Budesonide - Flexhaler (Pulmicort)

Trade Name : PULMICORT

AstraZeneca Pharmaceuticals LP

AEROSOL, POWDER

Strength 180 ug/1

BUDESONIDE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Budesonide - Flexhaler (Pulmicort) which is also known as PULMICORT and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 180 ug/1 per ml. Read more

Budesonide - Flexhaler (Pulmicort) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older.
Limitations of Use:
PULMICORT FLEXHALER is a corticosteroid indicated for:
Limitations of Use:
Not indicated for the relief of acute bronchospasm ()

u2022
1

PULMICORT FLEXHALER should be administered twice daily by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing .
Patients should be instructed to prime PULMICORT FLEXHALER prior to its initial use, and instructed to inhale deeply and forcefully each time the device is used.
The safety and efficacy of PULMICORT FLEXHALER when administered in excess of recommended doses have not been established.
After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with PULMICORT FLEXHALER, increasing the dose may provide additional asthma control.
If asthma symptoms arise in the period between doses, an inhaled, short-acting beta-agonist should be taken for immediate relief.
Patients 18 Years of Age and Older: For patients 18 years of age and older, the recommended starting dosage is 360u00a0mcg twice daily. In some adult patients, a starting dose of 180u00a0mcg twice daily may be adequate. The maximum dosage should not exceed 720u00a0mcg twice daily.
Patients 6 to 17 Years of Age: The recommended starting dosage is 180u00a0mcg twice daily. In some pediatric patients, a starting dose of 360u00a0mcg twice daily may be appropriate. The maximum dosage should not exceed 360u00a0mcg twice daily.
For all patients, it is desirable to titrate to the lowest effective dose after adequate asthma stability is achieved.
Improvement in asthma control following inhaled administration of budesonide can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks, or longer. Individual patients will experience a variable onset and degree of symptom relief.
If a previously effective dosage regimen of PULMICORT FLEXHALER fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options (e.g., replacing the lower strength of PULMICORT FLEXHALER with the higher strength or initiating oral corticosteroids) should be considered.
For oral inhalation only.

PULMICORT FLEXHALER is available as a dry powder for inhalation containing budesonide in the following 2 strengths: 90u00a0mcg and 180u00a0mcg. Each inhaler contains 60 or 120 actuations.
FLEXHALER device containing budesonide (90u00a0mcg or 180u00a0mcg) as an inhalation powder ()

The use of PULMICORT FLEXHALER is contraindicated in the following conditions:

No data

Localized Infections:
Deterioration of Asthma or Acute Episodes:
Hypersensitivity Reactions:
Immunosuppression:
Transferring Patients from Systemic Corticosteroid Therapy:
Hypercorticism and Adrenal Suppression:
Reduction in Bone Mineral Density with Long term Administration:
Effects on Growth:
Glaucoma and Cataracts:
Paradoxical Bronchospasm:
Eosinophilic Conditions and Churg-Strauss Syndrome:

Systemic and inhaled corticosteroid use may result in the following:
Most common adverse reactions (incidence u22651%) are nasopharyngitis, nasal congestion, pharyngitis, rhinitis allergic, viral upper respiratory tract infection, nausea, viral gastroenteritis, otitis media, oral candidiasis ()
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of CYP3A4 may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the co-administration of PULMICORT FLEXHALER with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) .

u2022

No data

The potential for acute toxic effects following overdose of PULMICORT FLEXHALER is low. If used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism may occur . Another budesonide-containing dry powder inhaler at 3200u00a0mcg daily administered for 6 weeks caused a significant reduction (27%) in the plasma cortisol response to a 6-hour infusion of ACTH compared with placebo (+1%). The corresponding effect of 10 mg prednisone daily was a 35% reduction in the plasma cortisol response to ACTH.
Postmarketing experience showed that acute overdose of inhaled budesonide commonly remained asymptomatic. The use of excessive doses (up to 6400u00a0mcg daily) for prolonged periods showed systemic corticosteroid effects such as hypercorticism.

