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All about: Amoxicillin Suspension

Big Image Dosage Form: Suspension

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin for oral suspension and other antibacterial drugs, Amoxicillin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Amoxicillin Description

Amoxicillin is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it 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 with the following structural formula:

The Amoxicillin molecular formula is C16H19N3O5S•3H2O and the molecular weight is 419.45.

Amoxicillin powder for oral suspension is intended for oral administration.

Powder for Oral Suspension

Each 5 mL of reconstituted oral suspension contains Amoxicillin trihydrate equivalent to 125 mg or 250 mg of Amoxicillin, respectively.

In addition, the inactive ingredients for Amoxicillin oral suspension are: acacia, Atmos 300, DC antifoam AF emulsion, FD&C Red No. 40, lecithin, natural & artificial flavorings, silicon dioxide colloidal, sodium benzoate, sodium citrate, and sucrose.

Amoxicillin - Clinical Pharmacology

Amoxicillin is stable in the presence of gastric acid and may be given without regard to meals. Amoxicillin is rapidly absorbed after oral administration. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. The half-life of Amoxicillin is 61.3 minutes. Most of the Amoxicillin is excreted unchanged in the urine; its excretion can be delayed by concurrent administration of probenecid. Amoxicillin is not highly protein-bound. In blood serum, Amoxicillin is approximately 20% protein-bound.

Orally administered doses of Amoxicillin suspension 125 mg/5 mL and 250 mg/5 mL result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3.0 mcg/mL and 3.5 mcg/mL to 5.0 mcg/mL, respectively.

Dose AUC0-∞
(mcg/hr/mL
Cmax
(mcg/mL)

 Administered at the start of a light meal.

 Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.

Amoxicillin Amoxicillin
(±S.D.)
Amoxicillin
(±S.D.)
400 mg
(5 mL of suspension)
17.1 (3.1) 5.92 (1.62)

Detectable serum levels are observed up to 8 hours after an orally administered dose of Amoxicillin. Following a 1 gram dose and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid. Approximately 60% of an orally administered dose of Amoxicillin is excreted in the urine within 6 to 8 hours.

Microbiology

Amoxicillin is similar to ampicillin in its bactericidal action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. Amoxicillin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Aerobic gram-positive microorganisms:

Enterococcus faecalis
Staphylococcus spp.† (β-lactamase-negative strains only)
Streptococcus pneumoniae
Streptococcus spp. (α- and β-hemolytic strains only)

†Staphylococci which are susceptible to Amoxicillin but resistant to methicillin/oxacillin should be considered as resistant to Amoxicillin.

Aerobic gram-negative microorganisms:

Escherichia coli (β-lactamase-negative strains only)
Haemophilus influenzae (β-lactamase-negative strains only)
Neisseria gonorrhoeae (β-lactamase-negative strains only)
Proteus mirabilis (β-lactamase-negative strains only)

Helicobacter:

Helicobacter pylori

Susceptibility Tests

Dilution Techniques:

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of ampicillin powder. Ampicillin is sometimes used to predict susceptibility of Streptococcus pneumoniae to Amoxicillin; however, some intermediate strains have been shown to be susceptible to Amoxicillin. Therefore, Streptococcus pneumoniae susceptibility should be tested using Amoxicillin powder. The MIC values should be interpreted according to the following criteria:

For gram-positive aerobes:

a Staphylococci which are susceptible to Amoxicillin but resistant to methicillin/oxacillin should be considered as resistant to Amoxicillin.

b These interpretive standards are applicable only to broth microdilution susceptibility tests using cation-adjusted Mueller-Hinton broth with 2 - 5% lysed horse blood.

Enterococcus
MIC (mcg/mL) Interpretation
≤8 Susceptible (S)
≥16 Resistant (R)
Staphylococcusa
MIC (mcg/mL) Interpretation
≤0.25 Susceptible (S)
≥0.5 Resistant (R)
Streptococcus (except S. pneumoniae)
MIC (mcg/mL) Interpretation
≤0.25 Susceptible (S)
0.5 to 4 Intermediate (I)
≥8 Resistant (R)
S. pneumoniaeb (from non-meningitis sources)
(Amoxicillin powder should be used to determine susceptibility.)
MIC (mcg/mL) Interpretation
≤2 Susceptible (S)
4 Intermediate (I)
≥8 Resistant (R)

NOTE: These interpretive criteria are based on the recommended dose for respiratory tract infections.

