Albalon

Follow all directions on the product package, or use as directed by your doctor. If you are uncertain about any of the information, consult your doctor or pharmacist.To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.Remove contact lenses before applying the eye drops. Wait at least 10 minutes after using this medication before inserting contact lenses.Before using, check this product visually. Do not use if the liquid has changed color or is cloudy. Use in affected eye(s) as directed.Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over the eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of the eye near the nose and apply gentle pressure. This will prevent the medication from draining away from the eye. Try not to blink and do not rub the eye. Repeat these steps if your dose is for more than 1 drop and for the other eye if so directed.Do not rinse the dropper. Replace the dropper cap tightly after each use.If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.Overuse of this type of medication may result in increased eye redness (rebound hyperemia). Tell your doctor if this occurs or if your condition persists or worsens after 48 hours. If you develop eye pain/vision changes or think you may have a serious medical problem, seek immediate medical attention

Albalon is a brand name medication included in the following groups of medications: Sympathomimetics used as decongestants, Sympathomimetics, combinations excl. corticosteroids, Sympathomimetics, plain. For more information about Albalon see its generic Naphazoline

Naphazoline ophthalmic is for temporary relief of minor eye redness or discomfort caused by minor irritants.

You should not use naphazoline ophthalmic if you have narrow-angle glaucoma.

Stop using this medicine and call your doctor at once if you have ongoing or worsening eye redness, eye pain, vision changes, severe dizziness, or headache, buzzing in your ears, or feeling short of breath.

You should not use naphazoline ophthalmic if you are allergic to it, or if you have narrow-angle glaucoma.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• heart disease, high blood pressure;

• diabetes;

• a thyroid disorder; or

• an eye injury or infection.

FDA pregnancy category C. It is not known whether naphazoline ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether naphazoline ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Using the medication too long or too often may worsen your symptoms and cause damage to the blood vessels in your eyes.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eye and gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops recommended.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using naphazoline ophthalmic and call your doctor at once if you have:

• ongoing or worsening eye redness;

• eye pain;

• changes in your vision;

• chest pain, fast or uneven heart rate; or

• severe headache, buzzing in your ears, anxiety, confusion, or feeling short of breath.

Common side effects may include:

• mild burning or stinging of the eye;

• blurred vision, watery eyes; or

• mild headache, dizziness, nervousness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask a doctor or pharmacist if it is safe for you to use naphazoline ophthalmic if you are also using any of the following drugs:

• an antidepressant--amitriptyline, clomipramine, desipramine, desvenlafaxine, doxepin, duloxetine, imipramine, maprotiline, milnacipran, nortriptyline, venlafaxine;

• ergot medicine--ergotamine, dihydroergotamine, ergonovine, methylergonovine; or

• an MAO inhibitor--furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine.

This list is not complete and other drugs may interact with naphazoline ophthalmic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Sterile

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. The active ingredient is represented by the structural formula:

Chemical Name:

2-(1-Naphthylmethyl)-2-imidazoline monohydrochloride

Contains:

Active: naphazoline HCl 0.1%. Preservative: benzalkonium chloride 0.004%.
Inactives: citric acid, monohydrate; edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium citrate, dihydrate; and sodium hydroxide to adjust the pH. It has a shelf life pH range of 5.5 to 6.5.

General:

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

Patient Information:

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. (See WARNINGS.)

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. See “WARNINGS.” and “CONTRAINDICATIONS.”