naphazoline/pheniramine

Naphazoline/pheniramine ophthalmic is a combination medication used for the temporary relief of redness, watering, itching and swelling of eyes from allergic conjunctivitis, due to allergens such as ragweed, pollen, grass and animal dander and hair. Naphazoline is a decongestant that reduces eye redness, and pheniramine is an antihistamine that reduces allergic reactions in the eyes. Naphazoline/pheniramine ophthalmic is a solution topically applied to the eye and is available over the counter (OTC). The two components of the drug work in the following ways:

• Naphazoline: Naphazoline reduces redness of the eye by constricting small blood vessels (arterioles) and reducing blood flow in the outer membrane (conjunctiva) in the whites of the eyes and the inner eyelid surfaces. Naphazoline is an alpha1 agonist that works by stimulating alpha adrenergic receptors, protein molecules that make smooth muscles around blood vessels contract, causing vasoconstriction and reduction in blood flow.
• Pheniramine: Pheniramine is an antihistamine that blocks the release of histamine by mast cells in the eye in response to allergens. Mast cells are a type of immune cells and the release of histamine causes inflammatory symptoms such as swelling, watering and itching that result from allergic eye reactions. Mast cells are found all over the body, and it is abundant in the conjunctiva of the eye.

• Do not use naphazoline/pheniramine ophthalmic if you are hypersensitive to any component of the formulation.
• Do not administer OTC naphazoline/pheniramine ophthalmic to children below 6 years, unless directed and supervised by a pediatrician.
• Naphazoline/pheniramine ophthalmic can cause transient stinging or tingling.
• Excessive use of naphazoline/pheniramine ophthalmic can increase eye redness.
• Naphazoline/pheniramine eye drops can dilate pupils and cause blurred vision and light sensitivity.
• Check with your physician before using naphazoline/pheniramine ophthalmic, if you have any of the following:
  • Narrow angle glaucoma, a condition with high intraocular pressure that can progressively damage the optic nerve
  • Infection or injury in the eye
  • High blood pressure (hypertension)
  • Heart disease
  • Enlarged prostate and associated urinary issues
  • Overactive thyroid (hyperthyroidism)
  • Diabetes mellitus
• Discontinue naphazoline/pheniramine ophthalmic and consult with your physician if:
  • Eye redness and/or irritation worsen or persist for longer than 72 hours
  • You develop eye pain or vision changes

Common side effects of naphazoline/pheniramine ophthalmic include:

• Stinging or tingling sensation in the eye
• Redness of the eye (ocular hyperemia)
• Blurred vision
• Dilation of pupils (mydriasis)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Ophthalmic solution

• 0.025%/0.3%
• 0.027%/0.3%

Adult and Pediatric:

• Children below 6 years: Safety and efficacy not established
• Indicated for adults and children 6 years and above

Allergic Conjunctivitis

• Instill 1-2 drops in affected eye(s) up to 4 times daily

Other Information

• Remove contact lenses before using
• Store at room temperature; protect from light and excessive heat; use before expiration date

Overdose

• Ophthalmic use of naphazoline/pheniramine solution is unlikely to result in an overdose.
• Overdose from oral ingestion of naphazoline may cause drowsiness, slow and shallow breathing and reduced body temperature. Severe overdose, particularly in children can cause serious adverse reactions including central nervous system depression with symptoms such as respiratory depression, sedation and excessively slow heartbeat (bradycardia) that can progress to coma and death.
• Pheniramine overdose can rarely cause irregular heart rhythms, skin eruptions, muscle breakdown (rhabdomyolysis) and acute kidney injury.
• Overdose is treated with symptomatic and supportive care, including administration of activated charcoal, if overdose is detected and treated early.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of naphazoline/pheniramine ophthalmic include:
  • ergot derivatives
  • iobenguane radiopharmaceutical products
  • kratom
  • lisuride
  • monoamine oxidase inhibitors
• Serious interactions of naphazoline/pheniramine ophthalmic include:
  • bromocriptine
  • cocaine topical
  • esketamine
  • linezolid
  • zavegepant
• Naphazoline/pheniramine has moderate interactions with at least 14 different drugs.
• Naphazoline/pheniramine has no known mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There is insufficient data on the safety of naphazoline/pheniramine ophthalmic use in pregnant women. Use with caution during pregnancy, only if clearly needed.
• It is not known if the ophthalmic application of naphazoline/pheniramine results in sufficient systemic absorption for the drug to be present in breastmilk. Risk to the breastfeeding infant cannot be excluded. Use with caution in nursing mothers.
• Do not use any OTC drugs, including naphazoline/pheniramine ophthalmic, without checking with your physician if you are pregnant or breastfeeding.

• Use naphazoline/pheniramine ophthalmic exactly as directed.
• Naphazoline/pheniramine ophthalmic solution is only for external topical use in the eyes.
• Do not use it if the solution changes color or becomes cloudy.
• Remove contact lenses before applying.
• Do not touch the tip of the dispenser to any surface, to avoid contamination.
• Replace the cap on the container after each use.
• Store safely out of reach of children.
• In case of oral ingestion and overdose, seek immediate medical help or contact Poison Control.