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|Otrivin With Measured-Dose Pump Nasal

XYLOMETAZOLINE (Nasal)

Some commonly used brand names are:

In the U.S.—

• Otrivin Nasal Drops
• Otrivin Nasal Spray
• Otrivin Pediatric Nasal Drops

In Canada—

• Decongest Nasal Spray
• Otrivin Nasal Drops
• Otrivin Nasal Spray
• Otrivin Nasal Spray with Eucalyptol
• Otrivin Nasal Spray with Moisturizers
• Otrivin Pediatric Nasal Drops
• Otrivin Pediatric Nasal Spray
• Otrivin With Measured-Dose Pump
• Otrivin Measured-Dose Pump with Moisturizers

Category

• Decongestant, topical

Description

Xylometazoline (zye-loe-met-AZ-oh-leen) is used for the temporary relief of congestion or stuffiness in the nose 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.

Xylometazoline is available in the following dosage forms:

• Nasal
• Nasal drops (U.S. and Canada)
• 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 xylometazoline, the following should be considered:

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

Pregnancy—Studies on effects of nasal xylometazoline in pregnancy have not been done in humans.

Breast-feeding—It is not known whether xylometazoline passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.

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

Older adults—Many medicines have not been studied specifically 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 comparing use of xylometazoline in the elderly with use in other age groups.

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. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

• Type 2 diabetes mellitus—Xylometazoline may worsen circulatory problems

• Enlarged prostate—Urination difficulty may worsen due to constrictive effects of xylometazoline

• Glaucoma—Xylometazoline may worsen the circulatory problems

• Heart or blood vessel disease or
• High blood pressure—Xylometazoline 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. Place the drops into each nostril and immediately bend head forward toward the knees for a few seconds 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 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 your 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, unless otherwise directed by 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 nasal xylometazoline 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 nasal xylometazoline. If your dose is different, do not change it unless your doctor tells you to do so.

• For stuffy nose:
  • For nasal solution (nose drops or nose spray) dosage forms:
    • Adults and children 12 years of age and older—Use one to three drops or sprays of a 0.1% solution in each nostril every eight to ten hours as needed.
    • Children 2 to 12 years of age—Use two or three drops or sprays of a 0.05% solution in each nostril every eight to ten hours as needed.
    • Children up to 2 years of age—Use and dose must be determined by your doctor.
    • The following dosage guidelines are used in Canada for children up to 12 years of age:
      • Children 6 to 12 years of age—Use two or three drops or sprays of a 0.05% solution in each nostril every eight to ten hours as needed.
      • Children up to 6 years of age—Use one drop or spray of a 0.05% solution in each nostril every eight to ten hours as needed.

Missed dose—If you miss a dose of this medicine and you remember within an hour or so of the missed dose, use it right away. 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.
• 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

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 of inside of nose; discharge of fluid from the nose; 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: 11/06/2003

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