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AUGMENTIN ES-600
Overview
What is AUGMENTIN ES-600?
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 CHNOS•3HO, and
the molecular weight is 419.46. Chemically, amoxicillin is (2,5,6)-6-[()-(-)-2-Amino-2-(-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 . 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 CHKNO, and the
molecular weight is 237.25. Chemically, clavulanate potassium is potassium
()-(2,5)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate
and may be represented structurally as:
What does AUGMENTIN ES-600 look like?
What are the available doses of AUGMENTIN ES-600?
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What should I talk to my health care provider before I take AUGMENTIN ES-600?
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How should I use AUGMENTIN ES-600?
AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to
(penicillin MICs ≤ 2 mcg/mL), (including β-lactamase–producing strains), or
(including
β-lactamase–producing strains) characterized by the following risk
factors:
[See , .]
NOTE:
S. pneumoniae
S. pneumoniae
Therapy may be instituted prior to obtaining the results from
bacteriological studies when there is reason to believe the infection may
involve both (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.
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 be substituted for AUGMENTIN ES-600 Powder for Oral Suspension as they are not interchangeable.
What interacts with AUGMENTIN ES-600?
AUGMENTIN ES-600 Powder for Oral Suspension is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN.
What are the warnings of AUGMENTIN ES-600?
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 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 .)
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.
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 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
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
and .)
What are the precautions of AUGMENTIN ES-600?
General:
While amoxicillin/clavulanate possesses the characteristic low
toxicity of the penicillin group of antibiotics, periodic assessment of
organ system functions, including renal, hepatic, and hematopoietic
function, is advisable if therapy is for longer than the drug is approved
for administration.
A high percentage of patients with mononucleosis who receive
ampicillin develop an erythematous skin rash. Thus, ampicillin-class
antibiotics should not be administered to patients with mononucleosis.
The possibility of superinfections with mycotic or bacterial
pathogens should be kept in mind during therapy. If superinfections occur
(usually involving or
), the drug should be
discontinued and/or appropriate therapy instituted.
Prescribing AUGMENTIN ES-600 Powder for Oral Suspension in the absence of a proven or strongly
suspected bacterial infection or a prophylactic indication is unlikely to
provide benefit to the patient and increases the risk of the development
of drug-resistant bacteria.
Information for the Patient:
AUGMENTIN ES-600 Powder for Oral Suspension should be taken every 12 hours with a meal or
snack to reduce the possibility of gastrointestinal upset. If diarrhea
develops and is severe or lasts more than 2 or 3 days, call your
doctor.
Diarrhea is a common problem caused by antibiotics which usually
ends when the antibiotic is discontinued. Sometimes after starting
treatment with antibiotics, patients can develop watery and bloody stools
(with or without stomach cramps and fever) even as late as 2 or more
months after having taken the last dose of the antibiotic. If this
occurs, patients should contact their physician as soon as
possible.
Keep suspension refrigerated. Shake well before using. When
dosing a child with the suspension (liquid) of AUGMENTIN ES-600 Powder for Oral Suspension, use a
dosing spoon or medicine dropper. Be sure to rinse the spoon or dropper
after each use. Bottles of suspension of AUGMENTIN ES-600 Powder for Oral Suspension may contain
more liquid than required. Follow your doctor’s instructions about the
amount to use and the days of treatment your child requires. Discard any
unused medicine.
Patients should be counseled that antibacterial drugs, including
AUGMENTIN ES-600 Powder for Oral Suspension, should only be used to treat bacterial infections. They
do not treat viral infections (e.g., the common cold). When AUGMENTIN ES-600 Powder for Oral Suspension is prescribed to treat a bacterial infection, patients should be told
that although it is common to feel better early in the course of therapy,
the medication should be taken exactly as directed. Skipping doses or not
completing the full course of therapy may: (1) decrease the effectiveness
of the immediate treatment, and (2) increase the likelihood that bacteria
will develop resistance and will not be treatable by AUGMENTIN ES-600 Powder for Oral Suspension or
other antibacterial drugs in the future.
Phenylketonurics:
Each 5 mL of the 600 mg/42.9 mg per 5 mL suspension of AUGMENTIN ES-600 Powder for Oral Suspension contains 7 mg phenylalanine.
Drug Interactions:
Probenecid decreases the renal tubular secretion of amoxicillin.
Concurrent use with AUGMENTIN ES-600 Powder for Oral Suspension may result in increased and
prolonged blood levels of amoxicillin. Co-administration of probenecid
cannot be recommended.
