Alvesco

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Alvesco uses


1 INDICATIONS AND USAGE

Alvesco Nasal Aerosol is a corticosteroid indicated for treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.

1.1 Treatment of Allergic Rhinitis

Alvesco® (ciclesonide) Nasal Aerosol is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

For Intranasal use only

  • 1 actuation per nostril once daily. (2.1)

2.1 Administration Information

Administer Alvesco by the intranasal route only. Prior to initial use, Alvesco must be primed by actuating three times. If Alvesco is not used for ten consecutive days, it must be primed by actuating three times. If Alvesco is dropped, the canister and actuator may become separated. If this happens, reassemble Alvesco and test spray once into the air before using. Illustrated patient's instructions for proper use accompany each package of Alvesco.

2.2 Allergic Rhinitis

Adults and Adolescents (12 Years of Age and Older): The recommended dose of Alvesco is 1 actuation per nostril once daily (37 mcg per actuation). The maximum total daily dosage should not exceed 1 actuation in each nostril (74 mcg per day).

3 DOSAGE FORMS AND STRENGTHS

Alvesco Nasal Aerosol is provided at strength of 37 mcg per actuation strength containing 60 actuations per canister.

  • Nasal Aerosol: 37 mcg of Alvesco per actuation. (3)
  • Supplied in a 6.1 g canister containing 60 actuations. (16)
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4 CONTRAINDICATIONS

Alvesco is contraindicated in patients with a known hypersensitivity to Alvesco or any of the ingredients of Alvesco [see Warnings and Precautions (5.3)].

  • Patients with a known hypersensitivity to Alvesco or any of the ingredients of Alvesco. (4)

5 WARNINGS AND PRECAUTIONS

  • Local Nasal Effects, including epistaxis, ulceration, nasal septal perforations, Candida albicans infection impaired wound healing: Prior to initiating therapy, examine patients for evidence of septal perforation, erosions, ulceration, nasal surgery, and trauma. Avoid spraying Alvesco directly onto the nasal septum. Avoid use in patients with recent septal perforation, nasal erosion, nasal ulcers, nasal surgery, or nasal trauma. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Discontinue Alvesco if erosions, ulcerations or perforations occur.
  • Development of glaucoma or cataracts: Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, or cataracts. (5.2)
  • Hypersensitivity reactions have been reported following administration of Alvesco with manifestations such as angioedema, with swelling of the lips, tongue and pharynx. (5.3)
  • Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chicken pox or measles in susceptible individuals. Use caution in patients with the above because of the potential for worsening of these infections. (5.4)
  • Hypercorticism and adrenal suppression: May occur with higher than recommended dosages or in susceptible individuals at recommended dosages. If such changes occur, discontinue Alvesco slowly. (5.5)
  • Potential reduction in growth velocity in children: Monitor growth routinely in pediatric patients receiving Alvesco. (5.6, 8.4)

5.1 Local Nasal Effects

Epistaxis and Nasal Ulceration: In clinical trials of 2 to 26 weeks in duration, epistaxis was observed more frequently in patients treated with Alvesco than those who received placebo. In the 26-week open-label extension of the perennial allergic rhinitis trial, nasal ulceration was identified in 4 of 824 patients administered Alvesco (148 mcg). [see Adverse Reactions (6)]

The occurrence of local nasal adverse events was further evaluated in a separate, postmarketing 26-week randomized, open-label, active-controlled nasal and ocular safety trial conducted in patients with perennial allergic rhinitis. In this study epistaxis was observed in 6% of patients treated with Alvesco and nasal ulceration was identified in 3 of 367 patients administered Alvesco. [see Adverse Reactions (6)]

