- Childrens Flonase
- Local Nasal Effects
- Glaucoma And Cataracts
- Hypersensitivity Reactions including Anaphylaxis
- Hypercorticism And Adrenal Suppression
- Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors
- Effect On Growth
- Patient Counseling Information
- Nonclinical Toxicology
- Carcinogenesis, Mutagenesis, Impairment Of Fertility
- Clinical Studies
- Use In Specific Populations
- Nursing Mothers
- Pediatric Use
- Geriatric Use
- Hepatic Impairment
- Renal Impairment
- CHILDREN’S RHINOCORT® ALLERGY SPRAY
- Salinex® Nasal Spray 30ml Children 2 years and older
- Nasacort Children’s Allergy 24 Hour Spray 60 Sprays0.37oz
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Do not share this medicine with another person, even if they have the same symptoms you have.
The usual dose of fluticasone nasal is 1 to 2 sprays into each nostril once or twice per day. Your dose will depend on the fluticasone brand or strength you use, and your dose may change once your symptoms improve. Follow all dosing instructions very carefully.
Xhance is not approved for use by anyone younger than 18 years old. Do not use Flonase in a child younger than 4 years old. Do not use Veramyst in a child younger than 2 years old.
Any child using fluticasone nasal should be supervised by an adult while using the nasal spray.
This medicine comes with patient instructions for safe and effective use, and directions for priming the nasal spray device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Shake the nasal spray just before each use.
If you switched to fluticasone from another steroid medicine, do not stop using the other steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about tapering your steroid dose before stopping completely.
To be sure fluticasone nasal is not causing harmful effects on your nose or sinuses, your doctor may need to check your progress on a regular basis.
It may take up to several days before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after a week of treatment.
Store fluticasone nasal in an upright position at room temperature, away from moisture and heat. Throw the spray bottle away after you have used 120 sprays, even if there is still medicine left in the bottle.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
An overdose of fluticasone 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.
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Copyright 1996-2020 Cerner Multum, Inc.
Latest Update: 11/9/2018, Version: 9.01
Included as part of the PRECAUTIONS section.
Local Nasal Effects
In clinical trials of 2 to 26 weeks’ duration, epistaxis was observed more frequently in subjects treated with FLONASE Nasal Spray than those who received placebo .
Postmarketing cases of nasal ulceration have been reported in patients treated with FLONASE Nasal Spray .
In clinical trials with fluticasone propionate administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of FLONASE Nasal Spray. Patients using FLONASE Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.
Nasal Septal Perforation
Postmarketing cases of nasal septal perforation have been reported in patients treated with FLONASE Nasal Spray .
Impaired Wound Healing
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should avoid using FLONASE Nasal Spray until healing has occurred.
Glaucoma And Cataracts
Use of intranasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Hypersensitivity Reactions including Anaphylaxis
Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, and rash) have been reported after administration of FLONASE Nasal Spray. Discontinue FLONASE
Nasal Spray if such reactions occur . Rarely, immediate hypersensitivity reactions may occur after the administration of FLONASE Nasal Spray.
Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the complete prescribing information for VZIG and IG.) If chickenpox develops, treatment with antiviral agents may be considered.
Intranasal corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Hypercorticism And Adrenal Suppression
When intranasal corticosteroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of FLONASE Nasal Spray should be discontinued slowly consistent with accepted procedures for discontinuing oral corticosteroid therapy.
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal (e.g., joint and/or muscular pain, lassitude, depression). Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.
Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors
The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, nefazodone, voriconazole) with FLONASE Nasal Spray is not recommended because increased systemic corticosteroid adverse effects may occur .
Effect On Growth
Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients . Monitor the growth routinely of pediatric patients receiving FLONASE Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including FLONASE Nasal Spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms .
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
Inform patients that treatment with FLONASE Nasal Spray may lead to adverse reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment with FLONASE Nasal Spray. In addition, FLONASE Nasal Spray has been associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use FLONASE Nasal Spray until healing has occurred .
