Forair

What are the side effects you encounter while taking this medicine?
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Forair uses

Forair consists of Fluticasone, Salmeterol.

Fluticasone:


1 INDICATIONS AND USAGE

Forair Nasal Spray is a corticosteroid indicated for treatment of symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years. (1.1)

1.1 Treatment of Allergic Rhinitis

Forair (Fluticasone)® (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.

2 DOSAGE AND ADMINISTRATION

Administer Forair Nasal Spray by the intranasal route only. Prime Forair (Fluticasone) Nasal Spray before using for the first time by shaking the contents well and releasing 6 sprays into the air away from the face. When Forair (Fluticasone) Nasal Spray 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. Shake Forair (Fluticasone) Nasal Spray well before each use.

Titrate an individual patient to the minimum effective dosage to reduce the possibility of side effects.

For intranasal use only. Usual starting dosages:

  • Adults and adolescents ≥12 years: 110 mcg (2 sprays per nostril) once daily. (2.1)
  • Children 2-11 years: 55 mcg (1 spray per nostril) once daily. (2.2)
  • Priming information: Prime Forair (Fluticasone) Nasal Spray before using for the first time, when not used for more than 30 days, or if the cap has been left off the bottle for 5 days or longer. (2)

2.1 Adults and Adolescents Aged 12 Years and Older

The recommended starting dosage is 110 mcg once daily administered as 2 sprays (27.5 mcg/spray) in each nostril. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage to 55 mcg (1 spray in each nostril) once daily may be effective in maintaining control of allergic rhinitis symptoms.

2.2 Children Aged 2 to 11 Years

The recommended starting dosage in children is 55 mcg once daily administered as 1 spray (27.5 mcg/spray) in each nostril. Children not adequately responding to 55 mcg may use 110 mcg (2 sprays in each nostril) once daily. Once symptoms have been controlled, dosage reduction to 55 mcg once daily is recommended.

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3 DOSAGE FORMS AND STRENGTHS

Forair (Fluticasone) Nasal Spray is a nasal spray suspension. Each spray (50 microliters) delivers 27.5 mcg of Forair (Fluticasone) furoate.

Nasal spray: 27.5 mcg of Forair (Fluticasone) furoate in each 50-microliter spray. (3)

Supplied in 10-g bottle containing 120 sprays. (16)

4 CONTRAINDICATIONS

Forair (Fluticasone) Nasal Spray is contraindicated in patients with hypersensitivity to any of its ingredients .

Hypersensitivity to ingredients. (4)

5 WARNINGS AND PRECAUTIONS

  • Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.
  • Development of glaucoma or posterior subcapsular cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. (5.2)
  • Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, may occur after administration of Forair (Fluticasone) Nasal Spray. (5.3)
  • Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. (5.4)
  • Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Forair (Fluticasone) Nasal Spray slowly. (5.5)
  • Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving Forair (Fluticasone) Nasal Spray. (5.7, 8.4)

5.1 Local Nasal Effects

Epistaxis and Nasal Ulceration

In clinical trials of 2 to 52 weeks’ duration, epistaxis and nasal ulcerations were observed more frequently and some epistaxis events were more severe in patients treated with Forair (Fluticasone) Nasal Spray than those who received placebo .

Candida Infection

Evidence of localized infections of the nose with Candida albicans was seen on nasal exams in 7 of 2,745 patients treated with Forair (Fluticasone) Nasal Spray during clinical trials and was reported as an adverse event in 3 patients. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of Forair (Fluticasone) Nasal Spray. Therefore, patients using Forair (Fluticasone) 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 following the intranasal application of Forair (Fluticasone) 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 not use Forair (Fluticasone) Nasal Spray until healing has occurred.

5.2 Glaucoma and Cataracts

Nasal 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.

