Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age
Infection	Severity^a	Usual Adult Dose	Usual Dose for Children > 3 Months^b
Ear/Nose/Throat Skin/Skin Structure 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 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
^a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. ^b 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.

Table 2. Amount of Water for Mixing Oral Suspension
Strength	Bottle Size	Amount of Water Required for Reconstitution
Oral Suspension 125 mg/5 mL	80 mL	69 mL
	100 mL	86 mL
	150 mL	128 mL
Oral Suspension 250 mg/5 mL	80 mL	56 mL
	100 mL	70 mL
	150 mL	104 mL

Table 3: Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults
*Dose Amoxicillin**	AUC_0-∞ (mcg·hr/mL) Amoxicillin (±S.D.)	C_max (mcg/mL)^† 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.

Table 4. Susceptibility Interpretive Criteria for Amoxicillin
	Minimum Inhibitory Concentration (mcg/mL)	Disk Diffusion (zone diameter in mm)
Susceptible	Intermediate	Resistant	Susceptible	Intermediate	Resistant
Streptococcus P neumoniae (non-meningitis isolates)*	≤ 2	4	≥ 8	-	-	-
* 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 mm⁴.

Table 5. Acceptable Quality Control Ranges for Amoxicillin^a
Quality Control Microorganism	Minimum Inhibitory Concentrations (mcg/mL)	Disc Diffusion Zone Diameter (mm)
Streptococcus pneumoniae ATCC^b 49619	0.03 to 0.12	----
Klebsiella pneumoniae ATCC 700603	> 128	----
^a QC limits for testing E. coli 35218 when tested on Haemophilus Test Medium (HTM) are ≥ 256 mcg/mL for amoxicillin; testing amoxicillin may help to determine if the isolate has maintained its ability to produce beta-lactamase⁴. ^b ATCC = American Type Culture Collection

Table 6. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen
Study	Triple Therapy	Triple Therapy
Evaluable Analysis ^a [95% Confidence Interval] (number of patients)	Intent-to-Treat Analysis ^b [95% Confidence Interval] (number of patients)
Study 1	92 [80.0 - 97.7] (n = 48)	86 [73.3 - 93.5] (n = 55)
Study 2	86 [75.7 - 93.6] (n = 66)	83 [72.0 - 90.8] (n = 70)
^a 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. ^b 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.

Table 7. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen
Study	Dual Therapy	Dual Therapy
Evaluable Analysis ^a [95% Confidence Interval] (number of patients)	Intent-to-Treat Analysis ^b [95% Confidence Interval] (number of patients)
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)
^a 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. ^b 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.

Amoxicillin (amoxicillin 250 mg) Dailymed

Generic: amoxicillin

view more pill photos

All Imprints

amoxicillin tablet - wc 731 capsule orange

amoxicillin 500 mg - wc 731 capsule orange

amoxicillin 250 mg - wc 730 capsule orange

Go PRO for all pill images

Recent Major Changes Section

Indications and Usage, Gonorrhea (1.5) Removed 9/2015Dosage and Administration, Gonorrhea (2.1) Removed 9/2015

1 Indications And Usage

Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.

Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1 – 1.4)

In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.5)

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 infections that are proven or strongly suspected to be caused by bacteria. (1.6)

1.1Infections of the Ear, Nose, and Throat:

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.

1.2Infections of the Genitourinary Tract:

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.

1.3Infections of the Skin and Skin Structure:

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.

1.4Infections of the Lower Respiratory Tract:

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

1.5 Infection

Triple therapy for Helicobacter pylori with clarithromycin and 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.

Dual therapy for H. pylori with 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.

1.6Usage

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 infections that are proven or strongly suspected to be caused by 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.

2 Dosage And Administration

In adults, 750-1750 mg/day in divided doses every 8-12 hours. In Pediatric Patients > 3 Months of Age, 20-45 mg/kg/day in divided doses every 8-12 hours. Refer to full prescribing information for specific dosing regimens. (2.1, 2.2, 2.3)

The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours. (2.2)

Dosing for H. pylori Infection: Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. (2.3)

Reduce the dose in patients with severe renal impairment (GFR <30 mL/min). (2.4)

2.1 Dosing for Adult and PediatricPatients > 3 Monthsof Age

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. In some 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.

Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age

Infection Severity^a Usual Adult Dose Usual Dose for Children > 3 Months^b

Ear/Nose/Throat Skin/Skin Structure 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 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

^a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.

^b 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.

2.2Dosing in Neonatesand Infants Aged 12 Weeks ( 3 Months)

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. 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 every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

2.3Dosing for Infection

Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

Please refer to clarithromycin and lansoprazole full prescribing information.

2.4Dosing in Renal Impairment

Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.

Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose.

Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.

Patients with a glomerular filtration rate less than 10 mL/min 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.

2.5Directions for Mixing OralSuspension

Tap bottle until all powder flows freely. Add approximately ½ of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

Table 2. Amount of Water for Mixing Oral Suspension

Strength Bottle Size Amount of Water Required for Reconstitution

Oral Suspension 125 mg/5 mL 80 mL 69 mL

100 mL 86 mL

150 mL 128 mL

Oral Suspension 250 mg/5 mL 80 mL 56 mL

100 mL 70 mL

150 mL 104 mL

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.

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 is preferable, but not required.

3 Dosage Forms And Strengths

Amoxicillin Capsules 250 mg: Peach/orange capsule marked WC 730. Each capsule contains amoxicillin trihydrate equivalent to 250 mg amoxicillin as the trihydrate.500 mg: Peach/orange capsule marked WC 731. Each capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin as the trihydrate.

Amoxicillin for Oral Suspension 125 mg/5 mL: Each 5 ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 125 mg amoxicillin.250 mg/ 5 mL: Each 5 ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 250 mg amoxicillin.

Amoxicillin Tablets 875 mg: White, oblong, film-coated tablet engraved S score line 145 on one side. Each tablet contains 875 mg amoxicillin as the trihydrate.

Amoxicillin Tablets, (Chewable) 125 mg: Pink, biconvex, oval embossed 231 on one side and logo on reverse. Each tablet contains 125 mg amoxicillin as the trihydrate. 250 mg: Pink, biconvex, oval embossed 232 on one side and logo on reverse. Each tablet contains 250 mg amoxicillin as the trihydrate.

Capsules: 250 mg, 500 mg (3)

Tablets: 875 mg (3)

Powder for Oral Suspension: 125 mg/5 mL, 250 mg/5 mL (3)

Tablets (chewable): 125 mg, 250 mg (3)

4 Contraindications

Amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other β-lactam antibiotics (e.g., penicillins and cephalosporins).

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other beta-lactams (e.g., penicillins or cephalosporins) (4)

5 Warnings And Precautions

Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy. Serious anaphylactic reactions require immediate emergency treatment with supportive measures. (5.1)

Clostridium difficile-associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. (5.2)

5.1 Anaphylactic Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. 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 regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate therapy instituted.

5.2 Associated Diarrhea

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 antibacterial use.

Careful medical history is necessary since CDAD has been reported to occur over 2 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.

5.3Development of Drug-Resistant Bacteria

Prescribing amoxicillin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria

5.4Use in PatientsWith Mononucleosis

A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus amoxicillin should not be administered to patients with mononucleosis.

5.5Phenylketonurics

Amoxicillin chewable tablets contain aspartame which contains phenylalanine. Each 125-mg chewable tablet of amoxicillin contains 0.85 mg phenylalanine; each 250-mg chewable tablet contains 1.7 mg phenylalanine. The other formulations of amoxicillin do not contain phenylalanine.

6 Adverse Reactions

The following are discussed in more detail in other sections of the labeling:

Anaphylactic reactions [see Warnings and Precautions (5.1)]

CDAD [see Warnings and Precautions (5.2)]

The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact DAVA Pharmaceuticals at 1-800-444-4011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical TrialsExperience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea.

Triple therapy: The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%).

Dual therapy: The most frequently reported adverse events for patients who received double therapy amoxicillin/lansoprazole were diarrhea (8%) and headache (7%). For more information on adverse reactions with clarithromycin or lansoprazole, refer to the Adverse Reactions section of their package inserts.

