Brand Information

Strength	Rate	Packing Style
160mcg+4.5mcg+730mcg	550.00	160/4.5ug/dose inhalation powder

Drug Interaction:

Corticosteroids Intranasal -

Includes - Beclomethasone,Budesonide , Fluticasone, Mometasone, Triamcinolone

Refer - Budesonide

Varicella vaccine Ketoconazole

Indication:

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use

SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT® 80/4.5 (budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol SYMBICORT® 160/4.5 (budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol FOR ORAL INHALATION

Initial US Approval: 2006

U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08

Drug name Indication Date of Approval

226. Budesonide 17-10-08

+ Formoterol 980/160mcg+ 4.5mcg)

Inhalational powder

(Addl.indication)

Indicated in the regular treatment of patints with moderate

to severe COPD with frequent symtoms and a history of

exacerbation

Corticosteroids Intranasal -

Includes - Beclomethasone,Budesonide , Fluticasone, Mometasone, Triamcinolone

Refer - Budesonide

Bronchial asthma

Approved by the FDA on February 21, 1994

Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Budesonide Anti-asthmatic February 1988

2.Budesonide +Formoterol 80/160mg + 4.5mcg 17-10-2008

inhalational powder

Addl.Indication

FIXED DOSE COMBINATIONS APPROVED BY DCG(I)

FROM JANUARY 1961 TILL NOVEMBER 2014

Name of Drug Indication Date of Approval

1.Budesonide + 17-10-2008

Formoterol ( 80/160mcg + 2.5mcg)

Inhalational powder

Addl.Indication

Indicated in the regular treatment of patients with moderate to severe

COPD with frequent symptoms and a history of exacerbations

2.Budesonide IP 0.5mg+ 21-11-2011

Formoterol Fumarate Dihydrate IP

eq to Formoterol Fumarate 20mcg/20mcg

Respirator suspension

Addl.Stgh

For the treatment of asthma where the use of corticosteroid and long

acting Beta blocker agonists in combination is appropiate

3. Budesonide IP 1mg/0.5mg + 04-01-2012

Formoteroal Fumarate Dihydrate IP

eq. to Formoterol Fumarate 20mcg/20mcg

Respirator suspension

Addl.Indication

In the regular treatment of patients with moderate to severe

chronic Obstructive Pulmonary Disease (COPD) with frequent

symptoms and a history of excacerbations

Indicated in the regular treatment of patients with moderate to severe

COPD with frequent symptoms and a history of exacerbtions

3. Budesonide IP 1mg + Formoterol fumarate 04-01-2012

dihydrate IP eqv to formoterol fumarate

20mcg /20mcg respirator suspension

Addl.Indication

In the regular treatment of patients with moderate to severe

chronic obstructive pulmonary disease (COPD) with

frequent history of exacerbations

4.Budesonide IP 1mg/0.5mg + Formoterol 21-11-2011

fumarate dihydrate IP eqv. to formoterol

fumarate 20mcg/20mcg respirator suspn

Adddl.Stgth

For the treatment of Asthma where the use of corticosteroid and

long acting beta agonist in combination is appropiate

Patent Expiry Date of drugs (Ref - IDMA Publication)

Chemical Category Manufacturer/ US Patent

Ingredient- Marketer Expiration Date

Budesonide Respiratory Astra-Zeneca 13-03-2007

Adverse Reaction:

Corticosteroids Intranasal -

Includes - Beclomethasone,Budesonide , Fluticasone, Mometasone, Triamcinolone

Refer - Budesonide

Cough Paradoxical bronchospasm uncommon urticaria, glaucoma, cataract Anaphylaxis Rash, contact dermatitis angeoedema ( discontinue therapy )

Contra-Indications:

Hypersensitivity. active pulmonary TB

Special precautions:

Quiescent pulmonary tubrculosis Fungal or viral infections in the airways

Oral steroid dependence Prolonged treatment within high doses increases risk of adrenal suppression and systemic effects

Consider additional steroid in stress or surgery Monitorheight of children on prolonged therapy

Chicken pox, measles Pregnancy and lactation.

Dosages/ Overdosage Etc:

Approved by the FDA on February 21, 1994

Indication-

Bronchial asthma

Dosage:

Adults and children more than 6 years of age.

Recommended starting dose is 256mcg daily, given either 2 sprays in each nostril in the morning and evening or as 4 sprays in each nostril in the morning

Children under 6 years of age. Not recommended.

