What does veramyst treat

Veramyst can cause dizziness. Do not drive or operate machinery until you know how Veramyst affects you. To avoid withdrawal side effects, do not stop using Veramyst spray at once. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether. Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Veramyst there are no specific foods that you must exclude from your diet when receiving Veramyst.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Veramyst and other medicines may affect each other, causing side effects. See "Drug Interactions" section. The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. Veramyst falls into category C.

There are no adequate and well-controlled studies in pregnant women. Veramyst Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn baby. It is not known whether fluticasone furoate the active ingredient in Veramyst is excreted in human breast milk. However, other corticosteroids have been detected in human milk.

Since there are no data from controlled trials on the use of Veramyst by nursing mothers, caution should be exercised when Veramyst is administered to a nursing woman. Take Veramyst exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Veramyst treats the symptoms of nasal allergies. Veramyst may begin to work within 24 hours after you take your first dose. It may take several days before it has its greatest effect. Veramyst Overview Updated: April 11, Veramyst comes in a nasal spray and is used once a day. How was your experience with Veramyst? First, a little about yourself Male Female. What tips would you provide a friend before taking Veramyst?

Choose one. Back Next. How well did Veramyst work for you? Did you experience many side effects while taking this drug? How likely would you be to recommend Veramyst to a friend? Back Submit. Veramyst Cautionary Labels Back to Top. Uses of Veramyst Back to Top. Manufacturer Back to Top. Generic Back to Top. Fluticasone Furoate For more information on this medication choose from the list of selections below.

Veramyst Drug Class Back to Top. Veramyst is part of the drug class: Corticosteroid Decongestants. Side Effects of Veramyst Back to Top. Common side effects of Veramyst include: headache nosebleeds irritated or burning nose runny nose cough nausea stomach pain vomiting diarrhea dizziness This is not a complete list of Veramyst side effects.

Veramyst Interactions Back to Top. Especially tell your doctor if you take: Some antibiotics and some antifungals, including: clarithromycin Biaxin ; erythromycin Ery-Tab ; isoniazid Nydrazid ; itraconazole Sporanox ; ketoconazole Nizoral ; telithromycin Ketek.

Protease inhibitors, including: amprenavir Agenerase ; atazanavir Reyataz ; fosamprenavir Lexiva ; indinavir Crixivan ; nelfinavir Viracept ; ritonavir Norvir ; saquinavir Invirase.

Veramyst Precautions Back to Top. Veramyst may cause serious side effects including: nasal fungal infection. This happened in about 1 out of 1, patients in clinical studies with Veramyst. Do not use Veramyst 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.

You should have regular eye exams. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.

There are no adequate and well-controlled studies in pregnant women. Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored. It is not known whether fluticasone furoate is excreted in human breast milk. However, other corticosteroids have been detected in human milk. Since there are no data from controlled trials on the use of intranasal fluticasone furoate by nursing mothers, caution should be exercised when VERAMYST Nasal Spray is administered to a nursing woman.

Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of 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 reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. Other reported clinical experience has not identified differences in responses between the elderly and 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.

No dosage adjustment is required in patients with renal impairment [see Clinical Pharmacology Single- and repeat-dose studies with orally inhaled fluticasone furoate doses of 50 to 4, mcg have shown decreased mean serum cortisol at doses of mcg or higher.

Fluticasone furoate is a white powder with a molecular weight of It is practically insoluble in water. VERAMYST Nasal Spray is an aqueous suspension of micronized fluticasone furoate for topical administration to the nasal mucosa by means of a metering 50 microliters , atomizing spray pump.

After initial priming [see Dosage and Administration 2 ] , each actuation delivers It has a pH of approximately 6. Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. The precise mechanism through which fluticasone furoate affects rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of actions on multiple cell types e. Specific effects of fluticasone furoate demonstrated in in vitro and in vivo models included activation of the glucocorticoid response element, inhibition of pro-inflammatory transcription factors such as NFkB, and inhibition of antigen-induced lung eosinophilia in sensitized rats.

Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately The clinical relevance of these findings is unknown.

In addition, one week safety study and one week safety and efficacy study included assessments of hour urinary cortisol excretion. Details of the studies and results are described below. In all 4 studies, since serum fluticasone determinations were generally below the limit of quantification, compliance was assured by efficacy assessments.

In a 6-week randomized, double-blind, parallel-group study in adult and adolescent patients aged 12 years and older with perennial allergic rhinitis, VERAMYST Nasal Spray mcg was compared with both placebo nasal spray and prednisone as a positive-control group that received prednisone 10 mg orally once daily for the final 7 days of the treatment period.

Adrenal function was assessed by hour urinary cortisol excretion before and after 6 weeks of treatment and by serial serum cortisol levels.

Patients were domiciled for collection of hour urinary cortisol. Urinary cortisol data were not available for the positive-control prednisone treatment group.

