Sodium chloride (inhalation)

Sodium chloride (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

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

Sodium chloride (inhalation) is a that is FDA approved for the {{{indicationType}}} of . Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Intended for use in respiratory therapy or for tracheal or lavage. This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.

Dosing Information

• Directions for use: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume.
• Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Warnings

• Not for injection or in preparations to be used for injection.

• This device is not for parenteral use or for preparations intended for parenteral use.

• CAUTION: Contents are sterile in the unopened, undamaged package.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Sodium chloride (inhalation) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Inhalant

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

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

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

• Sodium Chloride Inhalation Solution, 0.9% is supplied in single-use plastic vials in the following packaging configurations.

• NDC 0487-9301-03 3 mL, 100 vials per carton
• NDC 0487-9301-33 3 mL, 30 vials per carton/1 vial per foil pouch
• NDC 0487-9302-01 5 mL, 100 vials per carton
• Internal contents sterile. External surface of vial not sterile.

• Store at controlled room temperature 15° to 30°C (59° to 86°F).

Storage

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

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

There is limited information regarding Sodium chloride (inhalation) 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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