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];

Disclaimer

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Overview

Amoxicillin is an antibiotic that is FDA approved for the treatment of Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below:

  • Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
  • Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis.
  • Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli.
  • Infections of the lower respiratory tract -due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
  • Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females).
  • H. pylori eradication to reduce the risk of duodenal ulcer recurrence
  • Triple Therapy: Amoxicillin/clarithromycin/lansoprazole

Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.. Common adverse reactions include Rash, Diarrhea, nauseas. 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Amoxicillin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Amoxicillin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Amoxicillin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Amoxicillin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Amoxicillin in pediatric patients.

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.

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