For serum cortisol levels, after 6 weeks of treatment there was a change from baseline in the mean hours of The second 6-week study conducted in children aged 2 to 11 years was of similar design to the adult study, including adrenal function assessments, but did not include a prednisone positive-control arm.

For serum cortisol levels, after 6 weeks, there was a change from baseline in mean hours of After 52 weeks of treatment, the mean change from baseline hour urinary cortisol excretion was 5. The difference from placebo in mean change from baseline hour urinary cortisol excretion was 2. Adrenal function was assessed by measurement of hour urinary free cortisol in a subset of patients who were aged 6 to 11 years to patients per group before and after 12 weeks of treatment.

When the results of the HPA axis assessments described above are taken as a whole, an effect of intranasal fluticasone furoate on adrenal function cannot be ruled out, especially in pediatric patients. The effect of a single dose of 4, mcg of orally inhaled fluticasone furoate on the QTc interval was evaluated over 24 hours in 40 healthy male and female subjects in a placebo and positive a single dose of mg oral moxifloxacin controlled cross-over study.

The QTcF maximal mean change from baseline following fluticasone furoate was similar to that observed with placebo with a treatment difference of 0. In contrast, moxifloxacin given as a mg tablet resulted in prolongation of the QTcF maximal mean change from baseline compared with placebo with a treatment difference of 9. While a single dose of fluticasone furoate had no effect on the QTc interval, the effects of fluticasone furoate may not be at steady state following single dose.

The effect of fluticasone furoate on the QTc interval following multiple dose administration is unknown. Following intranasal administration of fluticasone furoate, most of the dose is eventually swallowed and undergoes incomplete absorption and extensive first-pass metabolism in the liver and gut, resulting in negligible systemic exposure.

There was no relationship between these concentrations and cortisol levels in these subjects. The reasons for these high concentrations are unknown.

The average absolute bioavailability was 0. Due to the low bioavailability by the intranasal route, the majority of the pharmacokinetic data was obtained via other routes of administration. Oral bioavailability is on average 1. In vivo studies have revealed no evidence of cleavage of the furoate moiety to form fluticasone. Fluticasone furoate is cleared total plasma clearance of The elimination phase half-life averaged Fluticasone furoate is typically not quantifiable in plasma following intranasal dosing of mcg once daily with the exception of isolated cases of very high plasma levels see Absorption.

There was no evidence to suggest that the presence or absence of detectable levels of fluticasone furoate was related to gender, age, or race. Reduced liver function may affect the elimination of corticosteroids. Since fluticasone furoate undergoes extensive first-pass metabolism by the hepatic CYP3A4, the pharmacokinetics of fluticasone furoate may be altered in patients with hepatic impairment.

Fluticasone furoate is not detectable in urine from healthy subjects following intranasal dosing. No dosage adjustment is required in patients with renal impairment. Fluticasone furoate did not induce gene mutation in bacteria or chromosomal damage in a mammalian cell mutation test in mouse lymphoma LY cells in vitro. There was also no evidence of genotoxicity in the in vivo micronucleus test in rats. The 5 clinical trials included one 2-week dose-ranging trial in patients with seasonal allergic rhinitis, three 2-week confirmatory efficacy trials in patients with seasonal allergic rhinitis, and one 4-week efficacy trial in patients with perennial allergic rhinitis.

These trials included 1, patients males and 1, females. Assessment of efficacy was based on total nasal symptom score TNSS. Morning and evening rTNSS scores were averaged over the treatment period and the difference from placebo in the change from baseline rTNSS was the primary efficacy endpoint.

An overall RQLQ score is calculated from the mean of all items in the instrument. The dose-ranging trial was a 2-week trial that evaluated the efficacy of 4 dosages of fluticasone furoate nasal spray , , , and 55 mcg in patients with seasonal allergic rhinitis.

In this trial, each of the 4 dosages of fluticasone furoate nasal spray demonstrated greater decreases in the rTNSS than placebo, and the difference was statistically significant Table 3. Each of the 4 dosages of fluticasone furoate nasal spray also demonstrated greater decreases in the AM iTNSS than placebo, and the difference between each of the 4 fluticasone furoate treatment groups and placebo was statistically significant, indicating that the effect was maintained over the hour dosing interval.

Three clinical trials were designed to evaluate the efficacy of VERAMYST Nasal Spray mcg once daily compared with placebo in patients with seasonal allergic rhinitis over a 2-week treatment period. Table 4 displays the efficacy results from a representative trial in patients with seasonal allergic rhinitis. One clinical trial was designed to evaluate the efficacy of VERAMYST Nasal Spray mcg once daily compared with placebo in patients with perennial allergic rhinitis over a 4-week treatment period.