6.2Postmarketing or OtherExperience

In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of penicillins. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin.

Infections and Infestations: Mucocutaneous candidiasis.

Gastrointestinal: Black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions: Anaphylaxis [see Warnings and Precautions (5.1) ]. 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.

Liver: A moderate rise in AST and/or ALT 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 been reported [see Overdosage (10) ].

Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. 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.

Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

7 Drug Interactions

Probenicid decreases renal tubular secretion of amoxicillin which may result in increased blood levels of amoxicillin. (7.1)

Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. (7.2)

Coadministration with allopurinol increases the risk of rash. (7.3)

Amoxicillin may reduce the efficacy of oral contraceptives. (7.4)

7.1Probenecid

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.

7.2Oral Anticoagulants

Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

7.3Allopurinol

The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

7.4Oral Contraceptives

Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

7.5Other Antibacterials

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.

7.6Effects on Laboratory Tests

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 or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

8 Use In Specific Populations

Pediatric: Modify dose in patients 12 weeks or younger (≤ 3 months). (8.4)

8.1Pregnancy

Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of 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, amoxicillin should be used during pregnancy only if clearly needed.

8.2 Labor and Delivery

Oral ampicillin is poorly absorbed during labor. 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 of the necessity for an obstetrical intervention.

8.3Nursing Mothers

Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.

8.4Pediatric Use

Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (≤ 3 months) [see Dosage and Administration (2.2)].

8.5Geriatric Use

An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6Dosing in RenalImpairment

Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR <30 mL/min). See Dosing in Renal Impairment (2.4) for specific recommendations in patients with renal impairment.

10 Overdosage

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. 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.

Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin¹.

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.

11 Description

Amoxicillin is 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.

INACTIVE INGREDIENT SECTION

Amoxicillin Capsules, USP Each capsule, for oral administration, provide amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin Inactive Ingredients: CAPSULES-DRUG PRODUCT: Magnesium Stearate, Sodium Lauryl Sulfate.CAPSULE SHELL AND PRINT CONSTITUENTS: Gelatin, Sodium Lauryl Sulfate, Titanium Dioxide, D&C Red No. 33; FD&C Blue No. 1; FD&C Red No. 40; FD&C Yellow No. 6. In addition, each 250 mg capsule contains up to 0.0027 mEq (0.062 mg) of sodium; the 500 mg capsule contains up to 0.0052 mEq (0.119 mg) of sodium.

Amoxicillin Tablets, USP Each tablet, for oral administration, provide amoxicillin trihydrate equivalent to 875 mg amoxicillin.Inactive Ingredients: TABLETS: Colloidal Silicon Dioxide, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Soy Lecithin, Talc, Titanium Dioxide. In addition, each tablet contains up to 0.032 mEq (0.74 mg) of Sodium.

Amoxicillin for Oral Suspension, USP Each 5 mL of reconstituted suspension contains amoxicillin trihydrate equivalent to 125 mg or 250 mg of amoxicillin, when the dry powder is reconstituted according to directions.Inactive Ingredients: SUSPENSION: Carboxymethylcellulose Sodium, Colloidal Silicon Dioxide, Flavors, Microcrystalline Cellulose, Sodium Citrate, Sodium Propionate, Sucrose, FD&C Red No. 40, FD&C Yellow No. 6. In addition, each 5 mL of the 125 mg reconstituted suspension contains up to 0.209 mEq (4.80 mg) of sodium; each 5 mL of the 250 mg reconstituted suspension contains up to 0.417 mEq (9.60 mg) of sodium.

Amoxicillin Tablets, USP (Chewable) Each chewable tablet, for oral administration, contains amoxicillin trihydrate equivalent to 125 mg or 250 mg amoxicillin. Inactive Ingredients: CHEWABLE TABLETS: Aspartame*, Flavor, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Sorbitol, FD&C Red No. 40. THIS PRODUCT CONTAINS ASPARTAME AND IS NOT INTENDED FOR USE BY PHENYLKETONURICS: CONTAINS PHENYLALANINE. [*see PRECAUTIONS ].

12 Clinical Pharmacology

12.1 Mechanism of Action

Amoxicillin is an antibacterial drug. [see Microbiology (12.4)].

