AMOXICILLIN

/AMOXICILLIN
AMOXICILLIN2018-09-06T09:12:40+00:00

Prescription Drug Name:

AMOXICILLIN

ID:

6C5772D3-FB26-EA0B-4F96-8002671D8166

Code:

34391-3

DESCRIPTION


id: E20B9DD0-EC53-463A-DACC-6F0857058170
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Amoxicillin formulations 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 C16H19N3O5S•3H2O, and the molecular weight is 419.45.Amoxicillin capsules, tablets, and oral suspension are intended for oral administration.Capsules: Each amoxicillin capsule contains amoxicillin trihydrate equivalent to amoxicillin anhydrous 250 mg or 500 mg. Inactive ingredients: black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, magnesium stearate, microcrystalline cellulose, shellac, sodium lauryl sulfate and titanium dioxide. In addition 250 mg capsule contains FD&C Red No. 40 and 500 mg capsule contains D&C Red No. 28 and FD&C Blue No. 1.Tablets: Each amoxicillin tablet contains amoxicillin trihydrate equivalent to amoxicillin anhydrous 500 mg or 875 mg. Inactive ingredients: colloidal silicon dioxide, crospovidone, D&C Red No. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.Chewable Tablets 125 mg and 250 mg: Each amoxicillin chewable tablet contains amoxicillin trihydrate equivalent to amoxicillin anhydrous 125 mg, 200 mg, 250 mg or 400 mg. Inactive ingredients: aspartame•, FD&C Red No. 40 aluminum lake, magnesium stearate, mannitol and strawberry guarana flavor. Additionally the 125 mg and 250 mg tablets contain corn starch, compressible sugar and talc, while the 200 mg and 400 mg tablets contain crospovidone.•See PRECAUTIONS.Powder for Oral Suspension: Each 5 mL of reconstituted suspension contains, 200 mg or 400 mg amoxicillin as the trihydrate.Each 5 mL of both the 200 mg and 400 mg reconstituted suspension contains 0.24 mEq (5.59 mg) of sodium.Amoxicillin trihydrate for oral suspension 200 mg/5 mL and 400 mg/5 mL is (reconstituted) a fruity flavor containing inactive ingredients: colloidal silicon dioxide, FD&C yellow no.6, flavor strawberry guarana, flavor tutti frutti, sodium benzoate, sodium citrate, sucrose, xanthan gum.

CLINICAL PHARMACOLOGY


id: D5DD9F82-0E1A-3D2D-B295-DB09DE654886
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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 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 of amoxicillin with 875 mg of amoxicillin/ clavulanate potassium showed that the 875 g 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 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 amoxicillin chewable tablets and 400 mg/5 mL suspension to 24 adult volunteers yielded comparable pharmacokinetic data:

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 (1 chewable tablet) 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.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 faecalisStaphylococcus spp. (β-lactamase-negative strains only)Streptococcus pneumoniaeStreptococcus 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 pyloriSusceptibility 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 source.)(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. 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 2-5% 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.1e 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. pneumoniaeS. 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).2Interpretation 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.2i 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


id: 301B34BB-A8C8-FE1C-28B2-ED1320CAB66C
displayName: INDICATIONS AND USAGE SECTION
FDA Article Code: 34067-9

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 recurrenceTriple 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.)To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, amoxicillin tablets, amoxicillin tablets (chewable) and amoxicillin for oral suspension and other antibacterial drugs, amoxicillin capsules, amoxicillin tablets, amoxicillin tablets (chewable) and amoxicillin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Indicated surgical procedures should be performed.

CONTRAINDICATIONS


id: E76F5FC6-CA81-2342-A954-9A81E964C732
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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

WARNINGS


id: 2B08ACBB-470C-A404-C96B-5B238CC43CDA
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

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.Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, 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.

ADVERSE REACTIONS


id: AD11BD44-588B-58C1-F626-0F5E4B0C5E7D
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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:Infections and Infestations: Mucocutaneous candidiasis.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.)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.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.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.Triple Therapy: Amoxicillin/Clarithromycin/Lansoprazole: The most frequently reported adverse events for patients who received triple therapy were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.Dual Therapy: Amoxicillin/Lansoprazole: The most frequently reported adverse events for patients who received amoxicillin 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


id: E37BE530-987F-24CA-CB0B-5211FEF1371A
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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.3Interstitial 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.

DOSAGE AND ADMINISTRATION


id: 8ED6911B-8597-900E-5C55-7283BCAEF4C2
displayName: DOSAGE AND ADMINISTRATION SECTION
FDA Article Code: 34068-7

Amoxicillin capsules, chewable tablets, and oral suspensions 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.Amoxicillin tablets, chewable should be chewed before swallowingNeonates and Infants aged ≤ 12 weeks (≤ 3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.Adults and Pediatric Patients > 3 months

Infection Severity Usual Adult Dose Usual Dose for Children >3 months§ π
Ear/Nose/Throat Mild/Moderate 500 mg every12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
  Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Skin/Skin Structure Mild/Moderate 500 mg every12 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 every12 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 every12 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 every12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Gonorrhea Acute, uncomplicated
ano-genital and urethral infections in males and females
  3 grams as
single oral
dose
Prepubertal children:
50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.
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.π Each strength of the suspension of amoxicillin 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.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.H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple Therapy: Amoxicillin/clarithromycin/ lansoprazoleThe recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)Dual Therapy:Amoxicillin/lansoprazoleThe recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/minute should not receive 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.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.200 mg/5 mL
Bottle Size Amount of Water Required for Reconstitution
   
