Budesonide And Formoterol Fumarate Dihydrate (Symbicort)

Trade Name : SYMBICORT

AstraZeneca Pharmaceuticals LP

AEROSOL

Strength 1604.5 ug/1ug/1

BUDESONIDE; FORMOTEROL FUMARATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Budesonide And Formoterol Fumarate Dihydrate (Symbicort) which is also known as SYMBICORT and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 160; 4.5 ug/1; ug/1 per ml. Read more

Budesonide And Formoterol Fumarate Dihydrate (Symbicort) 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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About GNH

No data

SYMBICORT is a combination product containing a corticosteroid and a long-acting beta-adrenergic agonist indicated for:
Important limitations:

For oral inhalation only.

SYMBICORT is available as a metered-dose inhaler containing a combination of budesonide (80 or 160 mcg) and formoterol (4.5 mcg) as an inhalation aerosol in the following two strengths: 80/4.5 and 160/4.5. Each dosage strength contains 60 or 120 actuations per/canister. Each strength of SYMBICORT is supplied with a red plastic actuator with a gray dust cap.
Metered-dose inhaler containing a combination of budesonide (80 or 160 mcg) and formoterol (4.5 mcg) as an inhalation aerosol. n

The use of SYMBICORT is contraindicated in the following conditions:

No data

5.16n- 5.18

LABA use may result in the following:
Systemic and inhaled corticosteroid use may result in the following:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the 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.
Most common adverse reactions (incidence 3%) are:
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or .

In clinical studies, concurrent administration of SYMBICORT and other drugs, such as short-acting beta-agonists, intranasal corticosteroids, and antihistamines/decongestants has not resulted in an increased frequency of adverse reactions. No formal drug interaction studies have been performed with SYMBICORT.

Hepatic impairment: Monitor patients for signs of increased drug exposure. n

SYMBICORT
SYMBICORT contains both budesonide and formoterol; therefore, the risks associated with overdosage for the individual components described below apply to SYMBICORT. In pharmacokinetic studies, single doses of 960/54 mcg (12 actuations of SYMBICORT 80/4.5) and 1280/36 mcg (8 actuations of 160/4.5), were administered to patients with COPD. A total of 1920/54 mcg (12 actuations of SYMBICORT 160/4.5) was administered as a single dose to both healthy subjects and patients with asthma. In a long-term active-controlled safety study in adolescent and adult asthma patients 12 years of age and older, SYMBICORT 160/4.5 was administered for up to 12 months at doses up to twice the highest recommended daily dose. There were no clinically significant adverse reactions observed in any of these studies.
Budesonide
The potential for acute toxic effects following overdose of budesonide is low. If used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism may occur . Budesonide at five times the highest recommended dose (3200 mcg daily) administered to humans 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.
Formoterol
An overdose of formoterol would likely lead to an exaggeration of effects that are typical for beta-agonists: seizures, angina, hypertension, hypotension, tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache, tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, hyperglycemia, hypokalemia. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of formoterol. No clinically significant adverse reactions were seen when formoterol was delivered to adult patients with acute bronchoconstriction at a dose of 90 mcg/day over 3 hours or to stable asthmatics 3 times a day at a total dose of 54 mcg/day for 3 days.
Treatment of formoterol overdosage consists of discontinuation of the medication together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of formoterol. Cardiac monitoring is recommended in cases of overdosage.

SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only.
Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations n n . After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant.
SYMBICORT should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face.
One active component of SYMBICORT is budesonide, 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 which 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.
The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta-agonist designated chemically as (R*,R*)-(u00b1)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is CHNO and its molecular weight is 840.9. Its structural formula is:
Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25u00b0C is 7.9 for the phenolic group and 9.2 for the amino group.

