Class: Vasoconstrictors
ATC Class: R03AA01
VA Class: RE102
Chemical Name: N,α-dimethyl-cyclohexylethylamine
Molecular Formula: C10 H21 N
CAS Number: 101-40-6
Brands: Benzedrex
Introduction
Vasoconstrictor, an aliphatic amine.a
Uses for Propylhexedrine
Nasal Congestion
Self-medication for temporary relief of nasal congestion associated with the common cold, hay fever, or other allergies.101 a b
As effective as other topical vasoconstrictors.a
Topical nasal decongestants often preferred for short-term treatment; oral agents preferred for prolonged treatment.a (See Overuse under Cautions.)
Reduce swelling and facilitate visualization of nasal and pharyngeal membranes prior to surgery or diagnostic procedures.a
Open obstructed eustachian ostia in patients with ear inflammation.a
Propylhexedrine Dosage and Administration
Administration
Intranasal Administration
Administer topically to the nasal mucosa as an inhalation.a b
Avoid contamination of the inhaler tip; inhaler is for single-patient use only.a b
Warm drug container in the hands prior to use to increase drug volatility.a
Inhale vapor through each nostril while head is erect; blow nose thoroughly after 3–5 minutes.a
Supervise use by children 6–12 years of age.b
Dosage
The Benzedrex propylhexedrine inhaler delivers 0.4–0.5 mg of the drug in each 800 mL of air.b
Pediatric Patients
Nasal Congestion
Intranasal
Children ≥6 years of age: 2 inhalations (0.4–0.5 mg) in each nostril no more than every 2 hours.a b
If symptoms are not improved after 3 consecutive days, consult a clinician.a b (See Overuse under Cautions.)
Adults
Nasal Congestion
Intranasal
2 inhalations (0.4–0.5 mg) in each nostril no more than every 2 hours.a b
If symptoms are not improved after 3 consecutive days, consult a clinician.a b (See Overuse under Cautions.)
Prescribing Limits
Pediatric Patients
Nasal Congestion
Intranasal
Children ≥6 years of age: Maximum of every 2 hours; maximum duration of 3 consecutive days.a b
Adults
Nasal Congestion
Intranasal
Maximum of every 2 hours; maximum duration of 3 consecutive days.a b
Special Populations
No special populations dosage recommendations at this time.a b
Cautions for Propylhexedrine
Warnings/Precautions
General Precautions
Overuse
Possible irritation of nasal mucosa and adverse systemic effects (particularly in children) with excessive dosage and/or prolonged or too frequent use.a Possible rebound congestion (rhinitis, chronic redness and swelling of the nasal mucosa); avoid prolonged use.a b (See Advice to Patients.)
Overdosage following oral ingestion may result in psychotic reactions, palpitation, ventricular extrasystoles, and shock.a
Sympathomimetic Effects
Possible headache, hypertension, nervousness, and increased ventricular rate.a Use with caution in patients with thyroid disease (e.g., hyperthyroidism), heart disease, hypertension, or diabetes mellitus.a
Specific Populations
Pregnancy
Safety during pregnancy not established.a
Pediatric Use
Safety and efficacy not established in children <6 years of age.a b
Possible irritation of nasal mucosa and adverse systemic effects associated with excessive dosage, prolonged or too frequent use, or inadvertent ingestion of nasal solution.a
Common Adverse Effects
Burning, stinging, sneezing, increase in nasal discharge. a b
Interactions for Propylhexedrine
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
MAO inhibitors | Potential for enhanced sympathomimetic effects a | Interaction unlikely; however, use concomitantly with cautiona |
Propylhexedrine Pharmacokinetics
Absorption
Bioavailability
Occasionally, absorption may be sufficient to produce systemic effects.a
Onset
Following intranasal administration, local vasoconstriction usually occurs within 0.5–5 minutes.a
Duration
Following intranasal administration, local vasoconstriction persists for 30–120 minutes.a
Elimination
Metabolism
Metabolized in the liver.a
Elimination Route
Excreted in urine as unchanged drug and metabolites.a
Stability
Storage
Intranasal
Inhaler
Tight container at 15–30°C.b Avoid excessive heat.a
Inhaler remains potent for 2–3 months after first use, depending on the degree of use.a b
ActionsActions
Structurally and pharmacologically related to amphetamine.a
Exact mechanism of action unknown but thought to be similar to amphetamine.a
Indirectly stimulates α-adrenergic receptors of the sympathetic nervous system; exerts a minor stimulant effect on β-adrenergic receptors.a
Intranasal application constricts dilated arterioles, reduces nasal blood flow and congestion, and may open obstructed eustachian ostia.a Temporarily improves nasal ventilation and aeration.a
Advice to Patients
Importance of replacing or discarding inhaler 2–3 months after first use.a b
Importance of discontinuing drug and consulting a clinician if nasal congestion worsens or persists for >3 days.a b
Overuse of nasal inhaler may cause recurrence or exacerbation of nasal congestion; importance of not using more frequently than every 2 hours or for >3 days.a b
Importance of avoiding contamination of the inhaler.a b To minimize risk of spreading infections, do not share inhaler with other individuals.a b
Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.a
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.a
Importance of informing patients of other important precautionary information.a (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Nasal | Inhalant | 250 mg | Benzedrex Inhaler | Ascher |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
Only references cited for selected revisions after 1984 are available electronically.
101. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for over-the-counter nasal decongestant drug products. 21 CFR Parts 310 and 341. Final rule. [Docket No. 2004N- 0289] Fed Regist. 2005; 70:58974-7.
102. Spector SL, Bernstein IL, Li JT et al for the Joint Task Force on Practice Parameters et al. Parameters for the diagnosis and management of sinusitis. J Allergy Clin Immunol. 1998; 102(Suppl):S107-44.
103. American Academy of Pediatrics: subcommittee on management of sinusitis and committee on quality improvement. Clinical practice guideline: Management of sinusitis. Pediatrics. 2001; 108:798-808. [PubMed 11533355]
a. AHFS drug information 2007. McEvoy GK, ed. Propylhexedrine. Bethesda, MD: American Society of Health-Systems Pharmacists; 2007:2867.
b. B.F. Ascher Pharmaceuticals. Benzedrex (propylhexedrine) inhaler patient information. Lenaxa, KS. Available at: . Accessed 2008 Mar 5.
More Propylhexedrine resources
- Propylhexedrine Drug Interactions
- Propylhexedrine Support Group
- 0 Reviews · Be the first to review/rate this drug
No comments:
Post a Comment