Naphazoline and pheniramine are used together in an ophthalmic preparation for the temporary relief of ocular pruritus and redness due to common allergens (i.e., ragweed, pollen, grass, animal hair and dander). Naphazoline's decongestant activity decreases the ocular inflammation and redness. Pheniramine is an H1-blocker that reduces ocular itching and congestion.
Administration
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Ophthalmic Administration
-Naphazoline; pheniramine is administered topically to the eye. Remove contact lenses before using.
-Do not to touch the tip of the dropper to the eye, fingertips, or other surface.
-Instruct patient on proper instillation of eye solution.
-Replace cap after using. Instruct patients not to use if solution becomes cloudy or changes color.
Advise patients to discontinue use of naphazoline; pheniramine if ocular pain or ocular irritation occurs or if symptoms worsen or persist longer than 72 hours. Overuse of naphazoline; pheniramine may result in increased conjunctival hyperemia.
Naphazoline; pheniramine should be used cautiously in patients with closed-angle glaucoma.
Naphazoline; pheniramine should be used cautiously in patients with cardiac disease or hypertension.
Naphazoline; pheniramine should be used cautiously in patients with prostatic hypertrophy.
Naphazoline; pheniramine is in FDA pregnancy category C. Limited human data suggest a possible relationship between oral administration of pheniramine in the first trimester and respiratory malformations and eye/ear defects. However, when used anytime during pregnancy, no association to congential abnormalities was found. Additionally, it is not known if naphazoline can cause fetal harm when administered to a pregnant woman. Limited data have not demonstrated a clinically significant effect on the fetus during first trimester exposure of naphazoline; however, other sympathomimetic drugs have been associated with minor malformations, inguinal hernia, and clubfoot. According to the manufacturer, naphazoline should be given to a pregnant woman only if clearly needed.
According to the manufacturer, it is not known whether naphazoline is excreted in human milk. Because the systemic concentrations of naphazoline would be expected to be low following ocular administration, it is likely that the risk of exposure of the drug to a nursing infant would be minimal. No data are available regarding the use of pheniramine during breast-feeding. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature.
Instruct patients to removed contact lenses prior to ophthalmic administration of naphazoline; phenylephrine. The inactive preservative, benzalkonium chloride, may be absorbed to the surface of soft contact lenses.
For the temporary relief of ocular pruritus and conjunctival hyperemia caused by pollen, ragweed, grass, and animal hair and dander:
Ophthalmic dosage:
Adults, Adolescents, and Children >= 6 years: Instill 1-2 drops into the affected eye(s) up to 4 times daily.
Maximum Dosage Limits:
-Adults
8 drops/day in each affected eye.
-Geriatric
8 drops/day in each affected eye.
-Adolescents
8 drops/day in each affected eye.
-Children
>= 6 years: 8 drops/day in each affected eye.
< 6 years: Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Naphazoline; Pheniramine products.
Mechanism of Action:-Naphazoline: Naphazoline stimulates alpha-adrenergic receptors in the arterioles of the conjunctiva. Ophthalmic administration causes vasoconstriction of conjunctival blood vessels thereby decreasing conjunctival congestion.
-Pheniramine: Pheniramine is an H1-receptor antagonist.
Naphazoline; pheniramine is administered ophthalmically.