Mometasone Nasal Spray

Name: Mometasone Nasal Spray

What special precautions should I follow?

Before using mometasone nasal spray,

  • tell your doctor and pharmacist if you are allergic to mometasone, any other medications, or any of the ingredients in mometasone nasal spray. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention ketoconazole (Extina, Nizoral, Xolegel). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have recently had surgery on your nose, or injured your nose in any way, or if you have sores in your nose, if you have or have ever had cataracts (clouding of the lens of the eye), glaucoma (an eye disease), any type of infection, or a herpes infection of the eye (an infection that causes a sore on the eyelid or eye surface). Also tell your doctor if you have chicken pox, measles, or tuberculosis (TB; a type of lung infection), or if you have been around someone who has one of these conditions.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using mometasone nasal spray, call your doctor.

What side effects can this medication cause?

Mometasone nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • fever, chills, tiredness, nausea, or vomiting
  • nosebleeds
  • headache
  • sore throat
  • increased menstrual pain
  • muscle or joint pain
  • sinus pain
  • weakness
  • diarrhea
  • chest pain
  • red or itchy eyes
  • ear pain
  • heartburn

Some side effects can be serious. If you experience any of the following symptoms, stop using mometasone nasal spray or get emergency medical treatment:

  • wheezing
  • hives
  • rash
  • itching
  • difficulty breathing or swallowing
  • vision problems
  • redness or white patches in your throat, mouth, or nose

You should know that this medication may cause children to grow at a slower rate. Talk to your child's doctor to see how long your child needs to use this medication. Talk to your child's doctor if you have concerns about your child's growth while they are using this medication.

Mometasone nasal spray may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Indications and Usage for Mometasone Nasal Spray

<content styleCode="bold">1.1 Treatment of Allergic Rhinitis </content>1.1 Treatment of Allergic Rhinitis

Mometasone furoate nasal spray 50 mcg is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older.

<content styleCode="bold">1.2 Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis </content>1.2 Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis

Mometasone furoate nasal spray 50 mcg is indicated for the relief of nasal congestion associated with seasonal allergic rhinitis, in adults and pediatric patients 2 years of age and older.

<content styleCode="bold">1.3 Prophylaxis of Seasonal Allergic Rhinitis </content>1.3 Prophylaxis of Seasonal Allergic Rhinitis

Mometasone furoate nasal spray 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older.

<content styleCode="bold">1.4 Treatment of Nasal Polyps </content>1.4 Treatment of Nasal Polyps

Mometasone furoate  nasal spray 50 mcg is indicated for the treatment of nasal polyps in patients 18 years of age and older.

Contraindications

Mometasone furoate nasal spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients.

Adverse Reactions

Systemic and local corticosteroid use may result in the following:

  • Epistaxis, ulcerations, Candida albicans infection, impaired wound healing [see Warnings and Precautions (5.1)]
  • Cataracts and glaucoma [see Warnings and Precautions (5.2)]
  • Immunosuppression [see Warnings and Precautions (5.4)]
  • Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see Warnings and Precautions (5.5, 5.6), Use in Specific Populations (8.4)]

<content styleCode="bold">6.1 Clinical Trials Experience </content>6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Allergic Rhinitis

Adults and adolescents 12 years of age and older

In controlled US and international clinical studies, a total of 3210 adult and adolescent patients 12 years and older with allergic rhinitis received treatment with mometasone furoate nasal spray 50 mcg at doses of 50 to 800 mcg/day. The majority of patients (n = 2103) were treated with 200 mcg/day. A total of 350 adult and adolescent patients have been treated for one year or longer. Adverse events did not differ significantly based on age, sex, or race. Four percent or less of patients in clinical trials discontinued treatment because of adverse events and the discontinuation rate was similar for the vehicle and active comparators.

All adverse events (regardless of relationship to treatment) reported by 5% or more of adult and adolescent patients ages 12 years and older who received mometasone furoate nasal spray 50 mcg, 200 mcg/day vs. placebo and that were more common with mometasone furoate nasal spray 50 mcg than placebo, are displayed in TABLE 1 below.