12.3 Pharmacokinetics

Absorption: Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from the tablets and suspension of amoxicillin has been partially investigated; 400-mg and 875-mg formulations have been studied only when administered at the start of a light meal.

Orally administered doses of 250-mg and 500-mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5.0 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.

Mean amoxicillin pharmacokinetic parameters from an open, two-part, single-dose crossover bioequivalence study in 27 adults comparing 875 mg of amoxicillin tablets with 875 mg of AUGMENTIN^® (amoxicillin/clavulanate potassium) showed that the 875-mg tablet of amoxicillin produces an AUC_0-∞ of 35.4 ± 8.1 mcg·hr/mL and a C_max 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 3.0 mcg/mL and 3.5 mcg/mL to 5.0 mcg/mL, respectively.

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

Table 3: Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults

Dose* Amoxicillin AUC_0-∞ (mcg·hr/mL) Amoxicillin (±S.D.) C_max (mcg/mL)^† 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.

Distribution: Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. In blood serum, amoxicillin is approximately 20% protein-bound. 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.

Metabolism and Excretion: The half-life of amoxicillin is 61.3 minutes. Approximately 60% of an orally administered dose of amoxicillin is excreted in the urine within 6 to 8 hours. Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxicillin. Since most of the amoxicillin is excreted unchanged in the urine, its excretion can be delayed by concurrent administration of probenecid [see Drug Interactions (7.1)].

12.4 Microbiology

Mechanism of Action

Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.

Mechanism of Resistance

Resistance to amoxicillin is mediated primarily through enzymes called beta-lactamases that cleave the beta-lactam ring of amoxicillin, rendering it inactive.

Amoxicillin has been shown to be active against most isolates of the bacteria uled below, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Gram-Positive Bacteria Enterococcus faecalis Staphylococcus spp. Streptococcus pneumoniae Streptococcus spp. (alpha and beta-hemolytic)

Gram-Negative Bacteria Escherichia coli Haemophilus influenzaeHelicobacter pyloriProteus mirabilis

Susceptibility Test Methods:

When available, the clinical microbiology laboratory should provide cumulative in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial.

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 test method -(broth or agar)^2,4. The MIC values should be interpreted according to the criteria in Table 4.

Diffusion Techniques: Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds^3,4. The zone size should be determined using a standardized test method³.

Susceptibility to amoxicillin of Enterococcus spp., Enterobacteriaceae, and H. influenzae, may be inferred by testing ampicillin⁴. Susceptibility to amoxicillin of Staphylococcus spp., and beta-hemolytic Streptococcus spp., may be inferred by testing penicillin⁴. The majority of isolates of Enterococcus spp. that are resistant to ampicillin or amoxicillin produce a TEM-type beta-lactamase. A beta-lactamase test can provide a rapid means of determining resistance to ampicillin and amoxicillin⁴.

Susceptibility to amoxicillin of Streptococcus pneumoniae (non-meningitis isolates) may be inferred by testing penicillin or oxacillin⁴. The interpretive criteria for S. pneumoniae to amoxicillin are provided in Table 4⁴.

Table 4. Susceptibility Interpretive Criteria for Amoxicillin

Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion (zone diameter in mm)

Susceptible Intermediate Resistant Susceptible Intermediate Resistant

Streptococcus P neumoniae (non-meningitis isolates)*
≤ 2 4 ≥ 8 - - -

* 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 mm⁴.

A report of “Susceptible” indicates the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches a concentration at the infection site necessary to inhibit growth of the pathogen. 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. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentration usually achievable at the infection site; other therapy should be selected.

Susceptibility Testing for Helicobacter pylori

Amoxicillin in vitro susceptibility testing methods for determining minimum inhibitory concentrations (MICs) and zone sizes have not been standardized, validated, or approved for testing H. pylori. Specimens for H. pylori and clarithromycin susceptibility test results should be obtained on isolates from patients who fail triple therapy. If clarithromycin resistance is found, a non-clarithromycin-containing regimen should be used.

