Amoxicillin description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Amoxicillin

RedPharm Drug Inc.

Amoxicillin Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx only

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

AMOXICILLIN DESCRIPTION

SRRRpAmoxicillin

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

Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.

Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide; Capsule contents - cellulose microcrystalline and magnesium stearate.

Meets USP Dissolution Test 2.


CLINICAL PHARMACOLOGY

Dose* AUC0-∞ (mcg.hr./mL) Cmax (mcg/mL)
Amoxicillin amoxicillin
(±S.D.)
amoxicillin
(±S.D.)
400 mg (5 mL of suspension) 17.1 (3.1) 5.92 (1.62)
400 mg (chewable tablet) 17.9 (2.4) 5.18 (1.64)


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 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 of 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 of Amoxicillin tablets with 875 mg of amoxicillin and clavulanate potassium showed that the 875 mg 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.

Oral administration of single doses of amoxicillin 400 mg chewable tablets and 400 mg/5 mL suspension to 24 adult volunteers yielded the following pharmacokinetic data:

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 mcg/mL and 3.5 mcg/mL to 5 mcg/ mL, respectively.

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. 1 (β-lactamase-negative strains only)
Streptococcus pneumoniae
Streptococcus spp. (α- and β-hemolytic strains only)

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

1

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)

Staphylococcus 2

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. pneumoniae 3 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 doses for respiratory tract infections.

For Gram-Negative Aerobes:

Enterobacteriaceae

MIC (mcg/mL) Interpretation
≤ 8 Susceptible (S)
16 Intermediate (I)
≥ 32 Resistant (R)

H. influenzae 4

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)
E. coli ATCC 25922 2 to 8
E. faecalis ATCC 29212 0.5 to 2
H. influenzae ATCC 49247* 2 to 8
S. aureus ATCC 29213 .25 to 1
H. influenzae1

Using amoxicillin to determine susceptibility:


Microorganism
MIC Range (mcg/ml)
S. pneumoniae
ATCC 49619*
0.03 to .12
*S. pneumoniae

H. influenzaeHaemophilus1

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)

Staphylococcus 5

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. influenzae 6

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)
E. coli
ATCC 25922
16 to 22
H. influenzae
ATCC 49247*
13 to 21
S. aureus
ATCC 25923
27 to 35
H. influenzae2

Using 1 mcg oxacillin disk:


Microorganism
Zone Diameter (mm)
S. pneumoniae
ATCC 49619*
8 to 12

*S. pneumoniae 2
H. influenzaeHaemophilus2


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 nonclarithromycin-containing regimen should be used.

AMOXICILLIN INDICATIONS AND USAGE

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), 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

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 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 .)

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 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 .)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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.

AMOXICILLIN CONTRAINDICATIONS

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 C. difficile colitis.

PRECAUTIONS

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 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 antibacterial drugs including amoxicillin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin 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 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 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

2

Pregnancy

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

Pediatric Use

DOSAGE AND ADMINISTRATION: Neonates and Infants.

Geriatric Use

An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. Of the 1,811 subjects treated with capsules of amoxicillin, 85% were less than 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 eldery 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.

AMOXICILLIN ADVERSE REACTIONS

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 lifethreatening 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 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.

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.

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.

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 plus lansoprazole 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.

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, 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.

AMOXICILLIN DOSAGE AND ADMINISTRATION

Capsules, tablets and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension 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.

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 q12h.

Infection
Severity*
Usual Adult Dose
Usual Dose for children over 3 months
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
Lover 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
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 250 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours
or
40mg/kg/day in divided doses every 8 hours
Gonorrhea Acute, uncomplicated ano-genital and
urethral infections in males and females

3 grams as single oral dose
NOTE: SINCE PROBENECID IS
CONTRAINDICATED IN CHILDREN UNDER
2 YEARS, DO NOT USE THIS REGIMINE 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.

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 followup 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

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 .)

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.

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 less than 30 mL/minute should not receive the 875 mg tablet. 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 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.

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.

125 mg/5 mL
Bottle Size Amount of Water Required for Reconstitution
80 mL 55 mL
100 mL 68 mL
150 mL 102 mL
  Each teaspoonful (5 mL) will contain 125 mg amoxicillin.
200 mg/5 mL
Bottle Size Amount of Water Required for Reconstitution
50 mL 34 mL
75 mL 51 mL
100 mL 68 mL
  Each teaspoonful (5 mL) will contain 200 mg amoxicillin.
250 mg/5 mL
Bottle Size Amount of Water Required for Reconstitution
80 mL 55 mL
100 mL 68 mL
150 mL 102 mL
  Each teaspoonful (5 mL) will contain 250 mg amoxicillin.
400 mg/5 mL
Bottle Size Amount of Water Required for Reconstitution
50 mL 34 mL
75 mL 51 mL
100 mL 68 mL
  Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

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 SUPPLIED

Amoxicillin Capsules, USP,

500 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 500 on one side and GG 849 on the other side.
NDC 67296-0220-5.................................................... bottles of 40

Store capsules at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Dispense in a tight container.


CLINICAL STUDIES

H. pylori

Randomized, double-blind clinical studies performed in the United States in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 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 2 different eradication regimen were established:

Triple Therapy: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily.

Dual Therapy: Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily.

All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment.

Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.


Triple Therapy
Triple Therapy
Study
valuable Analysis*
Intent-to-Treat Analysis
Study 1
92‡ 86‡

[80.0-97.7]
[73.3-93.5]

(n=48) (n=55)
Study 2
86§ 83§

[75.7-93.5]
[72.0-90.8]

(n=66)
(n=70)


H. pylori®
H. pylori



H. pylori Eradication Rates – Dual Therapy (amoxicillin/lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients)

Dual Therapy
Dual Therapy
Study valuable Analysis*
Intent-to-Treat Analysis
Study 1
77‡ 70‡

[62.5-77.5]
[56.8-81.2]

(n=51)
(n=60)
Study 2
86§ 61§

[51.9-77.5]
[48.5-72.9]

(n=58)
(n=67)

H. pylori®
H. pylori


REFERENCES

  • National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Fourth Edition; Approved Standard. NCCLS Document M7-A4, Vol. 17, No. 2. NCCLS, Wayne, PA, January 1997.
  • National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests – Sixth Edition; Approved Standard. NCCLS Document M2-A6, Vol. 17, No. 1. NCCLS, Wayne, PA, January 1997.
  • Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988;30:66-67.

CLINITEST® is a registered trademark of Miles, Inc.
CLINISTIX® is a registered trademark of Bayer Corporation.
CLOtest® is a registered trademark of Kimberly-Clark Corporation.

Revised 02-2007

Manufactured in Austria by Sandoz GmbH
for Sandoz Inc., Princeton, NJ 08540


Amoxicillin

Amoxicillin

Amoxicillin CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:67296-0220(NDC:0781-2613)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AMOXICILLIN amoxicillin anhydrous 500 mg

Inactive Ingredients

Ingredient Name Strength
FERRIC OXIDE YELLOW
titanium dioxide
GELATIN
FERROSOFERRIC OXIDE
cellulose, microcrystalline
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
yellow (opaque) 22 mm AMOX;500;GG;849 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67296-0220-5 40 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065291 2007-11-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.