For gram-negative aerobes:

c These interpretive standards are applicable only to broth microdilution test with Haemophilus influenzae using Haemophilus Test Medium (HTM).1

Enterobacteriaceae
MIC (mcg/mL) Interpretation
≤8 Susceptible (S)
16 Intermediate (I)
≥32 Resistant (R)
H. influenzaec
MIC (mcg/mL) Interpretation
≤1 Susceptible (S)
2 Intermediate (I)
≥4 Resistant (R)

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard ampicillin powder should provide the following MIC values:

Microorganism MIC range (mcg/mL)

d This quality control range is applicable to only H. influenzae ATCC 49247 tested by a broth microdilution procedure using Haemophilus Test Medium (HTM).1

E. coli ATCC 25922 2 to 8
E. faecalis ATCC 29212 0.5 to 2
H. influenzae ATCC 49247d 2 to 8
S. aureus ATCC 29213 0.25 to 1

Using Amoxicillin to determine susceptibility:

Microorganism MIC range (mcg/mL)

e This quality control range is applicable to only S. pneumoniae ATCC 49619 tested by the broth microdilution procedure using cation-adjusted Mueller-Hinton broth with 2–5% lysed horse blood.

S. pneumoniae ATCC 49619e 0.03 to 0.12

Diffusion Techniques:

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 10 mcg ampicillin to test the susceptibility of microorganisms, except S. pneumoniae, to Amoxicillin. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for ampicillin.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 10 mcg ampicillin disk should be interpreted according to the following criteria:

For gram-positive aerobes:

f Staphylococci which are susceptible to Amoxicillin but resistant to methicillin/oxacillin should be considered as resistant to Amoxicillin.

Enterococcus
Zone Diameter (mm) Interpretation
≥17 Susceptible (S)
≤16 Resistant (R)
Staphylococcusf
Zone Diameter (mm) Interpretation
≥29 Susceptible (S)
≤28 Resistant (R)
β-hemolytic streptococci
Zone Diameter (mm) Interpretation
≥26 Susceptible (S)
19 to 25 Intermediate (I)
≤18 Resistant (R)

NOTE: For streptococci (other than β-hemolytic streptococci and S. pneumoniae), an ampicillin MIC should be determined.

S. pneumoniae

S. pneumoniae should be tested using a 1-mcg oxacillin disk. Isolates with oxacillin zone sizes of ≥20 mm are susceptible to Amoxicillin. An Amoxicillin MIC should be determined on isolates of S. pneumoniae with oxacillin zone sizes of ≤19 mm.

For gram-negative aerobes:

g These interpretive standards are applicable only to disk diffusion susceptibility tests with H. influenzae using Haemophilus Test Medium (HTM).2

Enterobacteriaceae
Zone Diameter (mm) Interpretation
≥17 Susceptible (S)
14 to 16 Intermediate (I)
≤13 Resistant (R)
H. influenzaeg
Zone Diameter (mm) Interpretation
≥22 Susceptible (S)
19 to 21 Intermediate (I)
≤18 Resistant (R)

Interpretation should be as stated above for results using dilution techniques.

As with standard dilution techniques, disk diffusion susceptibility test procedures require the use of laboratory control microorganisms. The 10-mcg ampicillin disk should provide the following zone diameters in these laboratory test quality control strains:

Microorganism Zone Diameter (mm)

h This quality control range is applicable to only H. influenzae ATCC 49247 tested by a disk diffusion procedure using Haemophilus Test Medium (HTM).2

E. coli ATCC 25922 16 to 22
H. influenzae ATCC 49247h 13 to 21
S. aureus ATCC 25923 27 to 35

Using 1 mcg oxacillin disk:

Microorganism Zone Diameter (mm)

i This quality control range is applicable to only S. pneumoniae ATCC 49619 tested by a disk diffusion procedure using Mueller-Hinton agar supplemented with 5% sheep blood and incubated in 5% CO2.

