Sodium chloride (inhalation)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Sodium chloride (inhalation) is an aerosol that is FDA approved for the procedure of respiratory therapy or for tracheal or lavage.. Common adverse reactions include allergic reaction.
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
There is limited information regarding Sodium chloride (inhalation) Contraindications in the drug label.
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
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3D model (JSmol)
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| KEGG | |
| MeSH | Sodium+chloride |
PubChem CID
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| Molar mass | 58.44 g mol−1 |
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| Template:Chembox header2 | Except where noted otherwise, data are given for materials in their standard state (at 25 °C, 100 kPa) Infobox disclaimer and references | |
Mechanism of Action
There is limited information regarding Sodium chloride (inhalation) Mechanism of Action in the drug label.
Structure
There is limited information regarding Sodium chloride (inhalation) Structure in the drug label.
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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