Phenylephrine (spray)

Phenylephrine (spray)
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

Phenylephrine (spray) is a decongestant that is FDA approved for the treatment of nasal congestion due to the common cold, hay fever or other upper respiratory allergies. Common adverse reactions include pain in eye, nasal congestion, 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

Dosing information

• adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours
• children under 12 years: ask a doctor

• Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Phenylephrine (spray) in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Phenylephrine (spray) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Phenylephrine (spray) in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Phenylephrine (spray) Contraindications in the drug label.

Warnings

• Ask a doctor before use if you have

• heart disease
• diabetes
• thyroid disease
• high blood pressure
• 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. Frequent or prolonged use may cause nasal congestion to come back or get worse.
• use only as directed
• 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

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Phenylephrine (spray) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Phenylephrine (spray) in the drug label.

Drug Interactions

There is limited information regarding Phenylephrine (spray) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• ask a health professional before use.

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

Labor and Delivery

There is no FDA guidance on use of Phenylephrine (spray) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Phenylephrine (spray) with respect to nursing mothers.

Pediatric Use

• Keep out of reach of children.

• In case of overdose, get medical help or contact a Poison Control Center right away.

Geriatic Use

There is no FDA guidance on the use of Phenylephrine (spray) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Phenylephrine (spray) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Phenylephrine (spray) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Phenylephrine (spray) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Phenylephrine (spray) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Phenylephrine (spray) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Phenylephrine (spray) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Nasal

Monitoring

There is limited information regarding Monitoring of Phenylephrine (spray) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Phenylephrine (spray) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Phenylephrine (spray) in the drug label.

Pharmacology

Phenylephrine (spray)
Systematic (IUPAC) name
(R)-3-[-1-hydroxy-2-(methylamino)ethyl]phenol
Identifiers
CAS number	59-42-7 61-76-7 (hydrochloride)
ATC code	C01CA06 R01AA04 (WHO), R01AB01 (WHO) (combinations), R01BA03 (WHO), S01FB01 (WHO), S01GA05 (WHO)
PubChem	6041
DrugBank	DB00388
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	167.205 g/mol
SMILES	eMolecules & PubChem
Pharmacokinetic data
Bioavailability	38% through GI tract
Protein binding	95%
Metabolism	Hepatic (monoamine oxidase)
Half life	2.1–3.4 h
Excretion	?
Therapeutic considerations
Pregnancy cat.	B2(AU) C(US)
Legal status	GSL(UK) OTC(US)
Routes	Oral, intranasal, ophthalmic, intravenous, intramuscular

Mechanism of Action

There is limited information regarding Phenylephrine (spray) Mechanism of Action in the drug label.

Structure

There is limited information regarding Phenylephrine (spray) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Phenylephrine (spray) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Phenylephrine (spray) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Phenylephrine (spray) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Phenylephrine (spray) in the drug label.

How Supplied

• store at 20°-25°C (68°-77°F)

Storage

There is limited information regarding Phenylephrine (spray) 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 Phenylephrine (spray) in the drug label.

Precautions with Alcohol

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

Brand Names

• Equate

Look-Alike Drug Names

There is limited information regarding Phenylephrine (spray) 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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