Abnormal prolongation of prothrombin time (increased
international normalized ratio [INR]) has been reported rarely in
patients receiving amoxicillin and oral anticoagulants. Appropriate
monitoring should be undertaken when anticoagulants are prescribed
concurrently. Adjustments in the dose of oral anticoagulants may be
necessary to maintain the desired level of anticoagulation.
The concurrent administration of allopurinol and ampicillin
increases substantially the incidence of rashes in patients receiving
both drugs as compared to patients receiving ampicillin alone. It is not
known whether this potentiation of ampicillin rashes is due to
allopurinol or the hyperuricemia present in these patients. There are no
data with AUGMENTIN ES-600 Powder for Oral Suspension and allopurinol administered concurrently.
In common with other broad-spectrum antibiotics, amoxicillin/clavulanate may reduce the efficacy of oral contraceptives.
Drug/Laboratory Test Interactions:
Oral administration of AUGMENTIN will result in high urine concentrations of amoxicillin. High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST, Benedict’s Solution, or
Fehling’s Solution. Since this effect may also occur with amoxicillin and
therefore AUGMENTIN ES-600 Powder for Oral Suspension, it is recommended that glucose tests based on
enzymatic glucose oxidase reactions (such as CLINISTIX) be
used.
Following administration of ampicillin to pregnant women, a
transient decrease in plasma concentration of total conjugated estriol,
estriol-glucuronide, conjugated estrone, and estradiol has been noted.
This effect may also occur with amoxicillin and therefore
AUGMENTIN ES-600 Powder for Oral Suspension.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long-term studies in animals have not been performed to evaluate carcinogenic potential. The mutagenic potential of AUGMENTIN was investigated in vitro with an Ames test, a human lymphocyte cytogenetic assay, a yeast test, and a mouse lymphoma forward mutation assay, and in vivo with mouse micronucleus tests and a dominant lethal test. All were negative apart from the in vitro mouse lymphoma assay where weak activity was found at very high, cytotoxic concentrations. AUGMENTIN at oral doses of up to 1,200 mg/kg/day (5.7 times the maximum adult human dose based on body surface area) was found to have no effect on fertility and reproductive performance in rats, dosed with a 2:1 ratio formulation of amoxicillin:clavulanate.
Teratogenic Effects:
Pregnancy (Category B). Reproduction studies performed in pregnant rats and mice given AUGMENTIN at oral dosages up to 1,200 mg/kg/day (4.9 and 2.8 times the maximum adult human oral dose based on body surface area, respectively), 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 human milk; therefore, caution should be exercised when AUGMENTIN is administered to a nursing woman.
Pediatric Use:
Safety and efficacy of AUGMENTIN ES-600 Powder for Oral Suspension in infants younger than 3
months have not been established. Safety and efficacy of AUGMENTIN ES-600 Powder for Oral Suspension
have been demonstrated for treatment of acute otitis media in infants and
children 3 months to 12 years (see ).
The safety and effectiveness of AUGMENTIN ES-600 Powder for Oral Suspension have been established for the treatment of pediatric patients (3 months to 12 years) with acute bacterial sinusitis. This use is supported by evidence from adequate and well-controlled studies of AUGMENTIN XR™ Extended Release Tablets in adults with acute bacterial sinusitis, studies of AUGMENTIN ES-600 Powder for Oral Suspension in pediatric patients with acute otitis media, and by similar pharmacokinetics of amoxicillin and clavulanate in pediatric patients taking AUGMENTIN ES-600 Powder for Oral Suspension (see ) and adults taking AUGMENTIN XR.
What are the side effects of AUGMENTIN ES-600?
AUGMENTIN ES-600 Powder for Oral Suspension is generally well tolerated. The majority of side
effects observed in pediatric clinical trials of acute otitis media were either
mild or moderate, and transient in nature; 4.4% of patients discontinued
therapy because of drug-related side effects. The most commonly reported side
effects with probable or suspected relationship to AUGMENTIN ES-600 Powder for Oral Suspension were
contact dermatitis, i.e., diaper rash (3.5%), diarrhea (2.9%), vomiting (2.2%),
moniliasis (1.4%), and rash (1.1%). The most common adverse experiences leading
to withdrawal that were of probable or suspected relationship to AUGMENTIN ES-600 Powder for Oral Suspension were diarrhea (2.5%) and vomiting (1.4%).
The following adverse reactions have been reported for ampicillin-class antibiotics:
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. (See .)
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. (See .)
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 (see ).
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.
What should I look out for while using AUGMENTIN ES-600?
AUGMENTIN ES-600 Powder for Oral Suspension is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN.
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.
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 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
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
and .)
What might happen if I take too much AUGMENTIN ES-600?
Following overdosage, patients have experienced primarily
gastrointestinal symptoms including stomach and abdominal pain, vomiting, and
diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small
number of patients.
