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|Dristan 12-Hr Nasal Spray Nasal

OXYMETAZOLINE (Nasal)

Some commonly used brand names are:

In the U.S.—

• Afrin Cherry 12 Hour Nasal Spray
• Afrin Extra Moisturizing 12 Hour Nasal Spray
• Afrin Original 12 Hour Nasal Spray
• Afrin Original 12 Hour Nose Drops
• Afrin Sinus 12 Hour Nasal Spray
• Afrin Original 12 Hour Pump Mist
• Dristan 12-Hr Nasal Spray
• Duramist Plus Up To 12 Hour Nasal Decongestant Spray
• Duration 12 Hour Nasal Spray
• Genasal Nasal Spray Up to 12 Hour Relief
• Nasal Relief 12 Hour Nasal Spray
• Neo-Synephrine 12 Hour Extra Moisturizing Spray
• Neo-Synephrine 12 Hour Spray
• Nostrilla 12 Hour Nasal Decongestant
• Twice-A-Day Extra Moisturizing 12 Hour Nasal Spray
• Twice-A-Day Soothing 12 Hour Nasal Spray
• Vicks Sinex 12-Hour Nasal Spray
• Vicks Sinex 12-Hour Ultra Fine Mist for Sinus Relief
• 4-Way 12-Hour Nasal Spray

In Canada—

• Dristan Long Lasting Nasal Mist
• Dristan Long Lasting Mentholated Nasal Spray
• Drixoral Nasal Solution

Generic name product may be available in the U.S.

Category

• Decongestant, topical

Description

Oxymetazoline (ox-i-met-AZ-oh-leen) is used for the temporary relief of nasal (of the nose) congestion or stuffiness caused by hay fever or other allergies, colds, or sinus trouble.

This medicine may also be used for other conditions as determined by your doctor.

This medicine is available without a prescription; however, your doctor may have special instructions on the proper use or dose for your medical condition.

Oxymetazoline is available in the following dosage forms:

• Nasal
• Nasal drops (U.S.)
• Nasal spray (U.S. and Canada)

Before Using This Medicine

If you are using this medicine without a prescription, carefully read and follow any precautions on the label. For oxymetazoline, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to oxymetazoline or any other nasal decongestant. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Oxymetazoline has not been studied in pregnant women. Before using this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Oxymetazoline may be absorbed into the body. However, oxymetazoline has not been reported to cause problems in nursing babies.

Children—Children may be especially sensitive to the effects of oxymetazoline. This may increase the chance of side effects during treatment.

Older adults—Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of oxymetazoline in the elderly.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using oxymetazoline, it is especially important that your health care professional know if you are taking any other prescription, including the following, or nonprescription (over-the-counter [OTC]) medicine.

• Maprotiline or
• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl, Pamelor], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Taking oxymetazoline while you are taking maprotiline, tricyclic antidepressants, MAO inhibitors or within 2 weeks of taking MAO inhibitors may cause constriction of blood vessels

Other medical problems—The presence of other medical problems may affect the use of oxymetazoline. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus

• Dry membranes in nose

• Enlarged prostate—Difficulty urinating may worsen

• Glaucoma

• Heart or blood vessel disease or
• High blood pressure—Oxymetazoline may make the condition worse

• Overactive thyroid

Proper Use of This Medicine

To use the nose drops :

• Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang the head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.
• Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.
• To avoid spreading the infection, do not use the container for more than one person.

To use the nose spray :

• Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. For best results, spray once into each nostril, wait 3 to 5 minutes to allow the medicine to work, then blow the nose gently and thoroughly. Repeat until the complete dose is used.
• Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.
• To avoid spreading the infection, do not use the container for more than one person.

Use this medicine only as directed . Do not use more of it, do not use it more often, and do not use it for longer than 3 days without first checking with your doctor. To do so may make your runny or stuffy nose worse and may also increase the chance of side effects.

Dosing—The dose of oxymetazoline will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of oxymetazoline. If your dose is different, do not change it unless your doctor tells you to do so.

• For nasal dosage form (nose drops or spray):
  • For nasal congestion or stuffiness:
    • Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours.
    • Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed dose—If you are using this medicine on a regular schedule and you miss a dose, use it right away if you remember within an hour or so of the missed dose. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light, at room temperature.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

When this medicine is used for short periods of time at low doses, side effects usually are rare. However, check with your doctor as soon as possible if any of the following occur:

Increase in runny or stuffy nose

The above side effects are more likely to occur in children because there is a greater chance in children that too much of this medicine may be absorbed into the body.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your health care professional if any of the following side effects continue or are bothersome:

Burning, dryness, or stinging inside of nose; increase in nasal discharge; sneezing

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your health care professional.

Revised: 6/14/2000

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