Tetrahydrozoline

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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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

## 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

## Package and Label Display Panel

# 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