Glaucoma and cataract formation was evaluated with intraocular pressure measurements and slit lamp examinations in 1 controlled 12-month trial in 806 adolescent and adult patients aged 12 years and older and in 1 controlled 12-week trial in 558 children aged 2 to 11 years. The patients had perennial allergic rhinitis and were treated with either Forair (Fluticasone) Nasal Spray (110 mcg once daily in adult and adolescent patients and 55 or 110 mcg once daily in pediatric patients) or placebo. Intraocular pressure remained within the normal range (less than 21 mmHg) in greater than or equal to 98% of the patients in any treatment group in both trials. However, in the 12-month trial in adolescents and adults, 12 patients, all treated with Forair (Fluticasone) Nasal Spray 110 mcg once daily, had intraocular pressure measurements that increased above normal levels (greater than or equal to 21 mmHg). In the same trial, 7 patients (6 treated with Forair (Fluticasone) Nasal Spray 110 mcg once daily and 1 patient treated with placebo) had cataracts identified during the trial that were not present at baseline.

5.3 Hypersensitivity Reactions, Including Anaphylaxis

Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, may occur after administration of Forair (Fluticasone) Nasal Spray. Discontinue Forair (Fluticasone) Nasal Spray if such reactions occur .

5.4 Immunosuppression

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 children or adults who have not had these diseases or have not 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 may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If chickenpox or measles develops, treatment with antiviral agents may be considered.

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 because of the potential for worsening of these infections.

5.5 Hypothalamic-Pituitary-Adrenal Axis Effects

Hypercorticism and Adrenal Suppression

When intranasal steroids 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 Forair (Fluticasone) 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 those 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.

5.6 Use of Cytochrome P450 3A4 Inhibitors

Coadministration with ritonavir is not recommended because of the risk of systemic effects secondary to increased exposure to Forair furoate. Use caution with the coadministration of Forair (Fluticasone) Nasal Spray and other potent cytochrome P450 3A4(CYP3A4) inhibitors, such as ketoconazole .

5.7 Effect on Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving Forair (Fluticasone) Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including Forair (Fluticasone) Nasal Spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms .

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6 ADVERSE REACTIONS

Systemic and local corticosteroid use may result in the following:

  • Epistaxis, ulcerations, Candida albicans infection, impaired wound healing, and nasal septal perforation
  • Cataracts and glaucoma
  • Immunosuppression
  • Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction

The most common adverse reactions (>1% incidence) included headache, epistaxis, pharyngolaryngeal pain, nasal ulceration, back pain, pyrexia, and cough. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

The safety data described below reflect exposure to Forair (Fluticasone) Nasal Spray in 1,563 patients with seasonal or perennial allergic rhinitis in 9 controlled clinical trials of 2 to 12 weeks’ duration. The data from adults and adolescents are based upon 6 clinical trials in which 768 patients with seasonal or perennial allergic rhinitis (473 females and 295 males aged 12 years and older) were treated with Forair (Fluticasone) Nasal Spray 110 mcg once daily for 2 to 6 weeks. The racial distribution of adult and adolescent patients receiving Forair (Fluticasone) Nasal Spray was 82% white, 5% black, and 13% other. The data from pediatric patients are based upon 3 clinical trials in which 795 children with seasonal or perennial rhinitis (352 females and 443 males aged 2 to 11 years) were treated with Forair (Fluticasone) Nasal Spray 55 or 110 mcg once daily for 2 to 12 weeks. The racial distribution of pediatric patients receiving Forair (Fluticasone) Nasal Spray was 75% white, 11% black, and 14% other.

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.

Adults and Adolescents Aged 12 Years and Older

Overall adverse reactions were reported with approximately the same frequency by patients treated with Forair (Fluticasone) Nasal Spray and those receiving placebo. Less than 3% of patients in clinical trials discontinued treatment because of adverse reactions. The rate of withdrawal among patients receiving Forair (Fluticasone) Nasal Spray was similar to or lower than the rate among patients receiving placebo.

Table 1 displays the common adverse reactions (greater than 1% in any patient group receiving Forair (Fluticasone) Nasal Spray) that occurred more frequently in patients aged 12 years and older treated with Forair (Fluticasone) Nasal Spray compared with placebo-treated patients.


Adverse Event


Adult and Adolescent Patients Aged 12 Years and Older


Vehicle Placebo

(n = 774)


Forair (Fluticasone) Nasal Spray

110 mcg Once Daily

(n = 768)


Headache


54 (7%)


72 (9%)


Epistaxis


32 (4%)


45 (6%)


Pharyngolaryngeal pain


8 (1%)


15 (2%)


Nasal ulceration


3 (<1%)


11 (1%)


Back pain


7 (<1%)


9 (1%)


There were no differences in the incidence of adverse reactions based on gender or race. Clinical trials did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger subjects.