Glaucoma and Cataracts
Inform patients that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Advise patients to notify their healthcare providers if a change in vision is noted while using FLONASE Nasal Spray .
Hypersensitivity Reactions, including Anaphylaxis
Inform patients that hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, contact dermatitis, and rash, may occur after administration of FLONASE Nasal Spray. If such reactions occur, patients should discontinue use of FLONASE Nasal Spray .
Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and if they are exposed to consult their healthcare provider without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex .
Reduced Growth Velocity
Advise parents that FLONASE Nasal Spray may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route .
Use Daily for Best Effect
Inform patients that they should use FLONASE Nasal Spray on a regular basis. FLONASE Nasal Spray, like other corticosteroids, does not have an immediate effect on rhinitis symptoms. Maximum benefit may not be reached for several days. Patients should not increase the prescribed dosage but should contact their healthcare providers if symptoms do not improve or if the condition worsens.
Keep Spray Out of Eyes and Mouth
Inform patients to avoid spraying FLONASE Nasal Spray in their eyes and mouth.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Fluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1,000 mcg/kg (approximately 20 times the MRHDID in adults and approximately 10 times the MRHDID in children on a mcg/m² basis) for 78 weeks or in rats at inhalation doses up to 57 mcg/kg (approximately 2 times the MRHDID in adults and approximately equivalent to the MRHDID in children on a mcg/m² basis) for 104 weeks.
Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro. No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the mouse micronucleus test.
No evidence of impairment of fertility was observed in male and female rats at subcutaneous doses up to 50 mcg/kg (approximately 2 times the MRHDID in adults on a mcg/m² basis). Prostate weight was significantly reduced at a subcutaneous dose of 50 mcg/kg.
Perennial Nonallergic Rhinitis
Three randomized, double-blind, parallel-group, vehicle placebo-controlled trials were conducted in 1,191 subjects to investigate regular use of FLONASE Nasal Spray in subjects with perennial nonallergic rhinitis. These trials evaluated subject-rated total nasal symptom scores (TNSS) that included nasal obstruction, postnasal drip, rhinorrhea in subjects treated for 28 days of double-blind therapy and in 1 of the 3 trials for 6 months of open-label treatment. Two of these trials demonstrated that subjects treated with FLONASE Nasal Spray (100 mcg twice daily) exhibited statistically significant decreases in TNSS compared with subjects treated with vehicle.
Use In Specific Populations
Pregnancy Category C. There are no adequate and well-controlled trials with FLONASE Nasal Spray in pregnant women. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Because animal reproduction studies are not always predictive of human response, FLONASE Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women should be advised to contact their physicians if they become pregnant while taking FLONASE Nasal Spray.
Mice and rats at fluticasone propionate doses approximately 1 and 4 times, respectively, the maximum recommended human daily intranasal dose (MRHDID) for adults (on a mg/m² basis at maternal subcutaneous doses of 45 and 100 mcg/kg/day, respectively) showed fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification. No teratogenicity was seen in rats at doses up to 3 times the MRHDID (on a mg/m² basis at maternal inhalation doses up to 68.7 mcg/kg/day).
In rabbits, fetal weight reduction and cleft palate were observed at a fluticasone propionate dose approximately 0.3 times the MRHDID for adults (on a mg/m² basis at a maternal subcutaneous dose of 4 mcg/kg/day). However, no teratogenic effects were reported at fluticasone propionate doses up to approximately 20 times the MRHDID for adults (on a mg/m² basis at a maternal oral dose up to 300 mcg/kg/day). No fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration .
Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits.
Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is a natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy.
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.
It is not known whether fluticasone propionate is excreted in human breast milk. However, other corticosteroids have been detected in human milk. Subcutaneous administration to lactating rats of tritiated fluticasone propionate at a dose approximately 0.4 times the MRHDID for adults on a mg/m² basis resulted in measurable radioactivity in milk.
Since there are no data from controlled trials on the use of intranasal FLONASE Nasal Spray by nursing mothers, caution should be exercised when FLONASE Nasal Spray is administered to a nursing woman.