Nasal Septal Perforation: Nasal septal perforation has been reported in patients following the intranasal application of Alvesco. Three short-term placebo-controlled trials (2 weeks) and one long-term (26 weeks with placebo control and 26 weeks open-label extension without placebo control) trial were conducted in patients with seasonal and perennial allergic rhinitis. Nasal septal perforations were reported in 2 patients out of 2335 treated with Alvesco compared with none of 892 treated with placebo. No nasal septal perforations were reported in 367 patients treated with Alvesco in a postmarketing 26-week, open-label, active-controlled trial in patients with perennial allergic rhinitis. [see Adverse Reactions (6)]

Before starting Alvesco conduct a nasal examination to ensure that patients are free of nasal disease other than allergic rhinitis. Periodically monitor patients with nasal examinations during treatment for adverse effects in the nasal cavity. If an adverse reaction (e.g. erosion, ulceration, perforation) is noted, discontinue Alvesco. Avoid spraying Alvesco directly onto the nasal septum.

Candida Infection: In clinical trials with another formulation of Alvesco, the development of localized infections of the nose or pharynx with Candida albicans has occurred. If such an infection develops with Alvesco, it may require treatment with appropriate local therapy and discontinuation of Alvesco.

Impaired Wound Healing: Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use Alvesco until healing has occurred.

5.2 Glaucoma and Cataracts

Nasal and inhaled corticosteroids may result in the development of glaucoma and cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, or cataracts.

5.3 Hypersensitivity

Alvesco is contraindicated in patients with a known hypersensitivity to Alvesco or any of the ingredients of Alvesco. Cases of hypersensitivity reactions following administration of Alvesco with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported.

5.4 Immunosuppression

Patients who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox 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 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 or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chicken pox, 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 develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; or in patients with 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 Suppression

Hypercorticism and adrenal suppression may occur when intranasal corticosteroids, such as Alvesco, are used at higher than recommended dosages or in susceptible individuals at recommended dosages. If such changes occur, the dosage of Alvesco should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid 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 muscular pain, lassitude, and 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 Effect on Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely (e.g., via stadiometry) in pediatric patients receiving Alvesco. [see Pediatric Use (8.4)]

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6 ADVERSE REACTIONS

Systemic and local corticosteroid use may result in the following:

  • Epistaxis, ulcerations, nasal septal perforations, Candida albicans infection, impaired wound healing [see Warnings and Precautions ]
  • Glaucoma and cataracts [see Warnings and Precautions (5.2)]
  • Immunosuppression [see Warnings and Precautions (5.4)]
  • Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see Warnings and Precautions (5.5, 5.6), Use in Specific Populations (8.4)]

The most common adverse reactions (≥2% incidence) included nasal discomfort, headache and epistaxis. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Sunovion Pharmaceuticals Inc. at 1-877-737-7226 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

The safety data described below for adults and adolescents 12 years of age and older are based on 4 clinical trials evaluating doses of Alvesco nasal aerosol from 74 to 282 mcg. Three of the clinical trials were 2 to 6 weeks in duration and one trial was 26 weeks in duration with an additional 26-week open-label extension. Data from the first 6 weeks of the 26-week trial were pooled with data from the three 2-week trials. Short-term data (2 to 6 weeks) included 3001 patients with seasonal and perennial allergic rhinitis, of these, 884 received ZETONNA 74 mcg once daily and 892 received placebo. The short-term data included 1098 (36.6%) males, 1903 (63.4%) females, 2587 (86.2%) Caucasians, 320 (10.7%) Blacks, 49 (1.6%) Asians, and 45 (1.5%) patients classified as Other. The 26-week trial was conducted in 1110 patients with perennial allergic rhinitis [394 (35.5%) males and 716 (64.5%) females, ages 12 to 78 years old] treated with Alvesco 74 mcg, 148 mcg or placebo once daily. Of these patients, 298 were treated with 74 mcg Alvesco, 505 with 148 mcg, and 307 with placebo. The racial distribution in this trial included 922 (83.1%) Caucasians, 146 (13.2%) Blacks, 18 (1.6%) Asians, and 24 (2.2%) patients classified as Other. The 26-week open-label extension included 824 patients [295 (35.8%) males and 529 (64.2%) females, ages 12 to 79 years old] given Alvesco 148 mcg once daily. The racial distribution in the open-label extension included 690 (83.7%) Caucasians, 104 (12.6%) Blacks, 15 (1.8%) Asians, and 15 (1.8%) patients classified as Other.