Pediatric Patients Aged 2 to 11 Years

In the 3 clinical trials in pediatric patients aged 2 to younger than 12 years, overall adverse reactions were reported with approximately the same frequency by patients treated with Forair (Fluticasone) Nasal Spray and those receiving placebo. Table 2 displays the common adverse reactions (greater than 3% in any patient group receiving Forair (Fluticasone) Nasal Spray) that occurred more frequently in patients aged 2 to 11 years treated with Forair (Fluticasone) Nasal Spray compared with placebo-treated patients.


Adverse Event


Pediatric Patients Aged 2 to Younger than 12 Years


Vehicle Placebo

(n = 429)


Forair (Fluticasone) Nasal Spray

55 mcg Once Daily

(n = 369)


Forair (Fluticasone) Nasal Spray

110 mcg Once Daily

(n = 426)


Headache


31 (7%)


28 (8%)


33 (8%)


Nasopharyngitis


21 (5%)


20 (5%)


21 (5%)


Epistaxis


19 (4%)


17 (5%)


17 (4%)


Pyrexia


7 (2%)


17 (5%)


19 (4%)


Pharyngolaryngeal pain


14 (3%)


16 (4%)


12 (3%)


Cough


12 (3%)


12 (3%)


16 (4%)


There were no differences in the incidence of adverse reactions based on gender or race. Pyrexia occurred more frequently in children aged 2 to younger than 6 years compared with children aged 6 to younger than 12 years.

Long-term (52-Week) Safety Trial

In a 52-week, placebo-controlled, long-term safety trial, 605 patients (307 females and 298 males aged 12 years and older) with perennial allergic rhinitis were treated with Forair (Fluticasone) Nasal Spray 110 mcg once daily for 12 months and 201 were treated with placebo nasal spray. While most adverse reactions were similar in type and rate between the treatment groups, epistaxis occurred more frequently in patients who received Forair (Fluticasone) Nasal Spray (123/605, 20%) than in patients who received placebo (17/201, 8%). Epistaxis tended to be more severe in patients treated with Forair (Fluticasone) Nasal Spray. All 17 reports of epistaxis that occurred in patients who received placebo were of mild intensity, while 83, 39, and 1 of the total 123 epistaxis events in patients treated with Forair (Fluticasone) Nasal Spray were of mild, moderate, and severe intensity, respectively. No patient experienced a nasal septal perforation during this trial.

6.2 Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing use of Forair (Fluticasone) Nasal Spray. 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 Forair (Fluticasone) furoate or a combination of these factors.

Immune System Disorders

Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria.

Respiratory, Thoracic, and Mediastinal Disorders

Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness, and nasal septal perforation.

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7 DRUG INTERACTIONS

Forair (Fluticasone) furoate is cleared by extensive first-pass metabolism mediated by CYP3A4. In a drug interaction trial of intranasal Forair (Fluticasone) furoate and the CYP3A4 inhibitor ketoconazole given as a 200-mg once-daily dose for 7 days, 6 of 20 subjects receiving Forair (Fluticasone) furoate and ketoconazole had measurable but low levels of Forair (Fluticasone) furoate compared with 1 of 20 receiving Forair (Fluticasone) furoate and placebo. Based on this trial and the low systemic exposure, there was a 5% reduction in 24-hour serum cortisol levels with ketoconazole compared with placebo. The data from this trial should be carefully interpreted because the trial was conducted with ketoconazole 200 mg once daily rather than 400 mg, which is the maximum recommended dosage. Therefore, caution is required with the coadministration of Forair (Fluticasone) Nasal Spray and ketoconazole or other potent CYP3A4 inhibitors.

Based on data with another glucocorticoid, Forair (Fluticasone) propionate, metabolized by CYP3A4, coadministration of Forair (Fluticasone) Nasal Spray with the potent CYP3A4 inhibitor ritonavir is not recommended because of the risk of systemic effects secondary to increased exposure to Forair (Fluticasone) furoate. High exposure to corticosteroids increases the potential for systemic side effects, such as cortisol suppression.

