Amoxicillin And Clavulanate Potassium Suspension
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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 AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, 600 MG/42.9 MG PER 5 ML, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, 600 MG/42.9 MG PER 5 ML 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.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL 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
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL 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. Amoxicillin and Clavulanate Potassium for oral suspension, 600 mg/42.9 mg per 5 mL 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 amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL 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
Amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the ß-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 ß-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of ß-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated ß-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:
Inactive Ingredients: Powder for Oral Suspension— Aspartame, colloidal silicon dioxide, hypromellose, orange powder flavor, silicon dioxide, succinic acid, xanthan gum.
- See PRECAUTIONS–Information for the Patient/Phenylketonurics.
Each 5 mL of reconstituted suspension contains 600 mg amoxicillin as the trihydrate and 42.9 mg clavulanic acid as the potassium salt (clavulanate potassium).
Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL contains 0.248 mEq potassium.
Sources
Amoxicillin And Clavulanate Potassium Suspension Manufacturers
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West-ward Pharmaceutical Corp
![Amoxicillin And Clavulanate Potassium Suspension [West-ward Pharmaceutical Corp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Amoxicillin And Clavulanate Potassium Suspension | West-ward Pharmaceutical Corp
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/28.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions of amoxicillin and clavulanate potassium should not be substituted for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, as they are not interchangeable.
DosagePediatric patients 3 months and older: Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium for oral suspension, 600 mg/42.9 mg per 5 mL 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 dailyPediatric patients weighing 40 kg and more: Experience with amoxicillin and clavulanate potassium for oral suspension,600 mg/42.9 mg per 5 mL in this group is not available.
Adults: Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL in place of the amoxicillin and clavulanate potassium 500-mg/125 mg or 875-mg/125 mg tablet.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral SuspensionPrepare 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.
Amoxicillin and Clavulanate Potassium for oral suspension, 600 mg/42.9 mg per 5 mL Bottle Size Amount of Water
Required for Reconstitution 75 mL 66 mL 125 mL 110 mL 200 mL 176 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.
AdministrationTo minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal.
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Rebel Distributors Corp.
Amoxicillin And Clavulanate Potassium Suspension | Rebel Distributors Corp.
Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (asthe potassium salt) as any of the other suspensions of Amoxicillin and Clavulanate Potassium. Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/28.5 mg per 5 mL suspension ofAmoxicillin and Clavulanate Potassium contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions of Amoxicillin and Clavulanate Potassium should not be substituted for Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL as they are not interchangeable.
Dosage Pediatric patients 3 months and olderBased on the amoxicillin component (600 mg/42.9 mg per 5 mL), the recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium for OralSuspension 600 mg/42.9 mg per 5 mLproviding 90 mg/kg/day 8 3 mL twice daily 12 4.5 mL twice daily 16 6 mL twice daily 20 7.5 mL twice daily 24 9 mL twice daily 28 10.5 mL twice daily 32 12 mL twice daily 36 13.5 mL twice daily Pediatric patients weighing 40 kg and moreExperience with Amoxicillin and Clavulanate Potassium for Oral Suspension (600 mg/42.9 mg per 5 mL formulation) in this group is not available.
AdultsExperience with Amoxicillin and Clavulanate Potassium for Oral Suspension (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given Amoxicillin and Clavulanate Potassium for Oral Suspension (600 mg/42.9 mg per 5 mL) in place of the 500 mg/125 mg or 875 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral SuspensionPrepare 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.
Amoxicillin and Clavulanate Potassium for Oral Suspension (600 mg/42.9 mg per 5 mL Suspension)
Bottle Size Amount of Water Required for Reconstitution 75 mL 62 mL 125 mL 103 mL 200 mL 165 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 PharmacistThe resulting suspension is stable for 10 days under refrigeration.
AdministrationTo minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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Sandoz Inc
Amoxicillin And Clavulanate Potassium Suspension | Apotex Corp
2.1 Dosage InformationThe dose of ibandronate sodium tablet is one 150 mg tablet taken once monthly on the same date each month.
