Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3219
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AMOXIL (Powder, For Suspension)
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Capsules,
chewable tablets, and oral suspensions of AMOXIL may be given without
regard to meals. The 400-mg suspension, 400-mg chewable tablet, and
the 875-mg tablet 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.<br/>Neonates and Infants Age:<br/>d���12 Weeks (���3 Months): Due to incompletely
developed renal function affecting elimination of amoxicillin in this
age group, the recommended upper dose of AMOXIL is 30 mg/kg/day
divided q12h.<br/>Adults and Pediatric Patients>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. Each strength
of the suspension of AMOXIL is available as a chewable tablet for
use by older children. 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.<br/>General: 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.<br/>H. pylori Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence: Triple Therapy: AMOXIL/clarithromycin/lansoprazole The recommended adult oral dose is 1 gram AMOXIL,
500 mg clarithromycin, and 30 mg lansoprazole, all given
twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)<br/>Dual Therapy: AMOXIL/lansoprazole The
recommended adult oral dose is 1 gram AMOXIL 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.<br/>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/min. should not receive
the 875-mg tablet. Patients with a glomerular filtration rate of 10
to 30 mL/min. should receive 500 mg or 250 mg every
12 hours, depending on the severity of the infection. Patients
with a less than 10 mL/min. glomerular filtration rate should
receive 500 mg or 250 mg every 24 hours, depending on 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.<br/>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. Each teaspoonful (5 mL) will contain 200 mg
amoxicillin. Each teaspoonful (5 mL) will contain 250 mg
amoxicillin. Each teaspoonful (5 mL) will contain 400 mg
amoxicillin.<br/>Directions for Mixing Pediatric Drops: Prepare pediatric
drops at time of dispensing as follows: Add the required amount of
water (see table below) to the bottle and shake vigorously. Each mL
of suspension will then contain amoxicillin trihydrate equivalent
to 50 mg amoxicillin. NOTE: SHAKE
BOTH ORAL SUSPENSION AND PEDIATRIC DROPS 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.
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Formulations
of AMOXIL contain 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 CHNOS���3HO, and the molecular weight is 419.45. Capsules, tablets, and powder
for oral suspension of AMOXIL are intended for oral administration.<br/>Capsules: Each capsule of AMOXIL, with royal blue opaque cap
and pink opaque body, contains 500 mg amoxicillin as the trihydrate.
The cap and body of the 500-mg capsule are imprinted with AMOXIL and
500. Inactive ingredients: D&C Red No. 28, FD&C Blue
No. 1, FD&C Red No. 40, gelatin, magnesium stearate,
and titanium dioxide.<br/>Tablets: Each tablet contains 500 mg or 875 mg
amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink
tablet is debossed with AMOXIL centered over 500 or 875, respectively.
The 875-mg tablet is scored on the reverse side. Inactive ingredients:
Colloidal silicon dioxide, crospovidone, FD&C Red No. 30
aluminum lake, hypromellose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, sodium starch glycolate, and titanium
dioxide.<br/>Chewable Tablets: Each cherry-banana-peppermint-flavored tablet contains
200 mg or 400 mg amoxicillin as the trihydrate. Each 200-mg chewable tablet contains 0.0005 mEq
(0.0107 mg) of sodium; the 400-mg chewable tablet contains 0.0009 mEq
(0.0215 mg) of sodium. The 200-mg and 400-mg pale pink round
tablets are imprinted with the product name AMOXIL and 200 or 400
along the edge of 1 side. Inactive ingredients: Aspartame, crospovidone NF, FD&C Red No. 40 aluminum lake, flavorings,
magnesium stearate, and mannitol. See PRECAUTIONS.<br/>Powder for Oral Suspension: Each 5 mL of reconstituted suspension contains
200 mg, 250 mg, or 400 mg amoxicillin as the trihydrate.
Each 5 mL of the 250-mg reconstituted suspension contains 0.15 mEq
(3.36 mg) of sodium. Each 5 mL of the 200-mg reconstituted
suspension contains 0.15 mEq (3.39 mg) of sodium; each 5 mL
of the 400-mgreconstituted suspension contains 0.19 mEq (4.33 mg)
of sodium.<br/>Pediatric Drops for Oral Suspension: Each mL of reconstituted suspension contains 50 mg
amoxicillin as the trihydrate and 0.03 mEq (0.69 mg) of
sodium. Amoxicillin trihydrate for oral
suspension 200 mg/5 mL, 250 mg/5 mL (or 50 mg/mL),
and 400 mg/5 mL are bubble-gum-flavored pink suspensions.
Inactive ingredients: FD&C Red No. 3, flavorings, silica
gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.