Enzyme induction and inhibition data suggest that Forair (Fluticasone) furoate is unlikely to significantly alter the cytochrome P450-mediated metabolism of other compounds at clinically relevant intranasal dosages.

Potent inhibitors of cytochrome P450 3A4 (CYP3A4) may increase exposure to Forair (Fluticasone) furoate.

  • Coadministration of ritonavir is not recommended. (5.6, 7)
  • Use caution with coadministration of other potent CYP3A4 inhibitors, such as ketoconazole. (5.6, 7)
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8 USE IN SPECIFIC POPULATIONS

Hepatic impairment may increase exposure to Forair furoate. Use with caution in patients with moderate or severe hepatic impairment. (8.6)

8.1 Pregnancy

Teratogenic Effects

Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.

There were no teratogenic effects in rats and rabbits at inhaled Forair (Fluticasone) furoate dosages of up to 91 and 8 mcg/kg/day, respectively (approximately 7 and 1 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). There was also no effect on pre- or post-natal development in rats treated with up to 27 mcg/kg/day by inhalation during gestation and lactation (approximately 2 times the maximum recommended daily intranasal dose in adults on a mcg/m2 basis).

There are no adequate and well-controlled studies in pregnant women. Forair (Fluticasone) Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

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

8.3 Nursing Mothers

It is not known whether Forair 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 Forair (Fluticasone) furoate by nursing mothers, caution should be exercised when Forair (Fluticasone) Nasal Spray is administered to a nursing woman.

8.4 Pediatric Use

Controlled clinical trials with Forair (Fluticasone) Nasal Spray included 1,224 patients aged 2 to 11 years and 344 adolescent patients aged 12 to 17 years . The safety and effectiveness of Forair (Fluticasone) Nasal Spray in children younger than 2 years have not been established.

Controlled clinical trials 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. 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 Forair (Fluticasone) 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/benefits of treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including Forair (Fluticasone) Nasal Spray, each patient’s dose should be titrated to the lowest dosage that effectively controls his/her symptoms.

A randomized, double-blind, parallel-group, multicenter, 1-year placebo-controlled clinical growth trial evaluated the effect of 110 mcg of Forair (Fluticasone) Nasal Spray once daily on growth velocity in 474 prepubescent children (girls aged 5 to 7.5 years and boys aged 5 to 8.5 years) with stadiometry. Mean growth velocity over the 52-week treatment period was lower in the patients receiving Forair (Fluticasone) Nasal Spray (5.19 cm/year compared with placebo (5.46 cm/year). The mean treatment difference was -0.27 cm/year (95% CI: -0.48 to -0.06) .

8.5 Geriatric Use

Clinical studies of Forair Nasal Spray did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. 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.

8.6 Hepatic Impairment

Use Forair (Fluticasone) Nasal Spray with caution in patients with moderate or severe hepatic impairment .

8.7 Renal Impairment

No dosage adjustment is required in patients with renal impairment .

10 OVERDOSAGE

Chronic overdosage may result in signs/symptoms of hypercorticism . There are no data on the effects of acute or chronic overdosage with Forair (Fluticasone) Nasal Spray. Because of low systemic bioavailability and an absence of acute drug-related systemic findings in clinical trials (with dosages of up to 440 mcg/day for 2 weeks [4 times the maximum recommended daily dose]), overdose is unlikely to require any therapy other than observation.

Intranasal administration of up to 2,640 mcg/day (24 times the recommended adult dose) of Forair (Fluticasone) furoate was administered to healthy human volunteers for 3 days. Single- and repeat-dose trials with orally inhaled Forair (Fluticasone) furoate doses of 50 to 4,000 mcg have shown decreased mean serum cortisol at doses of 500 mcg or higher. The oral median lethal dose in mice and rats was greater than 2,000 mg/kg (approximately 74,000 and 147,000 times, respectively, the maximum recommended daily intranasal dose in adults and 52,000 and 105,000 times, respectively, the maximum recommended daily intranasal dose in children, on a mcg/m2 basis).