The safety and effectiveness of FLONASE Nasal Spray in children aged 4 years and older have been established .Six hundred fifty (650) subjects aged 4 to 11 years and 440 subjects aged 12 to 17 years were studied in US clinical trials with fluticasone propionate nasal spray. The safety and effectiveness of FLONASE Nasal Spray in children younger than 4 years have not been established.
Effects on Growth
Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. This effect was 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 intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch-up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including FLONASE Nasal Spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. To minimize the systemic effects of intranasal corticosteroids, including FLONASE Nasal Spray, each patient’s dosage should be titrated to the lowest dosage that effectively controls his/her symptoms.
A 1-year placebo-controlled trial was conducted in 150 pediatric subjects (aged 3 to 9 years) to assess the effect of FLONASE Nasal Spray (single daily dose of 200 mcg) on growth velocity. From the primary population receiving FLONASE Nasal Spray (n = 56) and placebo (n = 52), the point estimate for growth velocity with FLONASE Nasal Spray was 0.14 cm/year lower than placebo (95% CI: -0.54, 0.27 cm/year). Thus, no statistically significant effect on growth was noted compared with placebo. No evidence of clinically relevant changes in HPA axis function or bone mineral density was observed as assessed by 12-hour urinary cortisol excretion and dual-energy x-ray absorptiometry, respectively.
The potential for FLONASE Nasal Spray to cause growth suppression in susceptible patients or when given at higher than recommended dosages cannot be ruled out.
A limited number of subjects aged 65 years and older (n = 129) or 75 years and older (n = 11) have been treated with FLONASE Nasal Spray in clinical trials. While the number of subjects is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Formal pharmacokinetic trials using FLONASE Nasal Spray have not been conducted in subjects with hepatic impairment. Since fluticasone propionate is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate in plasma. Therefore, patients with hepatic disease should be closely monitored.
Formal pharmacokinetic trials using FLONASE Nasal Spray have not been conducted in subjects with renal impairment.
Climate changes that we are seeing are predicted to increase the length of pollinating seasons and therefore increase the amount of pollen produced, which will only make people with allergies (and children with developing allergies) even more miserable with symptoms of runny nose, sneezing, throat clearing and itchy eyes.
The use of intranasal steroids has been effective in controlling allergy symptoms. But the first thing to remember is that, unlike an antihistamine, intranasal steroids require several days of consistent use before you will see any real change in allergy symptoms. (I must repeat that line 10 times a day, especially to my teenage patients who want instant gratification!).
For anyone who knows the season for their allergies (depending on the pollen one is sensitive to), I recommend starting the intranasal steroid spray one to two weeks before symptoms typically begin. Using the nasal spray daily and continuing throughout the allergy season will provide the best results, and watching the pollen counts in your area will be important to time the use of intranasal steroids.
Although some children seem to be more sensitive about using an intranasal steroid spray, it is well tolerated by most with few side effects.
Prescription intranasal steroid sprays have been approved for use in children as young as 2 years old and the over-the-counter sprays for children 4 years and older. The most commonly reported side effects are nasal irritation, burning and bloody noses. I always try to show my patients how to use the spray properly and to “aim” the spray toward the outer aspect of the inside of the nostril rather than towards the septum (middle), which may help reduce irritation and bloody noses. By spraying toward the outer aspect you also maximize the amount of area that is covered by the spray.
Everyone seems to have their “favorite” intranasal steroid, as some are an aqueous spray and others are an aerosolized puff. But in many cases the product choice may be based on the age of the patient, prescription vs. OTC, insurance coverage and cost. Although there are many to choose from, there have been no head to head studies with these medications, and their efficacy is generally thought to be comparable. Discuss your choices with your own pediatrician.
Lastly, there was a study done in 2014 published in The Journal of Allergy and Clinical Immunology, which measured growth rates in children between 5 and 8 years of age who were treated with an intranasal steroid, specifically Veramyst (fluticasone furoate) as compared to a placebo. The study did show a significant improvement in nasal allergy symptom scores, but there was a 0.27 cm (0.65 inch) reduction in growth rate over the course of the year as compared to placebo. Due to this study, I use the lowest effective dose for the shortest amount of time in younger patients, and I explain the reasoning to their parents.
