Dosage form: nasal spray, metered Fluticasone propionate is a substrate of cytochrome P450 3A4. Eye Disorders: Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and cataracts. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms. Administer fluticasone propionate nasal spray by the intranasal route only. Bloody nose chest tightness cough fever headache When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of fluticasone propionate nasal spray. 5 0 obj Nasal Ulceration: Postmarketing cases of nasal ulceration have been reported in patients treated with fluticasone propionate nasal spray [see Adverse Reactions (6.2)]. Due to the low bioavailability by the intranasal route, the majority of the pharmacokinetic data was obtained via other routes of administration. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route [see Warnings and Precautions (5.7), Pediatric Use (8.4)]. Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. endobj 2. /PCSp 4 0 R 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. Two of these trials demonstrated that patients treated with Fluticasone Propionate Nasal Spray, USP, at a dosage of 100 mcg twice daily exhibited statistically significant decreases in TNSS compared with patients treated with vehicle. From the primary population receiving fluticasone propionate nasal spray (n=56) and placebo (n=52), the point estimate for growth velocity with fluticasone propionate nasal spray was 0.14 cm/year lower than placebo (95% CI:-0.54, 0.27 cm/year). /CSp /DeviceRGB [/Pattern /DeviceRGB] The most common side effects associated with fluticasone are headache, throat infection, nasal irritation, sneezing, cough, nausea, vomiting. Fluticasone works by reducing. ED is often a symptom of another health problem or health-related factor. Sometimes your doctor may recommend using 1 spray in each nostril twice a day (morning and evening). Therefore, coadministration of fluticasone propionate and ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects. It's monophasic, meaning all active tablets contain the same amount of hormones. Each 100 mg spray delivers 50 mcg of fluticasone propionate, USP. Systemic corticosteroid side effects were not reported during controlled clinical studies up to 6 months duration with Fluticasone Propionate Nasal Spray, USP. (2.2) DOSAGE FORMS AND STRENGTHS Nasal spray: 50 mcg of fluticasone propionate in each 100-mg spray. Fluticasone Propionate Nasal Spray USP, 50 mcg. Fluticasone In vitro dose response studies on a cloned human glucocorticoid receptor system involving binding and gene expression afforded 50% responses at 1.25 and 0.17 nM concentrations, respectively. Package insert / product label 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 fluticasone propionate nasal spray is not recommended because increased systemic corticosteroid adverse effects may occur [see Drug Interactions (7.1), Clinical Pharmacology (12.3)]. Epistaxis 5. endobj Intranasal administration of 2 mg (10 times the recommended dose) of fluticasone propionate twice daily for 7 days was administered to healthy human volunteers. Use Daily for Best Effect: Inform patients that they should use fluticasone propionate nasal spray on a regular basis. 4 CONTRAINDICATIONS . See What are the ingredients in fluticasone propionate nasal spray? below for a complete list of ingredients. Fluticasone propionate nasal spray may cause serious side effects, including: The most common side effects of fluticasone propionate nasal spray include: These are not all the possible side effects with fluticasone propionate nasal spray. There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. The growth of pediatric patients receiving intranasal corticosteroids, including fluticasone propionate nasal spray, should be monitored routinely (e.g., via stadiometry). In 1 trial, 200 mcg/day was slightly more effective than 50 mcg/day during the first few days of treatment; thereafter, no difference was seen. In some circumstances, this medicine may not be suitable and your doctor may wish to give you a different medicine. Propionate Fluticasone propionate nasal spray, USP is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. We comply with the HONcode standard for trustworthy health information. Step 3: 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. Fluticasone propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human transcortin. It is necessary to prime the pump into the air the first time it is used, or when you have not used it for a week or more. >> What are the possible side effects of fluticasone propionate nasal spray? Make sure that your doctor knows what other medicines you are taking. 9. [0 /XYZ 69.5999999 The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. 222 Greenstone Limited #60758011905 Prednisolone Acetate 1% Drops Bottle 5 mL Prednisolone acetate ophthalmic suspension, USP 1% is supplied sterile #721880 Fluticasone propionate is a substrate of cytochrome P450 3A4. The NOAEL was observed with a dose approximately 0.25 times the MRHDID (on a mcg/m2 basis with a maternal nose-only inhalation dose of 5.5 mcg/kg/day). Store between 4 and 30C (39F and 86F). 