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

Short-Term (2-6 weeks) Trials:

In three short-term trials and the first 6 weeks of one long-term trial, conducted in the US, 884 patients with a history of seasonal or perennial allergic rhinitis were treated with Alvesco 74 mcg daily. Adverse reactions did not differ appreciably based on age, gender, or race. The table below displays reactions that occurred with an incidence of at least 2.0% and more frequently with Alvesco 74 mcg than with placebo in seasonal or perennial allergic rhinitis clinical trials of 2 to 6 weeks duration.

a Nasal discomfort includes both nasal discomfort and instillation site discomfort

Adverse Reaction Alvesco Nasal Aerosol

74 mcg Once Daily

N = 884

Placebo

N = 892

Nasal discomforta 28 (3.2%) 16 (1.8%)
Headache 27 (3.1%) 11 (1.2%)
Epistaxis 26 (2.9%) 24 (2.7%)

When considering the data from higher doses evaluated in the short-term trials, epistaxis demonstrated a dose response. In addition, two patients treated with Alvesco 74 mcg experienced nasal septal perforations in the short-term trials compared to no patients treated with placebo.

Approximately 1.2% of patients treated with Alvesco 74 mcg in clinical trials discontinued because of adverse reactions; this rate was similar for patients treated with placebo. Discontinuations due to local adverse reactions were similar in Alvesco 74 mcg treated patients (0.8%) compared to placebo treated patients (0.8%). Local adverse reactions leading to discontinuation that occurred only in Alvesco treated patients included ear infection, nasal discomfort, nasal dryness, nasal mucosal/septum disorders, pharyngitis, streptococcal pharyngitis, sinus headache, and tonsillitis.

Long-Term (26-Week Double-Blind and 26-Week Open-Label) Safety Trial:

In one 26-week double-blind, placebo-controlled safety trial that included 1110 adult and adolescent patients with perennial allergic rhinitis, additional adverse reactions, with an incidence of at least 2%, that occurred more frequently with Alvesco than with placebo were upper respiratory tract infection, urinary tract infection, oropharyngeal pain, nasal mucosal/septum disorders, viral upper respiratory tract infection, cough, influenza, bronchitis, streptococcal pharyngitis, muscle strain, and nausea. Nasal discomfort (5.7%) and epistaxis

(11.4%) were also more frequent in the 26-week safety trial compared to clinical trials 2 to 6 weeks in duration. Nasal mucosal/septum disorders and cough demonstrated a dose response.

Discontinuations due to adverse reactions were higher in Alvesco treated patients compared to placebo treated patients and demonstrated a dose response. Local adverse reactions leading to discontinuation were also higher in Alvesco 74 mcg treated patients (1.7%) compared to placebo treated patients (0.7%). The only local adverse reaction leading to discontinuation that occurred in Alvesco treated patients and was not observed in the 2- to 6-week trials was upper respiratory tract infection.

A total of 824 patients with perennial allergic rhinitis who completed the 26-week double-blind trial enrolled into an open-label extension and received Alvesco 148 mcg for 26 weeks. Additional adverse reactions, observed with an incidence of at least 2% were sinusitis, nasopharyngitis, and back pain.

A total of 4 nasal septal ulcerations were also reported in the 26-week open-label extension.

There were no reports of nasal septal perforations in the long-term safety trial.