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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 the tablets and suspension
of AMOXIL 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 5.0 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 of AMOXIL
with 875 mg of AUGMENTIN (amoxicillin/clavulanate
potassium) showed that the 875-mg tablet of AMOXIL produces an AUCof 35.4��8.1 mcg���hr/mL
and a Cof 13.8��4.1 mcg/mL. Dosing
was at the start of a light meal following an overnight fast. 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. Oral administration of single
doses of 400-mg chewable tablets and 400 mg/5 mL suspension
of AMOXIL to 24 adult volunteers yielded comparable pharmacokinetic
data: 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.<br/>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.<br/>Aerobic Gram-Positive Microorganisms: Enterococcus faecalis Staphylococcus spp.(��-lactamase���negative
strains only) Streptococcus pneumoniae Streptococcus spp. (��- and��-hemolytic
strains only) Staphylococci which
are susceptible to amoxicillin but resistant to methicillin/oxacillin
should be considered as resistant to amoxicillin.<br/>Aerobic Gram-Negative Microorganisms: Escherichia coli (��-lactamase���negative strains only) Haemophilus influenzae (��-lactamase���negative
strains only) Neisseria
gonorrhoeae (��-lactamase���negative strains only) Proteus mirabilis (��-lactamase���negative strains only)<br/>Helicobacter: Helicobacter pylori<br/>Susceptibility Tests:<br/>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 method(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:<br/>For Gram-Positive Aerobes: Enterococcus Staphylococcus Streptococcus (except S. pneumoniae) S. pneumoniaefrom non-meningitis sources. (Amoxicillin powder should be used to
determine susceptibility.) NOTE: These
interpretive criteria are based on the recommended doses for respiratory
tract infections.<br/>For Gram-Negative Aerobes: Enterobacteriaceae H. influenzae 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. c. These interpretive standards are applicable only to
broth microdilution test with H. influenzae using Haemophilus Test Medium (HTM). 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: Using amoxicillin to determine susceptibility: d.This quality control range is applicable
to only H. influenzae ATCC 49247
tested by a broth microdilution procedure using HTM. 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.<br/>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 procedurerequires 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 forampicillin. 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:<br/>For Gram-Positive Aerobes: Enterococcus Staphylococcus ��-hemolytic streptococci NOTE: For
streptococci (other than��-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.<br/>For Gram-Negative Aerobes: Enterobacteriaceae H. influenzae 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). 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: Using 1-mcg oxacillin disk: h.This quality control
range is applicable to only H. influenzae ATCC 49247 tested by a disk diffusion procedure using HTM. 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% CO.<br/>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.
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A history of allergic reaction to any of the
penicillins is a contraindication.
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Capsules of AMOXIL: Each capsule contains 500 mg amoxicillin as
the trihydrate. 500-mg
Capsule<br/>Tablets of AMOXIL: Each tablet contains 500 mg or 875 mg
amoxicillin as the trihydrate. 500-mg Tablet 875-mg Tablet<br/>Chewable Tablets of AMOXIL: Each cherry-banana-peppermint-flavored tablet contains
200 mg or 400 mg amoxicillin as the trihydrate. 200-mg Tablet 400-mg Tablet<br/>AMOXIL for Oral Suspension: Each 5 mL of reconstituted bubble-gum-flavored
suspension contains 200, 250, or 400 mg amoxicillin as the trihydrate. 200 mg/5 mL 250 mg/5 mL 400 mg/5 mL<br/>Pediatric Drops of AMOXIL for Oral Suspension: Each mL of bubble-gum-flavored reconstituted suspension
contains 50 mg amoxicillin as the trihydrate. Store at or below 20��C
(68��F) ���500-mg capsules ���250-mg unreconstituted powder Store at or below 25��C (77��F) ���200-mg and 400-mg unreconstituted
powder ���200-mg and 400-mg chewable tablets ���500-mg and 875-mg tablets Dispense in a tight container.
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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. 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. Prescribing
AMOXIL 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.<br/>Phenylketonurics: Each 200-mg chewable tablet of AMOXIL contains 1.82 mg
phenylalanine; each 400-mg chewable tablet contains 3.64 mg phenylalanine.
The suspensions of AMOXIL do not contain phenylalanine and can be
used by phenylketonurics.<br/>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.<br/>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. In common with other antibiotics, AMOXIL may affect the gut flora,
leading to lower estrogen reabsorption and reduced efficacy of combined
oral estrogen/progesterone contraceptives.<br/>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.<br/>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 (AUGMENTIN). AUGMENTIN was non-mutagenic
in the Ames bacterial mutation assay, and the yeast gene conversion
assay. AUGMENTIN was weakly positive in themouse lymphoma assay,
but the trend toward increased mutation frequencies in this assay
occurred at doses that were also associated with decreased cell survival.