Budesonide, the active component of PULMICORT FLEXHALER, is a corticosteroid designated chemically as (RS)-11u03b2, 16u03b1, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is CHO and its molecular weight is 430.5. Its structural formula is:
Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 10.
PULMICORT FLEXHALER is an inhalation-driven multi-dose dry powder inhaler containing a formulation of 1u00a0mg per actuation of micronized budesonide and micronized lactose monohydrate which contains trace levels of milk proteins n n . Each actuation of PULMICORT FLEXHALER 180u00a0mcg delivers 160u00a0mcg budesonide from the mouthpiece and each actuation of PULMICORT FLEXHALER 90u00a0mcg delivers 80u00a0mcg budesonide from the mouthpiece (based on testing at 60u00a0L/min for 2 sec). Each PULMICORT FLEXHALER 180u00a0mcg contains 120 actuations and each PULMICORT FLEXHALER 90u00a0mcg contains 60 actuations.
In vitron- [see n- Arrayn- ]

No data

In a 104-week oral study in Sprague-Dawley rats, a statistically significant increase in the incidence of gliomas was observed in male rats receiving an oral dose of 50 mcg/kg/day (approximately 0.3 times the MRHDID in adults and children 6 to 17 years of age on a mcg/m basis). No tumorigenicity was seen in male rats at oral doses up to 25 mcg/kg (approximately 0.2 times the MRHDID in adults and children 6 to 17 years of age, on a mcg/m basis) and in female rats at oral doses up to 50 mc/kg (approximately 0.3 times, the MRHDID doses in adults and children 6 to 17 years of age, respectively, on a mcg/m basis). In two additional two-year studies in male Fischer and Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of 50 mcg/kg (approximately 0.3 times the MRHDID in adults and children 6 to 17 years of age, respectively, on a mcg/m basis). However, in the male Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of hepatocellular tumors at an oral dose of 50 mcg/kg (approximately 0.3 times the MRHDID in adults and children 6 to 17 years of age on a mcg/m2 basis). The concurrent reference corticosteroids (prednisone and triamcinolone acetonide) in these two studies showed similar findings.
There was no evidence of a carcinogenic effect when budesonide was administered orally for 91 weeks to mice at doses up to 200 mcg/kg/day (approximately 0.7 times the MRHDID in adults and children 6 to 17 years of age on a mcg/m basis). Budesonide was not mutagenic or clastogenic in six different test systems: Ames Salmonella/microsome plate test, mouse micronucleus test, mouse lymphoma test, chromosome aberration test in human lymphocytes, sex-linked recessive lethal test in Drosophila melanogaster, and DNA repair analysis in rat hepatocyte culture.
Fertility and reproductive performance were unaffected in rats at subcutaneous doses up to 80 mcg/kg (approximately 0.5 times the MRHDID in adults on a mcg/m2 basis). At a subcutaneous dose of 20 mcg/kg/day (approximately 0.1 times the maximum recommended daily inhalation dose in adults on a mcg/m2 basis), decreases in maternal body weight gain, prenatal viability, and viability of the young at birth and during lactation were observed. No such effects were noted at 5 mcg/kg (approximately 0.03 times the MRHDID in adults on a mcg/m2 basis).

