MOMETASONE FUROATE- mometasone spray, metered

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)

Dostupno od:

Amneal Pharmaceuticals LLC

INN (International ime):

MOMETASONE FUROATE

Sastav:

MOMETASONE FUROATE 50 ug

Administracija rute:

NASAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Mometasone furoate nasal spray 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older. Mometasone furoate  nasal spray 50 mcg is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age and older. Mometasone furoate nasal spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients [see Warnings and Precautions (5.3), Description (11)] . Risk Summary Mometasone is minimally absorbed systemically following nasal use, and maternal use is not expected to result in fetal exposure to the drug. Available data from observational studies of mometasone use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies with pregnant mice, rats, or rabbits (subcutaneous, subcutaneous/topical dermal/oral, and topical dermal/oral, respectively), mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (MRHD) on a mcg/m2 or AUC basis [see Data] . However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at a dose less than the maximum recommended daily intranasal dose (MRDID) (on a mcg/m2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at approximately 2 times the MRDID (on a mcg/m2 basis with a maternal subcutaneous dose of 180 mcg/kg). No toxicity was observed with a dose that produced an exposure less than the MRDID (on a mcg/m2 basis with maternal topical dermal doses of 20 mcg/kg and above). In an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 10 times the MRDID (on a mcg/m2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at a dose approximately 6 times the MRDID (on a mcg/m2 basis with maternal topical dermal doses of 300 mcg/kg and above). In another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation. Treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at a dose less than the MRDID (on a mcg/m2 basis with a maternal subcutaneous dose of 15 mcg/kg). There were no findings at a dose less than the MRDID (on a mcg/m2 basis with a maternal subcutaneous dose of 7.5 mcg/kg). Embryofetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis. In the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 6 times the MRDID (on a mcg/m2 basis with maternal topical dermal doses of 150 mcg/kg and above). In the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at a dose approximately 30 times of the MRDID (on a mcg/m2 basis with a maternal oral dose of 700 mcg/kg). At approximately 110 times the MRDID (on a mcg/m2 basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed. No effects were observed at a dose approximately 6 times the MRDID (on a mcg/m2 basis with a maternal oral dose of 140 mcg/kg). Risk Summary There are no available data on the presence of mometasone furoate nasal spray in human milk, the effects on the breastfed child, or the effects on milk production. However, mometasone is minimally absorbed systemically by the mother following nasal use, and breastfeeding is not expected to result in exposure of the infant to mometasone. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mometasone furoate nasal spray and any potential adverse effects on the breastfed infant from mometasone furoate nasal spray or from the underlying maternal condition. The safety and effectiveness of mometasone furoate  nasal spray for prophylaxis of the nasal symptoms of seasonal allergic rhinitis in pediatric patients 12 years of age and older have been established [see Adverse Reactions (6.1)  and Clinical Studies (14.1)] . Use of mometasone furoate  nasal spray for this indication is supported by evidence from controlled trials in adult and pediatric patients 12 years of age and older [see Clinical Studies (14.1)] .  The safety and effectiveness of mometasone furoate nasal spray for the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients less than 18 years of age have not been established. Effectiveness was not demonstrated in one 4-month trial conducted to evaluate the safety and efficacy of mometasone furoate in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients 6 to 17 years of age. The primary objective of the study was to evaluate safety; efficacy parameters were collected as secondary endpoints. A total of 127 patients with chronic rhinosinusitis with nasal polyps were randomized to placebo or mometasone furoate nasal spray 100 mcg once or twice daily (patients 6 to 11 years of age) or 200 mcg once or twice daily (patients 12 to 17 years of age). The results of this trial did not support the efficacy of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients. The adverse reactions reported in this trial were similar to the adverse reactions reported in patients 18 years of age and older with chronic rhinosinusitis with nasal polyps. Effect on Growth Controlled clinical studies have shown nasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up” growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving nasal corticosteroids, including mometasone furoate nasal spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of nasal corticosteroids, including mometasone furoate nasal spray, each patient should be titrated to his/her lowest effective dose. A clinical study to assess the effect of mometasone furoate nasal spray (100 mcg total daily dose) on growth velocity has been conducted in pediatric patients 3 to 9 years of age with allergic rhinitis. No statistically significant effect on growth velocity was observed for mometasone furoate  nasal spray compared to placebo following one year of treatment. No evidence of clinically relevant HPA axis suppression was observed following a 30-minute cosyntropin infusion. The potential of mometasone furoate nasal spray to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out. A total of 280 patients above 64 years of age with allergic rhinitis or chronic rhinosinusitis with nasal polyps (age range 64 to 86 years) have been treated with mometasone furoate nasal spray for up to 3 or 4 months, respectively. No observed differences in safety and/or effectiveness in geriatric patients compared to younger adult patients. Concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see Clinical Pharmacology (12.3)] . Mometasone Furoate (moe met’ a sone fure’ oh ate) Nasal Spray, 50 mcg For use in your nose only. Read the Patient Instructions for Use carefully before you start to use your mometasone furoate nasal spray. If you have any questions, ask your healthcare provider. Shake the bottle well before each use. - Remove the plastic cap (see Figure 1). - Before you use mometasone furoate for the first time, prime the pump by pressing downward on the shoulders of the white nasal applicator using your index finger and middle finger while holding the base of the bottle with your thumb (see Figure 2). Do Not pierce the nasal applicator. Press down and release the pump 10 times or until a fine spray appears. Do Not spray into eyes. The pump is now ready to use. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by spraying 2 times or until a fine spray appears. - Gently blow your nose to clear the nostrils. Close 1 nostril. Tilt your head forward slightly, keep the bottle upright, carefully insert the nasal applicator into the other nostril (see Figure 3). Do Not spray directly onto the nasal septum (the wall between the two nostrils). - For each spray, hold the spray bottle upright and press firmly downward 1 time on the shoulders of the white nasal applicator using your index and middle fingers while supporting the base of the bottle with your thumb. Breathe gently inward through the nostril (see Figure 4). Note: It is important to keep the mometasone furoate unit in an upright orientation (as seen in Figure 4). Failure to do so may result in an incomplete or non-existent spray. Note: It is important to keep the mometasone furoate unit in an upright orientation (as seen in Figure 4). Failure to do so may result in an incomplete or non-existent spray. - Then breathe out through the mouth. - Repeat in the other nostril. - Wipe the nasal applicator with a clean tissue and replace the plastic cap. Each bottle of mometasone furoate nasal spray contains enough medicine for you to spray medicine from the bottle 120 times. Do not use the bottle of mometasone furoate nasal spray after 120 sprays. Additional sprays after the 120 sprays may not contain the right amount of medicine, you should keep track of the number of sprays used from each bottle of mometasone furoate nasal spray, and throw away the bottle even if it has medicine still left in. Do not count any sprays used for priming the device. Talk with your healthcare provider before your supply runs out to see if you should get a refill of your medicine. Pediatric Use: Administration to children should be supervised by an adult. Steps 1 through 7 from the Patient Instructions for Use  should be followed. Cleaning: Do not try to unblock the nasal applicator with a sharp object. Please see Patient Instructions for Cleaning Applicator. Patient Instructions for Cleaning Applicator - To clean the nasal applicator, remove the plastic cap (see Figure 5).                   Figure 5                   Figure 5 - Pull gently upward on the white nasal applicator to remove (see Figure 6).                      Figure 6                      Figure 6 - Soak the nasal applicator in cold tap water and rinse both ends of the nasal applicator under cold tap water and dry (see Figure 7). Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine. Figure 7 4. Rinse the plastic cap under cold water and dry (see Figure 8). Figure 8   5. Put the nasal applicator back together making sure the pump stem is reinserted into the applicator’s center hole (see Figure 9). Figure 9 6. Reprime the pump by pressing downward on the shoulders of the white nasal applicator using your index and middle fingers while holding the base of the bottle with your thumb. Press down and release the pump 2 times or until a fine spray appears. Do Not spray into eyes. The pump is now ready to use. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by spraying 2 times or until a fine spray appears (see Figure 10). Figure 10 7. Replace the plastic cap (see Figure 11). Figure 11 This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ  08807 Rev. 08-2022-03