Long-Term (6-Month Open-Label) Nasal Safety Trial:

Nasal and ocular safety was evaluated in one 26-week, postmarketing, randomized, open-label, active-controlled trial, in adult and adolescent patients 12-74 years of age with a history of perennial allergic rhinitis. A total of 737 patients were treated with Alvesco 74 mcg or Alvesco nasal spray 200 mcg once daily. The combined incidence of nasal mucosal or septum disorders, including erosions and ulcerations, was 3 (0.8%) for Alvesco 74 mcg and 4 (1.1%) for Alvesco nasal spray 200 mcg treated patients. There were no nasal septal perforations reported with either treatment. Ocular findings, including the development or worsening of lens opacities, increase in intraocular pressure, and worsening visual acuity, were also evaluated over the 26-week treatment period. The occurrence of ocular safety events was similar for the Alvesco 74 mcg and Alvesco nasal spray 200 mcg treatment groups.

6.2 Post-marketing Experience

The following adverse reactions have been identified during post-approval use of other formulations of Alvesco, ALVESCO® Inhalation Aerosol and OMNARIS® 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.

ALVESCO® Inhalation Aerosol: immediate or delayed hypersensitivity reactions such as angioedema with swelling of the lips, tongue, and pharynx.

OMNARIS® Nasal Spray: nasal congestion, nasal ulcer, and dizziness. Localized infections of the nose or mouth with Candida albicans have also occurred with OMNARIS® Nasal Spray.

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7 DRUG INTERACTIONS

In vitro studies and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions [see Clinical Pharmacology (12.3)]. In a drug interaction study, co-administration of orally inhaled Alvesco and oral ketoconazole, a potent inhibitor of cytochrome P450 3A4, increased the exposure (AUC) of des-ciclesonide by approximately 3.6-fold at steady state, while levels of Alvesco remained unchanged. Erythromycin, a moderate inhibitor of cytochrome P450 3A4, had no effect on the pharmacokinetics of either des-ciclesonide or erythromycin following oral inhalation of Alvesco [see Clinical Pharmacology (12.3)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C.

There are no adequate and well-controlled trials in pregnant women. Alvesco should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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.

Oral administration of Alvesco in rats at approximately 120 times the maximum recommended human daily intranasal dose in adults (on a mcg/m2 basis at a maternal dose of 900 mcg/kg/day) produced no teratogenicity or other fetal effects. However, subcutaneous administration of Alvesco in rabbits at similar to MRHDID (on a mcg/m2 basis at a maternal dose of 5 mcg/kg/day) produced fetal toxicity. This included fetal loss, reduced fetal weight, cleft palate, skeletal abnormalities including incomplete ossifications, and skin effects. No toxicity was observed at ¼ of the MRHDID in adults (on a mcg/m2 basis at a maternal dose of 1 mcg/kg/day).

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 if Alvesco is excreted in human milk. However, other corticosteroids are excreted in human milk. In a study with lactating rats, minimal but detectable levels of radiolabeled Alvesco were recovered in milk. Caution should be used when Alvesco is administered to nursing women.

8.4 Pediatric Use

The safety and effectiveness for seasonal and perennial allergic rhinitis in children 12 years of age and older have been established. The safety and efficacy of Alvesco for treatment of the symptoms of seasonal and perennial allergic rhinitis in patients 11 years of age and younger have not been established.

The safety and efficacy of Alvesco in pediatric patients 6-11 years of age were evaluated in two randomized, double blind, parallel placebo-controlled clinical trials in 1693 pediatric patients with allergic rhinitis. Of the two trials, one was 2 weeks in duration and evaluated the efficacy of two doses of Alvesco in 847 patients with seasonal allergic rhinitis. The second clinical trial was 12 weeks in duration and evaluated the efficacy of two doses of Alvesco (37 mcg and 74 mcg once daily) in 846 patients with perennial allergic rhinitis. The trials were similar in design to the trials conducted in adolescents and adults. The primary efficacy endpoint was the difference from placebo in the change from baseline of the average morning and evening reflective total nasal symptom scores (rTNSS) averaged over 2 weeks of treatment in the seasonal allergic rhinitis trial and over the first 6 weeks of treatment in the perennial allergic rhinitis trial. In the 2-week trial in patients with seasonal allergic rhinitis, treatment with Alvesco at either dose failed to demonstrate efficacy. In the 12-week trial in patients with perennial allergic rhinitis, Alvesco 37 mcg and 74 mcg once daily both demonstrated significant improvement in rTNSS compared to placebo with treatment differences of 0.59 (95% CI: 0.23, 0.95) and 0.47 (95% CI: 0.11, 0.83), respectively. The safety profile observed in children 6 to 11 years of age with seasonal or perennial allergic rhinitis was similar to the adverse reactions observed in the clinical trial population of patients 12 year of age and older [see Adverse Reactions (6.1)].