2.2 Important Administration InstructionsInstruct Patients to do the following:
Take ibandronate sodium tablets at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, (see DRUG INTERACTIONS [7.1]). Avoid the use of water with supplements including mineral water because they may have a higher concentration of calcium.
Swallow ibandronate sodium tablets whole with a full glass of plain water (6 to 8 oz) while standing or sitting in an upright position to reduce the potential for esophageal irritation. Avoid lying down for 60 minutes after taking ibandronate sodium tablets (see WARNINGS AND PRECAUTIONS [5.1]). Do not chew or suck the tablet because of a potential for oropharyngeal ulceration.
Do not eat, drink anything except plain water, or take other medications for at least 60 minutes after taking ibandronate sodium tablets.
2.3 Recommendations for Calcium and Vitamin D SupplementationInstruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. Avoid the use of calcium supplements within 60 minutes of ibandronate sodium administration because co-administration of ibandronate sodium tablets and calcium may interfere with the absorption of ibandronate sodium (see DRUG INTERACTIONS [7.1]).
2.4 Administration Instructions for Missed Once-Monthly DosesIf the once-monthly dose is missed, instruct patients to do the following:
If the next scheduled ibandronate sodium tablet day is more than 7 days away, take one ibandronate sodium 150 mg tablet in the morning following the date that it is remembered. If the next scheduled ibandronate sodium tablets day is only 1 to 7 days away, wait until the subsequent month’s scheduled ibandronate sodium tablet day to take their tablet.For subsequent monthly doses for both of the above scenarios, instruct patients to return to their original schedule by taking one ibandronate sodium 150 mg tablet every month on their previous chosen day.
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Physicians Total Care, Inc.
Amoxicillin And Clavulanate Potassium Suspension | Physicians Total Care, Inc.
Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (asthe potassium salt) as any of the other suspensions of Amoxicillin and Clavulanate Potassium. Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/28.5 mg per 5 mL suspension ofAmoxicillin and Clavulanate Potassium contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions of Amoxicillin and Clavulanate Potassium should not be substituted for Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL as they are not interchangeable.
Dosage Pediatric Patients 3 Months and OlderBased on the amoxicillin component (600 mg per 5 mL), the recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg)
Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL Providing 90 mg/kg/day
8
3 mL twice daily
12
4.5 mL twice daily
16
6 mL twice daily
20
7.5 mL twice daily
24
9 mL twice daily
28
10.5 mL twice daily
32
12 mL twice daily
36
13.5 mL twice daily
Pediatric Patients Weighing 40 kg and MoreExperience with Amoxicillin and Clavulanate Potassium for Oral Suspension (600 mg/42.9 mg per 5 mL formulation) in this group is not available.
AdultsExperience with Amoxicillin and Clavulanate Potassium for Oral Suspension (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given Amoxicillin and Clavulanate Potassium for Oral Suspension (600 mg/42.9 mg per 5 mL) in place of the 500 mg/125 mg or 875 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Directions for Mixing Oral SuspensionPrepare 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.
Amoxicillin and Clavulanate Potassium for Oral Suspension (600 mg/42.9 mg per 5 mL Suspension)
Bottle Size
Amount of Water Required for Reconstitution
75 mL
62 mL
125 mL
103 mL
200 mL
165 mL
Each 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.
AdministrationTo minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
![Amoxicillin And Clavulanate Potassium Suspension [Rebel Distributors Corp.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b58ec5f9-0715-4562-9aeb-915329a4eef8&name=b58ec5f9-0715-4562-9aeb-915329a4eef8-03.jpg)
![Amoxicillin And Clavulanate Potassium Suspension [Sandoz Inc]](http://www.recallguide.org/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Amoxicillin And Clavulanate Potassium Suspension [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=be64cd87-af1b-4beb-957f-963b61fd95bf&name=AmoxicillinandClavPot125mLpackagelabel.jpg)
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