Proizvod sažetak:

Mometasone furoate nasal spray, 50 mcg is supplied in a white, high-density, polyethylene bottle fitted with a white metered-dose, manual spray pump, and turquoise cap. It contains 17 g of product formulation, 120 sprays, each delivering 50 mcg of mometasone furoate, USP per actuation. NDC 65162-891-29 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. When mometasone furoate nasal spray, 50 mcg is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable. SHAKE WELL BEFORE EACH USE. Keep out of reach of children.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

MOMETASONE FUROATE- MOMETASONE SPRAY, METERED
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOMETASONE FUROATE
NASAL SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR MOMETASONE
FUROATE NASAL SPRAY.
MOMETASONE FUROATE NASAL SPRAY
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Indications and Usage (1) (removed) 06/2022
Dosage and Administration (2) (removed) 06/2022
INDICATIONS AND USAGE
Mometasone furoate nasal spray is a corticosteroid indicated for:
Prophylaxis of Nasal Symptoms of Seasonal Allergic Rhinitis in adult
and pediatric patients 12 years of
age and older (1.1)
Treatment of Chronic Rhinosinusitis with Nasal Polyps in adult
patients 18 years of age and older (1.2)
DOSAGE AND ADMINISTRATION
For Nasal Use Only.
Prophylaxis of Seasonal Allergic Rhinitis in Adult and Pediatric
Patients 12 Years of Age and Older: 2
sprays in each nostril once daily (2.2)
Treatment of Chronic Rhinosinusitis with Nasal Polyps in Adults (18
yrs. and older): 2 sprays in each
nostril twice daily. 2 sprays in each nostril once daily may also be
effective in some patients (2.3)
DOSAGE FORMS AND STRENGTHS
Nasal spray: 50 mcg of mometasone furoate, USP in each spray (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to mometasone furoate or any of
the ingredients of mometasone
furoate nasal spray. (4)
WARNINGS AND PRECAUTIONS
Epistaxis, nasal ulceration, _Candida albicans_ infection, nasal
septal perforation, impaired wound healing.
Monitor patients periodically for signs of adverse effects on the
nasal mucosa. Avoid use in patients
with recent nasal ulcers, nasal surgery, or nasal trauma. (5.1)
Glaucoma and cataracts. Consider referral to an ophthalmologist in
patients who develop ocular
symptoms or use mometasone furoate nasal spray long term. (5.2)
Potential worsening of existing tuberculosis; fungal, bacterial,
viral, or parasitic infections; or ocular
herpes simplex. More serious or even fatal course of ch