The effect of Alvesco on the HPA axis was evaluated in one placebo-controlled clinical study of 6 weeks in duration in children 6 to11 years of age with perennial allergic rhinitis [see Clinical Pharmacology (12.2)].

Studies in children under 6 years of age have not been conducted.

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 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 Alvesco, should be monitored routinely (e.g., via stadiometry). A 52-week, multi-center, double-blind, randomized, placebo-controlled parallel-group trial was conducted to assess the effect of orally inhaled Alvesco (ALVESCO® Inhalation Aerosol) on growth rate in 609 pediatric patients with mild persistent asthma, aged 5 to 8.5 years. Treatment groups included orally inhaled Alvesco 40 mcg or 160 mcg or placebo given once daily. Growth was measured by stadiometer height during the baseline, treatment and follow-up periods. The primary comparison was the difference in growth rates between Alvesco 40 and 160 mcg and placebo groups. Conclusions cannot be drawn from this trial because compliance could not be assured. Alvesco blood levels were also not measured during the one-year treatment period. There was no difference in efficacy measures between the placebo and the orally inhaled Alvesco (ALVESCO® Inhalation Aerosol) groups.

The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

The potential for Alvesco to cause growth suppression in susceptible patients or when given at higher than recommended dosages cannot be ruled out.

8.5 Geriatric Use

Clinical trials of Alvesco did not include sufficient numbers of patients age 65 and over to determine whether they responded differently from younger patients. 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 reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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10 OVERDOSAGE

Chronic overdosage may result in signs or symptoms of hypercorticism [see Warnings and Precautions (5.5)]. There are no data on the effects of acute or chronic overdosage with Alvesco.

11 DESCRIPTION

The active component of Alvesco is Alvesco, a non-halogenated glucocorticoid having the chemical name pregna -1,4-diene-3,20-dione, 16,17-[[R-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11ß,16α)-. Alvesco is delivered as the R-epimer. The empirical formula is C32H44O7 and its molecular weight is 540.7. Its structural formula is as follows:

Priming Your Alvesco Nasal Aerosol For Use

  • Remove Alvesco Nasal Aerosol from its package.
  • Before you use Alvesco Nasal Aerosol for the first time or if you have not used your medicine for 10 days in a row, you will need to prime your Alvesco Nasal Aerosol.
  • Open the purple plastic dust cap by gently squeezing both sides and pulling the cap away from the nasal actuator. Hold the nasal actuator upright. (See Figure B )
  • Spray 3 times into the air away from the face, by pressing down fully on the top of the canister three times (See Figure C ). Make sure the canister returns to its original position after each spray.

Using Your Alvesco Nasal Aerosol

Step 1. Open the purple plastic dust cap.

Step 2. Hold the nasal actuator upright, with the nose piece pointing upwards, between your thumb and forefinger (and middle finger) (See Figure D ).

Step 3. Tilt your head back slightly and insert the end of the nose piece into 1 nostril, pointing it slightly toward the outside nostril wall away from the nasal septum (the wall between the 2 nostrils), while holding your other nostril closed with 1 finger (See Figure E ). Do not get any spray in your eyes or directly on your nasal septum.

Step 4. Press down on the canister to release 1 spray and at the same time breathe in gently through the nostril. Hold your breath for a few seconds then breathe out slowly through your mouth.

