Aztreonam (inhalation): Difference between revisions

Aztreonam (inhalation)
	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

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Revision as of 19:49, 12 May 2015

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

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Overview

Aztreonam (inhalation) is an antibiotic that is FDA approved for the treatment of respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa,. Common adverse reactions include chest discomfort, abdominal pain, cough, nasal congestion, wheezing, fever.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

CAYSTON® is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric ... CAYSTON® is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see CLINICAL STUDIES (14)].

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CAYSTON and other antibacterial drugs, CAYSTON should be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs. 2.1 Dosing Information - The recommended dose of CAYSTON for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of aztreonam ... 2.1 Dosing Information The recommended dose of CAYSTON for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of aztreonam) reconstituted with 1 mL of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off CAYSTON therapy). Dosage is not based on weight or adjusted for age. Doses should be taken at least 4 hours apart.

CAYSTON is administered by inhalation using an Altera® Nebulizer System. Patients should use a bronchodilator before administration of CAYSTON.

2.2 Instructions for CAYSTON Reconstitution CAYSTON should be administered immediately after reconstitution. Do not reconstitute CAYSTON until ready to administer a dose.

Take one amber glass vial containing CAYSTON and one diluent ampule from the carton. To open the glass vial, carefully remove the metal ring by lifting or pulling the tab and remove the gray rubber stopper. Twist the tip off the diluent ampule and squeeze the liquid into the glass vial. Replace the rubber stopper, then gently swirl the vial until contents have completely dissolved.

The empty vial, stopper, and diluent ampule should be disposed of properly upon completion of dosing.

2.3 Instructions for CAYSTON Administration CAYSTON is administered by inhalation using an Altera Nebulizer System. CAYSTON should not be administered with any other nebulizer. CAYSTON should not be mixed with any other drugs in the Altera Nebulizer Handset.

CAYSTON is not for intravenous or intramuscular administration.

Patients should use a bronchodilator before administration of CAYSTON. Short-acting bronchodilators can be taken between 15 minutes and 4 hours prior to each dose of CAYSTON. Alternatively, long-acting bronchodilators can be taken between 30 minutes and 12 hours prior to administration of CAYSTON. For patients taking multiple inhaled therapies, the recommended order of administration is as follows: bronchodilator, mucolytics, and lastly, CAYSTON.

To administer CAYSTON, pour the reconstituted solution into the handset of the nebulizer system. Turn the unit on. Place the mouthpiece of the handset in your mouth and breathe normally only through your mouth. Administration typically takes between 2 and 3 minutes. Further patient instructions on how to administer CAYSTON are provided in the FDA-APPROVED PATIENT LABELING. Instructions on testing nebulizer functionality and cleaning the handset are provided in the Instructions for Use included with the nebulizer system. A dose of CAYSTON consists of a single-use vial of sterile, lyophilized aztreonam (75 mg) reconstituted with a 1 mL ampule of sterile diluent (0.17% sodium chloride). Reconstituted ... A dose of CAYSTON consists of a single-use vial of sterile, lyophilized aztreonam (75 mg) reconstituted with a 1 mL ampule of sterile diluent (0.17% sodium chloride). Reconstituted CAYSTON is administered by inhalation.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Bacterial musculoskeletal infection
Febrile neutropenia, Empiric therapy

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Aztreonam (inhalation) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Aztreonam (inhalation) in pediatric patients.

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

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

Contraindications

Condition1

Warnings

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Aztreonam (inhalation) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Aztreonam (inhalation) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Aztreonam (inhalation) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Aztreonam (inhalation) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Aztreonam (inhalation) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Aztreonam (inhalation) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Aztreonam (inhalation) with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Aztreonam (inhalation) in the drug label.

Description

IV Compatibility

There is limited information regarding IV Compatibility of Aztreonam (inhalation) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Aztreonam (inhalation) in the drug label.

Pharmacology

There is limited information regarding Aztreonam (inhalation) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Aztreonam (inhalation)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Aztreonam (inhalation) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Aztreonam (inhalation) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Aztreonam (inhalation) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Aztreonam (inhalation) in the drug label.

How Supplied

Storage

There is limited information regarding Aztreonam (inhalation) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Aztreonam (inhalation) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Aztreonam (inhalation) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Aztreonam (inhalation) in the drug label.