S. pneumoniae ATCC 49619i 8 to 12

Susceptibility testing for Helicobacter pylori

In vitro susceptibility testing methods and diagnostic products currently available for determining minimum inhibitory concentrations (MICs) and zone sizes have not been standardized, validated, or approved for testing H. pylori microorganisms.

Culture and susceptibility testing should be obtained in patients who fail triple therapy. If clarithromycin resistance is found, a non-clarithromycin-containing regimen should be used.

Indications and Usage for Amoxicillin

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below:

Infections of the ear, nose, and throat due to Streptococcus spp. (α- and β-hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp., or H. influenzae

Infections of the genitourinary tract due to E. coli, P. mirabilis, or E. faecalis

Infections of the skin and skin structure due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli

Infections of the lower respiratory tract due to Streptococcus spp. (α- and β-hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp. or H. influenzae

Gonorrhea, acute uncomplicated (ano-genital and urethral infections) due to N. gonorrhoeae (males and females)

Therapy may be instituted prior to obtaining results from bacteriological and susceptibility studies to determine the causative organisms and their susceptibility to Amoxicillin.

Indicated surgical procedures should be performed.

H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Triple therapy: Amoxicillin/clarithromycin/lansoprazole

Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

Dual therapy: Amoxicillin/lansoprazole

Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin oral suspension and other antibacterial drugs, Amoxicillin 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 selections of therapy.

Contraindications

A history of allergic reaction to any of the penicillins is a contraindication.

Warnings

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS. 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, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, Amoxicillin SHOULD BE DISCONTINUED AND 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 may range 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 a 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 Clostridium difficile colitis.

Precautions

General

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy instituted.

Prescribing Amoxicillin 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 Patients

Amoxicillin may be taken every 8 hours or every 12 hours, depending on the strength of the product prescribed.

Patients should be counseled that anti-bacterial drugs including Amoxicillin for oral suspension should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Amoxicillin 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 Amoxicillin for oral suspension or other antibacterial drugs in the future.

Laboratory Tests

As with any potent drug, periodic assessment of renal, hepatic and hematopoietic function should be made during prolonged therapy.

All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with Amoxicillin should have a follow-up serologic test for syphilis after 3 months.

Drug Interactions

Probenecid decreases the renal tubular secretion of Amoxicillin. Concurrent use with Amoxicillin may result in increased and prolonged blood levels.

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

Drug/Laboratory Test Interactions

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, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX® or TesTape®) 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of Amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of Amoxicillin and potassium clavulanate. Amoxicillin/potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin/potassium clavulanate was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. Amoxicillin/potassium clavulanate was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 3 times the human dose in mg/m2).

Pregnancy:

Teratogenic Effects: Pregnancy Category B

Reproduction studies have been performed in mice and rats at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Amoxicillin. 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 poorly absorbed during labor. Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions, but moderately increased the height and duration of contractions. However, it is not known whether use of Amoxicillin 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.

Nursing Mothers

Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when Amoxicillin is administered to a nursing woman.

Pediatric Use

Because of incompletely developed renal function in neonates and young infants, the elimination of Amoxicillin may be delayed. Dosing of Amoxicillin should be modified in pediatric patients 12 weeks or younger (≤3 months). (See DOSAGE AND ADMINISTRATION—Neonates and infants.)

Adverse Reactions

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever or urticaria. The following adverse reactions have been reported as associated with the use of penicillins:

Gastrointestinal

Nausea, vomiting, diarrhea, and hemorrhagic/pseudomembranous colitis.

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)

Hypersensitivity Reactions

Serum sickness like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson Syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.

NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, Amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to Amoxicillin therapy.

Renal

Crystalluria has also been reported.

Liver

A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatis jaundice, hepatic cholestasis and acute cytolytic hepatitis have 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.

Central Nervous System

Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness 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.

Combination therapy with clarithromycin and lansoprazole

In clinical trials using combination therapy with Amoxicillin plus clarithromycin and lansoprazole, and Amoxicillin plus lansoprazole, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that have been previously reported with Amoxicillin, clarithromycin, or lansoprazole.