However, unlike the trials in patients with seasonal allergic rhinitis, patients with perennial allergic rhinitis who were treated with VERAMYST Nasal Spray mcg did not demonstrate statistically significant improvement from baseline in rTOSS or in disease-specific quality of life as measured by the RQLQ compared with placebo. Table 4 displays the efficacy results from the clinical trial in patients with perennial allergic rhinitis.

Onset of action was evaluated by frequent instantaneous TNSS assessments after the first dose in the clinical trials in patients with seasonal allergic rhinitis and perennial allergic rhinitis. Onset of action was generally observed within 24 hours in patients with seasonal allergic rhinitis.

In patients with perennial rhinitis, onset of action was observed after 4 days of treatment. Continued improvement in symptoms was observed over approximately 1 and 3 weeks in patients with seasonal or perennial allergic rhinitis, respectively.

The efficacy and safety of VERAMYST Nasal Spray were evaluated in 1, children boys and girls , mean age of 8 years with seasonal or perennial allergic rhinitis in 2 controlled clinical trials.

In seasonal allergic rhinitis, the difference in rTNSS was statistically significant only for the mcg dose. In perennial allergic rhinitis, the difference in rTNSS was statistically significant only for the mcg dose. Changes in rTOSS in the seasonal allergic rhinitis trial were not statistically significant compared with placebo for either dose.

Each bottle contains a net fill weight of 10 g of white, liquid suspension and will provide metered sprays. After priming [see Dosage and Administration 2 ] , each spray delivers a fine mist containing The contents of the bottle can be viewed through an indicator window. Shake the contents well before each use. The correct amount of medication in each spray cannot be assured before the initial priming and after sprays have been used, even though the bottle is not completely empty.

The nasal device should be discarded after sprays have been used. Do not freeze or refrigerate. In addition, nasal corticosteroids are associated with nasal septal perforation and impaired wound healing. Patients should be informed that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use.

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex [see Warnings and Precautions 5.

Although significant improvement is usually achieved within 24 hours in patients with seasonal allergic rhinitis and 4 days in patients with perennial allergic rhinitis, maximum benefit may not be reached for several days. The patient should not increase the prescribed dosage but should contact the physician if symptoms do not improve or if the condition worsens.

Tulsa, OK There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment. Corticosteroids are natural substances found in the body that reduce inflammation. When you spray VERAMYST into your nose, it helps reduce the nasal symptoms of allergic rhinitis inflammation of the lining of the nose , such as stuffy nose, runny nose, itching, and sneezing.

Tell your healthcare provider about all of your medical conditions, including if you are:. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Be certain to tell your healthcare provider if you are taking a medicine that contains ritonavir commonly used to treat HIV infection or AIDS. If you have allergic rhinitis, your nose becomes stuffy, runny, and itchy.

You may also sneeze a lot. You may also have red, itchy, watery eyes; itchy throat; or blocked, itchy ears. Inactive ingredients: 0. If you have any questions, ask your healthcare provider or pharmacist. It contains sprays or 30 sprays if it is a sample plus the first priming sprays. Be careful not to drop it. If you accidentally drop the device, check it for damage.

If the device is damaged, return it to your pharmacist. The Cap has a tab that keeps the Mist-Release Button from being pressed accidentally. It also helps keep the nozzle clean. Do not throw the cap away.

Always keep the cap on the device when you are not using it. The Nozzle is small and short, so it will fit inside your nose.

The medicine comes out of the nozzle. Pressing the Mist-Release Button sprays a measured amount of medicine from the nozzle as a gentle, fine mist. Because the button is on the side of the device, you can keep the nozzle in the right place in your nose while you press the button. The Window lets you see if there is medicine left in the bottle when you hold it in front of a bright light. You may not be able to see the medicine in a full bottle because the liquid level is above the window.

Priming helps to make sure you always get the same full dose of medicine. Follow the instructions below. Shake the bottle well. Then do these 3 simple steps: Place, Press, Repeat. Tilt your head forward a little bit. Hold the device upright. Point the end of the nozzle toward the side of your nose, away from the center of your nose septum.

This helps get the medicine to the right part of your nose. PRESS the button all the way in 1 time to spray the medicine in your nose while you are breathing in Figure 5. Do not get any spray in your eyes. If you do, rinse your eyes well with water. Put the cap back on the device after you have finished taking your dose.

After each use: wipe the nozzle with a clean, dry tissue Figure 8. Never try to clean the nozzle with a pin or anything sharp because this will damage the nozzle. Do not use water to clean the nozzle. Once a week: clean the inside of the cap with a clean, dry tissue Figure 9. This will help keep the nozzle from getting blocked. In cases where it has not been used for more than 30 days or if the cap has been left off the bottle for 5 days or longer, prime the pump again until a fine mist appears.

Store between 15 o and 30 o C 59 o and 86 o F. Do not refrigerate or freeze. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.