Again, you can discuss this with your pediatrician before beginning intranasal steroids. Just make sure you use the intranasal spray consistently during the height of allergy season. I tell my own family, “It doesn’t work as well if it sits on the counter for a few days between use!”
Submit questions at www.kidsdr.com.
CHILDREN’S RHINOCORT® ALLERGY SPRAY
Do not use:
- in children under 6 years of age
- if you have ever had an allergic reaction to any of the ingredients
Ask a doctor before use if you:
- have had recent nose ulcers or nose surgery
- have had a nose injury that has not healed
- are using a steroid medicine for asthma, allergies or skin rash
- have an eye infection
- have or had glaucoma or cataracts
When using this product:
- the growth rate of some children may be slower
- some symptoms may get better on the first day of treatment. It may take up to two weeks of daily use to feel the most symptom relief
- do not share this bottle with anyone else as this may spread germs
- remember to tell your doctor about all medicines you take, including this one
Stop use and ask a doctor if:
- you have, or come into contact with someone who has chickenpox, measles or tuberculosis
- you have or develop symptoms of an infection such as persistent fever
- you have any change in vision
- you have severe or frequent nosebleeds
If pregnant or breast-feeding: ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Salinex® Nasal Spray 30ml Children 2 years and older
Recommended use or purpose:
Helps reduce symptoms of a dry, irritated nose.
9 mg/ml sodium chloride, benzalkonium chloride, glycerin, purified water.
Adults and children over 2 years: 1-2 sprays (0.1 ml) 1-3 times daily. Blow nose. Bend head forward and tilt to right. Place tip of nozzle in left nostril. Do not insert more than ¼ inch. Press down and follow same procedure in right nostril. Blow nose. Rinse nozzle with hot water before and after use, wipe with tissue.
Consult doctor before use if you have asthma or other chronic respiratory complaints. Do not share. Do not swallow. Consult doctor if: symptoms persist or worsen, no improvement after clearing nose, discharge is thick and yellow or green, skin at the base of the nose becomes raw or crusted, child has other signs of illness (fever, ear infection). If discomfort, discontinue use.
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*For additional information, or to learn more about the proper use of this product, be sure to read the product leaflet and/or product monograph before usee.
® Registered trademark owned or used under license by Sandoz Canada Inc.
Nasacort Children’s Allergy 24 Hour Spray 60 Sprays0.37oz
- Nasal Congestion
- Runny Nose
- Itchy Nose
- 24 Hr Relief
- Age 2+
- Original Prescription Strength
- 60 Sprays
- Triamcinolone Acetonide Nasal Spray 55mcg per Spray Allergy Symptom Reliever (Glucocorticoid)
*Triamcinolone acetonide is a steroid medicine known as a glucocorticoid
Made in France
Directions Read insert (inside package) on how to:
- get a new bottle ready (primed) before first use
- prime bottle again if not used for more than 2 weeks
- use the spray
- clean the spray nozzle
Adults and children 12 years of age and older.
- once daily, spray 2 times into each nostril while sniffing gently
- once your allergy symptoms improve, reduce to 1 spray in each nostril per day
Children 2 to under 12 Years of age.
- the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.
Children 6 to under 12 years of age.
- an adult should supervise use
- once daily, spray 1 time into each nostril while sniffing gently
- if allergy symptoms do not improve increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spay in each nostril per day
- an adult should supervise use
- once daily, spray 1 time into each nostril while sniffing gently
Children under 2 years of age. do not use
- do not use more than directed
- if you forget a dose, do not double the next dose
- do not spray into eyes or mouth
- if allergy symptoms do not improve after one week, stop using and talk to a doctor
- do not use for the common cold
- shake well before each use
- do not use if sealed package is torn or opened
- keep package and insert. They contain important information
- store between 20 degrees-25 degrees C (68 degrees-77 degrees F)