50 mL 33 mL
75 mL 49 mL
100 mL 66 mL
Each teaspoonful (5 mL) will contain 200 mg amoxicillin400 mg/5 mL
Bottle Size Amount of Water Required for Reconstitution
50 mL 33 mL
75 mL 49 mL
100 mL 66 mL
Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

HOW SUPPLIED


id: C0BA718B-1700-2180-B296-1549C7BF4DAA
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Amoxicillin Capsules, USP:Each capsule contains 250 mg or 500 mg amoxicillin as the trihydrate.250 mg Capsule250 mg yellow opaque cap and yellow opaque body, size 2, printed “RX654” on both cap and body.NDC 63304-654-20 bottles of 20NDC 63304-654-30 bottles of 30NDC 63304-654-01 bottles of 100NDC 63304-654-05 bottles of 500NDC 63304-654-77 Unit-dose 100s500 mg Capsule500 mg maroon opaque cap and yellow opaque body, size 0-el, printed “RX655” on both cap and body.NDC 63304-762-82 bottles of 12NDC 63304-762-20 bottles of 20NDC 63304-762-01 bottles of 100NDC 63304-762-13 bottles of 120NDC 63304-762-05 bottles of 500Amoxicillin Tablets, USP:Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate.500 mg Tablet500 mg pink colored, film coated, capsule shaped tablets; debossed with “RX762” on one side and plain on the other side.NDC 63304-762-82 bottles of 12NDC 63304-762-20 bottles of 20NDC 63304-762-01 bottles of 100NDC 63304-762-13 bottles of 120NDC 63304-762-05 bottles of 500875 mg Tablet875 mg pink colored, film coated, capsule shaped tablets; debossed with “RX763” on one side and scored on reverse side.NDC 63304-763-82 bottles of 12NDC 63304-763-20 bottles of 20NDC 63304-763-01 bottles of 100NDC 63304-763-13 bottles of 120NDC 63304-763-05 bottles of 500Amoxicillin Chewable Tablets, USP: Each chewable tablet contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.125 mg Tablet 125 mg pink colored, strawberry flavored, oval biconvex tablets, with mottled appearance; debossed with “RX514” on one side.NDC 63304-514-01 bottles of 100NDC 63304-514-05 bottles of 500200 mg Tablet200 mg light pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX760” on one side.NDC 63304-760-20 bottles of 20NDC 63304-760-01 bottles of 100NDC 63304-760-05 bottles of 500250 mg Tablet 250 mg pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX515” on one side.NDC 63304-515-30 bottles of 30NDC 63304-515-01 bottles of 100NDC 63304-515-04 bottles of 250400 mg Tablet400 mg light pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX716” on one side.NDC 63304-761-20 bottles of 20NDC 63304-761-01 bottles of 100NDC 63304-761-05 bottles of 500Amoxicillin For Oral Suspension USP is available in:The 200 mg per 5 mL oral suspension* is off white to light orange granular powder forming a light orange to orange suspension on constitution with water. The resulting suspension has a characteristic fruity flavor and is available as follows:NDC 63304-969-03 50 mL bottlesNDC 63304-969-01 75 mL bottlesNDC 63304-969-04 100 mL bottlesThe 400 mg per 5 mL oral suspension* is off white to light orange granular powder forming a light orange to orange suspension* on constitution with water. The resulting suspension has a characteristic fruity flavor and is available as follows:NDC 63304-970-03 50 mL bottle NDC 63304-970-01 75 mL bottleNDC 63304-970-04 100 mL bottle*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.
Dispense in a tight container.Store amoxicillin capsules 250 mg and 500 mg,  amoxicillin tablets 500 mg and 875 mg, amoxicillin chewable tablets 125 mg, 200 mg, 250 mg and 400 mg and amoxicillin unreconstituted powder 200 mg/5 mL and 400 mg/5 mL at controlled room temperature 15° – 30° C (59° – 86° F) (see USP).

CLINICAL STUDIES


id: 21D9AEBF-81EC-C77B-FCEF-E5BEC5CE912E
displayName: CLINICAL STUDIES SECTION
FDA Article Code: 34092-7

H. Pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: 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 regimens 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.H. pylori Eradication Rates – Triple Therapy (amoxicillin/clarithromycin/lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients)

Study Triple Therapy Triple Therapy
Evaluable Analysis Intent-to-Treat Analysis
Study 1 92§ [80 to 97.7] (n = 48) 86§ [73.3–93.5] (n = 55)
Study 2 86ll [75.7–93.6] (n = 66) 83ll [72 to 90.8] (n = 70)
This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, (Delta West Ltd., Bentley, Australia), histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.§ (p< 0.05) versus lansoprazole/amoxicillin and lansoprazole/clarithromycin dual therapy.ll (p< 0.05) versus clarithromycin/amoxicillin dual therapy.H. pylori Eradication Rates – Dual Therapy (amoxicillin/lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients)
Study Dual Therapy Dual Therapy
Evaluable Analysis Intent-to-Treat Analysis††
Study 1 77‡‡ [62.5–87.2] (n=51) 70‡‡ [56.8–81.2] (n=60)
Study 2 66§§[51.9–77.5] (n=58) 61§§[48.5–72.9] (n=67)
This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy.†† Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.‡‡ (p < 0.05) versus lansoprazole alone.§§ (p < 0.05) versus lansoprazole alone or amoxicillin alone.

REFERENCES


id: 30385467-A428-2DE1-DA91-5F5ACE0C2754
displayName: REFERENCES SECTION
FDA Article Code: 34093-5

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.Manufactured for: Ranbaxy Laboratories, Inc.Jacksonville, FL 32257 USA by: Ranbaxy Laboratories Limited New Delhi − 110 019, IndiaApril 2008