The safety and efficacy of PULMICORT FLEXHALER were evaluated in two 12-week, double-blind, randomized, parallel-group, placebo-controlled clinical studies conducted at sites in the United States and Asia involving 1137 patients aged 6 to 80 years with mild to moderate asthma. Study 1 evaluated PULMICORT FLEXHALER 180u00a0mcg, PULMICORT TURBUHALER 200u00a0mcg, and placebo, each administered as 1 inhalation once daily or 2 inhalations twice daily in patients 18 years of age and older with mild to moderate asthma previously treated with inhaled corticosteroids. The delivered dose of PULMICORT FLEXHALER 180u00a0mcg and PULMICORT TURBUHALER 200u00a0mcg are the same; each delivers 160u00a0mcg from the mouthpiece. Study 2 evaluated PULMICORT FLEXHALER 90u00a0mcg, 2 inhalations once daily or 4 inhalations twice daily, PULMICORT TURBUHALER 200u00a0mcg, 1 inhalation once daily or 2 inhalations twice daily, and placebo in pediatric patients aged 6 to 17 years with mild to moderate asthma. Both of the studies had a 2-week placebo treatment run-in period followed by a 12-week randomized treatment period. The primary endpoint was the difference between baseline and the mean of the treatment-period FEV (adults) or FEV % predicted (children).
Patients u2265 18 years of age and older (Study 1)
This study enrolled 621 patients aged u226518 to 80 years with mild-to-moderate asthma (mean baseline % predicted FEV 64.3%) whose symptoms were previously controlled on inhaled corticosteroids. Mean change from baseline in FEV in the PULMICORT FLEXHALER 180u00a0mcg, 2 inhalations twice-daily group was 0.28u00a0liters, as compared to 0.10u00a0liters in the placebo group (p<0.001). Secondary endpoints of morning and evening peak expiratory flow rate, daytime asthma symptom severity, nighttime asthma symptom severity, daily rescue medication use, and the percentage of patients who met predefined asthma related withdrawal criteria showed differences from baseline favoring PULMICORT FLEXHALER over placebo (p<0.001).
12-Week Trial in Adult Patients with Mild to Moderate Asthma (Study 1) Mean Change from Baseline in FEV (L)
Patients 6 to 17 years of age (Study 2)
This study enrolled 516 patients aged 6 to 17 years with mild asthma (mean baseline % predicted FEV 84.9%). The study population included patients previously treated with inhaled corticosteroids for no more than 30 days before the study began (4%) and patients who were nau00efve to inhaled corticosteroids (96%). Mean change from baseline in % predicted FEV during the 12-week treatment period in the PULMICORT FLEXHALER 90u00a0mcg, 4 inhalations twice daily treatment group was 5.6 compared with 0.2 in the placebo group (p<0.001). Secondary endpoints of morning and evening PEF showed differences from baseline favoring PULMICORT FLEXHALER over placebo (p<0.001).
12-Week Trial in Pediatric Patients With Mild Asthma (Study 2) Mean Change from Baseline in Percent Predicted FEVn

PULMICORT FLEXHALER is available as a dry powder for inhalation containing budesonide in the following 2 strengths: 90u00a0mcg and 180u00a0mcg. Each dosage strength contains 60 or 120 actuations per device. 180u00a0mcg/dose (NDC 0186-0916-12) with a target fill weight of 225u00a0mg (range 200-250), and 90u00a0mcg/dose, 60 dose (NDC 0186-0917-06) with a target fill weight of 165 mg (range 140-190).
PULMICORT FLEXHALER consists of a number of assembled plastic details, the main parts being the dosing mechanism, the storage unit for drug substance, and the mouthpiece. The inhaler is protected by a white outer tubular cover screwed onto the inhaler. The body of the inhaler is white and the turning grip is brown. The PULMICORT FLEXHALER inhaler cannot be refilled and should be discarded when empty.
The number in the middle of the dose indicator window shows how many doses are left in the inhaler. The inhaler is empty when the number zero (u201c0u201d) on the red background reaches the middle of the window. If the unit is used beyond the point at which the zero reaches the middle of the window, the correct amount of medication may not be obtained and the unit should be discarded.
Store in a dry place at controlled room temperature 20-25u00b0C (68-77u00b0F) [see USP] with the cover tightly in place. Keep out of the reach of children.

Patients being treated with PULMICORT FLEXHALER should receive the following information and instructions. This information is intended to aid the patient in the safe and effective use of the medication. It is not a disclosure of all possible adverse or intended effects. For proper use of PULMICORT FLEXHALER and to attain maximum improvement, the patient should read and follow the accompanying n

