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Naphazoline and pheniramine: Drug information

Naphazoline and pheniramine: Drug information
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For additional information see "Naphazoline and pheniramine: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Naphcon-A [OTC];
  • Opcon-A [OTC];
  • Visine [OTC];
  • Visine-A [OTC]
Brand Names: Canada
  • Naphcon-A;
  • Visine Advanced Allergy
Pharmacologic Category
  • Alkylamine Derivative;
  • Alpha1 Agonist;
  • Histamine H1 Antagonist;
  • Histamine H1 Antagonist, First Generation;
  • Imidazoline Derivative;
  • Ophthalmic Agent, Vasoconstrictor
Dosing: Adult
Ocular itching/redness

Ocular itching/redness: Ophthalmic: Instill 1 to 2 drops into the affected eye(s) up to 4 times daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

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

Dosing: Liver Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Ocular itching/redness

Ocular itching/redness: Children ≥6 years and Adolescents: Ophthalmic: Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

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

Dosing: Liver Impairment: Pediatric

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

Adverse Reactions

There are no adverse reactions listed in the manufacturer's labeling.

Postmarketing: Ophthalmic: Mydriasis (Nakatsuka 2018)

Contraindications

OTC labeling: When used for self-medication, do not use if you have hypersensitivity to naphazoline, pheniramine, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Ocular effects: Pupils may become enlarged with use; temporary light sensitivity may occur. Brief tingling after administration may occur.

Disease-related concerns:

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

• Diabetes: Use naphazoline with caution in patients with diabetes mellitus.

• Hyperthyroidism: Use naphazoline with caution in patients with hyperthyroidism.

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

Dosage form specific issues:

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

Other warnings/precautions:

• Appropriate use: For ophthalmic use only. Inadvertent contamination of multiple-dose ophthalmic solutions, has caused bacterial keratitis; avoid contamination.

• Self-medication (OTC use): When used for self-medication (OTC), patients with narrow-angle glaucoma or prostatic hyperplasia should consult health care provider before use. Do not use >72 hours; overuse may cause more eye redness. Notify healthcare provider if eye pain or vision changes occur or if redness or irritation gets worse or lasts >72 hours. Do not use with contact lenses. Do not use if solution changes color or becomes cloudy.

• Accidental ingestion: Accidental ingestion by children of over-the-counter (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).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, ophthalmic:

Naphcon-A: Naphazoline hydrochloride 0.025% and pheniramine maleate 0.3% (5 mL) [contains benzalkonium chloride; 2 bottles/box], (15 mL) [contains benzalkonium chloride]

Opcon-A: Naphazoline hydrochloride 0.027% and pheniramine maleate 0.315% (15 mL) [contains benzalkonium chloride]

Visine: Naphazoline hydrochloride 0.025% and pheniramine maleate 0.3% (15 mL) [contains benzalkonium chloride, edetate disodium]

Visine-A: Naphazoline hydrochloride 0.025% and pheniramine maleate 0.3% (15 mL) [contains benzalkonium chloride]

Generic: Naphazoline hydrochloride 0.027% and pheniramine maleate 0.315% (15 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Naphcon-A Ophthalmic)

0.025-0.3% (per mL): $0.63

Solution (Opcon-A Ophthalmic)

0.027-0.315% (per mL): $0.42

Solution (Visine Ophthalmic)

0.025-0.3% (per mL): $0.51

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Ophthalmic: For ophthalmic use only. Remove contact lenses prior to administration. Avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. Do not use if solution changes color or becomes cloudy.

Administration: Pediatric

Ophthalmic: For ophthalmic use only. Remove contact lenses prior to administration (solution contains benzalkonium chloride). Avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. Do not use if solution changes color or becomes cloudy.

Use: Labeled Indications

Ocular itching/redness: Temporary relief of itching and redness of the eye(s) caused by grass, ragweed, pollen, animal dander and hair.

Medication Safety Issues
Sound-alike/look-alike issues:

Visine may be confused with Visken

Other safety concerns:

Accidental ingestion: Serious adverse reactions (eg, coma, bradycardia, respiratory depression, sedation) requiring hospitalization have been reported in children ≤5 years of age who have accidentally ingested even small amounts (eg, 1-2 mL) of imidazoline-derivative (ie, tetrahydrozoline, oxymetazoline, or naphazoline) eye drops or nasal sprays. Store these products out of reach of children at all times. Contact poison control or seek medical attention if accidental ingestion occurs.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Atropine (Systemic): May increase hypertensive effects of Alpha1-Agonists. Risk C: Monitor

Bornaprine: Sympathomimetics may increase anticholinergic effects of Bornaprine. Risk C: Monitor

Bromocriptine: May increase hypertensive effects of Alpha1-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider Therapy Modification

Cannabinoid-Containing Products: May increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Cocaine (Topical): May increase hypertensive effects of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider Therapy Modification

Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor

Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May increase vasoconstricting effects of Alpha1-Agonists. Risk X: Avoid

Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor

Esketamine (Nasal): Decongestants (Nasally Administered) may decrease therapeutic effects of Esketamine (Nasal). Management: Patients who require a nasal decongestant on an esketamine dosing day should administer the nasal decongestant at least 1 hour before esketamine. Risk D: Consider Therapy Modification

FentaNYL: Decongestants may decrease serum concentration of FentaNYL. Risk C: Monitor

Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor

Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may decrease therapeutic effects of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid

Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid

Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor

Linezolid: May increase hypertensive effects of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider Therapy Modification

Lisuride: May increase hypertensive effects of Alpha1-Agonists. Risk X: Avoid

Metergoline: May increase adverse/toxic effects of Alpha1-Agonists. Risk C: Monitor

Monoamine Oxidase Inhibitors: May increase hypertensive effects 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. Risk X: Avoid

Pergolide: May increase hypertensive effects of Alpha1-Agonists. Risk C: Monitor

Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor

Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor

Tricyclic Antidepressants: May increase therapeutic effects of Alpha1-Agonists. Tricyclic Antidepressants may decrease therapeutic effects of Alpha1-Agonists. Risk C: Monitor

Zavegepant: Decongestants (Nasally Administered) may decrease serum concentration of Zavegepant. Management: Avoid the concurrent administration of intranasal decongestants with zavegepant. If combined use is unavoidable, intranasal decongestants should be administered at least 1 hour after zavegepant administration. Risk D: Consider Therapy Modification

Pregnancy Considerations

Refer to individual monographs.

Breastfeeding Considerations

Refer to individual monographs.

Mechanism of Action

Naphazoline: Stimulates alpha-adrenergic receptors in the arterioles of the conjunctiva to produce vasoconstriction.

Pheniramine: Inhibits the effect of histamine on conjunctival epithelial cells by preventing its release from mast cells.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Konjunktival | Naphcon a;
  • (AR) Argentina: Mira klonal | Mirus | Refenax | Visuclar;
  • (AU) Australia: Naphcon a | Visine Allergy;
  • (BD) Bangladesh: Napcon | Naphcon a | Napolin;
  • (BR) Brazil: Clanistil | Claril | Cloridrato de nafazolina + maleato de feniramina | Cristalin | Ocutil | Uniclarin;
  • (CL) Chile: Clarimir-f | Dessolets | Miral | Mirus | Naphcon A Allergy Relief;
  • (CN) China: Naphazoline hydrochloride and pheniramine maleate | Naphcon a;
  • (CO) Colombia: Oq-Fresh;
  • (DE) Germany: Konjunktival | Rhinosovil;
  • (DO) Dominican Republic: Alerpic | Naphcon a | Solutina f | Visina A;
  • (EC) Ecuador: Naphcon a;
  • (EG) Egypt: Nafenira | Naphcon a | Naphcozole;
  • (HK) Hong Kong: Konjunktival | Naphcon a | Nazorin | Opcon a;
  • (ID) Indonesia: Cendo Vernacel | Flamergi | Isotic azora | Naphcon a;
  • (IN) India: New vasicon;
  • (IT) Italy: Nafcon a;
  • (JO) Jordan: Naphcon A Allergy Relief;
  • (KE) Kenya: Flamergi;
  • (KR) Korea, Republic of: Cleantime | Naparin | Naphcon a | Nazolin | Nazorin;
  • (KW) Kuwait: Naphcon a;
  • (LB) Lebanon: Konjunktival | Naphcon a;
  • (MX) Mexico: Fazolin f | Fenexil of | Fenixil OF | Ista-sol | Lubriamsa | Mirus | Ocurelif | Opcon a | Solutina f;
  • (MY) Malaysia: Naphcon A Allergy Relief;
  • (NZ) New Zealand: Naphazoline/Pheniramine | Naphcon a | Visine Allergy;
  • (PE) Peru: Naphcon a | Soluclear | Vistaclar duo;
  • (PH) Philippines: Decocon a | Irazol | Naphcon a | Optaphen | Phenazol;
  • (PK) Pakistan: Naphcon a | Naphstine | Opticon a;
  • (PR) Puerto Rico: Opcon a;
  • (PY) Paraguay: Mira klonal | Mirus | Refenax;
  • (QA) Qatar: Naphcon-A;
  • (SA) Saudi Arabia: Naphcon a;
  • (SG) Singapore: Naphcon a;
  • (TH) Thailand: Konjunktival | Naphcon a;
  • (UA) Ukraine: Naphcon A Allergy Relief;
  • (UY) Uruguay: Mirus | Opcon a;
  • (VE) Venezuela, Bolivarian Republic of: Soluclear;
  • (ZM) Zambia: Naphcon a
  1. Food and Drug Administration. FDA Drug Safety Communication: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays. U.S. Food and Drug Administration. October 25, 2012. Available at http://www.fda.gov/Drugs/DrugSafety/ucm325257.htm. Accessed September 5, 2013.
  2. Nakatsuka AS, Beaver HA, Lee AG. Mydriasis due to Opcon-A: an indication to avoid pharmacologic testing for anisocoria. Can J Ophthalmol. 2018;53(1):e6-e7. doi:10.1016/j.jcjo.2017.05.014 [PubMed 29426462]
  3. Naphcon A (naphazoline and pheniramine) [prescribing information]. Fort Worth, TX: Alcon; 2015.
  4. Opcon-A (naphazoline and pheniramine) [prescribing information]. Bridgewater, NJ: Bausch & Lomb; January 2015.
  5. Visine (naphazoline and pheniramine) [prescribing information]. Skilman, NJ: Johnson & Johnson; Received September 2019.
  6. Visine A (naphazoline and pheniramine) [prescribing information]. Skilman, NJ: Johnson & Johnson; August 2016.
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