Amoxicillin Capsules USP, 250 mg and, Amoxicillin Capsules USP, 500 mg

DESCRIPTION

id: 636975d7-6074-9fad-e053-2991aa0a8eec
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Formulations of amoxicillin capsules 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 (2
S, 5
R, 6
R)-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 C
₁₆H
₁₉N
₃O
₅S•3H
₂O, and the molecular weight is 419.45. Each amoxicillin capsule USP, for oral administration, contains either 250 mg or 500 mg of amoxicillin as the trihydrate. In addition, the capsules also contain the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, titanium dioxide, and yellow iron oxide. Additionally, the 250 mg capsules contain black iron oxide and red iron oxide. The 250 mg capsule with caramel cap and ivory body is imprinted with West-ward 938, while the 500 mg capsule with ivory cap and ivory body is imprinted with West-ward 939.

CLINICAL PHARMACOLOGY

id: 6368132c-9884-6291-e053-2a91aa0a5364
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. 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.

INDICATIONS AND USAGE

id: 6368132c-9888-6291-e053-2a91aa0a5364
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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

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

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

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

Infections of the lower respiratory tract due to Streptococcus spp. (α- and β-hemolytic strains only),
S. pneumoniae, Staphylococcus spp., or
H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) due to
N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence Triple therapy: Amoxicillin /clarithromycin/lansoprazole

Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 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/lansoprazole

Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 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.
) Indicated surgical procedures should be performed.

CONTRAINDICATIONS

id: 6368132c-9889-6291-e053-2a91aa0a5364
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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

WARNINGS

id: 6368132c-988a-6291-e053-2a91aa0a5364
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. 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.

ADVERSE REACTIONS

id: 6368132c-9897-6291-e053-2a91aa0a5364
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:
Gastrointestinal:
Nausea, vomiting, diarrhea, and hemorrhagic / pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See
WARNINGS.
)
Hypersensitivity Reactions:
Serum sickness–like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported. NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to amoxicillin therapy.
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.

OVERDOSAGE

id: 6368132c-989a-6291-e053-2a91aa0a5364
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.
³ Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after over-dosage 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: 6368132c-989b-6291-e053-2a91aa0a5364
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Amoxicillin capsules may be given without regard to meals. However, food effect studies have not been performed with the 500 mg formulation.

HOW SUPPLIED

id: 6368132c-98a2-6291-e053-2a91aa0a5364
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Capsules:

Amoxicillin Capsules USP, 500 mg are available as ivory cap and ivory body. The cap of the 500 mg capsule is imprinted with West-ward and the body with 939. Amoxicillin capsules USP, 250 mg, are available as caramel cap and ivory body. The cap of the 250 mg capsule is imprinted with West-ward and the body with 938. They are supplied by
Altura Pharmaceuticals, Inc. as follows:

NDC	Strength	Quantity/Form	Color	Source Prod. Code
63874-101-21	250 mg	21 Capsules in a Plastic Bottle	BROWN	0143-9938
63874-101-28	250 mg	28 Capsules in a Plastic Bottle	BROWN	0143-9938
63874-101-30	250 mg	30 Capsules in a Plastic Bottle	BROWN	0143-9938
63874-101-40	250 mg	40 Capsules in a Plastic Bottle	BROWN	0143-9938
63874-101-01	250 mg	100 Capsules in a Plastic Bottle	BROWN	0143-9938
63874-102-21	500 mg	21 Capsules in a Plastic Bottle	WHITE	0143-9939
63874-102-28	500 mg	28 Capsules in a Plastic Bottle	WHITE	0143-9939
63874-102-30	500 mg	30 Capsules in a Plastic Bottle	WHITE	0143-9939
63874-102-40	500 mg	40 Capsules in a Plastic Bottle	WHITE	0143-9939
63874-102-01	500 mg	100 Capsules in a Plastic Bottle	WHITE	0143-9939

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

CLINICAL STUDIES

id: 6368132c-98a3-6291-e053-2a91aa0a5364
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 3 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)

* This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within one year) and H. pylori infection at baseline defined as at least two of three 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 one year). All dropouts were included as failures of therapy.
‡ (p<0.05) versus lansoprazole/amoxicillin and lansoprazole/clarithromycin dual therapy.
§ (p<0.05) versus clarithromycin/amoxicillin dual therapy.
Study	Triple Therapy	Triple Therapy
	Evaluable Analysis*	Intent-to-Treat Analysis†
Study 1	92‡	86‡
	[80 – 97.7]	[73.3 – 93.5]
	(n = 48)	(n = 55)
Study 2	86§	83§
	[75.7 – 93.6]	[72 – 90.8]
	(n = 66)	(n = 70)

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

* This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within one year) and H. pylori infection at baseline defined as at least two of three 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 one year). All dropouts were included as failures of therapy.
‡ (p<0.05) versus lansoprazole alone.
§ (p<0.05) versus lansoprazole alone or amoxicillin alone.
Study	Dual Therapy	Dual Therapy
	Evaluable Analysis*	Intent-to-Treat
		Analysis†
Study 1	77‡	70‡
	[62.5 – 87.2]	[56.8 – 81.2]
	(n = 51)	(n = 60)
Study 2	66§	61§
	[51.9 – 77.5]	[48.5 – 72.9]
	(n = 58)	(n = 67)

REFERENCES

id: 6368132c-98a4-6291-e053-2a91aa0a5364
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 West-ward Pharmaceutical Corp.

Eatontown, NJ 07724

Distributor Manufactured by :

Hikma Pharmaceuticals

P.O. Box 182400

Amman 11118 – Jordan This Product was Repackaged By: Altura Pharmaceuticals, Inc.