AUGMENTIN 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/m).<br/>Pregnancy:<br/>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 predictiveof human response, this drug should
be used during pregnancy only if clearly needed.<br/>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.<br/>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.<br/>Pediatric Use: Because of incompletely developed renal function
in neonates and young infants, the elimination of amoxicillin may
be delayed. Dosing of AMOXIL should be modified in pediatric patients
12 weeks or younger (���3 months). (See DOSAGE AND
ADMINISTRATION: Neonates and Infants.)<br/>Geriatric Use: An analysis of clinical studies of AMOXIL was conducted
to determine whether subjects aged 65 and over respond differently
from younger subjects. Of the 1,811 subjects treated with capsules
of AMOXIL, 85% were<60 years old, 15% were���61 years old
and 7% were���71 years old.This analysis and other reported clinical experience have not identified
differences in responses between the elderly and younger patients,
but a greater sensitivity of some older individuals cannot be ruled
out. This drug is known to be substantially
excreted by the kidney, and the risk of toxic reactions to this drug
may be greater in patients with impaired renal function. Because elderly
patients are more likely to have decreased renal function, care should
be taken in dose selection, and it may be useful to monitor renal
function.<br/>Information for Patients: AMOXIL may be taken every 8 hours or every 12 hours,
depending on the strength of the product prescribed. Patients should be counseled that antibacterial drugs, including
AMOXIL, should only be used to treat bacterial infections. They do
not treat viral infections (e.g., the common cold). When AMOXIL 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 shouldbe 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
AMOXIL or other antibacterial drugs in the future. 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.
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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. 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 amoxicillin.
Amoxicillin may be removed from circulation by hemodialysis.
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amoxicillin
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AMOXIL (Powder, For Suspension)
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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:<br/>Infections and Infestations: Mucocutaneous candidiasis.<br/>Gastrointestinal: Nausea, vomiting, diarrhea, black hairy tongue,
and hemorrhagic/pseudomembranous colitis. Onset
of pseudomembranous colitis symptoms may occur during or after antibiotic
treatment. (See WARNINGS.)<br/>Hypersensitivity Reactions: Anaphylaxis (See WARNING) 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.<br/>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.<br/>Renal: Crystalluria has also been reported (see OVERDOSAGE).<br/>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.<br/>Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia,
confusion, convulsions, behavioral changes, and/or dizziness have
been reported rarely.<br/>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.<br/>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 had been previously
reported with amoxicillin, clarithromycin, or lansoprazole.<br/>Triple Therapy:<br/>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.<br/>Dual Therapy:<br/>Amoxicillin/Lansoprazole: The most frequently
reported adverse events for patients who received amoxicillin three
times daily plus lansoprazole three times daily dual therapy were
diarrhea (8%) and headache (7%). No treatment-emergent adverse events
were observed at significantly higher rates with amoxicillin three
times daily pluslansoprazole three times daily dual therapy than
with lansoprazole alone. For more information
on adverse reactions with clarithromycin or lansoprazole, refer to
their package inserts, ADVERSE REACTIONS.
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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 AMOXIL, CAREFUL
INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS
TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC
REACTION OCCURS, AMOXIL 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. Clostridium difficile associated diarrhea
(CDAD) has been reported with use of nearly all antibacterial agents,
including AMOXIL, and may range in severity from mild diarrhea to
fatal colitis. Treatment with antibacterial agents alters the normal
flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B
which contribute to the development of CDAD. Hypertoxin producing
strains of C. difficile cause
increased morbidity and mortality, as these infections can be refractory
to antimicrobial therapy and may require colectomy. CDAD must be considered
in all patients who present with diarrhea following antibiotic use.
Careful medical history is necessary since CDAD has been reported
to occur over two months after the administration of antibacterial
agents. If CDAD is suspected or confirmed,
ongoing antibiotic use not directed against C. difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation,
antibiotic treatment of C. difficile, and surgical evaluation should
be instituted as clinically indicated.
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AMOXIL is indicated in the treatment of infections
due to susceptible (ONLY��-lactamase���negative) strains
of the designated microorganisms in the conditions listed below: Infections of the ear, nose,
and throat���due to Streptococcus spp. (��- and��-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. (��- and��-hemolytic strains
only), Staphylococcus spp.,
or E. coli. Infections of the lower
respiratory tract���due to Streptococcus spp. (��-
and��-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<br/>Triple Therapy: AMOXIL/clarithromycin/lansoprazole AMOXIL, 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.)<br/>Dual Therapy: AMOXIL/lansoprazole AMOXIL,
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 toreduce 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 AMOXIL and other antibacterial drugs, AMOXIL 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. Indicated surgical
procedures should be performed.
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AMOXIL
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