Sinarest Nasal

Oxymetazoline nasal (for the nose) is used for temporary relief of nasal congestion caused by allergies or the common cold.

Stop using this medicine and call your doctor at once if you have ongoing or worsening symptoms, or if you have severe burning or stinging in your nose after using the nasal spray

You should not use oxymetazoline nasal if you are allergic to it.

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, coronary artery disease;

• diabetes;

• a thyroid disorder; or

• enlarged prostate or urination problems.

FDA pregnancy category C. It is not known whether oxymetazoline nasal 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 oxymetazoline nasal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

This section provides information on the proper use of a number of products that contain oxymetazoline. It may not be specific to Sinarest Nasal. Please read with care.

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 a cold or infection, do not use the container for more than one person and throw the container away after your cold is better.

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. If needed, blow the nose gently again and repeat the spray process until the total 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 a cold or infection, do not use the container for more than one person and throw the container away after your cold is better.

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 checking with your doctor. To do so may make your runny or stuffy nose worse and may 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 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 miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, 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.

If you are taking this product under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting the nasal decongestant.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: high blood pressure medications (e.g., reserpine, guanethidine), tricyclic antidepressants (e.g., amitriptyline).

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Applies to oxymetazoline nasal: nasal solution, nasal spray

Along with its needed effects, oxymetazoline nasal (the active ingredient contained in Sinarest Nasal) 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 immediately if any of the following side effects occur while taking oxymetazoline nasal:

• Blurred vision
• fast, irregular, or pounding heartbeat
• headache, dizziness, drowsiness, or lightheadedness
• high blood pressure
• increase in runny or stuffy nose
• nervousness
• trembling
• trouble in sleeping
• weakness

Some side effects of oxymetazoline nasal 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 inside of nose
• sneezing