Mometasone Nasal

Mometasone nasal spray is used to treat and prevent the symptoms (e.g., stuffy or runny nose, itching sneezing) of seasonal (short-term) and perennial (year-round) allergic rhinitis (hay fever). mometasone 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.

mometasone is available only with your doctor's prescription.

(moe MET a sone)

• Mometasone Furoate

There are no dosage adjustments provided in the manufacturer’s labeling; drug accumulation may increase with severity of hepatic impairment.

Concerns related to adverse effects:

• Adrenal suppression: When recommended doses are exceeded, or in extremely sensitive individuals, may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis. Reports consistent with hypercortisolism are rare. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.

• Delayed wound healing: Avoid nasal corticosteroid use in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma until healing has occurred.

• Hypersensitivity reactions: Hypersensitivity reactions including wheezing have been reported; discontinue if such reactions occur.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid exposure to chickenpox and/or measles, especially if not immunized.

• Local nasal effects: Nasal septum perforation, epistaxis and localized Candida albicans infections of the nose and/or pharynx may occur. Periodically examine nasal mucosa in patients on long term therapy; discontinuation of therapy may be necessary if an infection occurs.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment: drug accumulation may increase with severity of hepatic impairment.

• Infections: Use caution or avoid in patients with active or latent tuberculosis or in patients with untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex; worsening of these conditions may occur. Do not use in untreated localized infection involving the nasal mucosa; concurrent antimicrobial therapy should be administered if bacterial infection of the sinuses is suspected/confirmed.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users or in patients who report visual changes.

Special populations:

• Pediatric: Avoid using higher than recommended dosages; suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercortisolism (Cushing syndrome) may occur; titrate to lowest effective dose. Reduction in growth velocity may occur when corticosteroids are administered to pediatric patients, even at recommended doses via intranasal route (monitor growth).

Other warnings/precautions:

• Appropriate use: Prior to use, the dose and duration of treatment should be based on the risk vs benefit for each individual patient. In general, use the smallest effective dose for the shortest duration of time to minimize adverse events. A gradual tapering of dose may be required prior to discontinuing therapy. There have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing inhalation therapy.

See also Precautions.

Nose/throat dryness or irritation, blood-tinged mucus/phlegm, and nosebleeds may occur. If any of these side effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: pain/sores in your nose, white patches in your nose/mouth, painful swallowing/trouble swallowing.

Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Medical examinations (especially of your nose and eyes) should be performed periodically during prolonged use of this medication to monitor your progress or check for side effects. Consult your doctor for more details.

Make sure all of your doctors know that you are using this medication or have used it in the past.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store upright at room temperature away from light and moisture. Do not store in the bathroom. Do not freeze. Keep all medications away from children and pets.

Different brands of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

2 sprays (50 mcg in each spray) in each nostril twice a day (total daily dose of 400 mcg)

Comments:
-A dose of 2 sprays (50 mcg in each spray) in each nostril once a day (total daily dose of 200 mcg) is also effective in some patients.

Use: Treatment of nasal polyps

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -Infants born of mothers who received corticosteroids during pregnancy should be observed for hypoadrenalism. -Most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy. -The safety and effectiveness of the implant in pregnant females have not been established.

Animal studies have shown reproductive toxicity. There are no adequate and well-controlled studies in pregnant women. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -The effects in the nursing infant are unknown. -The safety and effectiveness of the implant in nursing females have not been established.