What is Sinuva?

Mometasone nasal spray is used to treat and prevent the symptoms (eg, stuffy or runny nose, itching, sneezing) of seasonal (short-term) and perennial (year-round) allergic rhinitis (hay fever). This medicine is also used to treat nasal polyps in adults.

Mometasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing certain cells from releasing substances that cause an allergic reaction.

This medicine is available only with your doctor's prescription.

Use this medicine only as directed by your doctor. Do not use more of this medicine than your doctor ordered because it may increase the chance of absorption through the lining of the nose and result in unwanted effects.

This medicine usually comes with patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only in the nose. Do not get any of it into your eyes or on your skin. If it does get in these areas, rinse them with water right away and call your doctor.

This medicine must be used regularly as ordered by your doctor. It usually begins to work in about 2 days, but up to 2 weeks may pass before you feel its full effects.

Check with your doctor before using this medicine for nasal problems other than the one for which it was prescribed, since it should not be used on many bacterial, viral, or fungal nasal infections.

To use:

• Shake the bottle thoroughly before each use.
• When you use the spray for the first time, you must prime the bottle. To do this, pump the bottle 10 times or until a fine spray comes out. Now it is ready to use.
• If you do not use the bottle for 7 days or longer, prime it again by releasing 2 sprays.
• Before using the spray, gently blow your nose to clear the nostrils.
• Sit or stand up straight and tilt your head slightly forward. Insert the tip of the bottle into your right nostril. Spray into your right nostril.
• Breathe gently inward through the nostril and then breathe out through your mouth.
• Spray into your left nostril the same way.
• After using the spray, wipe the tip of the bottle with a clean tissue and put the cap back on.

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 (spray):
  • For prevention of seasonal allergic rhinitis:
    • Adults and children 12 years of age and older—2 sprays in each nostril once a day. Each spray contains 50 micrograms (mcg) of mometasone.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For treatment of nasal polyps:
    • Adults—2 sprays in each nostril 2 times a day or once a day. Each spray contains 50 micrograms (mcg) of mometasone.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of seasonal and perennial allergic rhinitis:
    • Adults and children 12 years of age and older—2 sprays in each nostril once a day. Each spray contains 50 micrograms (mcg) of mometasone.
    • Children 2 to 11 years of age—1 spray in each nostril once a day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

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.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away the bottle after you have used 120 sprays, even if there is still some medicine left in it. It is best to keep track of the number of sprays used so you will know when it is time to throw the bottle away.

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:

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.

Appropriate studies have not been performed on the relationship of age to the effects of mometasone nasal spray to treat symptoms of allergic rhinitis in children younger than 2 years of age, to prevent seasonal allergic rhinitis in children younger then 12 years of age, and to treat nasal polyps in children younger than 18 years of age. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mometasone nasal spray in the elderly.

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.

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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bemiparin
• Macimorelin
• Nadroparin
• Sargramostim

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ketoconazole

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.

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:

• Cataracts, history of or
• Glaucoma, history of—Use with caution. May make these conditions worse.

• Chickenpox, recent exposure or
• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, or fungus) or
• Measles, recent exposure or
• Tuberculosis, active or history of—This medicine can reduce the body's ability to fight off these infections.

• Injury to the nose, recent or
• Nose surgery, recent or
• Sores or ulcers in the nose, recent—This medicine may prevent proper healing of these conditions.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing.

This medicine may increase your risk of having problems with your nose. Check with your doctor right away if you or your child have bloody mucus, sores inside the nose, or unexplained nosebleeds while you are using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

If you or your child have difficulty with breathing, or any allergic reaction to this medicine, check with your doctor right away.

Avoid close contact with anyone who has chickenpox or measles if you have never had these conditions before. This is especially important for children. Tell your doctor right away if you think you have been exposed to chickenpox or measles.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or weight loss.

This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.