Amoxicillin

Amoxicillin
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Overview

Amoxicillin is an antibiotic that is FDA approved for the treatment of infections of the ear, nose, throat, genitourinary tract and lower respiratory tract. Also for Gonorrhea and helicobacter infections. Common adverse reactions include rash, diarrhea, nausea, headache and vulvovaginitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

‡ 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.

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:

Triple Therapy:
- Amoxicillin
- Clarithromycin
- Lansoprazole.

The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days.

Community Acquired Pneumonia

In patients wit comorbidities or use of antimicrobials within the previous 3 month
- Dosage: 875mg PO q12h OR 500mg q8h

Acute Bacterial Rhinosinusitis

Mild/Moderate: 500mg q12h or 250mg q8h
Severe: 875mg q12h or 500mg q8h

Gonorrhea, Acute uncomplicated anogenital and urethral infections due to Neisseria gonorrhoeae

Dosage: 3g as single oral dose

Helicobacter Pylori infection

Triple Therapy for 14 days
- Amoxicillin: 1g q12h PO
- Clarithromycin: 500mg q12h
- Lansoprazole: 30mg q12h
Dual Therapy
- Amoxicillin: 1g q8h
Lansoprazole: 30mg q8h

Infection of skin AND/OR subcutaneous tissue

Mild/moderate: 500mg q12h or 250mg q8h
Severe: 875mg q12h or 500mg q8h

Infectious disease of genitourinary system

Mild/Moderate: 500 mg q12h or 250mg q8h
Severe: 875mg q8h or 500mg q8h

Lower Respiratory Tract Infection

Dosage: 875 mg q12h or 500 mg q8h

Tonsillitis and/or Pharyngitis

Dosage: 775mg once daily taken within 1 hour of finishing a meal, for 10 days.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Bacterial Endocarditis Prophylaxis

Dosage: 2g PO q24h ^[1]

Chlamydial Infection

Pregnant women: 500mg q8h PO for 7 days. ^[2]

Lyme's Disease

Eritema migrans dosage: 500mg PO TID for 14-21 days
Seventh-cranial nerve palsy: 500mg PO TID for 14-21 days
Lyme's arthritis: 500mg PO TID for 14-21 days^[3]

Non–Guideline-Supported Use

Actinomycotic Infection

Dosage: 500mg q8h PO (in combination with cotrimoxazole (80mg/400mg) 2 tablets q12h for 2-5 months for home regimen) ^[4]

Acute Infective Exacerbation of Chronic Obstructive Pulmonary Disease

Dosage: 1g q12h PO. ^[5]

Cutaneous Anthrax

When first-line drugs are contraindicated in the patient
- Dosage: 1g q8h PO ^[6]

Periodontal infection

Dosage: 500mg Amoxicillin q8h in combination with metronidazole 250-400mg q8h^[7]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Otitis Media with Effusion

Mild/Moderate: 25 mg/kg/day in divided doses q12h OR 20 mg/kg/day in divided doses q8h
Severe: 45 mg/kg/day in divided doses q12h OR 40 mg/kg/day in divided doses q8h

Acute Bacterial Rhinosinusitis

Mild/Moderate: 25 mg/kg/day in divided doses q12h OR 20 mg/kg/day in divided doses q8h
Severe: 45 mg/kg/day in divided doses q12h OR 40 mg/kg/day in divided doses q8h

Gonorrhea, Acute uncomplicated anogenital and urethral infections due to Neisseria gonorrhoeae

Dosage: 50 mg/kg Amoxicillin combined with 25 mg/kg Probenecid (Only in pediatric population >2 years old).

Infection of skin AND/OR subcutaneous tissue

Mild/Moderate: 25mg/kg/day in divided doses q12h or 20mg/kg/day in divided doses q8h
Severe: 45mg/kg/day in divided doses q12h or 40mg/kg/day in divided doses q8h

Infectious disease of genitourinary system

Mild/Moderate: 25mg/kg/day in divided doses q12h or 20mg/kg/day in divided doses q8h
Severe: 45mg/kg/day in divided doses q12h or 40 mg/kg/day in divided doses q8h

Lower Respiratory Tract Infection

Dosage: 45mg/kg/day in divided doses q12h or 40mg/kg/day in divided doses q8h

Tonsillitis and/or Pharyngitis

Dosage: (>12 year old) 775mg once daily taken within 1 hour of finishing a meal, for 10 days.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Lyme's Disease

Eritema migrans dosage: 50mg/kg/day PO in 3 divided doses (Max: 1500mg)
Lyme's arthritis: 50 mg/kg/day PO in 3 divided doses (Max: 1500mg)
Seventh-cranial nerve palsy: 50 mg/kg/day PO in 3 divided doses (Max: 1500mg)^[3]

Streptococcal pharyngitis

Dosage: 50 mg/kg once daily (Max: 1 g/day) ^[8]

Non–Guideline-Supported Use

Periodontal infection

Dosage: 500mg Amoxicillin q8h in combination with metronidazole 250-400mg q8h^[7]

Post Infective Arthritis

Dosage: 40mg/kg/day (Max: 2g/day) for 10-14 days in combination with an antirheumathic drug. ^[9]

Preterm premature rupture of membranes

Dosage: Ampicillin 2 g IV every 6 hours with erythromycin 250 mg every 6 hours, for 48 hours followed by amoxicillin 250 mg orally every 8 hours and erythromycin base 333 mg every 8 hours for 5 days. ^[10]

Contraindications

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

Warnings

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. these reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with amoxicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate therapy instituted. serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.

