Mometasone Nasal

Name: Mometasone Nasal

Before Using mometasone

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 mometasone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to mometasone 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.

Pediatric

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.

Geriatric

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

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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. When you are taking mometasone, 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 mometasone 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 mometasone 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
  • Nadroparin
  • Pixantrone

Using mometasone 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

Interactions with Food/Tobacco/Alcohol

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 mometasone. 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.
  • Herpes simplex (virus) infection of the eye or
  • Infections (virus, bacteria, or fungus) or
  • Tuberculosis, active or history of—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—mometasone may prevent proper healing of these conditions.
  • Liver disease—Higher blood levels of mometasone may occur, which increases the risk of side effects.

mometasone Side Effects

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 immediately if any of the following side effects occur:

More common
  • Bloody mucus or unexplained nosebleeds
  • chills
  • cold or flu-like symptoms
  • cough or hoarseness
  • fever
  • headache
  • increased abdominal or stomach pain and cramping during menstrual periods
  • muscle or bone pain
  • stuffy or runny nose
Less common
  • Chest pain
  • discharge or redness in the eye, eyelid, or inner lining of the eyelid
  • earache
  • shortness of breath
  • tightness in the chest
  • troubled breathing
  • wheezing
Rare
  • Sores inside the nose
  • white patches inside the nose or mouth
Incidence not known
  • Difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • skin rash
  • unusual tiredness or weakness

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:

More common
  • Sore throat
Less common
  • Diarrhea
  • joint or muscle ache or pain
  • nasal burning or irritation
  • nausea
  • sneezing
  • stomach upset or discomfort following meals
Incidence not known
  • Bad, unusual, or unpleasant (after) taste or smell
  • change in taste or smell

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.

How do I store and/or throw out Mometasone?

  • Store spray at room temperature. Throw away any part not used after labeled number of doses are used.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Brand Names U.S.

  • Nasonex
  • Propel Mini

Special Populations Hepatic Function Impairment

Concentrations may increase with severity of hepatic impairment

Off Label Uses

Rhinosinusitis, adjunctive treatment (acute)

Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults and the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, mometasone (nasal), among other intranasal corticosteroids, is effective and recommended as an adjunctive treatment to antibiotic therapy for the management of ABRS primarily when a history of allergic rhinitis exists (according to IDSA guidelines).

Rhinosinusitis, treatment (acute, mild to moderate, uncomplicated)

Data from a randomized, double-blind, double-dummy, placebo-controlled study supports the use of intranasal mometasone in the treatment of acute, uncomplicated rhinosinusitis. Intranasal mometasone was more effective than placebo or amoxicillin in reducing major symptom scores. Symptomatic improvement occurred as early as day 2 of mometasone treatment [Meltzer 2005]. Additional trials may be necessary to further define the role of intranasal mometasone in this condition.

Chronic rhinosinusitis

Based on the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, mometasone (nasal), among other intranasal corticosteroids, is effective and recommended (with or without nasal saline irrigation) for the symptomatic relief of chronic rhinosinusitis.

Drug Interactions

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

Desmopressin: Corticosteroids (Nasal) may enhance the hyponatremic effect of Desmopressin. Avoid combination

Pregnancy Risk Factor C Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor. Intranasal corticosteroids are recommended for the treatment of rhinitis during pregnancy; the lowest effective dose should be used (NAEPP 2005; Wallace 2008).

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of mometasone nasal is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Mometasone nasal side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe or ongoing nosebleed;

  • white patches or sores in the nose that won't heal;

  • wheezing, trouble breathing;

  • vision problems; or

  • fever, chills, body aches, flu symptoms.

Although the risk of serious side effects is low when mometasone is used in the nose, side effects can occur if the medicine is absorbed into your bloodstream. Tell your doctor if you have possible signs of long-term steroid use:

  • weight gain (especially in your face or your upper back and torso);

  • slow wound healing, thinning skin, increased body hair;

  • changes in sexual function; or

  • muscle weakness, tired feeling, depression, anxiety, or feeling irritable.

Common side effects may include:

  • headache;

  • stuffy nose, sore throat, cough; or

  • flu-like symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect mometasone nasal?

Other drugs may interact with mometasone nasal, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

In Summary

Commonly reported side effects of mometasone nasal include: headache. See below for a comprehensive list of adverse effects.

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