Quality Control:

Standardized susceptibility test procedures ^2,3,4 require use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test control. Standard amoxicillin powder should provide the following range of MIC values provided in Table 5⁴. For the diffusion technique the criteria provided in Table 5 should be achieved.

Table 5. Acceptable Quality Control Ranges for Amoxicillin^a

Quality Control Microorganism Minimum Inhibitory Concentrations (mcg/mL) Disc Diffusion Zone Diameter (mm)

Streptococcus pneumoniae ATCC^b 49619 0.03 to 0.12 ----

Klebsiella pneumoniae ATCC 700603 > 128 ----

^a QC limits for testing E. coli 35218 when tested on Haemophilus Test Medium (HTM) are ≥ 256 mcg/mL for amoxicillin; testing amoxicillin may help to determine if the isolate has maintained its ability to produce beta-lactamase⁴.

^b ATCC = American Type Culture Collection

13 Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate (AUGMENTIN). AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. AUGMENTIN was negative in the mouse micronucleus test and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 2 times the 3 g human dose based on body surface area).

14 Clinical Studies

14.1 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 (see Table 6). Dual therapy: Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily (see Table 7). 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.

Table 6. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen

Study Triple Therapy Triple Therapy

Evaluable Analysis ^a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis ^b [95% Confidence Interval] (number of patients)

Study 1 92 [80.0 - 97.7] (n = 48) 86 [73.3 - 93.5] (n = 55)

Study 2 86 [75.7 - 93.6] (n = 66) 83 [72.0 - 90.8] (n = 70)

^a 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.

^b 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.

Table 7. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen

Study Dual Therapy Dual Therapy

Evaluable Analysis ^a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis ^b [95% Confidence Interval] (number of patients)

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)

^a 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.

^b 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.

15 References

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.

Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement, CLSI document M100-S25. CLSI document M100-S25, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

16 How Supplied/storage And Handling

Amoxicillin Capsules, USP are supplied as follows: Amoxicillin Capsules, USP 250 mg. Peach/orange capsule marked WC 730. Each capsule contains amoxicillin trihydrate equivalent to 250 mg amoxicillin as the trihydrate.NDC 67253-140-10                      250 mg - Bottles of 100 NDC 67253-140-50                      250 mg - Bottles of 500

Amoxicillin Capsules, USP 500 mg. Peach/orange capsule marked WC 731. Each capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin as the trihydrate.NDC 67253-141-10                      500 mg - Bottles of 100 NDC 67253-141-50                      500 mg - Bottles of 500NDC 67253-141-11                      500 mg - Bottles of 1000

Amoxicillin for Oral Suspension, USP is available as a powder which when reconstituted as directed yields a pink, bubble gum flavored suspension and is supplied as follows: Amoxicillin for Oral Suspension, USP 125 mg/5 mL Each 5 ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 125 mg amoxicillin.NDC 67253-142-08                      125 mg/5 ml - 80 mL individual bottles NDC 67253-142-10                      125 mg/5 ml - 100 mL individual bottlesNDC 67253-142·15                      125 mg/5 ml - 150 mL individual bottles Amoxicillin for Oral Suspension, USP 250 mg/ 5 mL Each 5 ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 250 mg amoxicillin.NDC 67253-143-08                      250 mg/5 mL - 80 ml individual bottles NDC 67253-143-10                      250 mg/5 mL -100 ml individual bottlesNDC 67253-143-15                      250 mg/5 mL - 150 ml individual bottles

Amoxicillin Tablets, USP are supplied as follows: Amoxicillin Tablets, USP 875 mg. White, oblong, film-coated tablet engraved S score line 145 on one side. Each tablet contains 875 mg amoxicillin as the trihydrate.NDC 67253-145-02                      20 Tablets NDC 67253-145-10                      100 Tablets NDC 67253-145-50                      500 Tablets

Amoxicillin Tablets, USP (Chewable) are supplied as follows: Amoxicillin Tablets, USP (Chewable) 125 mg. Pink, biconvex, oval embossed 231 on one side and logo on reverse. Each tablet contains 125 mg amoxicillin as the trihydrate.NDC 67253-151-06                      60 Tablets Amoxicillin Tablets, USP (Chewable) 250 mg. Pink, biconvex, oval embossed 232 on one side and logo on reverse. Each tablet contains 250 mg amoxicillin as the trihydrate.NDC 67253-152-10                      100 Tablets NDC 67253-152-50                       500 Tablets

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

17 Patient Counseling Information

Information for Patients

Patients should be advised that amoxicillin may be taken every 8 hours or every 12 hours, depending on the dose 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.