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. It provides a summary of information on your medicine. The 7 trials included 536 subjects (57 girls and 108 boys aged 4 to 11 years, 137 female and 234 male adolescents and adults) treated with fluticasone propionate nasal spray 200 mcg once daily over 2 to 4 weeks and 2 placebo-controlled clinical trials which included 246 subjects (119 female and 127 male adolescents and adults) treated with fluticasone propionate nasal spray 200 mcg once daily over 6 months (Table 1). No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the mouse micronucleus test. This inactive metabolite had less affinity (approximately 1/2,000) than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies. Ketoconazole: Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol. /CA 1.0 Caution should be exercised when other potent cytochrome P450 3A4 inhibitors are coadministered with fluticasone propionate. Therefore, patients with hepatic disease should be closely monitored. The relative difference in efficacy with as-needed use as compared to regularly administered doses was not studied. In clinical trials of 2 to 26 weeks duration, epistaxis was observed more frequently in subjects treated with fluticasone propionate nasal spray than those who received placebo [see Adverse Reactions (6.1)]. Cases of growth suppression have been reported for intranasal corticosteroids, including fluticasone propionate nasal spray [see Warnings and Precautions (5.7)]. endobj DO NOT give this medicine to anyone else. Other adverse events that occurred in 3% but 1% of patients and that were more common with fluticasone propionate (with uncertain relationship to treatment) included: blood in nasal mucus, runny nose, abdominal pain, diarrhea, fever, flu-like symptoms, aches and pains, dizziness, bronchitis. /SMask /None>> Illustrated patients instructions for proper use accompany each package of Fluticasone Propionate Nasal Spray, USP. (See the complete prescribing information for VZIG and IG.) Reduced Growth Velocity: Advise parents that fluticasone propionate nasal spray may cause a reduction in growth velocity when administered to pediatric patients. 2, However, no teratogenic effects were reported at oral doses up to 300 mcg/kg (approximately 25 times the maximum recommended daily intranasal dose in adults on a mcg/m basis), of fluticasone propionate to the rabbit. 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. Monitor the growth routinely of pediatric patients receiving fluticasone propionate nasal spray. The trials included 2,633 adults (1,439 men and 1,194 women) with a mean age of 37 (range, 18 to 79 years). If the nasal applicator becomes blocked, it can be removed as above and left to soak in warm water. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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 direct relationship of these finding to long-term symptom relief is not known. >> The pharmacists label will usually tell you what dose to take and how often. There are insufficient data on the use of fluticasone propionate nasal spray in pregnant women to inform a drug-associated risk. Fluticasone propionate nasal spray, USP is a nasal spray suspension. iFs^pnE }+;cx{ ykl2*\8Fq)X^P `o#. The potential for catch-up growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. In 7 trials in adults, Fluticasone Propionate Nasal Spray,USP, has decreased nasal mucosal eosinophils in 66% (35% for placebo) of patients and basophils in 39% (28% for placebo) of patients. For (4 years of age and older), the usual starting dosage is . 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. It belongs to a class of drugs known as corticosteroids. a certain fungal infection in your nose, mouth, or throat (thrush). After the first few days, patients may be able to reduce their dosage to 100 mcg (1 spray in each nostril) once daily for maintenance therapy. The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). >> 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. CLINICAL TRIALS: Individualization of Dosage. /GSa 3 0 R Fluticasone Propionate Bioequivalent to * : FLONASE Therapeutic Class (AHFS) : Corticosteroids for Nasal Inha Strength : 50MCG Pack Size (Form) : 15ML NASAL SPRAY (BOTTLE) Dosage Form : Solution Scored : N/A Color : MILKY WHITE Shape : N/A Markings : N/A Route of Administration : Nasal Storage Condition : Fluticasone propionate nasal spray, USP is an aqueous suspension. /Creator () How should I use fluticasone propionate nasal spray? Do not use this bottle for more than the labeled number of sprays even though the bottle is not completely empty. A decrease in nasal symptoms may occur as soon as 12 hours after starting therapy with Fluticasone Propionate Nasal Spray, USP. It is not a disclosure of all possible adverse or intended effects. To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Candida. Check with your health insurance company for TELADOC coverage eligibility. Some children may experience growth suppression when using fluticasone. Patients should use Fluticasone Propionate Nasal Spray, USP, at regular intervals for optimal effect. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. It is necessary to prime the pump before first use or after a period of non-use (1 week or more). The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. In addition, some patients may experience symptoms of corticosteroid withdrawal (e.g., joint and/or muscular pain, lassitude, depression). 