Amoxicillin Capsules

Name: Amoxicillin Capsules

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).

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)]

Clinical Trials Experience

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.

Postmarketing or Other Experience

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.

Drug Interactions

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Probenecid

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

Oral 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.

Allopurinol

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.

Oral Contraceptives

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

Other 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.

Effects 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.

Clinical Studies

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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 (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*
[95% Confidence Interval]
(number of patients)
Intent-to-Treat Analysis†
[95% Confidence Interval]
(number of patients)
* 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.

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)

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

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)

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.

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.

46108093

03-2013M

Manufactured in Austria by Sandoz GmbH for

Sandoz Inc., Princeton, NJ 08540

Marketed/ Packaged by:
Blenheim Pharmacal, Inc.
North Blenheim, NY 12131, (USA)

mg Capsule Label

NDC 10544-018-30

Amoxicillin Capsules, USP

500 mg

Rx only

30 Capsules

Blenheim Pharmacal, Inc.

AMOXICILLIN 
amoxicillin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10544-018(NDC:0781-2613)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW  
TITANIUM DIOXIDE  
GELATIN, UNSPECIFIED  
MICROCRYSTALLINE CELLULOSE  
MAGNESIUM STEARATE  
SHELLAC  
ISOPROPYL ALCOHOL  
BUTYL ALCOHOL  
PROPYLENE GLYCOL  
FERROSOFERRIC OXIDE  
AMMONIA  
POTASSIUM HYDROXIDE  
WATER  
ALCOHOL  
Product Characteristics
Color YELLOW (Opaque) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code AMOX;500;GG;849
Contains     
Packaging
# Item Code Package Description
1 NDC:10544-018-21 21 CAPSULE in 1 BOTTLE
2 NDC:10544-018-30 30 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064076 09/17/2010 10/31/2017
Labeler - Blenheim Pharmacal, Inc. (171434587)
Revised: 05/2017   Blenheim Pharmacal, Inc.
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