12540 McCann Drive

Santa Fe Springs, CA 90670

United States

Susceptibility Tests:

id: 637957d5-3e82-9f7a-e053-2a91aa0a4157
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Dilution Techniques: Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimi-crobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method
¹ (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 (mca /mL)
Interpretation ≤ 8 ≥ 16 Resistant (R)

Staphylococcus
^a

Interpretation

≤ 0.25

Susceptible (S)

≥ 0.5

Resistant (R)

NOTE: These interpretive criteria are based on the recommended doses for respiratory tract infections. For Gram-Negative Aerobes: Streptococcus (except S. pneumoniae) S. pneumoniae
^b from non-meningitis sources. (Amoxicillin powder should be used to determine susceptibility.)
MIC (mca /mL)
Interpretation ≤ 0.25 Susceptible (S) 0.5 to 4 Intermediate (I) ≥ 8 Resistant (R)
MIC (mca /mL)
Interpretation ≤ 2 Susceptible (S) 4 Intermediate (I) ≥ 8 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: Using
amoxicillin to determine susceptibility: 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 procedure
² 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: Staphylococcus
^f
Zone Diameter (mm)

Interpretation
≥ 29 Susceptible (S) ≤ 28 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: Enterobacteriacea
^e
Zone Diameter (mm)

Interpretation
≥17 Susceptible (S) 14 to 16 Intermediate (I) ≤13 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: H. influenzae
^g f. Staphylococci which are susceptible to amoxicillin but resistant to methicillin/ g. These interpretive standards are applicable only to disk diffusion susceptibility tests with
H. influenzae using Haemophilus Test Medium (HTM).
²
Zone Diameter (mm)

Interpretation
≥ 22 Susceptible (S) 19 to 21 Intermediate fl) ≤18 Resistant (R)
Microorqanism
Zone Diameter
(mm)
E. coli ATCC 25922 16 to 22
H. influenzae ATCC 49247h
S. aureus ATCC 25923 27 to 35 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.
² i. This quality control range is applicable to only
S. pneumoniae ATCC 49619 tested by a disk diffusion procedure using Mueller-Hinton agar supplemented with 5% sheep blood and incubated in 5% CO
₂.
Microorganism
Zone Diameter
(mm)
S. pneumoniae ATCC 49619i 8 to 12 β-hemolytic streptococci
Zone Diameter (mm)

Interpretation
≥ 26 19 to 25 Intermediate (I) ≤ 18 Resistant (R) Enterobacteriaceae H. influenzae
^c
MIC (mca /mL)
Interpretation ≤ 8 Susceptible (S) 16 Intermediate (I) ≥ 32 Resistant (R) Enterococcus 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
MIC (mcg/mL)
Interpretation ≤ 1 Susceptible (S) 2 Intermediate (I) ≥ 4 Resistant (R)
Microorganism
MIC (mcg /mL)
E. coli ATCC 25922 2 to 8
E. faecalis ATCC 29212 0.5 to 2
H. influenzae ATCC 49247
^d 2 to 8
S. aureus ATCC 29213 0.25 to 1 d. This quality control range is applicable to only
H. influenzae ATCC 49247 tested by a broth microdilution procedure using HTM.
¹ e. This quality control range is applicable to only
S. pneumoniae ATCC 49619 tested by the broth microdilution procedure using cation-adjusted Mueller-Hinton broth with 2-5% lysed horse blood.
Microorganism
MIC Range (mcg /mL)
S. pneumoniae ATCC 49619
^e 0.03 to 0.12
Zone Diameter (mm)

Interpretation
≥ 17 Susceptible (S) ≤ 16 Resistant (R)

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

id: 63799aab-7482-26c8-e053-2a91aa0a995b
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

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. All patients with gonorrhea should be evaluated for syphilis. (See
PRECAUTIONS – Laboratory Tests.
) Larger doses may be required for stubborn or severe infections. 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.
Infection
Severity*
Usual
Usual Dose
Adult Dose
for Children
>3 months
† Ear/nose/throat Mild/Moderate 500 mg 25 mg/kg/day every 12 hours in divided doses or every 12 hours 250 mg or every 8 hours 20 mg/kg/day in divided doses every 8 hours Severe 875 mg 45 mg/kg/day every 12 hours in divided doses or every 12 hours 500 mg or every 8 hours 40 mg/kg/day in divided doses every 8 hours Lower respiratory Mild/Moderate 875 mg 45 mg/kg/day Tract or Severe every 12 hours in divided doses or every 12 hours 500 mg every or 8 hours 40 mg/kg/day in divided doses every 8 hours Skin/Skin Mild/Moderate 500 mg 25 mg/kg/day Structure every 12 hours in divided doses or every 12 hours 250 mg every or 8 hours 20 mg/kg/day in divided doses every 8 hours Severe 875 mg 45 mg/kg/day every 12 hours in divided doses or every 12 hours 500 mg every or 8 hours 40 mg/kg/day in divided doses every 8 hours Genitourinary Mild/Moderate 500 mg 25 mg/kg/day Tract every 12 hours in divided doses or every 12 hours 250 mg every or 8 hours 20 mg/kg/day in divided doses every 8 hours Severe 875 mg 45 mg/kg/day every 12 hours in divided doses or every 12 hours 500 mg or every 8 hours 40 mg/kg/day in divided doses every 8 hours Gonorrhea 3 grams Prepubertal Acute, as children: uncomplicated single oral dose 50 mg/kg ano-genital and amoxicillin combined with 25 mg/kg probenecid urethral infections as a single dose. in males and
NOTE: SINCE females
PROBENECID IS
CONTRAINDICATED
IN CHILDREN
UNDER 2 YEARS.
DO NOT USE

THIS REGIMEN
IN THESE CASES