Patients should be counseled that diarrhea is a common problem caused by antibiotics, and it usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Patients should be aware that amoxicillin contains a penicillin class drug product that can cause allergic reactions in some individuals.

All brands uled are registered trademarks of their respective owners and not trademarks of DAVA Pharmaceuticals.

Manufactured For: DAVA Pharmaceuticals, Inc. Fort Lee, NJ 07024, USA

Manufactured By: Suir Pharma Ireland Ltd. Clonmel, Ireland.

Rev. 12/15

Principal Display Panel - Amoxicillin Capsules, Usp 250 Mg

Principal Display Panel - Amoxicillin Capsules, Usp 500 Mg

Principal Display Panel - Amoxicillin For Oral Suspension, Usp 125 Mg/5 Ml

Principal Display Panel - Amoxicillin For Oral Suspension, Usp 250 Mg/5 Ml

Principal Display Panel - Amoxicillin Tablets, Usp 875 Mg

Principal Display Panel - Amoxicillin Tablets, Usp (chewable) 125 Mg

Principal Display Panel - Amoxicillin Tablets, Usp (chewable) 250 Mg

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

PillSync may earn a commission via links on our site

Amoxicillin (amoxicillin 250 mg) Dailymed

May Be DiscontinuedTry Other Labelers

Version History

Generic: amoxicillin

All Imprints

FDA Adverse Reactions

Recent Major Changes Section

1 Indications And Usage

1.1Infections of the Ear, Nose, and Throat:

1.2Infections of the Genitourinary Tract:

1.3Infections of the Skin and Skin Structure:

1.4Infections of the Lower Respiratory Tract:

1.5 Infection

1.6Usage

2 Dosage And Administration

2.1 Dosing for Adult and PediatricPatients > 3 Monthsof Age

2.2Dosing in Neonatesand Infants Aged 12 Weeks ( 3 Months)

2.3Dosing for Infection

2.4Dosing in Renal Impairment

2.5Directions for Mixing OralSuspension

3 Dosage Forms And Strengths

4 Contraindications

5 Warnings And Precautions

5.1 Anaphylactic Reactions

5.2 Associated Diarrhea

5.3Development of Drug-Resistant Bacteria

5.4Use in PatientsWith Mononucleosis

5.5Phenylketonurics

6 Adverse Reactions

6.1Clinical TrialsExperience

6.2Postmarketing or OtherExperience

7 Drug Interactions

7.1Probenecid

7.2Oral Anticoagulants

7.3Allopurinol

7.4Oral Contraceptives

7.5Other Antibacterials

7.6Effects on Laboratory Tests

8 Use In Specific Populations

8.1Pregnancy

8.2 Labor and Delivery

8.3Nursing Mothers

8.4Pediatric Use

8.5Geriatric Use

8.6Dosing in RenalImpairment

10 Overdosage

11 Description

INACTIVE INGREDIENT SECTION

12 Clinical Pharmacology

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 Clinical Studies

14.1 Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

15 References

16 How Supplied/storage And Handling

STORAGE AND HANDLING SECTION

17 Patient Counseling Information

Principal Display Panel - Amoxicillin Capsules, Usp 250 Mg

Principal Display Panel - Amoxicillin Capsules, Usp 500 Mg

Principal Display Panel - Amoxicillin For Oral Suspension, Usp 125 Mg/5 Ml

Principal Display Panel - Amoxicillin For Oral Suspension, Usp 250 Mg/5 Ml

Principal Display Panel - Amoxicillin Tablets, Usp 875 Mg

Principal Display Panel - Amoxicillin Tablets, Usp (chewable) 125 Mg

Principal Display Panel - Amoxicillin Tablets, Usp (chewable) 250 Mg

May Be Discontinued
Try Other Labelers