Triple therapy: Amoxicillin/clarithromycin/lansoprazole

The most frequently reported adverse events for patients who received triple therapy were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual therapy: Amoxicillin/lansoprazole

The most frequently reported adverse events for patients who received Amoxicillin t.i.d. plus lansoprazole t.i.d. dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse events were observed at significantly higher rates with Amoxicillin t.i.d. plus lansoprazole t.i.d. dual therapy than with lansoprazole alone.

For more information on adverse reactions with clarithromycin or lansoprazole, refer to their package inserts, ADVERSE REACTIONS.

Overdosage

In case of overdosage, discontinue medication, 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.3

Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with Amoxicillin. Crystalluria has also been reported after Amoxicillin overdosage. 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 Amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.

Amoxicillin Dosage and Administration

Amoxicillin oral suspension may be given without regard to meals.

Neonates and infants aged ≤12 weeks (≤3 months)

Due to incompletely developed renal function affecting elimination of Amoxicillin in this age group, the recommended upper dose of Amoxicillin is 30 mg/kg/day divided q 12h.

Adults and pediatric patients >3 months

Infection Severity Usual Adult Dose Usual Dose for Children >3 Months§

 Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

§ The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

Ear/nose/throat Mild/Moderate 500 mg every 12 hours
or 250 mg every 8 hours
25 mg/kg/day in divided doses every 12 hours
or 20 mg/kg/day in divided doses every 8 hours
Severe 875 mg every 12 hours
or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours
or 40 mg/kg/day in divided doses every 8 hours
Lower respiratory
tract
Mild/Moderate
or Severe
875 mg every 12 hours
or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours
or 40 mg/kg/day in divided doses every 8 hours
Skin/skin
structure
Mild/Moderate
or Severe
500 mg every 12 hours
or 250 mg every 8 hours
25 mg/kg/day in divided doses every 12 hours
or 20 mg/kg/day in divided doses every 8 hours
Severe 875 mg every 12 hours
or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours
or 40 mg/kg/day in divided doses every 8 hours
Genitourinary
tract
Mild/Moderate
500 mg every 12 hours
or 250 mg every 8 hours
25 mg/kg/day in divided doses every 12 hours
or 20 mg/kg/day in divided doses every 8 hours
Severe 875 mg every 12 hours
or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours
or 40 mg/kg/day in divided doses every 8 hours
Gonorrhea Acyte
uncomplicated
ano-genital and
urethral infections
in males and females
3 grams as a single oral dose Prepubertal children:
50 mg/kg Amoxicillin combined with
25 mg/kg probenecid as a single dose
NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

After reconstitution the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS—Laboratory Tests.)

Larger doses may be required for stubborn or severe infections.

General

The children's dosage is intended for individuals whose weight will not cause a dosage to be calculated greater than that recommended for adults.

It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Triple therapy: Amoxicillin/clarithromycin/lansoprazole

The recommended adult oral dose is 1 gram Amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

Dual therapy: Amoxicillin/lansoprazole

The recommended adult oral dose is 1 gram Amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

Dosing recommendations for adults with impaired renal function

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 875 mg Amoxicillin. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection.

Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

There are currently no dosing recommendations for pediatric patients with impaired renal function.

Directions for Mixing Oral Suspension

Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder.

Add remainder of the water and again shake vigorously.

Bottle Size Amount of Water
Required for Reconstitution
125 mg/5 mL: Each teaspoonful (5 mL) will contain 125 mg Amoxicillin
80 mL 48 mL
100 mL 60 mL
150 mL 88 mL
250 mg/5 mL: Each teaspoonful (5 mL) will contain 250 mg Amoxicillin
80 mL 47 mL
100 mL 59 mL
150 mL 88 mL

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

How is Amoxicillin Supplied

Amoxicillin for Oral Suspension, USP.

Each 5 mL of reconstituted suspension contains Amoxicillin trihydrate equivalent to 125 or 250 mg Amoxicillin. The suspension has a raspberry-strawberry flavor.

125 mg/5 mL
      NDC 0781-6039-58   80 mL Bottle
      NDC 0781-6039-46   100 mL Bottle
      NDC 0781-6039-55   150 mL Bottle

250 mg/5 mL
      NDC 0781-6041-58   80 mL Bottle
      NDC 0781-6041-46   100 mL Bottle
      NDC 0781-6041-55   150 mL Bottle

Storage

Store unreconstituted powder at 25° C (77° F).