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. >> /Type /Page Fluticasone propionate nasal spray, USP is an aqueous suspension. Do not use fluticasone propionate nasal spray if you are allergic to fluticasone propionate or any of the ingredients in fluticasone propionate nasal spray. endobj 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. Best results will be obtained by using the spray on a regular basis. 1. Recommended starting dosages: Adults: 2 sprays per nostril once daily (200 mcg per day). Inactive ingredients: 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol and polysorbate 80. No evidence of impairment of fertility was observed in reproductive studies conducted in male and female rats at subcutaneous doses up to 50 mcg/kg (approximately 2 times the maximum recommended daily intranasal dose in adults on a mcg/m basis). 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. Patients not adequately responding to 1 spray in each nostril may use 2 sprays in each nostril once daily (total daily dose, 200 mcg). The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)]. When you prime the pump for the first time, press down and release the pump 6 times (Figure 2). F L U T I C A S O N E P R O P I O N A T E n a s a l s p r a y , U S P I n i t i a l U . Advise patients to notify their healthcare providers if a change in vision is noted while using fluticasone propionate nasal spray [see Warnings and Precautions (5.2)]. HPA Axis Effect: The potential systemic effects of fluticasone propionate nasal spray on the HPA axis were evaluated. << 214.559999 0] 5 WARNINGS AND PRECAUTIONS Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man. The overall racial distribution was 89% white, 4% black, and 7% other. Plasma fluticasone propionate concentrations following fluticasone propionate aqueous nasal spray alone were undetectable (<10 pg/mL) in most subjects, and when concentrations were detectable, peak levels (Cmax) averaged 11.9 pg/mL (range: 10.8 to 14.1 pg/mL) and AUC(0-) averaged 8.43 pgh/mL (range: 4.2 to 18.8 pgh/mL). If chickenpox develops, treatment with antiviral agents may be considered. In preclinical studies, fluticasone propionate revealed progesterone-like activity similar to the natural hormone. 2. Fluticasone Propionate Nasal Spray, USP, may begin to work within 12 hours of the first dose, but it takes several days of regular use to reach its greatest effect. It is also used to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. Active ingredient: fluticasone propionate, USP. [see Warnings and Precautions (5.7), Pediatric Use (8.4)]. General information about the safe and effective use of fluticasone propionate nasal spray. Hypersensitivity Reactions, including Anaphylaxis: Inform patients that hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, contact dermatitis, and rash, may occur after administration of fluticasone propionate nasal spray. Fluticasone propionate was 3-fold to 5-fold more potent than dexamethasone in these assays. A drug interaction study in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations (see and ). Do not give your fluticasone propionate nasal spray to other people, even if they have the same condition that you have. Rhinitis can also make your nose itchy, and you may sneeze a lot. How do I store Fluticasone Propionate Nasal Spray? Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. The recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg). The activity of fluticasone propionate nasal spray is due to the parent drug, fluticasone propionate. Do not take extra doses or stop taking fluticasone propionate nasal spray without talking to your healthcare provider. Fluticasone Propionate Nasal Spray, USP, 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. /Filter /FlateDecode In a drug interaction study, coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in increased fluticasone propionate exposure and reduced plasma cortisol AUC, but had no effect on urinary excretion of cortisol. Intranasal corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; or ocular herpes simplex. 14 0 obj If it doesnt, or you are not sure, ask your doctor or pharmacist. 2. 8. Use of intranasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Fluticasone nasal spray comes in brand and generic forms, and is available by a prescription or over-the-counter (OTC). It may harm them. If a second spray is required in that nostril, repeat steps 4 through 6. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. In an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.06 times the MRHDID and higher (on a mcg/m2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day). Prime fluticasone propionate nasal spray before using for the first time or after a period of non-use (1 week or more) by shaking the contents well and releasing 6 sprays into the air away from the face. /ca 1.0 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 beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Generic FORMS, and slightly soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble dimethyl! 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