TABLE 1: ADULT AND ADOLESCENT PATIENTS 12 YEARS AND OLDER – ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL ALLERGIC AND PERENNIAL ALLERGIC RHINITIS (PERCENT OF PATIENTS REPORTING)

MOMETASONE FUROATE200 mcg

(n = 2103)

VEHICLE

PLACEBO

(n = 1671)

Headache

26

22

Viral Infection

14

11

Pharyngitis

12

10

Epistaxis/Blood-Tinged Mucus

11

6

Coughing

7

6

Upper Respiratory Tract Infection

6

2

Dysmenorrhea

5

3

Musculoskeletal Pain

5

3

Sinusitis

5

3

Other adverse events which occurred in less than 5% but greater than or equal to 2% of adult and adolescent patients (ages 12 years and older) treated with mometasone furoate nasal spray 50 mcg, 200-mcg/day (regardless of relationship to treatment), and more frequently than in the placebo group included: arthralgia, asthma, bronchitis, chest pain, conjunctivitis, diarrhea, dyspepsia, earache, flu-like symptoms, myalgia, nausea, and rhinitis.

 

Pediatric patients <12 years of age

 

In controlled US and international studies, a total of 990 pediatric patients (ages 3 to 11 years) with allergic rhinitis received treatment with mometasone furoate  nasal spray 50 mcg, at doses of 25 to 200 mcg/day. The majority of pediatric patients (n = 720) were treated with 100 mcg/day. A total of 163 pediatric patients have been treated for one year or longer. Two percent or less of patients in clinical trials who received mometasone furoate  nasal spray 50 mcg discontinued treatment because of adverse events and the discontinuation rate was similar for the placebo and active comparators.

Adverse events which occurred in ≥5% of pediatric patients (ages 3 to 11 years) treated with mometasone furoate  nasal spray 50 mcg, 100 mcg/day vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included upper respiratory tract infection (5% in  mometasone furoate nasal spray 50 mcg group vs. 4% in placebo) and vomiting (5% in mometasone furoate  nasal spray 50 mcg group vs. 4% in placebo).

Other adverse events which occurred in less than 5% but greater than or equal to 2% of pediatric patients (ages 3 to 11 years) treated mometasone furoate  nasal spray 50 mcg, 100 mcg/day vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: diarrhea, nasal irritation, otitis media, and wheezing.

The adverse event (regardless of relationship to treatment) reported by 5% of pediatric patients ages 2 to 5 years who received mometasone furoate  nasal spray, 50 mcg, 100 mcg/day in a clinical trial vs. placebo including 56 subjects (28 each mometasone furoate  nasal spray, 50 mcg and placebo) and that was more common with mometasone furoate  nasal spray, 50 mcg than placebo, included: upper respiratory tract infection (7% vs. 0%, respectively). The other adverse event which occurred in less than 5% but greater than or equal to 2% of mometasone furoate pediatric patients ages 2 to 5 years treated with 100 mcg doses vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: skin trauma.

Nasal Polyps

Adults 18 years of age and older

In controlled clinical studies, the types of adverse events observed in patients with nasal polyps were similar to those observed for patients with allergic rhinitis. A total of 594 adult patients (ages 18 to 86 years) received mometasone furoate  nasal spray 50 mcg at doses of 200 mcg once or twice daily for up to 4 months for treatment of nasal polyps. The overall incidence of adverse events for patients treated with mometasone furoate  nasal spray 50 mcg was comparable to patients with the placebo except for epistaxis, which was 9% for 200 mcg once daily, 13% for 200 mcg twice daily, and 5% for the placebo.

Nasal ulcers and nasal and oral candidiasis were also reported in patients treated with mometasone furoate  nasal spray 50 mcg primarily in patients treated for longer than 4 weeks.

Nasal Congestion Associated with Seasonal Allergic Rhinitis

A total of 1008 patients aged 12 years and older received mometasone furoate  nasal spray 50 mcg 200 mcg/day (n = 506) or placebo (n = 502) for 15 days. Adverse events that occurred more frequently in patients treated with mometasone furoate nasal spray 50 mcg than in patients with the placebo included sinus headache (1.2% in mometasone furoate  nasal spray 50 mcg group vs. 0.2% in placebo) and epistaxis (1% in mometasone furoate  nasal spray 50 mcg group vs. 0.2% in placebo) and the overall adverse event profile was similar to that observed in the other allergic rhinitis trials.

