Pronunciation:

zye-loe-me-TAZ-oh-leen

Brand Names:

• Otrivin
• Otrivin Pediatric

Dosage Forms:

• Spray
• Solution

Classifications:

Therapeutic

Decongestant

Chemical

Imidazoline

Uses of This Medicine:

Xylometazoline 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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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.

Check with your doctor as soon as possible if any of the following side effects 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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Burning, dryness, or stinging of inside of nose

discharge of fluid from the nose

sneezing

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.