Patient Information:

Corticosteroids Intranasal -

Includes - Beclomethasone,Budesonide , Fluticasone, Mometasone, Triamcinolone

Refer - Budesonide

PATIENT COUNSELING INFORMATION

See Medication Guide

Asthma-Related Death-

Patients with asthma should be informed that formoterol fumarate dihydrate, one of the active ingredients in SYMBICORT, increases the risk of asthma-related death and may increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

They should also be informed that currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death.

Not for Acute Symptoms- SYMBICORT is not meant to relieve acute asthma symptoms or exacerbations of COPD and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist such as albuterol.

Patients should be instructed to notify their physician immediately if they experience any of the following:

• Decreasing effectiveness of inhaled, short-acting beta2-agonists

• Need for more inhalations than usual of inhaled, short-acting beta2-agonists

• Significant decrease in lung function as outlined by the physician

Patients should not stop therapy with SYMBICORT without physician/provider guidance since symptoms may recur after discontinuation.

Do Not Use Additional Long-Acting Beta2-Agonists- When patients are prescribed SYMBICORT, other long-acting beta2-agonists for asthma and COPD should not be used.

Risks Associated With Corticosteroid Therapy Local Effects: Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with SYMBICORT, but at times therapy with SYMBICORT may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised.

Pneumonia: Patients with COPD have a higher risk of pneumonia and should be instructed to contact their healthcare provider if they develop symptoms of pneumonia.

Immunosuppression:

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to consult their physician without delay.

Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex.

Hypercorticism and Adrenal Suppression: Patients should be advised that SYMBICORT may cause systemic corticosteroid effects of hypercorticism and adrenal suppression.

Additionally, patients should be instructed that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids.

Patients should taper slowly from systemic corticosteroids if transferring to SYMBICORT.

Reduction in Bone Mineral Density: Patients who are at an increased risk for decreased BMD should be advised that the use of corticosteroids may pose an additional risk.

Reduced Growth Velocity: Patients should be informed that orally inhaled corticosteroids, component of SYMBICORT, may cause a reduction in growth velocity when administered to pediatric patients.

Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route.

Ocular Effects: Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts or glaucoma); regular eye examinations should be considered.

Risks Associated With Beta-Agonist Therapy: Patients should be informed of adverse effects associated with beta2-agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.

SYMBICORT is a trademark of the AstraZeneca group of companies. ©AstraZeneca 2008, 2009, 2010

Manufactured for: AstraZeneca LP, Wilmington, DE 19850 By: AstraZeneca Dunkerque Production, Dunkerque, France Product of France

Pharmacology/ Pharmacokinetics:

Refer - Drug Facts And Comparisons (2010)

Corticosteroids Intranasal -

Includes - Beclomethasone,Budesonide , Fluticasone, Mometasone, Triamcinolone

Refer - Budesonide

Pharmacokinetics of Intranasal Steroids

Parameters

Bioavail Vd Protein Site of Metabolism Excretion t 1/2

libity binding Metabolism (activity) site

Beclomethasone

44% 20L 424L 87% - 17-monoprop feces(~60%) 0.5h

ionate active) urine(~12%) 2.7h

free (IV)

beclometha

sone

Budesonide

~34% 2 to3L/kg 85% to Liver 16a-hydroxy feces 2 to

90% (CYP3A) prednisolone urine 3h (IV)

and (~66%)

6b -hydroxy

budesonide

(<1% of parent)

Flunisoloide

50% NA NA Liver NA feces 1 to

(~50%) 2h

urine

(~50%)

Futicasone

<2% 4.2L/kg 91% Liver 17b-carboxylic feces 7.8h

(CYP3A) acid(inactive) (>95%)

urine

(>5%)

Mometasone

virtually NA 98%to Liver 6b-hydroxy feces 5.8h

undetect 99% (CYP3A) momentasone urine (IV)

able furoate

Triamcinolone

Minimal 99.5L NA Liver 6b-hydroxy feces 3.1h

triamcinolone (~60%)

acetonide urine

21-carboxy (~40%)

triamcinolone

acetonide

and

21-carboxy-

6b-hydroxy-

triamcinolone

acetonide

(substanitially

< parent)

Interaction with Food:

Swallow whole. Do not crush.
Avoid grapefruit juice

Pregnancy and lactation:

Observe caution. Contraindicated for use during pregnancy and lactation

SYMBICORT TURBUHALER s

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Interaction with Food

Pregnancy and lactation

Drug Interaction:

Indication:

Adverse Reaction:

Contra-Indications:

Dosages/ Overdosage Etc:

Patient Information:

Pharmacology/ Pharmacokinetics:

Interaction with Food:

Pregnancy and lactation:

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