<content styleCode="bold">6.2 Post-Marketing Experience </content>6.2 Post-Marketing Experience

The following adverse reactions have been identified during the post-marketing period for mometasone furoate  nasal spray 50 mcg: nasal burning and irritation, anaphylaxis and angioedema, disturbances in taste and smell and nasal septal perforation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Mometasone Nasal Spray Description

Mometasone furoate anhydrous, USP, the active component of mometasone furoate nasal spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11ß,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), and the following chemical structure:

Mometasone furoate anhydrous, USP is a white to off-white powder, with an empirical formula of C27H30Cl2O6, and a molecular weight of 521.43 g/mol. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is greater than 5000.

Mometasone furoate nasal spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate, USP in an aqueous medium containing benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80 and sodium citrate.  The pH is between 4.3 and 4.9.

Clinical Studies

<content styleCode="bold">14.1 Allergic Rhinitis in Adults and Adolescents </content>14.1 Allergic Rhinitis in Adults and Adolescents

The efficacy and safety of mometasone furoate nasal spray, 50 mcg in the prophylaxis and treatment of seasonal allergic rhinitis and the treatment of perennial allergic rhinitis have been evaluated in 18 controlled trials, and one uncontrolled clinical trial, in approximately 3000 adults (ages 17 to 85 years) and adolescents (ages 12 to 16 years). Of the total number of patients, there were 1757 males and 1453 females, including a total of 283 adolescents (182 boys and 101 girls) with seasonal allergic or perennial allergic rhinitis. Patients were treated with mometasone furoate nasal spray 50 mcg at doses ranging from 50 to 800 mcg/day. The majority of patients were treated with 200 mcg/day. The allergic rhinitis trials evaluated the total nasal symptom scores that included stuffiness, rhinorrhea, itching, and sneezing. Patients treated with mometasone furoate nasal spray 50 mcg, 200 mcg/day had a statistically significant decrease in total nasal symptom scores compared to placebo-treated patients. No additional benefit was observed for mometasone furoate doses greater than 200 mcg/day. A total of 350 patients have been treated with mometasone furoate nasal spray 50 mcg for 1 year or longer.

In patients with seasonal allergic rhinitis, mometasone furoate nasal spray 50 mcg, demonstrated improvement in nasal symptoms (vs. placebo) within 11 hours after the first dose based on one single-dose, parallel-group study of patients in an outdoor “park” setting (park study) and one environmental exposure unit (EEU) study, and within 2 days in two randomized, double-blind, placebo-controlled, parallel-group seasonal allergic rhinitis studies. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing.

Prophylaxis of seasonal allergic rhinitis for patients 12 years of age and older with mometasone furoate nasal spray 50 mcg, given at a dose of 200 mcg/day, was evaluated in two clinical studies in 284 patients. These studies were designed such that patients received 4 weeks of prophylaxis with mometasone furoate nasal spray 50 mcg prior to the anticipated onset of the pollen season; however, some patients received only 2 to 3 weeks of prophylaxis. Patients receiving 2 to 4 weeks of prophylaxis with mometasone furoate nasal spray 50 mcg demonstrated a statistically significantly smaller mean increase in total nasal symptom scores with onset of the pollen season as compared to placebo patients.

<content styleCode="bold">14.2 Allergic Rhinitis in Pediatrics </content>14.2 Allergic Rhinitis in Pediatrics

The efficacy and safety of mometasone furoate nasal spray 50 mcg in the treatment of seasonal allergic and perennial allergic rhinitis in pediatric patients (ages 3 to 11 years) have been evaluated in four controlled trials. This included approximately 990 pediatric patients ages 3 to 11 years (606 males and 384 females) with seasonal allergic or perennial allergic rhinitis treated with mometasone furoate nasal spray at doses ranging from 25 to 200 mcg/day. Pediatric patients treated with mometasone furoate nasal spray 50 mcg (100 mcg total daily dose, 374 patients) had a significant decrease in total nasal symptom (nasal congestion, rhinorrhea, itching, and sneezing) scores, compared to placebo-treated patients. No additional benefit was observed for the 200-mcg mometasone furoate total daily dose in pediatric patients (ages 3 to 11 years). A total of 163 pediatric patients have been treated for 1 year.