Step 5. Remove the nose piece from your nostril. Make sure the canister has returned to its original position and repeat steps 2-4 for the second spray in your other nostril.

Step 6. Replace the protective purple dust cap on the nasal actuator.

Step 7. Avoid blowing your nose for the next 15 minutes.

Cleaning Your Nasal Actuator

The outside of the nose piece should be cleaned weekly, by wiping with a clean, dry tissue or cloth (see Figure F ).

Do not wash or put any part of the Alvesco Nasal Aerosol canister or actuator in water.

How to Tell if Your Alvesco Nasal Aerosol Is Empty

  • Each canister of Alvesco Nasal Aerosol contains enough medicine for you to spray medicine 60 times (or 30 times for sample size product). This does not count the first 3 priming sprays.
  • The actuator of your Alvesco Nasal Aerosol is fitted with a dose indicator which shows you how much medicine is left after each use. The dose indicator will display the number of sprays remaining in groups of 5 or 10 actuations.
  • The display window will begin showing a green color. As you continue to use the medicine, the window will show a yellow color. A yellow color in the window means that you need to replace your medicine soon. When the medicine is almost empty, the window will show a red color.
  • When the window shows red and you see the dose indicator read zero, “0” (see Figure G ), you should throw away the canister and nasal actuator.
  • Do not throw your Alvesco Nasal Aerosol canister in the fire or an incinerator.
  • Do not use your Alvesco Nasal Aerosol after zero is shown in the window of the dose indicator even though it may look like there is medicine left in the canister. You may not get the right amount of medicine.
  • Talk with your healthcare provider before your supply of Alvesco Nasal Aerosol runs out to see if you should get a refill of your medicine.

What to Do if You Drop Your Alvesco Nasal Aerosol

  • If you drop your Alvesco Nasal Aerosol, the canister may become separated from the actuator. If this happens, insert the canister into the actuator as shown in Figure H , test spray once into the air away from your face, then use as described above.
  • If the Alvesco Nasal Aerosol is dropped, the dose counter may not work. It is recommended to keep track of the number of sprays taken from your Alvesco Nasal Aerosol based on your records.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

SUNOVION

Manufactured for:

Sunovion Pharmaceuticals Inc.

Marlborough, MA 01752 USA

Made in the United Kingdom

© 2014 Sunovion Pharmaceuticals Inc. All rights reserved.

For customer service, call 1-888-394-7377

901641R01

620392213

Figure A Figure B Figure C Figure D Figure E Figure F Figure G Figure H

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - carton – 37 mcg 60-count

NDC 63402-737-60

Net Contents: 6.1 g

Alvesco

(ciclesonide) Nasal Aerosol

37 mcg per actuation

For Intranasal Use Only.

Alvesco Nasal Aerosol Canister

Should Be Used with Alvesco

Nasal Aerosol Actuator Only.

60 Metered Actuations

Rx ONLY

Sunovion

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – canister - 37 mcg 60-count

NDC 63402-737-60

Net Contents: 6.1 g

Alvesco

(ciclesonide) Nasal Aerosol

37 mcg per actuation

For Intranasal Use Only.

Use with Alvesco Nasal Aerosol

Actuator Only.

60 Metered Actuations

Rx ONLY

Sunovion

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – actuator - 37 mcg 60-count

Alvesco

(ciclesonide) Nasal Aerosol

37 mcg per actuation

For Intranasal Use Only.

Use with Alvesco

Nasal Aerosol Canister Only.

60 Metered Actuations

Alvesco 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.


Alvesco 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.


Alvesco 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.


Alvesco 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.


Alvesco 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. Dailymed."ZETONNA (CICLESONIDE) AEROSOL, METERED [SUNOVION PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CICLESONIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "Ciclesonide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Alvesco?

Depending on the reaction of the Alvesco after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Alvesco 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 Alvesco 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 Alvesco, 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 Alvesco 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

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

One visitor reported age

Visitors%
30-451
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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