FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
NOT FOR INJECTION – FOR OPHTHALMIC USE ONLY. Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. Use in children, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.
Remove contact lenses before using.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
NAPHCON® FORTE (Naphazoline Hydrochloride Ophthalmic Solution USP), 0.1% is indicated for use as a topical ocular vasoconstrictor.
History
There is currently no drug history available for this drug.
Other Information
NAPHCON® FORTE (Naphazoline Hydrochloride Ophthalmic Solution USP), 0.1% is a sterile preparation. Naphazoline HCl, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. It occurs as a white, odorless crystalline powder having a bitter taste and is freely soluble in water and in alcohol. The active ingredient is represented by the structural formula:
C14H14N2HCl
MW=246.74
Chemical name:
2-(1-naphthylmethyl)-2-imidazoline monohydrochloride
Each mL contains: Active: Naphazoline Hydrochloride 0.1%. Preservative: Benzalkonium Chloride 0.01%. Inactives: Boric Acid, Sodium Chloride, Potassium Chloride, Edetate Disodium, Sodium Carbonate and/or Hydrochloric Acid (to adjust pH), Purified Water. DM-00
The solution has a pH of 5.5 to 7.0.
Sources
Naphcon Manufacturers
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Alcon
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