Amoxicillin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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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)
§ 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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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]; Associate Editor(s)-in-Chief: Mohamed Moubarak, M.D. [3]
Overview
Amoxicillin (INN), formerly amoxycillin (BAN), and abbreviated amox, is a moderate-spectrum, bacteriolytic, β-lactam antibiotic used to treat bacterial infections caused by susceptible microorganisms. It is usually the drug of choice within the class because it is better absorbed, following oral administration, than other β-lactam antibiotics. Amoxicillin is one of the most common antibiotics prescribed for children. The drug first became available in 1972.
Amoxicillin is susceptible to degradation by β-lactamase-producing bacteria, which are resistant to a broad spectrum of β-lactam antibiotics, such as penicillin. For this reason, it is often combined with clavulanic acid, a β-lactamase inhibitor. This increases effectiveness by reducing its susceptibility to β-lactamase resistance.[1]
Category
US Brand Names
MOXATAG®
FDA Package Insert
Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Overdosage | Dosage and Administration | How Supplied
Pill Images
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Mechanism of Action
Amoxicillin is similar to ampicillin in its bactericidal action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide.
References
- ↑ "Amoxicillin Susceptibility and Resistance Data" (PDF). Text "accessdate" ignored (help)