Phenylephrine (oral)

Phenylephrine (oral)
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: Adeel Jamil, M.D. [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 (oral) is an alpha-1 adrenergic receptor agonist that is FDA approved for the treatment of temporarily relieves sinus congestion and pressure, temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. Common adverse reactions include nausea, vomiting, headache, and nervousness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Temporarily relieves sinus congestion and pressure.

• Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies.

Dosing Information

• take every 4 hours
• do not take more than 6 doses in 24 hours
• adults and children 12 years of age and over: 1 tablet
• children under 12 years of age: ask a doctor

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Phenylephrine (oral) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

• Do not use if you are now taking a prescription monoamine exidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

• Ask a doctor before use if you have:

• heart disease
• high blood pressure
• diabetes
• trouble urinating due to an enlarge prostate gland
• thyroid disease

• When using this product, do not use more than directed.

• Stop use and ask a doctor if:

• you get nervous
• dizzy or
• sleepless
• symptoms do not improve within 7 days or are accompanied by fever

• If pregnant or breast-feeding, ask a health professional before use.

Adverse Reactions

Clinical Trials Experience

• Nausea, vomiting, headache, and nervousness

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Phenylephrine (oral) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Phenylephrine (oral) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Phenylephrine (oral) in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

Monitoring

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

IV Compatibility

There is limited information regarding the compatibility of Phenylephrine (oral) and IV administrations.

Overdosage

There is limited information regarding Phenylephrine (oral) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Phenylephrine (oral)
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

• Phenylephrine hydrochloride produces vasoconstriction that lasts longer than that of epinephrine and ephedrine. Responses are more sustained than those to epinephrine, lasting 20 minutes after intravenous and as long as 50 minutes after subcutaneous injection. Its action on the heart contrasts sharply with that of epinephrine and ephedrine, in that it slows the heart rate and increases the stroke output, producing no disturbance in the rhythm of the pulse.

• Phenylephrine is a powerful postsynaptic alpha-receptor stimulant with little effect on the beta receptors of the heart. In therapeutic doses, it produces little if any stimulation of either the spinal cord or cerebrum. A singular advantage of this drug is the fact that repeated injections produce comparable effects.

Structure

• Phenylephrine hydrochloride is a vasoconstrictor and pressor drug chemically related to epinephrine and ephedrine. Phenylephrine hydrochloride is a synthetic sympathomimetic agent in sterile form for parenteral injection. Chemically, phenylephrine hydrochloride is (-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride, and has the following structural formula:

This image is provided by the National Library of Medicine.

• Each mL contains: Phenylephrine Hydrochloride 10 mg; Sodium Chloride 3.5 mg; Sodium Citrate Dihydrate 4 mg; Citric Acid Monohydrate 1 mg; Sodium Metabisulfite 2 mg; Water for Injection q.s. pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid if necessary. pH 3.0-6.5.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Phenylephrine (oral) How Supplied in the drug label.

Storage

• Store at room temperature (59°-86°F)

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Phenylephrine (oral) Patient Counseling Information in the drug label.

Precautions with Alcohol

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

Brand Names

• PHENYLEPHRINE HYDROCHLORIDE®

Look-Alike Drug Names

There is limited information regarding Phenylephrine (oral) 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.