Class: Vasoconstrictors
VA Class: OP800
CAS Number: 550-99-2
Brands: AK-Con, Albalon, All Clear, All Clear AR, Clear Eyes, Clear Eyes ACR, Napha A, Napha Forte, Naphcon, Naphcon-A, Opcon A, VasoClear, VasoClear A, Vasocon-A, Visine A
Introduction
Vasoconstrictor; an imidazoline-derivative sympathomimetic amine.c
Uses for Naphazoline Hydrochloride
Conjunctival Congestion
Temporary relief of conjunctival congestion, itching, and minor irritation.a b
Used alone or in fixed combination with antihistamines (e.g., antazoline phosphate, pheniramine maleate) and/or astringents (e.g., zinc sulfate).a e f
Ineffective in the treatment of delayed hypersensitivity reactions such as contact dermatoconjunctivitis.c
Naphazoline Hydrochloride Dosage and Administration
Administration
Ophthalmic Administration
Apply topically to the conjunctiva.a b c
Avoid contamination of the dropper tip.a b d
Some manufacturers recommend that contact lenses be removed before administering the ophthalmic solution.a b e
Do not administer discolored or cloudy solutions.b d
Dosage
Available as naphazoline hydrochloride; dosage expressed in terms of the salt.
Pediatric Patients
Conjunctival Congestion
Ophthalmic
For self-medication in children ≥6 years of age, 1 or 2 drops of a 0.01–0.05% ophthalmic solution up to 4 times daily or as directed by clinician.c e f
Adults
Conjunctival Congestion
Ophthalmic
1 or 2 drops of a 0.1% ophthalmic solution every 3–4 hours as needed.c d
For self-medication, 1 or 2 drops of a 0.01–0.05% ophthalmic solution up to 4 times daily or as directed by clinician.a c e f
Cautions for Naphazoline Hydrochloride
Contraindications
Angle-closure glaucoma.c d
Known hypersensitivity to naphazoline or any ingredient in the formulation.a d
Warnings/Precautions
Warnings
MAO Inhibitors
Concomitant use with MAO inhibitor may result in severe hypertensive crisis.c d
General Precautions
Sympathomimetic Effects
Possible headache, hypertension, cardiac irregularities, nervousness, nausea, dizziness, weakness, and sweating.c Use with caution in patients with hypertension, cardiovascular abnormalities, diabetes mellitus, hyperthyroidism, infection, or injury.c d
Overuse
Possible conjunctival irritation and adverse systemic effects with excessive dosage and/or prolonged or too frequent use.c Possible rebound congestion, characterized by reactive hyperemia.a Avoid prolonged use.c
Glaucoma
Use not recommended in patients with glaucoma except under the advice and supervision of a physician.c
Use of Fixed Combinations
When used in fixed combination with antihistamines (e.g., antazoline phosphate, pheniramine maleate) and/or astringents (e.g., zinc sulfate), consider the cautions, precautions, and contraindications associated with the concomitant drug(s).c
Specific Populations
Pregnancy
Category C.d
Lactation
Not known whether naphazoline is distributed into milk.c Use with caution in nursing women.c d
Pediatric Use
Safety and efficacy of 0.1% ophthalmic solution not established in infants and children; potential for CNS depression, possibly progressing to coma and hypothermia, especially in infants.c d
0.01–0.05% ophthalmic solutions not recommended for self-medication in children <6 years of age.a e f
Possible conjunctival irritation and adverse systemic effects (including marked sedation) associated with excessive dosage and/or prolonged or too frequent use.c
Geriatric Use
Possible liberation of pigment granules, presumably from the iris following conjunctival application of naphazoline, especially high concentrations.c
Common Adverse Effects
Blurred vision, mild transient stinging and/or irritation.c
Interactions for Naphazoline Hydrochloride
Specific Drugs
Drug | Interaction |
---|---|
Antidepressants, tricyclic | Increased pressor effects of naphazolinec |
MAO inhibitors | Possible severe hypertensive reactionc d |
Maprotiline | Increased pressor effects of naphazolinec |
Naphazoline Hydrochloride Pharmacokinetics
Absorption
Bioavailability
Occasionally, absorption may be sufficient to produce systemic effects.c
Onset
Local vasoconstriction usually occurs within 10 minutes.c
Duration
Local vasoconstriction may persist for 2–6 hours.c
Stability
Storage
Ophthalmic
Solution
Room temperature; protect from light.a c d e f Do not store in aluminum containers.c
ActionsActions
Directly stimulates α-adrenergic receptors; exerts little or no effect on β-adrenergic receptors.c d
Constricts small arterioles and temporarily relieves conjunctival congestion following topical application.c d
May produce mydriasis when applied to the conjunctiva.c
Advice to Patients
Importance of discontinuing drug and consulting a clinician if ocular pain or visual changes occur, ocular redness or irritation worsens or persists for >72 hours, or manifestations of systemic absorption (e.g., headache, nausea, decrease in body temperature) occur.a b e
Overuse may produce increased redness of the eye.a b
Importance of avoiding contamination of the dropper tip.a b d
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c
Importance informing patients of other precautionary information.c (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
---|---|---|---|---|
Ophthalmic | Solution | 0.012% | All Clear (with benzalkonium chloride) | Bausch & Lomb |
Clear Eyes (with benzalkonium chloride and glycerin 0.2%) | Prestige Brands | |||
Naphcon (with benzalkonium chloride) | Alcon | |||
0.03% | All Clear AR (with benzalkonium chloride) | Bausch & Lomb | ||
0.1%* | AK-Con (with benzalkonium chloride) | Akorn | ||
Albalon (with benzalkonium chloride) | Allergan | |||
Naphazoline Hydrochloride Ophthalmic Solution | Bausch & Lomb |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
---|---|---|---|---|
Ophthalmic | Solution | 0.012% with Zinc Sulfate 0.25% | Clear Eyes ACR (with benzalkonium chloride and glycerin 0.2%) | Prestige Brands |
0.025% with Pheniramine Maleate 0.3% | Naphcon-A (with benzalkonium chloride) | Alcon | ||
Visine A | Pfizer | |||
0.027% with Pheniramine Maleate 0.315% | Opcon A | Bausch & Lomb | ||
0.05% with Antazoline Phosphate 0.5% | Vasocon-A (with benzalkonium chloride) | Novartis |
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 May 2004. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
a. Bausch & Lomb. Opcon-A (naphazoline hydrochloride) 0.02675% Opthalmic Solution prescribing information. Rochester, NY; 1998 Oct.(
b. Bausch & Lomb. All Clear AR (Naphazoline Hydrochloride) 0.03% with Pheniramine maleate 0.3% Ophthalmic Solution prescribing information. Rochester, NY; 2003.
c. AHFS Drug Information 2003. McEvoy GK, ed. Naphazoline Hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2003:2697-8.
d. Allergan. Albalon (naphazoline hydrochloride) 0.1% opthalmic solution prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004. Updated 2003 Jan.
e. Pfizer Consumer Healthcare. Visine-A (naphazoline hydrochloride) 0.025% with pheniramine maleate 0.3% Antihistamine and Redness Reliever opthalmic solution prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004. Undated.
f. Novartis Ophthalmics. Vascon-A (naphazoline hydrochloride) 0.05% with antazoline phosphate 0.5% Itching/Redness Reliever opthalmic solution prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004. Undated.
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