Tetrahydrozoline

Tetrahydrozoline
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]; 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

Tetrahydrozoline is a lubricant that is FDA approved for the treatment of redness of the eye due to minor eye irritations as a lubricant to prevent further irritation or to relieve dryness of the eye. Common adverse reactions include burning sensation in eye and mydriasis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Dryness of the eye

• Relieves redness of the eye due to minor eye irritations as a lubricant to prevent further irritation or to relieve dryness of the eye

Dosing information

• Instill 1 or 2 drops in the affected eye(s) up to four times daily

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tetrahydrozoline in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tetrahydrozoline in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Tetrahydrozoline in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tetrahydrozoline in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tetrahydrozoline in pediatric patients.

Contraindications

There is limited information regarding Tetrahydrozoline Contraindications in the drug label.

Warnings

• For external use only

• Ask a doctor before use if you have narrow angle glaucoma

• When using this product

• pupils may become enlarged temporarily
• to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
• if solution changes color or becomes cloudy, do not use
• overuse may produce increased redness of the eye
• remove contact lens before using

• Stop use and ask a doctor if you experience

• eye pain
• changes in vision
• continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Tetrahydrozoline in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Tetrahydrozoline in the drug label.

Drug Interactions

There is limited information regarding Tetrahydrozoline Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Ask a health professional before use.

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

Labor and Delivery

There is no FDA guidance on use of Tetrahydrozoline during labor and delivery.

Nursing Mothers

• Ask a health professional before use.

Pediatric Use

There is no FDA guidance on the use of Tetrahydrozoline with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Tetrahydrozoline with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Tetrahydrozoline with respect to specific gender populations.

Race

There is no FDA guidance on the use of Tetrahydrozoline with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Tetrahydrozoline in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tetrahydrozoline in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Tetrahydrozoline in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Tetrahydrozoline in patients who are immunocompromised.

Administration and Monitoring

Administration

• Topical

Monitoring

There is limited information regarding Monitoring of Tetrahydrozoline in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Tetrahydrozoline in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Tetrahydrozoline in the drug label.

Pharmacology

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Template:Chembox header2 | Tetrahydrozoline
Identifiers
CAS Number	84-22-0 N
3D model (JSmol)	Interactive image
ChEBI	CHEBI:28674 Y
ChEMBL	ChEMBL1266 Y
ChemSpider	5226 Y
ECHA InfoCard
KEGG	D08578 Y
PubChem CID	5419
UNII	S9U025Y077 Y
InChI InChI=1S/C13H16N2/c1-2-6-11-10(4-1)5-3-7-12(11)13-14-8-9-15-13/h1-2,4,6,12H,3,5,7-9H2,(H,14,15) Y Key: BYJAVTDNIXVSPW-UHFFFAOYSA-N Y InChI=1/C13H16N2/c1-2-6-11-10(4-1)5-3-7-12(11)13-14-8-9-15-13/h1-2,4,6,12H,3,5,7-9H2,(H,14,15) Key: BYJAVTDNIXVSPW-UHFFFAOYAC
SMILES N\1=C(\NCC/1)C3c2ccccc2CCC3
Properties
Chemical formula	C13H16N2
Molar mass	200.28 g/mol
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 Tetrahydrozoline Mechanism of Action in the drug label.

Structure

There is limited information regarding Tetrahydrozoline Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Tetrahydrozoline in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Tetrahydrozoline in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Tetrahydrozoline in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Tetrahydrozoline in the drug label.

How Supplied

There is limited information regarding Tetrahydrozoline How Supplied in the drug label.

Storage

There is limited information regarding Tetrahydrozoline 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 Tetrahydrozoline in the drug label.

Precautions with Alcohol

• Alcohol-Tetrahydrozoline 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 Tetrahydrozoline Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Tetrahydrozoline 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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