PULMICORT FLEXHALERu2122 (bew DEH so nide) 180u00a0mcg
(budesonide inhalation powder, 180u00a0mcg)
PULMICORT FLEXHALERu2122 90u00a0mcg
(budesonide inhalation powder, 90u00a0mcg)
Read the Patient Information that comes with PULMICORT FLEXHALER before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is PULMICORT FLEXHALER?
PULMICORT FLEXHALER is an inhaled corticosteroid medicine. PULMICORT FLEXHALER is used for long-term (maintenance) treatment of asthma and to prevent asthma symptoms in adults and children 6 years of age and older.
Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to asthma symptoms.
PULMICORT FLEXHALER helps reduce inflammation and helps keep the airways open to reduce asthma symptoms.
PULMICORT FLEXHALER does not treat the symptoms of a sudden asthma attack. Always have a short-acting beta-agonist medicine (rescue inhaler) with you to treat sudden symptoms. If you do not have an inhaled, short-acting bronchodilator, call your healthcare provider to have one prescribed for you.
It is not known if PULMICORT FLEXHALER is safe and effective in children younger than 6 years of age.
Who should not use PULMICORT FLEXHALER?
Do not use PULMICORT FLEXHALER:
What should I tell my healthcare provider before using PULMICORT FLEXHALER?
Before using PULMICORT FLEXHALER, tell your healthcare provider if you:
PULMICORT FLEXHALER may not be right for people who have or had any of these types of infections.
You are at risk for decreased bone mineral density if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using PULMICORT FLEXHALER with certain other medicines may affect each other causing side effects.
Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one listed above.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use PULMICORT FLEXHALER?
Use PULMICORT FLEXHALER exactly as prescribed by your healthcare provider. You must use PULMICORT FLEXHALER regularly for it to work.
If you use another inhaled medicine by mouth to treat your asthma, talk with your healthcare provider for instructions about when to use the other medicine and when to use your PULMICORT FLEXHALER.
What are the possible side effects of PULMICORT FLEXHALER?
PULMICORT FLEXHALER can cause serious side effects, including:
Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.
Common side effects reported by patients using PULMICORT FLEXHALER include:
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all of the side effects of PULMICORT FLEXHALER. Ask your healthcare provider or pharmacist for more information.
Call your healthcare provider for medical advice about side effects. You may report side effects to AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or .
How should I store PULMICORT FLEXHALER?
Store PULMICORT FLEXHALER at 68u00b0 to 77u00b0F (20u00b0 to 25u00b0C).
Keep your PULMICORT FLEXHALER and all medicines out of the reach of children.
General Information about PULMICORT FLEXHALER
Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information Leaflets. Do not use PULMICORT FLEXHALER for a condition for which it was not prescribed. Do not give PULMICORT FLEXHALER to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about PULMICORT FLEXHALER. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about PULMICORT FLEXHALER that is written for health professionals.
For more information, go to or call 1- 800-236-9933.
What are the ingredients in PULMICORT FLEXHALER?
Active ingredient: budesonide
Inactive ingredient: lactose
Patient Instructions for Use
How to use your PULMICORT FLEXHALER
Parts of your PULMICORT FLEXHALER
Figure 1
Arrayn- Priming PULMICORT FLEXHALER:
Before you use a new PULMICORT FLEXHALER for the first time, you must prime it.
To prime your PULMICORT FLEXHALER, follow the steps below:
You do not have to prime your PULMICORT FLEXHALER again after this even if you do not use it for a long period of time.
1u00a0Loading a dose
Figure 2
Figure 3
Figure 4
Figure 5
2 Inhaling a dose
Reading the Dose Indicator Window
Figure 6
Figure 7
Cleaning your PULMICORT FLEXHALER
Do not use your PULMICORT FLEXHALER if it has been damaged or if the mouthpiece has become detached. Talk to your healthcare provider or pharmacist if you have any problems with your PULMICORT FLEXHALER.
PULMICORT FLEXHALER is a trademark of the AstraZeneca group of companies.
u00a9AstraZeneca 2007, 2008, 2010, 2016, 2019
Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington DE 19850
By: AstraZeneca AB, Su00f6dertu00e4lje, Sweden
Product of Sweden

NDC 0186-0917-06
Pulmicort
Flexhaleru2122 90 mcg
(budesonide inhalation
powder, 90 mcg)
90 mcg
For Oral Inhalation.
60 Metered Doses
Dispense with enclosed Patient
Information and Instructions for Use.
Rx only
AstraZeneca

NDC 0186-0916-12
Pulmicort
Flexhaleru2122 180 mcg
(budesonide inhalation
powder, 180 mcg)
180 mcg
For Oral Inhalation.
120 Metered Doses
Dispense with enclosed Patient
Information and Instructions for Use.
Rx only
AstraZeneca

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Budesonide - Flexhaler (Pulmicort)

Trade Name : PULMICORT

AEROSOL, POWDER

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Budesonide - Flexhaler (Pulmicort)

Trade Name : PULMICORT

AEROSOL, POWDER

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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