CLASSES
Ocular Decongestants, Sympathomimetics
DESCRIPTION
Ophthalmic vasoconstrictor used for redness and lubrication
COMMON BRAND NAMES
AK-Con, Albalon, All Clear, Napha Forte, Naphcon Forte, Ocu-Zoline
HOW SUPPLIED
AK-Con/Albalon/Napha Forte/Naphazoline Hydrochloride/Naphcon Forte/Ocu-Zoline Ophthalmic Sol: 0.1%
DOSAGE & INDICATIONS
For use as a topical ocular vasoconstrictor in the treatment of conjunctival hyperemia.
Ophthalmic dosage
Adults
Instill 1—2 drops in the conjunctival sac(s) every 3—4 hours as needed.
MAXIMUM DOSAGE
Adults
16 drops/day in each eye
Geriatric
16 drops/day in each eye
Adolescents
Safety and efficacy not established.
Children
Safety and efficacy not established.
DOSING CONSIDERATIONS
Hepatic Impairment
No dosage adjustments are needed.
Renal Impairment
No dosage adjustments are needed.
STORAGE
AK-Con:
- Storage information not available
Albalon:
- Storage information not available
All Clear:
- Store at room temperature (between 59 to 86 degrees F)
All Clear AR:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Store between 59 to 77 degrees F
Napha Forte:
- Storage information not available
Naphcon:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Store at room temperature (between 59 to 86 degrees F)
Naphcon Forte:
- Storage information not available
Ocu-Zoline :
- Storage information not available
CONTRAINDICATIONS / PRECAUTIONS
Closed-angle glaucoma
Naphazoline causes vasoconstriction of conjunctival blood vessels, which may exacerbate the effects of glaucoma; thus, use of the prescription strength ophthalmic solution (i.e., naphazoline 0.1%) is contraindicated in patients with closed-angle glaucoma. Some over-the-counter ophthalmic solutions also contain naphazoline; however, they are formulated with a lower drug concentration (i.e., naphazoline 0.03% or less). Glaucoma patients should use these OTC products only after receiving approval from their prescriber.
MAOI therapy
Naphazoline should be used cautiously in patients receiving MAOI therapy as the combination of an MAOI and a sympathomimetic drug may result in hypertensive crisis.
Children, infants, neonates
The safety and efficacy of naphazoline ophthalmic solution have not been established in neonates, infants, children, and adolescents. Use in pediatric patients, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.
Contact lenses
Instruct patients to removed contact lenses prior to ophthalmic administration of naphazoline. The inactive preservative, benzalkonium chloride, may be absorbed to the surface of soft contact lenses.
Cardiac disease, hypertension
Naphazoline should be used with caution in patients with hypertension or cardiac disease as systemic absorption of the drug may result in increased blood pressure and cardiac irregularities.
Hyperthyroidism
Naphazoline should be used with caution in thyroid disease patients with hyperthyroidism, because they can be more sensitive to catecholamines.
Diabetes mellitus
Naphazoline should be used with caution in patients with diabetes mellitus as systemic absorption of the drug may result in hyperglycemia.
Ocular infection, ocular trauma
Use naphazoline ophthalmic solution with caution in the presence of ocular infection or ocular trauma.
Pregnancy
Naphazoline is classified as FDA pregnancy category C. It is not known if the drug 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.
Breast-feeding
According to the manufacturer, it is not known whether naphazoline is excreted in human milk. 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.
ADVERSE REACTIONS
Severe
keratitis / Delayed / Incidence not known
ocular hypertension / Delayed / Incidence not known
coma / Early / Incidence not known
bradycardia / Rapid / Incidence not known
Moderate
hypertension / Early / Incidence not known
blurred vision / Early / Incidence not known
hyperglycemia / Delayed / Incidence not known
respiratory depression / Rapid / Incidence not known
hypotension / Rapid / Incidence not known
sinus tachycardia / Rapid / Incidence not known
Mild
mydriasis / Early / Incidence not known
lacrimation / Early / Incidence not known
ocular irritation / Rapid / Incidence not known
hyperhidrosis / Delayed / Incidence not known
drowsiness / Early / Incidence not known
weakness / Early / Incidence not known
headache / Early / Incidence not known
dizziness / Early / Incidence not known
nausea / Early / Incidence not known
lethargy / Early / Incidence not known
vomiting / Early / Incidence not known
hypothermia / Delayed / Incidence not known
DRUG INTERACTIONS
There are no drug interactions associated with Naphazoline products.
PREGNANCY AND LACTATION
Pregnancy
Naphazoline is classified as FDA pregnancy category C. It is not known if the drug 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. 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.
MECHANISM OF ACTION
Naphazoline stimulates alpha-adrenergic receptors in the arterioles of the conjunctiva. Ophthalmic administration causes vasoconstriction of conjunctival blood vessels thereby decreasing conjunctival congestion. When applied topically to mucous membranes, the drug causes vasoconstriction that shrinks the mucus membranes, promotes drainage, and improves ventilation.
PHARMACOKINETICS
Naphazoline is administered ophthalmically.
Other Route(s)
Ophthalmic Route
After ophthalmic administration of naphazoline, local vasoconstriction usually occurs within 10 minutes and may persist for 2—6 hours.