Dispense in a tight container as defined in the USP/NF.

Clinical Studies

H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Randomized, double-blind clinical studies performed in the U.S. in patients with H. pylori  and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within one year) evaluated the efficacy of lansoprazole in combination with Amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with Amoxicillin capsules as dual 14-day therapy, for the eradication of H. pylori. Based on the results of these studies, the safety and efficacy of two different eradication regimens were established:

Triple therapy: Amoxicillin 1 gram b.i.d./clarithromycin 500 mg b.i.d./lansoprazole 30 mg b.i.d.

Dual therapy: Amoxicillin 1 gram t.i.d./lansoprazole 30 mg t.i.d.

Recent Drug Updates at DrugIndexOnline:





Anacin Anacin
Some commonly used brand names are: In the U.S.— Acuprin 81 1 Amigesic 8 Anacin Caplets 2 Anacin Maximum Strength 2 Anacin Tablets 2 Anaflex 750 8 Arthritis Pain Ascriptin 3 Arthritis Pain Formula 3 Arthritis Strength Bufferin 3 Arthropan 5 Aspergum 1 Aspirin Regimen Bayer Adult Low Dose more...

Anemagen Anemagen
Generic Name: multivitamins with iron (mull tee VYE tah mins with i ron) Brand Names: Allbee-C 800 with Iron, Anemagen, Anemagen FA, Bugs Bunny with Iron Chewable, Chromatinic, Contrin, Dayalets Plus Iron, Diatx Fe, Equi-Roca Plus, Equicyte Plus, Fe-Tinic 150 Forte, Femiron Multi with Iro more...

ipratropium inhalation ipratropium inhalation
Generic Name: ipratropium inhalation (IP ra TRO pee um) Brand Names: Atrovent, Atrovent HFA What is ipratropium inhalation? Ipratropium inhalation is used to prevent bronchospasm, or narrowing airways in the lungs, in people with bronchitis, emphysema, or COPD (chronic obstructive pulmon more...

K-Dur K-Dur
Some commonly used brand names are: In the U.S.— Cena-K 5 Effer-K 4 Gen-K 5 Glu-K 6 K-8 5 K+ 10 5 Kaochlor 10% 5 Kaochlor S-F 10% 5 Kaon 6 Kaon-Cl 5 Kaon-Cl-10 5 Kaon-Cl 20% Liquid 5 Kato 5 Kay Ciel 5 Kaylixir 6 K+ Care 5 K+ Care ET 2 K-Dur 5 K-Electrolyte 2 K-G Elixir 6 K-Ide 3 K-Lease 5 more...

Mycelex-3 Mycelex-3
Generic name: Butoconazole nitrate Brand names: Mycelex-3 Why is Mycelex-3 prescribed? Mycelex-3 Vaginal Cream cures yeast-like fungal infections of the vulva and vagina. Most important fact about Mycelex-3 To obtain maximum benefit, it is important that you continue to use Mycelex-3 for 3 con more...

Pamprin-IB Pamprin-IB
Some commonly used brand names are: In the U.S.— Actron 9 Advil 7 Advil Caplets 7 Advil, Children's 7 Aleve 14 Anaprox 14 Anaprox DS 14 Ansaid 6 Bayer Select Ibuprofen Pain Relief Formula Caplets 7 Cataflam 1 Clinoril 18 Cotylbutazone 16 Cramp End 7 Daypro 15 Dolgesic 7 Dolobid 2 EC-Napro more...

Panscol Panscol
Generic Name: salicylic acid topical (sah lih SIH lick AH sid) Brand Names: Compound W, Duofilm, Duoplant, Fungi-Nail, Ionil Shampoo, Keralyt, Mediplast, Neutrogena Acne Wash Oil Free, Neutrogena Healthy Scalp Dandruff Shampoo, Occlusal-HP, Oxy Clean Maximum Strength, Oxy Clean Medicated, more...

Ponstel Ponstel
Generic Name: mefenamic acid (me fe NAM ik) Brand Names: Ponstel What is Ponstel (mefenamic acid)? Mefenamic acid is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Mefenamic acid works by reducing hormones that cause inflammation and pain in the body. Mefenami more...