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 forthe temporary relief of congestion or stuffiness in the nose caused by hayfever or other allergies, colds, or sinus trouble.

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

This medicine is available without a prescription; however, your doctormay 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 medicinewithout 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 orallergic 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 pregnancyhave not been done in humans.

Breast-feeding?It is not known whether xylometazoline passes intobreast milk. However, this medicine has not been reported to cause problemsin nursing babies.

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

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof xylometazoline in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of xylometazoline. Make sure you tell your doctorif you have any other medical problems, especially:

• Type 2 diabetes mellitus?Xylometazoline may worsencirculatory problems

• Enlarged prostate?Urination difficulty may worsen due to constrictiveeffects 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 sittingup. Place the drops into each nostril and immediately bend head forward towardthe knees for a few seconds to allow the medicine to spread throughout thenose.
• Rinse the dropper with hot water and dry with a clean tissue. Replacethe cap right after use.

To use the nose spray:

• Blow your nose gently. With the head upright, spray the medicineinto 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 allowthe medicine to work, then blow your nose gently and thoroughly. Repeat untilthe complete dose is used.
• Rinse the tip of the spray bottle with hot water taking care notto suck water into the bottle, and dry with a clean tissue. Replace the capright after use.

To avoid spreading the infection, do not use the container for more thanone person.

Use this medicine only as directed. Do not usemore of it, do not use it more often, and do not use it for longer than 3days, unless otherwise directed by your doctor. To do so may make your runnyor stuffy nose worse and may also increase the chance of side effects.

Dosing?The dose of nasal xylometazoline will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of nasal xylometazoline. If your doseis different, do not change it unless your doctor tells you to do so.

• For stuffy nose:
  • For nasal solution (nose drops or nosespray) dosage forms:
    • Adults and children 12 years of age and older?Use one to threedrops or sprays of a 0.1% solution in each nostril every eight to ten hoursas needed.
    • Children 2 to 12 years of age?Use two or three drops or spraysof 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 determinedby your doctor.
    • The following dosage guidelines are used in Canada for children upto 12 years of age:
      • Children 6 to 12 years of age?Use two or three drops or spraysof 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 rememberwithin an hour or so of the missed dose, use it right away. However, if youdo not remember until later, skip the missed dose and go back to your regulardosing 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 surethat 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 unwantedeffects. Although not all of these side effects may occur, if they do occurthey may need medical attention.

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

Increase in runny or stuffy nose

Symptoms of too much medicine being absorbed into the body

Blurred vision; dizziness; headache or light-headedness; hives; nausea; nervousness; pounding, irregular, or fast heartbeat; rash; shortness of breath; swelling of eyelids, face, or lips; troubled breathing; trouble in sleeping; wheezing

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your health care professional if anyof 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 mayalso occur in some patients. If you notice any other effects, check with yourhealth care professional.