In the case of overdosage, discontinue AUGMENTIN ES-600 Powder for Oral Suspension, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.
Interstitial nephritis resulting in oliguric renal failure has been
reported in a small number of patients after overdosage with amoxicillin.
Crystalluria, in some cases leading to renal failure, has also been
reported after amoxicillin overdosage in adult and pediatric patients. In case
of overdosage, adequate fluid intake and diuresis should be maintained to
reduce the risk of amoxicillin crystalluria.
Renal impairment appears to be reversible with cessation of drug
administration. High blood levels may occur more readily in patients with
impaired renal function because of decreased renal clearance of both
amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from
the circulation by hemodialysis.
How should I store and handle AUGMENTIN ES-600?
StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] AUGMENTIN ES-600 Powder for Oral Suspension:HOW SUPPLIEDNDC 43598-003-51 75 mL bottleNDC 43598-003-69 125 mL bottleNDC 43598-003-54 200 mL bottleAUGMENTIN ES-600 Powder for Oral Suspension:HOW SUPPLIEDNDC 43598-003-51 75 mL bottleNDC 43598-003-69 125 mL bottleNDC 43598-003-54 200 mL bottleAUGMENTIN ES-600 Powder for Oral Suspension:HOW SUPPLIEDNDC 43598-003-51 75 mL bottleNDC 43598-003-69 125 mL bottleNDC 43598-003-54 200 mL bottleAUGMENTIN ES-600 Powder for Oral Suspension:HOW SUPPLIEDNDC 43598-003-51 75 mL bottleNDC 43598-003-69 125 mL bottleNDC 43598-003-54 200 mL bottleAUGMENTIN ES-600 Powder for Oral Suspension:HOW SUPPLIEDNDC 43598-003-51 75 mL bottleNDC 43598-003-69 125 mL bottleNDC 43598-003-54 200 mL bottle
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Amoxicillin is a semisynthetic antibiotic with a broad spectrum
of bactericidal activity against many gram-positive and gram-negative
microorganisms. Amoxicillin is, however, susceptible to degradation by
β-lactamases, and therefore, its spectrum of activity does not include
organisms which produce these enzymes. Clavulanic acid is a β-lactam,
structurally related to penicillin, which possesses the ability to
inactivate a wide range of β-lactamase enzymes commonly found in
microorganisms resistant to penicillins and cephalosporins. In
particular, it has good activity against the clinically important
plasmid-mediated β-lactamases frequently found responsible for transferred drug
resistance.
The clavulanic acid component of AUGMENTIN ES-600 Powder for Oral Suspension protects
amoxicillin from degradation by β-lactamase enzymes and effectively
extends the antibiotic spectrum of amoxicillin to include many bacteria
normally resistant to amoxicillin and other β-lactam antibiotics. Thus,
AUGMENTIN ES-600 Powder for Oral Suspension possesses the distinctive properties of a broad-spectrum
antibiotic and a β-lactamase inhibitor.
Amoxicillin/clavulanic acid has been shown to be active against
most isolates of the following microorganisms, both in vitro and in
clinical infections as described in the section.
Non-Clinical Toxicology
AUGMENTIN ES-600 Powder for Oral Suspension is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN.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.
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 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
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 and .)
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with AUGMENTIN ES-600 Powder for Oral Suspension may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid cannot be recommended.
Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with AUGMENTIN ES-600 Powder for Oral Suspension and allopurinol administered concurrently.
In common with other broad-spectrum antibiotics, amoxicillin/clavulanate may reduce the efficacy of oral contraceptives.
While amoxicillin/clavulanate possesses the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic function, is advisable if therapy is for longer than the drug is approved for administration.
A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving or ), the drug should be discontinued and/or appropriate therapy instituted.
Prescribing AUGMENTIN ES-600 Powder for Oral Suspension in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
AUGMENTIN ES-600 Powder for Oral Suspension is generally well tolerated. The majority of side effects observed in pediatric clinical trials of acute otitis media were either mild or moderate, and transient in nature; 4.4% of patients discontinued therapy because of drug-related side effects. The most commonly reported side effects with probable or suspected relationship to AUGMENTIN ES-600 Powder for Oral Suspension were contact dermatitis, i.e., diaper rash (3.5%), diarrhea (2.9%), vomiting (2.2%), moniliasis (1.4%), and rash (1.1%). The most common adverse experiences leading to withdrawal that were of probable or suspected relationship to AUGMENTIN ES-600 Powder for Oral Suspension were diarrhea (2.5%) and vomiting (1.4%).
The following adverse reactions have been reported for ampicillin-class antibiotics:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).