Augmentin Es-600
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Questions & Answers
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 AUGMENTIN ES-600 POWDER FOR ORAL SUSPENSION, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AUGMENTIN ES-600 POWDER FOR ORAL SUSPENSION 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/clavulanate potassium, 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.
AUGMENTIN ES-600 Powder for Oral Suspension should be used with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of amoxicillin/clavulanate potassium 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.)
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or
M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors:
- antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:
- age ≤ 2 years
- daycare attendance
[See CLINICAL PHARMACOLOGY, Microbiology.]
NOTE: Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. AUGMENTIN ES-600 Powder for Oral Suspension is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥ 4 mcg/mL.
Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC ≤ 2 mcg/mL) and the β-lactamase–producing organisms listed above.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN ES-600 Powder for Oral Suspension and other antibacterial drugs, AUGMENTIN ES-600 Powder for Oral Suspension 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.
History
There is currently no drug history available for this drug.
Other Information
AUGMENTIN ES-600 Powder for Oral Suspension 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 C16H19N3O5S•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:
Powder for Oral Suspension- Colloidal silicon dioxide, strawberry cream flavor, xanthan gum, aspartamea, sodium carboxymethylcellulose, and silicon dioxide.
a See PRECAUTIONS—Information for the Patient/Phenylketonurics.
Each 5 mL of reconstituted 600 mg/42.9 mg per 5 mL oral suspension of AUGMENTIN ES-600 contains 0.23 mEq potassium.
Sources
Augmentin Es-600 Manufacturers
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Dr Reddys Laboratories Inc
![Augmentin Es-600 (Amoxicillin And Clavulanate Potassium) Powder, For Suspension [Dr Reddys Laboratories Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Augmentin Es-600 | Dr Reddys Laboratories Inc
AUGMENTIN ES-600 Powder for Oral Suspension, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of AUGMENTIN. AUGMENTIN ES-600 Powder for Oral Suspension contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of AUGMENTIN contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of AUGMENTIN should not be substituted for AUGMENTIN ES-600 Powder for Oral Suspension as they are not interchangeable.
Dosage: Pediatric patients 3 months and older:Based on the amoxicillin component (600 mg/5 mL), the recommended dose of AUGMENTIN ES-600 Powder for Oral Suspension is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of AUGMENTIN ES-600 Powder for Oral Suspension providing 90 mg/kg/day 8 3.0 mL twice daily 12 4.5 mL twice daily 16 6.0 mL twice daily 20 7.5 mL twice daily 24 9.0 mL twice daily 28 10.5 mL twice daily 32 12.0 mL twice daily 36 13.5 mL twice daily Pediatric patients weighing 40 kg and more:Experience with AUGMENTIN ES-600 Powder for Oral Suspension in this group is not available.
Adults:Experience with AUGMENTIN ES-600 Powder for Oral Suspension in adults is not available and adults who have difficulty swallowing should not be given AUGMENTIN ES-600 Powder for Oral Suspension in place of the 500-mg or 875-mg tablet of AUGMENTIN.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral Suspension:Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
AUGMENTIN ES-600 Powder for Oral Suspension Bottle Size Amount of Water
Required for Reconstitution 75 mL 70 mL 125 mL 110 mL 200 mL 180 mLEach teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist:For patients who wish to alter the taste of AUGMENTIN ES-600 Powder for Oral Suspension, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of AUGMENTIN ES-600 Powder for Oral Suspension. The resulting suspension is stable for 10 days under refrigeration. Stability of AUGMENTIN ES-600 Powder for Oral Suspension when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the 5 flavors listed above.
Administration:To minimize the potential for gastrointestinal intolerance, AUGMENTIN ES-600 Powder for Oral Suspension should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when AUGMENTIN ES-600 Powder for Oral Suspension is administered at the start of a meal.
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