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Naphazoline (Ophthalmic)


General


Pronunciation

(naf AZ oh leen)


Brand Names: U.S.

  • Clear Eyes Redness Relief [OTC]
  • VasoClear [OTC] [DSC]

Indications


Use: Labeled Indications

Decrease in eye redness (vasoconstrictor):

Rx: Topical ocular vasoconstrictor.

OTC: Relief of redness of the eye due to minor irritation; temporary relief of burning and irritation due to dry eyes; as a protectant against further irritation or dryness of the eye.


Contraindications


Hypersensitivity to naphazoline or any component of the formulation; narrow-angle glaucoma or anatomically narrow angle

Documentation of allergenic cross-reactivity for ophthalmic vasoconstrictors is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity can not be ruled out with certainty.


Dosing and Administration


Dosing: Adult

Decrease in eye redness (vasoconstrictor): Ophthalmic:

Rx: 0.1% solution: 1 to 2 drops into conjunctival sac every 3 to 4 hours as needed

OTC: 0.012% or 0.03% solution: 1 to 2 drops into affected eye(s) up to 4 times daily


Dosing: Geriatric

Refer to adult dosing.


Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer 's labeling.


Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer 's labeling.


Administration

For topical ophthalmic use only. Remove contact lenses prior to administration. Do not touch tip of container to any surface, the eyelids, or the surrounding area. Do not use if solution changes color or becomes cloudy.


Storage

Store at room temperature.


Dosage Forms/Strengths


Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Ophthalmic, as hydrochloride:

Clear Eyes Redness Relief: 0.012% (6 mL) [contains benzalkonium chloride]

VasoClear: 0.02% (15 mL [DSC])

Generic: 0.1% (15 mL [DSC])


Drug Interactions

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Ergot Derivatives: May enhance the hypertensive effect of Alpha1-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha1-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

MAO Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Exceptions: Linezolid; Tedizolid. Avoid combination

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Tricyclic Antidepressants: May enhance the vasopressor effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the vasopressor effect of Alpha1-Agonists. Monitor therapy


Adverse Reactions


Frequency not defined: Ocular: Blurred vision, discomfort, intraocular pressure increased, irritation, lacrimation, mydriasis, punctuate keratitis, redness


Warnings/Precautions


Disease-related concerns:

- Cardiovascular disease: Use with caution in patients with cardiovascular abnormalities or hypertension.

- Diabetes: Use with caution in patients with diabetes mellitus.

- Hyperthyroidism: Use with caution in patients with hyperthyroidism.

- Infection/injury: Use with caution in patients with local infection or injury.

Concurrent drug therapy issues:

- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

- Benzalkonium chloride: May contain benzalkonium chloride which may be absorbed by soft contact lenses.

Other warnings/precautions:

- Appropriate use: For topical ophthalmic use only. Do not touch tip of container to any surface, the eyelids, or the surrounding area. Discontinue use and notify health care provider if symptoms worsen or persist >48 hours (>72 hours [OTC]) or if symptoms of systemic absorption occur (ie, dizziness, headache, nausea, decrease in body temperature, drowsiness). Overuse may produce increased redness of the eye; pupils may become enlarged temporarily.

- Self-medication (OTC use): Discontinue use and contact health care provider if eye pain or changes in vision occur.

- Accidental ingestion: Accidental ingestion by children of nonprescription (OTC) imidazoline-derivative eye drops and nasal sprays may result in serious harm. Serious adverse reactions (eg, coma, bradycardia, respiratory depression, sedation) requiring hospitalization have been reported in children ≤5 years of age who had ingested even small amounts (eg, 1 to 2 mL). Contact a poison control center and seek emergency medical care immediately for accidental ingestion (FDA Drug Safety Communication, 2012).


Pregnancy Risk Factor

C


Pregnancy Considerations

Animal reproduction studies have not been conducted.


Actions


Pharmacology

Stimulates alpha-adrenergic receptors in the arterioles of the conjunctiva and the nasal mucosa to produce vasoconstriction


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience stinging or blurred vision. Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, headache, dizziness, nausea, or fatigue (HCAHPS).

- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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