Oxymetazoline

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# Overview
Oxymetazoline is a nasal decongestant, opthalmologic agent that is FDA approved for the treatment of nasal congestion, ocular irritation in conjunctivitis.   Common adverse reactions include headache, insomnia, feeling nervous, rebound nasal congestion, dry nasal mucosa , nasal stinging/burning, sneezing.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
- temporarily relieves sinus congestion and pressure
- shrinks swollen nasal membranes so you can breathe more freely
- Dosing Information
- For CONJUNCTIVITIS, the usual adult dose of oxymetazoline for adults and children 6 years old or greater is 1 to 2 drops of 0.025% ophthalmic solution instilled into the affected eye(s) every 6 hours.
- Contact lens wear during ophthalmic use is not recommended
- Dosing Information
- For RHINITIS, the usual intranasal dose of oxymetazoline in adults and children 6 years old or greater is 2 to 3 drops or sprays of 0.05% solution in each nostril twice a day for up to 3 days

## Off-Label Use and Dosage (Adult)

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

### NonGuideline-Supported Use
- There is limited information regarding Off-Label NonGuideline-Supported Use of Oxymetazoline in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- Dosing Information
- For RHINITIS, the usual dose of oxymetazoline in children 2 to 5 years old is 2 to 3 drops of a 0.025% solution in each nostril twice a day for up to 3 days. Drops are preferred to spray dosage forms since dosage can be more easily controlled with the former.
- Use should be limited to less than 5 days to minimize occurrence of rebound congestion.

## Off-Label Use and Dosage (Pediatric)

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

### NonGuideline-Supported Use
- There is limited information regarding Off-Label NonGuideline-Supported Use of Oxymetazoline in pediatric patients.

# Contraindications
There is limited information regarding Oxymetazoline Contraindications in the drug label.

# Warnings
- Ask a doctor before use if you have
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- When using this product
- do not use more than directed
- do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
- temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
- use of this container by more than one person may spread infection
- Stop use and ask a doctor if
- symptoms persist
- If pregnant or breast-feeding,
- ask a health professional before use.
- Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

# Adverse Reactions

## Clinical Trials Experience
- There is limited information regarding Clinical Trial Experience of Oxymetazoline in the drug label.

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

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

# 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 Oxymetazoline in women who are pregnant.

### Labor and Delivery
- There is no FDA guidance on use of Oxymetazoline during labor and delivery.

### Nursing Mothers
- There is no FDA guidance on the use of Oxymetazoline with respect to nursing mothers.

### Pediatric Use
- There is no FDA guidance on the use of Oxymetazoline with respect to pediatric patients.

### Geriatic Use
- There is no FDA guidance on the use of Oxymetazoline with respect to geriatric patients.

### Gender
- There is no FDA guidance on the use of Oxymetazoline with respect to specific gender populations.

### Race
- There is no FDA guidance on the use of Oxymetazoline with respect to specific racial populations.

### Renal Impairment
- There is no FDA guidance on the use of Oxymetazoline in patients with renal impairment.

### Hepatic Impairment
- There is no FDA guidance on the use of Oxymetazoline in patients with hepatic impairment.

### Females of Reproductive Potential and Males
- There is no FDA guidance on the use of Oxymetazoline in women of reproductive potentials and males.

### Immunocompromised Patients
- There is no FDA guidance one the use of Oxymetazoline in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intravenous

### Monitoring
- There is limited information regarding Monitoring of Oxymetazoline in the drug label.

# IV Compatibility
- There is limited information regarding IV Compatibility of Oxymetazoline in the drug label.

# Overdosage
- There is limited information regarding Chronic Overdose of Oxymetazoline in the drug label.

# Pharmacology

## Mechanism of Action

## Structure

## Pharmacodynamics
- There is limited information regarding Pharmacodynamics of Oxymetazoline in the drug label.

## Pharmacokinetics
- There is limited information regarding Pharmacokinetics of Oxymetazoline in the drug label.

## Nonclinical Toxicology
- There is limited information regarding Nonclinical Toxicology of Oxymetazoline in the drug label.

# Clinical Studies
- There is limited information regarding Clinical Studies of Oxymetazoline in the drug label.

# How Supplied

## Storage
- store at 20-25C (68-77F)
- retain carton for future reference on full labeling

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
- children under 6 years of age: ask a doctor
- To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistance.

# Precautions with Alcohol
Alcohol-Oxymetazoline interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
Afrin,
4-Way Long Lasting,
Neo-Synephrine 12 Hour,
Vicks Sinex 12 Hour,
Visine L.R.,
Nasacon,
Sinarest Nasal,
Duramist Plus.

# Look-Alike Drug Names
- A  B

# Drug Shortage Status

# Price