Amoxicillin And Calvulanate Potassium
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Side Effects & Adverse Reactions
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH AMOXICILLIN AND CLAVULANATE POTASSIUM, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS AMOXICILLIN AND CLAVULANATE POTASSIUM SHOULD BE DISCONTINUED AND THE APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin and clavulanate potassium tablets, and has ranged in severity from mild to life-threatening, therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic associated colitis."
After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Amoxicillin and clavulanate potassium should be used with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of amoxicillin and clavulanate potassium tablets 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. (See CONTRAINDICATIONS and ADVERSE REACTIONS― Liver.)
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
To reduce the development of drug-resistant bacteria and maintain the effevtiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or trevent infections tat 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 modigying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Amoxicillin and clavulanate potassium tablets are 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 β-lactamase-producing strains of H. influenzae and M. catarrhalis.
Otitis Media- caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.
Sinusitis- caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections- caused by β-lactamase-producing strains of S. aureus, E. coli, and Klebsiella spp.
Urinary Tract Infections- caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp.
While amoxicillin and clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin and clavulanate potassium due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin and clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin and clavulanate potassium. (See Microbiology.)
Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin and clavulanate potassium tablets, should be performed together with any indicated surgical procedures.
History
There is currently no drug history available for this drug.
Other Information
Amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets(chewable) is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6- aminopenicillanic acid. The amoxicillin molecular formula is C 16H19N3O5S•3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z )-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4- oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:
Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as clavulanate potassium* or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as clavulanate potassium*. In addition, each film coated tablet containing 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as clavulanate potassium* and 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as clavulanate potassium* salt contains 0.63 mEq potassium.
*The potassium salt of clavulanic acid.
Inactive Ingredients: colloidal silicon dioxide, eudragit E 100, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, talc and titanium dioxide.
Sources
Amoxicillin And Calvulanate Potassium Manufacturers
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American Health Packaging
![Amoxicillin And Calvulanate Potassium (Amoxicillin And Clavulanate Potassium) Tablet [American Health Packaging]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Amoxicillin And Calvulanate Potassium | American Health Packaging
Since both the amoxicillin an clavulanate potassium tablets 250 mg/125 mg and amoxicillin and clavulanate potassium tablets 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg; therefore, two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.
Dosage:Adults: The usual adult dose sis one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium table 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 8 hours. Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the amoxicillin and clavulanate potassium tablet 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or amoxicillin and clavulanate potassium tablets 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or amoxicillin and clavulanate potassium tablets 250 mg/125 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or amoxicillin and clavulanate potassium tablets 250 mg125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Pediatric Patients:Pediatric patients weighing 40 kg or more should be dosed according to the adult recommendations. Due to the different amoxicillin to clavulanate acid ratios in the amoxicillin and clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablet 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
Administration:Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
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