Azithromycin (ophthalmic)

Azithromycin (ophthalmic)
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

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Azithromycin (ophthalmic) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Azithromycin (ophthalmic) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Azithromycin (ophthalmic) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Azithromycin (ophthalmic) 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 Azithromycin (ophthalmic) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Azithromycin (ophthalmic) in pediatric patients.

Contraindications

There is limited information regarding Azithromycin (ophthalmic) Contraindications in the drug label.

Warnings

There is limited information regarding Azithromycin (ophthalmic) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Azithromycin (ophthalmic) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Azithromycin (ophthalmic) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Azithromycin (ophthalmic) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Azithromycin (ophthalmic) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Azithromycin (ophthalmic) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Azithromycin (ophthalmic) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Azithromycin (ophthalmic) in geriatric settings.

Gender

There is no FDA guidance on the use of Azithromycin (ophthalmic) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Azithromycin (ophthalmic) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Azithromycin (ophthalmic) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Azithromycin (ophthalmic) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Azithromycin (ophthalmic) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Azithromycin (ophthalmic) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Azithromycin (ophthalmic) Administration in the drug label.

Monitoring

There is limited information regarding Azithromycin (ophthalmic) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Azithromycin (ophthalmic) and IV administrations.

Overdosage

There is limited information regarding Azithromycin (ophthalmic) 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 Azithromycin (ophthalmic) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Azithromycin (ophthalmic) Mechanism of Action in the drug label.

Structure

There is limited information regarding Azithromycin (ophthalmic) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Azithromycin (ophthalmic) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Azithromycin (ophthalmic) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Azithromycin (ophthalmic) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Azithromycin (ophthalmic) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Azithromycin (ophthalmic) How Supplied in the drug label.

Storage

There is limited information regarding Azithromycin (ophthalmic) 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 Azithromycin (ophthalmic) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Azithromycin (ophthalmic) 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 Azithromycin (ophthalmic) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Azithromycin (ophthalmic) 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.

Azithromycin (ophthalmic)
AZASITE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [3]

Overview

Azithromycin is an azalide, a subclass of macrolide antibiotics. It is derived from erythromycin, with a methyl-substituted nitrogen atom incorporated into the lactone ring, thus making the lactone ring 15-membered.

Category

Macrolide, Azalide

US Brand Names

AZASITE^®

FDA Package Insert

Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages

Mechanism of Action

Azithromycin prevents bacteria from growing by interfering with their protein synthesis. It binds to the 50S subunit of the bacterial ribosome, and thus inhibits translation of mRNA. Nucleic acid synthesis is not affected.