Flonase

Veramyst

You usually spray Flonase nasal spray in each nostril once or twice daily, in the morning and evening.

Sometimes, people use it on an as-needed basis to treat symptoms. The nasal spray is for use in the nose only. Be careful not to get this medication in your eyes.

Your doctor may decrease your dose once your symptoms are under control or increase your dose if your symptoms haven't improved after at least two weeks.

Flonase Overdose

It's important not to take more Flonase or fluticasone than your doctor prescribes.

Symptoms of an overdose of Flonase or fluticasone include:

• Enlarged face and neck
• New or worsening acne
• Easy bruising
• Extreme tiredness
• Muscle weakness
• Irregular menstrual cycles
• Loss of appetite
• Weight loss
• Irritability
• Depression
• Fainting or dizziness when you stand up after lying down or sitting
• Skin darkening

If you or someone else has symptoms of an overdose, call a poison control center at 1-800-222-1222 or call 911.

Missed Dose of Flonase

Once you start taking Flonase or fluticasone, your symptoms may not improve for at least 12 hours, and it could take several more days to experience the full benefit of the medication.

Fluticasone works best when used on a regular basis as directed by your doctor.

If you miss a dose of Flonase, skip the missed dose and take your next dose at its regularly scheduled time. Don't take a double dose to make up for a missed one.

Flonase is part of the drug class:

• Corticosteroid Decongestants

Use Flonase exactly as prescribed.

• Flonase comes in the form of a nasal spray and is usually sprayed once a day.
• Flonase is for use in your nose only. Do not spray it in your eyes or mouth.
• Children should use Flonase with an adult’s help, as instructed by the child’s healthcare provider.
• Flonase may take several days of regular use for your rhinitis symptoms to get better. If your symptoms do not improve or get worse, call your healthcare provider.
• If you miss a dose by several hours, skip the missed dose and take your next dose at the regular time. Do not take two doses of Flonase at the same time.

Prescription Form:

Use Flonase exactly as your healthcare provider tells you. Do not use Flonase more often than prescribed.

You will get the best results if you keep using Flonase regularly each day without missing a dose. After you begin to feel better, your healthcare provider may decrease your dose. Do not stop using Flonase unless your healthcare provider tells you to do so.

Over-the-Counter Form:

If your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection.

Stop use and ask your doctor if you you notice any vision changes, get a constant whistling sound from your nose, or you have severe or frequent nosebleeds.

Priming and Using Your Flonase Nasal Spray

Your Flonase must be primed before you use it for the first time and when you have not used it for a week or more.

How to prime your Flonase Nasal Spray:

• Shake the bottle gently and then remove the dust cover
• Hold the bottle with the nasal applicator pointing away from you and with your forefinger and middle finger on either side of the nasal applicator and your thumb underneath the bottle.
• Press down and release 6 times until a fine spray appears. The pump is now ready for use.

Using your Flonase Nasal Spray:

Step 1. Blow your nose to clear your nostrils.

Step 2. Close 1 nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril.

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. 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 eyes. Breathe gently inwards through the nostril.

Step 4. Breathe out through your mouth.

Step 5. If a second spray is required in that nostril, repeat steps 2 through 4.

Step 6. Repeat steps 2 through 5 in the other nostril.

Step 7. Wipe the nasal applicator with a clean tissue and replace the dust cover.

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. Do not take extra doses or stop taking Flonase without talking to your healthcare provider.

Cleaning your Flonase Nasal Spray:

Your nasal spray should be cleaned at least 1 time each week.

1. Remove the dust cover and then gently pull upwards to free the nasal applicator.

2. Wash the applicator and dust cover under warm tap water. Allow to dry at room temperature.

3. Place the applicator and dust cover back on the bottle.

4. 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. Do not try to unblock the nasal applicator by inserting a pin or other sharp object.

• Store Flonase between 39°F and 86°F (4°C and 30°C).
• Do not use your Flonase after the date shown as “EXP” on the label or box.
• Keep this and all medicines out of the reach of children.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine is only for allergies. Do not use it to treat asthma or a cold. Talk with the doctor.
• This medicine may raise the chance of cataracts or glaucoma. Talk with the doctor.
• Have an eye exam as you have been told by your doctor.
• Talk with your doctor if you come into contact with anyone who has chickenpox or measles and you have not had chickenpox, measles, or the vaccines for them.
• If you have come into contact with anyone who has tuberculosis (TB), talk with your doctor.
• If you have had any recent nose surgery, injury, ulcers, or sores, talk with your doctor.
• Stinging or sneezing may happen for a few seconds after you use Flonase. Talk with your doctor if this bothers you.
• When changing from an oral steroid to another form of a steroid, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call your doctor right away if you have any of these signs. If you have a bad injury, have surgery, or any type of infection, you may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you may need extra steroids.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Different brands of this medicine may be for use in different ages of children. Talk with the doctor before giving Flonase to a child.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Systemic and local corticosteroid use may result in the following:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled US clinical trials, more than 3,300 subjects with allergic and nonallergic rhinitis received treatment with intranasal fluticasone propionate. In general, adverse reactions in clinical trials have been primarily associated with irritation of the nasal mucous membranes, and the adverse reactions were reported with approximately the same frequency by subjects treated with placebo. Less than 2% of subjects in clinical trials discontinued because of adverse reactions; this rate was similar for vehicle placebo and active comparators.

The safety data described below are based on 7 placebo-controlled clinical trials in subjects with allergic rhinitis. 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 Flonase 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 Flonase 200 mcg once daily over 6 months (Table 1). Also included in Table 1 are adverse reactions from 2 trials in which 167 children (45 girls and 122 boys aged 4 to 11 years) were treated with Flonase 100 mcg once daily for 2 to 4 weeks.

Other adverse reactions with Flonase Nasal Spray observed with an incidence less than or equal to 3% but greater than or equal to 1% and more common than with placebo included: blood in nasal mucus, runny nose, abdominal pain, diarrhea, fever, flu‑like symptoms, aches and pains, dizziness, and bronchitis.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following adverse events have been identified during postapproval use of intranasal fluticasone propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

General Disorders and Administration Site Conditions

Hypersensitivity reactions, including angioedema, skin rash, edema of the face and tongue, pruritus, urticaria, bronchospasm, wheezing, dyspnea, and anaphylaxis/anaphylactoid reactions, which in rare instances were severe.

Ear and Labyrinth Disorders

Alteration or loss of sense of taste and/or smell and, rarely, nasal septal perforation, nasal ulcer, sore throat, throat irritation and dryness, cough, hoarseness, and voice changes.

Eye Disorders

Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and cataracts.

Cases of growth suppression have been reported for intranasal corticosteroids, including Flonase [see Warnings and Precautions (5.7)].

Inhibitors of Cytochrome P450 3A4

Fluticasone propionate is a substrate of CYP3A4. The use of strong 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.

Ritonavir

A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology (12.3)]. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate products, including Flonase, with ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.

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.

Pregnancy

Teratogenic Effects

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 4mcg/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 [see Clinical Pharmacology (12.3)].

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.

Nonteratogenic Effects

Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.

Nursing Mothers

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.

Pediatric Use

The safety and effectiveness of Flonase Nasal Spray in children aged 4 years and older have been established [see Adverse Reactions (6.1), Clinical Pharmacology (12.3)]. 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.

Geriatric Use

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.

Hepatic Impairment

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.

Renal Impairment

Formal pharmacokinetic trials using Flonase Nasal Spray have not been conducted in subjects with renal impairment.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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