<content styleCode="bold">14.3 Nasal Polyps in Adults 18 Years of Age and Older </content>14.3 Nasal Polyps in Adults 18 Years of Age and Older

Two studies were performed to evaluate the efficacy and safety of mometasone furoate nasal spray in the treatment of nasal polyps. These studies involved 664 patients with nasal polyps, 441 of whom received mometasone furoate nasal spray. These studies were randomized, double-blind, placebo-controlled, parallel-group, multicenter studies in patients 18 to 86 years of age with bilateral nasal polyps. Patients were randomized to receive mometasone furoate nasal spray 200 mcg once daily, 200 mcg twice daily or placebo for a period of 4 months. The co-primary efficacy endpoints were 1) change from baseline in nasal congestion/obstruction averaged over the first month of treatment; and 2) change from baseline to last assessment in bilateral polyp grade during the entire 4 months of treatment as assessed by endoscopy. Efficacy was demonstrated in both studies at a dose of 200 mcg twice daily and in one study at a dose of 200 mcg once a day (see TABLE 2 below).

TABLE 2: EFFECT OF MOMETASONE FUROATE NASAL SPRAY IN TWO RANDOMIZED, PLACEBO-CONTROLLED TRIALS IN PATIENTS WITH NASAL POLYPS

Mometasone Furoate200

mcg qd

Mometasone Furoate200 mcg bid

Placebo

P value for Mometasone Furoate 200 mcg qd vs. placebo

P value for Mometasone Furoate 200 mcg bid vs. placebo

Study 1

N=115

N=122

N=117

Baseline bilateral polyp grade‡

4.21

4.27

4.25

Mean change from baseline in bilateral polyps grade

-1.15

-0.96

-0.50

<0.001

0.01

Baseline nasal congestion§

2.29

2.35

2.28

Mean change from baseline in nasal congestion

-0.47

-0.61

-0.24

0.001

<0.001

Study 2

N=102

N=102

N=106

Baseline bilateral polyp grade‡

4

4.10

4.17

Mean change from baseline in bilateral polyps grade

-0.78

-0.96

-0.62

0.33

0.04

Baseline nasal congestion§

2.23

2.20

2.18

Mean change from baseline in nasal congestion

-0.42

-0.66

-0.23

0.01

<0.001

‡ polyps in each nasal fossa were graded by the investigator based on endoscopic visualization, using a scale of 0 to 3 where 0 = no polyps; 1 = polyps in the middle meatus, not reaching below the inferior border of the middle turbinate; 2 = polyps reaching below the inferior border of the middle turbinate but not the inferior border of the inferior turbinate; 3 = polyps reaching to or below the border of the inferior turbinate, or polyps medial to the middle turbinate (score reflects sum of left and right nasal fossa grades).

§ nasal congestion/obstruction was scored daily by the patient using a 0 to 3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms.

There were no clinically relevant differences in the effectiveness of mometasone furoate nasal spray, 50 mcg, in the studies evaluating treatment of nasal polyps across subgroups of patients defined by gender, age, or race.

<content styleCode="bold">14.4 Nasal Congestion Associated with Seasonal Allergic Rhinitis </content>14.4 Nasal Congestion Associated with Seasonal Allergic Rhinitis

 

The efficacy and safety of mometasone furoate nasal spray 50 mcg for nasal congestion associated with seasonal allergic rhinitis were evaluated in three randomized, placebo-controlled, double blind clinical trials of 15 days duration. The three trials included a total of 1008 patients 12 years of age and older with nasal congestion associated with seasonal allergic rhinitis, of whom 506 received mometasone furoate nasal spray 200 mcg daily and 502 received placebo. Of the 1008 patients, the majority 784 (78 %) were Caucasians. The majority of the patients were between 18 to < 65 years of age with a mean age of 38.8 years and were predominantly women (66%). The primary efficacy endpoint was the change from baseline in average morning and evening reflective nasal congestion score over treatment day 1 to day 15. The key secondary efficacy endpoint was the change from baseline in average morning and evening reflective total nasal symptom score (TNSS = rhinorrhea [nasal discharge/runny nose or postnasal drip], nasal congestion/stuffiness, nasal itching, sneezing) averaged over treatment day 1 to 15. Two out of three studies demonstrated that treatment with mometasone furoate nasal spray significantly reduced the nasal congestion symptom score and the TNSS compared to placebo in patients 12 years of age and older with seasonal allergic rhinitis (see TABLE 3 and 4 below).