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. difficult.

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

Clinical Trials Experience

Infections and Infestations

Mucocutaneous candidiasis.

Gastrointestinal

Hypersensitivity Reactions

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

Renal

Crystaluria

Hemic and Lymphatic Systems

NOTE: These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Central Nervous System

Miscellaneous

Tooth discoloration: brown, yellow, or gray staining.

====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.

Postmarketing Experience

There is limited information regarding Amoxicillin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Amoxicillin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Amoxicillin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Amoxicillin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Amoxicillin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Amoxicillin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Amoxicillin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Amoxicillin in geriatric settings.

Gender

There is no FDA guidance on the use of Amoxicillin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Amoxicillin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Amoxicillin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Amoxicillin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Amoxicillin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Amoxicillin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Amoxicillin Administration in the drug label.

Monitoring

There is limited information regarding Amoxicillin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Amoxicillin and IV administrations.

Overdosage

There is limited information regarding Amoxicillin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Amoxicillin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Amoxicillin Mechanism of Action in the drug label.

Structure

There is limited information regarding Amoxicillin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Amoxicillin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Amoxicillin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Amoxicillin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Amoxicillin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Amoxicillin How Supplied in the drug label.

Storage

There is limited information regarding Amoxicillin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Amoxicillin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Amoxicillin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Amoxicillin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Amoxicillin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

↑ Wilson W, Taubert KA, Gewitz M, Lockhart PB, Baddour LM, Levison M; et al. (2007). "Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group". Circulation. 116 (15): 1736–54. doi:10.1161/CIRCULATIONAHA.106.183095. PMID 17446442.
↑ "Centers for Disease Control and Prevention: Sexually transmitted diseases treatment guidelines, 2010" (PDF).
↑ ^3.0 ^3.1 Wormser GP, Dattwyler RJ, Shapiro ED, Halperin JJ, Steere AC, Klempner MS; et al. (2006). "The clinical assessment, treatment, and prevention of lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America". Clin Infect Dis. 43 (9): 1089–134. doi:10.1086/508667. PMID 17029130.
↑ Ramam M, Garg T, D'Souza P, Verma KK, Khaitan BK, Singh MK; et al. (2000). "A two-step schedule for the treatment of actinomycotic mycetomas". Acta Derm Venereol. 80 (5): 378–80. PMID 11200840.
↑ Georgopoulos A, Borek M, Ridl W, Amoxycillin Bronchitis Study Group (2001). "Randomized, double-blind, double-dummy study comparing the efficacy and safety of amoxycillin 1 g bd with amoxycillin 500 mg tds in the treatment of acute exacerbations of chronic bronchitis". J Antimicrob Chemother. 47 (1): 67–76. PMID 11152433.
↑ Inglesby TV, O'Toole T, Henderson DA, Bartlett JG, Ascher MS, Eitzen E; et al. (2002). "Anthrax as a biological weapon, 2002: updated recommendations for management". JAMA. 287 (17): 2236–52. PMID 11980524.
↑ ^7.0 ^7.1 Sgolastra F, Gatto R, Petrucci A, Monaco A (2012). "Effectiveness of systemic amoxicillin/metronidazole as adjunctive therapy to scaling and root planing in the treatment of chronic periodontitis: a systematic review and meta-analysis". J Periodontol. 83 (10): 1257–69. doi:10.1902/jop.2012.110625. PMID 22220767.
↑ "Prevention of Rheumatic Fever and Diagnosis and Treatment of Acute Streptococcal Pharyngitis". line feed character in |title= at position 48 (help)
↑ Astrauskiene D (2003). "Efficacy of empirically prescribed amoxicillin and amoxicillin + clavulanic acid in children's reactive arthritis: a randomised trial". Clin Exp Rheumatol. 21 (4): 515–21. PMID 12942708.
↑ "Antibiotic Therapy for Reduction of Infant Morbidity After Preterm Premature Rupture of the Membranes".

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[pmid11980524-6] Inglesby TV, O'Toole T, Henderson DA, Bartlett JG, Ascher MS, Eitzen E; et al. (2002). "Anthrax as a biological weapon, 2002: updated recommendations for management". JAMA. 287 (17): 2236–52. PMID 11980524.

[pmid22220767-7] 7.0 ^7.1 Sgolastra F, Gatto R, Petrucci A, Monaco A (2012). "Effectiveness of systemic amoxicillin/metronidazole as adjunctive therapy to scaling and root planing in the treatment of chronic periodontitis: a systematic review and meta-analysis". J Periodontol. 83 (10): 1257–69. doi:10.1902/jop.2012.110625. PMID 22220767.

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