DisperMox contains amoxicillin, 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. It may be represented structurally as:
The amoxicillin molecular formula is C16H19N3O5S•3H2O, and the molecular weight is 419.45. DisperMox is intended for oral administration.
Each DisperMox tablet contains amoxicillin trihydrate equivalent to amoxicillin anhydrous 200 mg, 400 mg or 600 mg. Inactive ingredients: aspartame•, colloidal silicon dioxide, croscarmellose sodium, FD&C Red no. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and strawberry guarana flavor.
• See PRECAUTIONS
DisperMox - Clinical Pharmacology
Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from conventional amoxicillin tablets and amoxicillin suspension has been partially investigated. The 400 mg and 875 mg formulations have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations. 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. In blood serum, amoxicillin is approximately 20% protein-bound.
Orally administered doses of 250 mg and 500 mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.
Mean amoxicillin pharmacokinetic parameters from an open, two-part, single-dose crossover bioequivalence study in 27 adults comparing 875 mg conventional tablets of amoxicillin with 875 mg conventional tablets of amoxicillin/clavulanate potassium showed that the 875 mg conventional tablet of amoxicillin produces an AUC0-∞ of 35.4 ± 8.1 mcg•hr/mL and a Cmax of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast.
Orally administered doses of conventional 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 mcg/mL and 3.5 mcg/mL to 5 mcg/mL, respectively.
Oral administration of single doses of 400 mg conventional amoxicillin chewable tablets and 400 mg/5 mL conventional suspension to 24 adult volunteers yielded comparable pharmacokinetic data:
| Dose † |
AUC0-∞(mcg•hr/mL) |
Cmax (mcg/mL) ‡ |
| amoxicillin |
amoxicillin |
amoxicillin |
| 400 mg (5 mL of suspension) |
17.1 (3.1) |
5.92 (1.62) |
| 400 mg (1 chewable tablets) |
17.9 (2.4) |
5.18 (1.64) |
† Administered at the start of a light meal.
‡ Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
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.
The following pharmacokinetic data is from Ranbaxy’s study of DisperMox tablets and conventional amoxicillin oral suspension, 400 mg/5 mL. A dispersed mixture of DisperMox tablets, 400 mg, produced blood levels similar to those achieved with the corresponding doses of conventional amoxicillin oral suspensions. Orally administered doses of conventional amoxicillin suspension, 400 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 3.3 mcg/mL to 11.5 mcg/mL. Orally administered doses of 400 mg DisperMox tablets result in average peak blood levels 1 to 2 hours after administration in the range of 3.2 mcg/mL to 11.5 mcg/mL.
Oral administration of single doses of 400 mg DisperMox tablets and 400 mg/5 mL conventional suspension to 24 adult volunteers yielded comparable pharmacokinetic data.
| Dose¶ |
In AUC0-∞ (mcg•hr/mL) |
Cmax (mcg/mL)†† |
| amoxicillin |
amoxicillin |
amoxicillin |
| 400 mg (5 mL of suspension) |
18.5 |
8.4 |
| 400 mg (1 tablet for oral suspension) |
17.9 |
7.5 |
¶ Dosing was following an overnight fast.
†† Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
A dispersed mixture of DisperMox tablets, 600 mg, produced blood levels similar to those achieved with the corresponding dose (7.5 mL of 400 mg/5 mL) of conventional amoxicillin suspension. Orally administered doses of conventional suspension resulted in average peak blood levels 1 to 2 hours after administration in the range of 5.1 mcg/mL to 19.3 mcg/mL. Orally administered doses of 600 mg DisperMox tablets result in average peak blood levels 1 to 2 hours after oral administration in the range of 5 mcg/mL to 18.9 mcg/mL.
Oral administration of single doses of 600 mg DisperMox tablets and 600 mg (7.5 mL of 400 mg/5 mL) of conventional suspension to 25 adult volunteers yielded comparable pharmacokinetic data.
| Dose¶ |
In AUC0-∞ (mcg•hr/mL) |
Cmax(mcg/mL)†† |
| amoxicillin |
amoxicillin |
amoxicillin |
| 600 mg (7.5 mL of 400 mg/5 mL suspension) |
31.4 |
12.3 |
| 600 mg (1 tablet for oral suspension) |
29 |
11.9 |
¶Dosing was following an overnight fast.
†† Mean values of 25 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
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 S. pneumoniae to amoxicillin; however, some intermediate strains have been shown to be susceptible to amoxicillin. Therefore, S. pneumoniae susceptibility should be tested using amoxicillin powder. The MIC values should be interpreted according to the following criteria:
For Gram-Positive Aerobes:| 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. (Amoxicilline 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 doses for respiratory tract infections.
For Gram-Negative Aerobes:
| 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. 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 to 5% lysed horse blood.
c. These interpretive standards are applicable only to broth microdilution test with H. influenzae using Haemophilus Test Medium (HTM).1
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) |
| 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) |
| S. pneumoniae |
ATCC 49619e |
0.03 to 0.12 |
d. This quality control range is applicable to only H. influenzae ATCC 49247 tested by a broth microdilution procedure using HTM.1
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 to 5% lysed horse blood.
Diffusion Techniques:
Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the 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:| 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:| 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) |
f. Staphylococci which are susceptible to amoxicillin but resistant to methicillin/oxacillin should be considered as resistant to amoxicillin.
g. These interpretive standards are applicable only to disk diffusion susceptibility tests with H. influenzae using Haemophilus Test Medium (HTM).2
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) |
| 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) |
| S. pneumoniae |
ATCC 49619i |
8 to 12 |
h. This quality control range is applicable to only H. influenzae ATCC 49247 tested by a disk diffusion procedure using HTM.2
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.
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 DisperMox
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DisperMox and other antibacterial drugs, DisperMox 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.
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY ß-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), S. 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), S. pneumoniae, Staphylococcus spp., or H. influenzae
Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females).
H. pylori eradication to reduce the risk of duodenal ulcer recurrence
Triple Therapy:
Amoxicillin/clarithromycin/lansoprazoleAmoxicillin, 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 1-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/lansoprazoleAmoxicillin, 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 1-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.)
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 DisperMox 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
Patients should be counseled that antibacterial drugs, including DisperMox should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When DisperMox 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 DisperMox or other antibacterial drugs in the future.
Amoxicillin may be taken every 8 hours or every 12 hours, depending on the strength of the product prescribed.
A Patient Information Sheet is provided with the drug product.
Phenylketonurics:
Each 200 mg Amoxicillin Tablet for Oral Suspension contains 5.6 mg phenylalanine; each 400 mg Amoxicillin Tablet for Oral Suspension contains 5.6 mg phenylalanine; each 600 mg Amoxicillin Tablet for Oral Suspension contains 11.23 mg phenylalanine.
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 of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.
Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the 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® ) 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 and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and 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 and 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 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 exanthemataus 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.
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 cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.
Renal:
Crystalluria has also been reported (see OVERDOSAGE)
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 disconti