TABLE 3: EFFECT OF MOMETASONE FUROATE NASAL SPRAY IN TWO RANDOMIZED, PLACEBO-CONTROLLED TRIALS ON NASAL CONGESTION IN PATIENTS WITH SEASONAL ALLERGIC RHINITIS

 

Treatment (Patient Number)

Baseline §

LS Mean *

Change from Baseline LS Mean *

Difference from Placebo LS Mean *

P value for Mometasone Furoate 200 mcg qd vs. placebo

Study 1

Mometasone furoate 200 mcg qd (N=176)

2.63

-0.64

-0.15

0.006

Placebo (N=175)

2.62

-0.49

Study 2

Mometasone furoate 200 mcg qd (N=168)

2.62

-0.71

-0.31

<0.001

Placebo (N=164)

2.60

-0.40

§ nasal congestion/obstruction was scored daily by the patient using a 0 to 3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms.

* LS Mean and p- value was from an ANCOVA model with treatment, baseline value, and center effects.

TABLE 4: EFFECT OF MOMETASONE FUROATE NASAL SPRAY ON TNSS IN TWO RANDOMIZED, PLACEBO-CONTROLLED TRIALS IN PATIENTS WITH SEASONAL ALLERGIC RHINITIS

 

Treatment (Patient Number)

Baseline § LS Mean *

Change from Baseline LS Mean *

Difference from Placebo LS Mean *

P value for Mometasone Furoate 200 mcg qd vs. placebo

Study 1

Mometasone furoate 200 mcg qd (N=176)

9.60

-2.68

-0.83

<0.001

Placebo (N=175)

9.66

-1.85

Study 2

Mometasone furoate 200 mcg qd (N=168)

9.39

-3

-1.27

<0.001

Placebo (N=164)

9.50

-1.73

§ TNSS was the sum of four individual symptom scores: rhinorrhea, nasal congestion/stuffiness, nasal itching and sneezing. Each symptom was to be rated on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe.

* LS Mean and p- value was from an ANCOVA model with treatment, baseline value, and center effects.

Based on results in other studies with mometasone furoate nasal spray in pediatric patients, effects on nasal congestion associated with seasonal allergic rhinitis in patients below 12 years of age is similar to those seen in adults and adolescents [see Clinical Studies (14.2)].

Patient Information

Mometasone (moe-MET-a-sone) Furoate Nasal Spray, 50 mcg

FOR INTRANASAL USE ONLY

 

Read the Patient Information that comes with mometasone furoate  before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your health-care provider about your medical condition or treatment. If you have any questions about mometasone furoate, ask your health-care provider.

What is mometasone furoate?

Mometasone furoate  nasal spray is a man-made (synthetic) corticosteroid medicine that is used to:

  • to treat the nasal symptoms of seasonal and year-round allergic rhinitis (inflammation of the lining of the nose) in adults and children 2 years of age and older.
  • to treat nasal congestion that happens with seasonal allergic rhinitis in adults and children 2 years of age and older.
  • to prevent nasal symptoms of seasonal allergic rhinitis in people 12 years of age and older.
  • to treat nasal polyps in people 18 years and older.

The safety and effectiveness of mometasone furoate  has not been shown:

  • In children under 2 years of age to treat allergic rhinitis.
  • In children under 18 years of age to treat nasal polyps.

Who should not use mometasone furoate?

 

Do not use mometasone furoate nasal spray if you are allergic to any of the ingredients in mometasone furoate nasal spray. See the end of this leaflet for a complete list of ingredients in mometasone furoate nasal spray.

What should I tell my health-care provider before using mometasone furoate?

 Before you take mometasone furoate, tell your health-care provider if you:

  • have had recent nasal sores, nasal surgery, or nasal injury.
  • have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eye).
  • have tuberculosis or any untreated fungal, bacterial, viral infections, or eye infections caused by herpes.
  • have been near someone who has chickenpox or measles.
  • are not feeling well or have any other symptoms that you do not understand.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if mometasone furoate will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or planning to breast-feed. It is not known whether mometasone furoate passes into your breast milk.

