amoxicillin makes Augmentin active against bacterial infections which have become resistant to Amoxicillin.

Uses of Augmentin

Augmentin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

• Lower Respiratory Tract Infections caused by ß-lactamase producing strains of H. influenzae and M. catarrhalis.
• Otitis Media caused by ß-lactamase producing strains of H. influenzae and M. catarrhalis.

Sinusitis caused by ß-lactamase producing strains of H. influenzae and M. catarrhalis.

Skin and Skin Structure Infections caused by ß-lactamase producing strains of S. aureus, E. coli, and Klebsiella spp.

• Urinary Tract Infections caused by ß-lactamase–producing strains of E. coli, Klebsiella spp., and Enterobacter spp.

4.AUGMENTIN EFFECTIVENESS
(When is Augmentin best taken?)

Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of Augmentin. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of Amoxicillin. While Augmentin can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state. In 1 study, the relative bioavailability of clavulanate was reduced when Augmentin was dosed at 30 and 150 minutes after the start of a high-fat breakfast. The safety and efficacy of Augmentin have been established in clinical trials where Augmentin was taken without regard to meals.

Amoxicillin serum concentrations achieved with Augmentin are similar to those produced by the oral administration of equivalent doses of Amoxicillin alone. The half-life of Amoxicillin after the oral administration of Augmentin is 1.3 hours and that of clavulanic acid is 1.0 hour.

Approximately 50% to 70% of the Amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of a single 250-mg or 500-mg tablet of Augmentin.

Concurrent administration of probenecid delays Amoxicillin excretion but does not delay renal excretion of clavulanic acid.

Neither component in Augmentin is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and Amoxicillin approximately 18% bound.

Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like Amoxicillin, is well distributed in body tissues.

5.AUGMENTIN EFFECTS ON SPECIAL POPULATION
(How do different people react to Augmentin?)

Teratogenic effects

Reproduction studies performed in pregnant rats and mice given Augmentin at oral dosages up to 1,200 mg/kg/day, equivalent to 7,200 and 4,080 mg/m2/day, respectively (4.9 and 2.8 times the maximum human oral dose based on body surface area), revealed no evidence of harm to the fetus due to Augmentin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Oral ampicillin-class Antibiotics are generally poorly absorbed during labor. Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions, and duration of contractions; however, it is not known whether the use of Augmentin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary. In a single study in women with premature rupture of fetal membranes, it was reported that prophylactic treatment with Augmentin may be associated with an increased risk of necrotizing enterocolitis in neonates.

Nursing Mothers

Ampicillin-class Antibiotics are excreted in the milk; therefore, caution should be exercised when Augmentin is administered to a nursing woman.

6.AUGMENTIN EFFECTS ON MEDICAL CONDITIONS
(How does Augmentin affect your existing condition/ailment?)

Augmentin should not be used if you suffer from liver or kidney disease or have a history of allergies. 

7.OTHER/ALTERNATE USES OF AUGMENTIN
(What else does Augmentin treat?)

Augmentin can also be used for animal bites and abdominal infections.

8.ADVERSE/SIDE EFFECTS of AUGMENTIN
(What are the side effects of Augmentin?)

Augmentin is generally well tolerated. The majority of side effects observed in clinical trials were of a mild and transient nature and less than 3% of patients discontinued therapy because of drug-related side effects. The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). The overall incidence of side effects, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported reactions include: Abdominal discomfort, flatulence, and headache.

The following adverse reactions have been reported:

Gastrointestinal

Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black "hairy" tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.

Hypersensitivity Reactions

Skin rashes, pruritus, urticaria, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme (rarely Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin.

Liver

A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class Antibiotics but the significance of these findings is unknown. Hepatic dysfunction, including increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been infrequently reported with Augmentin. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications.

Renal

Interstitial nephritis and hematuria have been reported rarely. Crystalluria has also been reported.

Hemic and Lymphatic Systems

Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in less than 1% of the patients treated with Augmentin. There have been reports of increased prothrombin time in patients receiving Augmentin and anticoagulant therapy concomitantly.

Central Nervous System

Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely.

Miscellaneous

Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.