Nasonex 50 micrograms/actuation Nasal Spray, Suspension - Summary of Product Characteristics (SPC)

Beconase Aqueous Nasal Spray

corticosteroid nasal spray glaucoma

If exposed to chickenpox, prophylaxis with varicella zoster immune globulin VZIG may be indicated. Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro. The safety and effectiveness of fluticasone propionate nasal spray in children aged 4 years and older have been established [see Adverse Reactions 6. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy CSCR which have been reported after use of systemic and topical corticosteroids. The first treatment phase was weeks long, and was followed by an additional eight-week phase when all patients received XHANCE mcg twice daily.

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These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Formal pharmacokinetic trials using Flonase Nasal Spray have not been conducted in subjects with hepatic impairment. FLONASE Nasal Spray, 50 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. 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. Depending on the amount swallowed, gastric lavage is recommended.

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. Six hundred fifty subjects aged 4 to 11 years and subjects aged 12 to 17 years were studied in US clinical trials with fluticasone propionate nasal spray. 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 growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. A 1-year placebo-controlled trial was conducted in pediatric subjects aged 3 to 9 years to assess the effect of FLONASE Nasal Spray single daily dose of mcg on growth velocity.

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 hour urinary cortisol excretion and dual-energy x-ray absorptiometry, respectively. 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. 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. Intranasal administration of 2 mg 10 times the recommended dose of fluticasone propionate twice daily for 7 days to healthy human volunteers was well tolerated.

Single oral doses up to 16 mg have been studied in human volunteers with no acute toxic effects reported. Repeat oral doses up to 80 mg daily for 10 days in volunteers and repeat oral doses up to 10 mg daily for 14 days in patients were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.

Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasonemonopropionate BMP , the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide.

Data from the McKenzie vasoconstrictor assay in man are consistent with these results. The clinical significance of these findings is unknown. The precise mechanism through which fluticasone propionate affects rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types e. The direct relationship of these findings to long-term symptom relief is not known. FLONASE Nasal Spray at either dosage for 4 weeks did not affect the adrenal response to 6-hour cosyntropin stimulation, while both dosages of oral prednisone significantly reduced the response to cosyntropin.

Due to the low bioavailability by the intranasal route, the majority of the pharmacokinetic data was obtained via other routes of administration.

Following intravenous administration, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding.

The volume of distribution averaged 4. Fluticasone propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human transcortin.

Following intravenous dosing, fluticasone propionate showed polyexponential kinetics and had a terminal elimination half-life of approximately 7.

The total blood clearance of fluticasone propionate is high average: Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man. Fluticasone propionate nasal spray was not studied in any special populations, and no gender-specific pharmacokinetic data have been obtained. Inhibitors of Cytochrome P 3A4: Coadministration of fluticasone propionate and the strong CYP3A4 inhibitor, ritonavir, is not recommended based upon a multiple-dose, crossover drug interaction trial in 18 healthy subjects.

Fluticasone propionate aqueous nasal spray mcg once daily was coadministered for 7 days with ritonavir mg twice daily. In a multiple-dose drug interaction study, coadministration of orally inhaled fluticasone propionate mcg twice daily and erythromycin mg 3 times daily did not affect fluticasone propionate pharmacokinetics. There may be new information. This Patient Information does not take the place of talking to your healthcare provider about your medical condition or treatment. FLONASE Nasal Spray is a prescription medicine used to treat non- allergy nasal symptoms such as runny nose, stuffy nose , sneezing, and nasal itching in adults and children aged 4 years and older.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal or anti- HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. Medicines are sometimes prescribed for purposes not mentioned in a Patient Information leaflet. It may harm them. If you would like more information, talk with your healthcare provider.

Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril See Figure D. Start to breathe in through your nose, and while breathing in press firmly and quickly down 1 time on the applicator to release the spray. To get a full dose, use your forefinger and middle finger to spray while supporting the base of the bottle with your thumb.

Avoid spraying in your eyes. Breathe in gently through the nostril See Figure E. Wipe the nasal applicator with a clean tissue and replace the dust cover See Figure F. Do not use this bottle for more than the labeled number of sprays even though the bottle is not completely empty. Before you throw the bottle away, you should talk to your healthcare provider to see if a refill is needed. If the nasal applicator becomes blocked, it can be removed and left to soak in warm water.

Rinse the nasal applicator with cold tap water. Dry the nasal applicator and place it back on the bottle. During the study, patients were regularly asked about their symptoms and assessed by investigators who checked for objective evidence of change in the disease and for adverse events. XHANCE is delivered into the nose by actuating the pump spray into one nostril while simultaneously blowing into the mouthpiece of the device.

The recommended adult dosage is one spray per nostril twice daily total daily dose of mcg. Two sprays per nostril twice daily may also be effective in some patients total daily dose of mcg. Strong cytochrome P 3A4 inhibitors e. May increase risk of systemic corticosteroid effects. XHANCE is a corticosteroid indicated for the treatment of nasal polyps in patients 18 years of age or older.

XHANCE fluticasone propionate nasal spray, 93 mcg, combines the novel Optinose Exhalation System with an aqueous suspension of microfine fluticasone propionate for topical intranasal administration by means of a metering, atomizing spray pump and exhaled breath.

XHANCE also contains microcrystalline cellulose and carboxymethylcellulose sodium, dextrose, benzalkonium chloride, polysorbate 80, edetate disodium dihydrate, and purified water. XHANCE is a prescription medication indicated for the treatment of nasal polyps in patients 18 years of age or older. Optinose is a specialty pharmaceutical company on a mission to improve lives with a focus on patients cared for directly by, or in consultation with, otolaryngology ENT or allergy specialists.

These exhalation delivery systems enable creation of products with the potential for meaningful new clinical benefits.

We expect subsequent Optinose pipeline products will aim to serve the needs of patients treated by ENT and allergy specialists and are expected to include those using EDS and other technologies. Optinose has corporate offices in the U. To learn more, please visit www.

Iamges: corticosteroid nasal spray glaucoma

corticosteroid nasal spray glaucoma

There may be new information. Common Eye disorders Glaucoma, raised intraocular pressure, cataract. Adults and Children 12 Years of Age and Older:

corticosteroid nasal spray glaucoma

After initial priming, each actuation delivers 50 mcg of fluticasone propionate in mg of formulation through the nasal adapter.

corticosteroid nasal spray glaucoma

Infants born of mothers who received corticosteroids during pregnancy should be tren ace quad injection carefully for hypoadrenalism. It is not known if Flonase Nasal Spray may harm your unborn baby. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. There corticosteroid nasal spray glaucoma no effect on fertility. Also, occasional sneezing attacks 10 per adult patients have occurred immediately following the corgicosteroid of the intranasal inhaler.