NAFAMINE
DESCRIPTION
Nafamine is a combination of naphazoline hydrochloride (0.025% and pheniramine
maleate (0.3%). It contains benzalkonium Chloride (0.01%) as a preservative.
Naphazoline hydrochloride, 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. Its chemical name is 2-(1-Naphthylmethyl)-2-imidazoline
monohydrochloride. Its empirical formula is C14H14N2·HCl and molecular
weight is 246.7. Pheniramine maleate, an antihistamine, is N,N-Dimethyl-g-phenyl-2-pyridinepropanamine
maleate. It is a white powder freely soluble in water and in alcohol.
Its empirical formula is C20H24N2O4 and molecular weight is 356.4
ACTIONS/CLINICAL PHARMACOLOGY
Naphazoline Hydrochloride
Naphazoline constricts the vascular system of the conjunctiva. It
is presumed that this effect is due to direct stimulation action of the
drug upon the alpha-adrenergic receptors in the arterioles of the conjunctiva,
resulting in decreased conjunctival congestion. Naphazoline belongs to
the imidazoline class of sympathomimetics.
Pheniramine Maleate
Pheniramine is an alkylamine derivative with the actions and uses
of antihistamines.
INDICATIONS AND USAGE
Temporary relief of the minor eye symptoms of itching and redness
caused by ragweed, pollen, grass, animal hair, and dander.
CONTRAINDICATIONS
Nafamine ophthalmic solution is contraindicated in the presence of
an anatomically narrow angle or in narrow-angle glaucoma or in persons
who have shown hypersensitivity to any component of this preparation.
WARNINGS
* Nafamine should not be used in patients with narrow-angle glaucoma.
* 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.
* To avoid contamination, do not touch tip of container to any surface.
Replace cap after using.
* If solution changes color or becomes cloudy, do not use.
* If you experience eye pain, changes in vision, continued redness or
irritation of the eye, or if the condition worsens, or persists for more
than 72 hours, discontinue use and consult a physician. Overuse of this
product may produce increased redness of the eye.
* If you are sensitive to any ingredient in this product, do not use.
Do not use this product if you have heart disease, high blood pressure,
difficulty in urination due to enlargement of the prostate gland or narrow
angle glaucoma unless directed by a physician.
* Accidental oral ingestion in infants and children may lead to coma and
marked reduction in body temperature. Before using in children under 6
years of age, consult your physician.
* Keep this and all drugs out of reach of children.
* Remove contact lenses before using.
PRECAUTIONS
General
* Use with caution in the presence of hypertension, cardiovascular abnormalities,
hyperglycemia(diabetes), hyperthyroidism, infection or injury.
* Patients should be advised to discontinue the drug and consult a physician
if relief is not obtained within 48 hours of therapy, if irritation, blurring
or redness persists or increases, or if symptoms of systemic absorption
occur, i.e., dizziness, headache, nausea, decrease in body temperature,
or drowsiness.
* To prevent contaminating the dropper tip and solution, do not touch
the eyelids or the surrounding area with the dropper tip of the bottle.
If solution changes color or becomes cloudy, do not use.
Drug Interactions
Concurrent use of maprotiline or tricyclic antidepressants and naphazoline
may potentiate the pressor effect of naphazoline. Patients under therapy
with MAO inhibitors may experience a severe hypertensive crisis if given
a sympathomimetic drug.
Pregnancy
PREGNANCY CATEGORY C: Animal reproduction studies have not been conducted
with naphazoline. It is also not known whether naphazoline can cause fetal
harm when administered to a pregnant woman or can affect reproduction
capacity. Naphazoline should be given to a pregnant woman only if clearly
needed.
Nursing Mothers
It is not known whether naphazoline is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised when
naphazoline is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS
Ocular
Mydriasis, increased redness, irritation, discomfort, blurring, punctate
keratitis, lacrimation, increased intraocular pressure.
Systemic
Dizziness, headache, nausea, sweating, nervousness, drowsiness, weakness,
hypertension, cardiac irregularities, and hyperglycemia.
DOSAGE AND ADMINISTRATION
Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.
HOW SUPPLIED
15mL plastic dropper bottle (sterile).
Store at 2°-27°C.
Protect from light.