Acute overdosage with the intranasal dosage form is unlikely since 1 bottle of Forair (Fluticasone) Nasal Spray contains approximately 3 mg of Forair (Fluticasone) furoate, and the bioavailability of Forair (Fluticasone) furoate is less than 1% for 2.64 mg/day given intranasally and 1% for 2 mg/day given as an oral solution.

11 DESCRIPTION

Forair (Fluticasone) furoate, the active component of Forair (Fluticasone) Nasal Spray, is a synthetic fluorinated corticosteroid having the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure:

  • With the cap on, shake the device well (Figure 1). This is important to make the medicine a liquid that will spray.
  • Take the cap off by squeezing the finger grips and pulling it straight off (Figure 2).
  • Hold the device with the nozzle pointing up and away from you. Place your thumb or fingers on the button. Press the button all the way in 6 times or until a fine mist sprays from the nozzle (Figure 3). Your Forair (Fluticasone) Nasal Spray is now ready to use.

How to use your Forair (Fluticasone) Nasal Spray

Follow the instructions below. If you have any questions, ask your healthcare provider or pharmacist.

Before taking a dose of Forair (Fluticasone) Nasal Spray, gently blow your nose to clear your nostrils. Shake the bottle well. Then do these 3 simple steps: Place, Press, Repeat.

1. PLACE

Tilt your head forward a little bit. Hold the device upright. PLACE the nozzle in one of your nostrils (Figure 4).

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.

2. PRESS

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.

Take the nozzle out of your nose. Breathe out through your mouth (Figure 6).

3. REPEAT

To deliver the medicine to the other nostril, REPEAT Steps 1 and 2 in the other nostril (Figure 7).

If your healthcare provider has told you to take 2 sprays in each nostril, do Steps 1-3 again.

Put the cap back on the device after you have finished taking your dose.

How to clean your Forair (Fluticasone) Nasal Spray

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.

How to store your Forair (Fluticasone) Nasal Spray

  • Keep your Forair (Fluticasone) Nasal Spray and all medicines out of the reach of children.
  • Store between 59°F and 86°F (15°C and 30°C). Do not refrigerate or freeze.
  • Store with the cap on.
  • Store in an upright position.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Forair (Fluticasone) is a registered trademark of the GSK group of companies.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2016 the GSK group of companies. All rights reserved.

July 2016

VRM:12PIL

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Salmeterol:


Forair (Salmeterol) is a long-acting beta2-adrenergic receptor agonist drug that is currently prescribed for the treatment of asthma and chronic obstructive pulmonary disease COPD.

Indication: For the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Forair (Salmeterol) is a long acting beta2-adrenoceptor agonist (LABA), usually only prescribed for severe persistent asthma following previous treatment with a short-acting beta agonist such as salbutamol and is prescribed concurrently with a corticosteroid, such as beclometasone. The primary noticable difference of Forair (Salmeterol) to salbutamol is that the duration of action lasts approximately 12 hours in comparison with 4-6 hours of salbutamol. When used regularly every day as presecribed, inhaled Forair (Salmeterol) decreases the number and severity of asthma attacks. However, it is not for use for relieving an asthma attack that has already started. Inhaled Forair (Salmeterol) works like other beta 2-agonists, causing bronchodilatation by relaxing the smooth muscle in the airway so as to treat the exacerbation of asthma. Forair (Salmeterol) is similar in action to formoterol, however formoterol has been demonstrated to have a faster onset of action than Forair (Salmeterol) as a result of a lower lipophilicity, and has also been demonstrated to be more potent - a 12 µg dose of formoterol has been demonstrated to be equivalent to a 50 µg dose of Forair (Salmeterol).

Forair pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Forair available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Forair destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Forair Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Forair pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. "Salmeterol". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  2. "Salmeterol". http://www.drugbank.ca/drugs/DB0093... (accessed August 28, 2018).
  3. "salmeterol: Link to the compound information in Wikipedia.". https://en.wikipedia.org/wiki/Salme... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Forair?

Depending on the reaction of the Forair after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Forair not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Forair addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Forair, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Forair consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

One visitor reported doses

What is the dose of Forair drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 201-500mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
201-500mg1
100.0%

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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