No data

No data

No data

SYMBICORT is available in two strengths and is supplied in the following package sizes:
Each strength is supplied as a pressurized aluminum canister with an attached counting device, a red plastic actuator body with a white mouthpiece, and attached gray dust cap. Each 120 inhalation canister has a net fill weight of 10.2 grams and each 60 inhalation canister has a net fill weight of 6.9 grams (SYMBICORT 80/4.5) or 6 grams (SYMBICORT 160/4.5). Each canister is packaged in a foil overwrap pouch with desiccant sachet and placed into a carton. Each carton contains one canister and a Patient Information leaflet.
The SYMBICORT canister should only be used with the SYMBICORT actuator, and the SYMBICORT actuator should not be used with any other inhalation drug product.
The correct amount of medication in each inhalation cannot be ensured after the labeled number of inhalations from the canister have been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of inhalations have been used or within 3 months after removal from the foil pouch. Never immerse the canister into water to determine the amount remaining in the canister (u201cfloat testu201d).
Store at controlled room temperature 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F) [see USP]. Store the inhaler with the mouthpiece down.
For best results, the canister should be at room temperature before use. Shake well for 5 seconds before using.
Keep out of the reach of children. Avoid spraying in eyes.
CONTENTS UNDER PRESSURE.
Do not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures over 120u00baF may cause bursting. Never throw container into fire or incinerator.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Serious Asthma-Related Events:
Not for Acute Symptoms:
Instruct patients to seek medical attention immediately if they experience any of the following:
Tell patients they should not stop therapy with SYMBICORT without physician/provider guidance since symptoms may recur after discontinuation.
Do Not Use Additional Long-Acting Beta-Agonists:
Local Effects:n- Candida albicans
Pneumonia:
Immunosuppression:
Hypercorticism and Adrenal Suppression:
Reduction in Bone Mineral Density:
Reduced Growth Velocity:
Ocular Effects:
Risks Associated With Beta-Agonist Therapy:
SYMBICORT is a trademark of the AstraZeneca group of companies.
u00a9AstraZeneca 2017
Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
By: AstraZeneca Dunkerque Production, Dunkerque, France
Product of France

Revised: December 2017
Instructions for Use
SYMBICORT (SIM-bi-kort)
(budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg)
Inhalation Aerosol
SYMBICORT (SIM-bi-kort)
(budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg)
Inhalation Aerosol
Upright Position
How to Use SYMBICORT
Follow the instructions below for using SYMBICORT. You will breathe-in (inhale) the medicine. If you have any questions, ask your doctor or pharmacist.
Preparing your SYMBICORT inhaler for use
If you do not use your SYMBICORT inhaler for more than 7 days or if you drop it, you will need to prime again.
Ways to hold the SYMBICORT inhaler for use
OR
Using your SYMBICORT inhaler
After using your SYMBICORT inhaler
Reading the counter
COUNTER
COUNTER
How to clean your SYMBICORT inhaler
Clean the white mouthpiece of your SYMBICORT inhaler every 7 days. To clean the mouthpiece:
Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
By: AstraZeneca Dunkerque Production, Dunkerque, France
Product of France
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
SYMBICORT is a trademark of the AstraZeneca group of companies. FORADIL AEROLIZER is a trademark of Novartis Pharmaceuticals Corporation.
u00a9AstraZeneca 2017
Revised: December 2017

NDC 0186-0370-20
Store Upright
Symbicort 160/4.5
budesonide 160 mcg/formoterol fumarate dehydrate 4.5 mcg
INHALATION AEROSOL
120 inhalations
For Oral Inhalation only
Rx only
Manufactured for:
AstraZeneca LP, Wilmington, DE 19850
By: AstraZeneca Dunkerque Production
Dunkerque, Franceu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Product of France
AstraZeneca

NDC 0186-0372-20
Store Upright
Symbicort 80/4.5
budesonide 80 mcg/formoterol fumarate dehydrate 4.5 mcg
INHALATION AEROSOL
120 inhalations
For Oral Inhalation only
Rx only
Manufactured for:
AstraZeneca LP, Wilmington, DE 19850
By: AstraZeneca Dunkerque Production
Dunkerque, Franceu00a0u00a0u00a0u00a0u00a0Product of France
AstraZeneca

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Budesonide And Formoterol Fumarate Dihydrate (Symbicort)

Trade Name : SYMBICORT

AEROSOL

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 And Formoterol Fumarate Dihydrate (Symbicort)

Trade Name : SYMBICORT

AEROSOL

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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