Amoxicillin

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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

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

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]

Non–Guideline-Supported Use

Periodontal infection

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

Contraindications

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

Warnings

There is limited information regarding Amoxicillin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

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.

  1. ↑ 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.
  2. ↑ "Centers for Disease Control and Prevention: Sexually transmitted diseases treatment guidelines, 2010" (PDF).
  3. ↑ 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.
  4. ↑ 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.
  5. ↑ 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.
  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.
  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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