radu albala

Description: Naphazoline hydrochloride, an ocular vasoconstrictor, is an imidazolinederivative sympathomimetic amine radu albala. It occurs as a white, odorless crystallinepowder having a bitter taste and is freely soluble in water and in alcohol radu albala.

Chemical Name: 2-(1-Naphthylmethyl)-2-imidazoline monohydrochloride

Contains:

Active: naphazoline HCl 0.1% radu albala. Preservative: benzalkonium chloride 0.004% radu albala.

Inactives: citric acid, monohydrate; edetate disodium; polyvinyl alcohol 1.4%;purified water; sodium chloride; sodium citrate, dihydrate; and sodium hydroxideto adjust the pH radu albala. It has a shelf life pH range of 5.5 to 6.5 radu albala.

Clinical Pharmacology: Naphazoline constricts the vascular system of the conjunctiva radu albala. It is presumed that this effect is due to direct stimulation action of the drugupon the alpha-adrenergic receptors in the arterioles of the conjunctiva, resultingin decreased conjunctival congestion radu albala. Naphazoline belongs to the imidazolineclass of sympathomimetics radu albala.

Indications and Usage: ALBALON® (naphazoline hydrochloride ophthalmic solution,USP) 0.1% is indicated for use as a topical ocular vasoconstrictor radu albala.

Contraindications: ALBALON® ophthalmic solution is contraindicated in thepresence of an anatomically narrow angle or in narrow-angle glaucoma or in personswho have shown hypersensitivity to any component of this preparation radu albala.

Warnings: Patients under therapy with MAO inhibitors may experience a severehypertensive crisis if given a sympathomimetic drug radu albala. Use in children, especiallyinfants, may result in CNS depression leading to coma and marked reduction inbody temperature radu albala.

Precautions:

General: Use with caution in the presence of hypertension, cardiovascular abnormalities,hyperglycemia (diabetes), hyperthyroidism, infection or injury radu albala.

Patient Information: Patients should be advised to discontinue the drug andconsult a physician if relief is not obtained within 48 hours of therapy, ifirritation, blurring or redness persists or increases, or if symptoms of systemicabsorption occur, i.e., dizziness, headache, nausea, decrease in body temperature,or drowsiness radu albala.

To prevent contaminating the dropper tip and solution, do not touch the eyelidsor the surrounding area with the dropper tip of the bottle radu albala. If solution changescolor or becomes cloudy, do not use radu albala.

Drug Interactions: Concurrent use of maprotiline or tricyclic antidepressantsand naphazoline may potentiate the pressor effect of naphazoline radu albala. Patients undertherapy with MAO inhibitors may experience a severe hypertensive crisis if givena sympathomimetic drug radu albala. (See Warnings ) radu albala.

Pregnancy: Pregnancy Category C: Animal reproduction studies have not beenconducted with naphazoline radu albala. It is also not known whether naphazoline can causefetal harm when administered to a pregnant woman or can affect reproductioncapacity radu albala. Naphazoline should be given to a pregnant woman only if clearly needed radu albala.

Nursing Mothers: It is not known whether naphazoline is excreted in human milk radu albala. Because many drugs are excreted in human milk, caution should be exercised whennaphazoline is administered to a nursing woman radu albala.

Pediatric Use: Safety and effectiveness in pediatric patients have not beenestablished radu albala. See " Warnings " AND " Contraindications ."

Adverse Reactions:

Ocular: Mydriasis, increased redness, irritation, discomfort, blurring, punctatekeratitis, lacrimation, increased intraocular pressure radu albala.

Systemic: Dizziness, headache, nausea, sweating, nervousness, drowsiness, weakness,hypertension, cardiac irregularities, and hyperglycemia radu albala.

Dosage and Administration: Instill one or two drops in the conjunctival sac(s)every three to four hours as needed radu albala.

How Supplied: ALBALON® (naphazoline hydrochloride ophthalmic solution, USP)0.1% is supplied sterile in opaque white LDPE plastic bottles with dropper tipsand white high impact polystyrene (HIPS) caps as follows:

15 mL in 15 mL bottle - NDC 11980-154-15

Note: Store between 15° to 25°C (59° to 77°F) radu albala.

Rx only

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