Tell your health-care provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Mometasone furoate and other medicines may affect each other and cause side effects. Mometasone furoate may affect the way other medicines work, and other medicines may affect how mometasone furoate works.

Know the list of medicine you take. Keep a list of your medications with you to show your health-care provider and pharmacist when a new medication is prescribed.

How should I use mometasone furoate?

  • Use mometasone furoate exactly as prescribed by your health-care provider.
  • This medicine is for use in the nose only. Do not spray it into your mouth or eyes.
  • An adult should help a young child use this medicine.
  • For best results, you should keep using mometasone furoate regularly each day without missing a dose. If you do miss a dose of mometasone furoate, take it as soon as you remember. However, do not take more than the daily dose prescribed by your doctor.
  • Do not use Mometasone furoate more often than prescribed. Ask your health-care provider if you have any questions.
  • For detailed instructions on how to use mometasone furoate nasal spray, see the “Patient’s Instructions for Use” at the end of this leaflet.

See your health-care provider regularly to assess your symptoms while taking mometasone furoate and to check for side effects.

What should I avoid while taking mometasone furoate?

If you are taking other corticosteroid medicines for allergy, either by mouth or injection, your health-care provider may advise you to stop taking them once you begin using mometasone furoate.

What are the possible side effects of mometasone furoate?

 

Mometasone furoate may cause serious side effects, including:

 

  • Thrush (candida), a fungal infection in your nose and throat. Tell your doctor if you have any redness or white colored patches in your nose or throat.
  • Slow wound healing. Do not use mometasone furoate until your nose has healed if you have a sore in your nose, if you have surgery on your nose, or if your nose has been injured.
  • Some people may have eye problems, including glaucoma and cataracts. You should have regular eye exams.
  • Immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using mometasone furoate. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor about any signs of infection while you are using mometasone furoate.
  • Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency can include: tiredness, weakness, nausea and vomiting and low blood pressure.

The most common side effects of mometasone furoate include:

  • Headache
  • •viral infection
  • sore throat
  • •nosebleeds
  • cough

Tell your health-care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of mometasone furoate. For more information ask your health-care provider or pharmacist.

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

How should I store mometasone furoate nasal spray?

 

  • Store mometasone furoate nasal spray at room temperature between 59°F to 86°F (15°C to 30°C).
  • Avoid prolonged exposure of mometasone furoate container to bright light.
  • Shake well before each use.

Keep mometasone furoate and all medicines out of the reach of children.

 

General information about mometasone furoate

Medicines are sometimes prescribed for conditions that are not listed in a Patient Information leaflet. Do not use Mometasone furoate for a condition for which it was not prescribed. Do not give mometasone furoate to other people even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet provides a summary of the most important information about mometasone furoate. If you would like more information, talk with your health-care provider. You can ask your health-care provider or pharmacist for information about mometasone furoate that is written for health professionals.

For more information, go to www.avkare.com or call 1-855-369-3993.

What are the ingredients in mometasone furoate nasal spray?

Active Ingredients: mometasone furoate anhydrous, USP

Inactive Ingredients: benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethycellulose sodium, polysorbate 80 and sodium citrate.

Manufactured for:

AvKARE, Inc.
Pulaski, TN 38478               

Manufactured by:
Amneal Pharmaceuticals LLC
Branchburg, NJ 08876

Mfg. Rev. 09-2016-00
AV 06/2017

Principal display panel

MOMETASONE FUROATE  
mometasone spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42291-575
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOMETASONE FUROATE (MOMETASONE) MOMETASONE FUROATE 50 ug
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
CITRIC ACID MONOHYDRATE  
GLYCERIN  
CELLULOSE, MICROCRYSTALLINE  
CARBOXYMETHYLCELLULOSE SODIUM  
POLYSORBATE 80  
SODIUM CITRATE  
Packaging
# Item Code Package Description
1 NDC:42291-575-12 1 BOTTLE, PUMP in 1 CARTON
1 120 SPRAY, METERED in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207989 06/08/2017
Labeler - AvKARE, Inc. (796560394)
Revised: 06/2017   AvKARE, Inc.
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