Precautions with Alcohol

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

Brand Names

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

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

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[1] Empty citation (help)

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[1]

[2]

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+|indication=respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa,
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+|adverseReactions=[[chest discomfort]],  [[abdominal pain]], [[cough]], nasal congestion, [[wheezing]],  [[fever]]
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 <!--FDA-Labeled Indications and Dosage (Adult)-->
-|fdaLIADAdult======Condition1=====
+|fdaLIADAdult=CAYSTON® is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric ...
+CAYSTON® is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see CLINICAL STUDIES (14)].
-* Dosing Information
+To reduce the development of drug-resistant bacteria and maintain the effectiveness of CAYSTON and other antibacterial drugs, CAYSTON should be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs.
+.1 Dosing Information - The recommended dose of CAYSTON for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of aztreonam ...
+.1 Dosing Information
+The recommended dose of CAYSTON for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of aztreonam) reconstituted with 1 mL of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off CAYSTON therapy). Dosage is not based on weight or adjusted for age. Doses should be taken at least 4 hours apart.
-:* Dosage
+CAYSTON is administered by inhalation using an Altera® Nebulizer System. Patients should use a bronchodilator before administration of CAYSTON.
-=====Condition2=====
+.2 Instructions for CAYSTON Reconstitution
+CAYSTON should be administered immediately after reconstitution. Do not reconstitute CAYSTON until ready to administer a dose.
-* Dosing Information
+Take one amber glass vial containing CAYSTON and one diluent ampule from the carton. To open the glass vial, carefully remove the metal ring by lifting or pulling the tab and remove the gray rubber stopper. Twist the tip off the diluent ampule and squeeze the liquid into the glass vial. Replace the rubber stopper, then gently swirl the vial until contents have completely dissolved.
-:* Dosage
+The empty vial, stopper, and diluent ampule should be disposed of properly upon completion of dosing.
-=====Condition3=====
+.3 Instructions for CAYSTON Administration
+CAYSTON is administered by inhalation using an Altera Nebulizer System. CAYSTON should not be administered with any other nebulizer. CAYSTON should not be mixed with any other drugs in the Altera Nebulizer Handset.
-* Dosing Information
+CAYSTON is not for intravenous or intramuscular administration.
-:* Dosage
+Patients should use a bronchodilator before administration of CAYSTON. Short-acting bronchodilators can be taken between 15 minutes and 4 hours prior to each dose of CAYSTON. Alternatively, long-acting bronchodilators can be taken between 30 minutes and 12 hours prior to administration of CAYSTON. For patients taking multiple inhaled therapies, the recommended order of administration is as follows: bronchodilator, mucolytics, and lastly, CAYSTON.
-=====Condition4=====
-* Dosing Information
-:* Dosage
-<!--Off-Label Use and Dosage (Adult)-->
-<!--Guideline-Supported Use (Adult)-->
-|offLabelAdultGuideSupport======Condition1=====
-* Developed by:
-* Class of Recommendation:
-* Strength of Evidence:
-* Dosing Information
-:* Dosage
-=====Condition2=====
+To administer CAYSTON, pour the reconstituted solution into the handset of the nebulizer system. Turn the unit on. Place the mouthpiece of the handset in your mouth and breathe normally only through your mouth. Administration typically takes between 2 and 3 minutes. Further patient instructions on how to administer CAYSTON are provided in the FDA-APPROVED PATIENT LABELING. Instructions on testing nebulizer functionality and cleaning the handset are provided in the Instructions for Use included with the nebulizer system.
+A dose of CAYSTON consists of a single-use vial of sterile, lyophilized aztreonam (75 mg) reconstituted with a 1 mL ampule of sterile diluent (0.17% sodium chloride). Reconstituted ...
+A dose of CAYSTON consists of a single-use vial of sterile, lyophilized aztreonam (75 mg) reconstituted with a 1 mL ampule of sterile diluent (0.17% sodium chloride). Reconstituted CAYSTON is administered by inhalation.
+|offLabelAdultGuideSupport=
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-|offLabelAdultNoGuideSupport======Condition1=====
+|offLabelAdultNoGuideSupport=* Bacterial musculoskeletal infection
+* Febrile neutropenia, Empiric therapy
-* Dosing Information
-:* Dosage
-=====Condition2=====
-There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
-<!--Pediatric Indications and Dosage-->
-<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 |fdaLIADPed======Condition1=====