Brand Information

Strength	Rate	Packing Style
0.025% + 0.1%+2.5% w/w	94.72	20g R- cream

Drug Interaction:

Improves respiratory function when used with a bronchodialator.

Indication:

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

Drug name Indication Date of Approval

55. Beclomethasone dipropionate 0,25mg 30-01-08

+ Econazole 10mg

+ Neomycin 5mg per gm of cream

For the topical treatment of bacterial and fungal

infections

Corticosteroids Inhalational -

Includes - Beclomethasone,Budesonide , Dexamethasone, Flunisolide, Triamcinolone

Refer - Beclomethasone

Inflammatory disorders

Asthma prophylaxis

Patent Expiry Date of drugs (Ref - IDMA Publication)

Chemical Category Manufacturer/ US Patent

Ingredient- Marketer Expiration Date

Patent Expiry Date of drugs (Ref - IDMA Publication)

Chemical Category Manufacturer/ US Patent

Ingredient- Marketer Expiration Date

Beclomethasone Respiratory Glaxo Welcome 24-12-1999

Beclomethasone Respiratory Schering-Plough 24-12-1999

New drugs approved For Marketing by Drug Controller General of India(DCGI )

during the period January 1988 to November 2014

(Ref- IDMA Annual Publication 2015)

Name of Drug Indication Date of Approval

1. Beclomethasone dipropionate 30-01-2008

0.25mg + Econazole 10mg +

Neomycin IP 0.5% w/w cream

For the topical treatment of bacterial and fungal treatment

2. Beclomethasone dipropionate IP 0.25% w/w + 15-09-2010

Neomycin sulphate IP 0.5%w/w cream

Additional lower strength

3. Beclomethasone dipropionate IP 100mcg + 05-01-2011

Formoterol fumarate dihydrate BP equiv. to

Formoterol fumarate 6mcg metered dose

inhaler

FIXED DOSE COMBINATIONS APPROVED BY DCG(I)

FROM JANUARY 1961 TILL NOVEMBER 2014

Name of Drug Indication Date of Approval

1.Beclomethasone Dipropionate 0.025%+ Apr-1974

Chinoform 3% Ointment and Cream

2.Beclomethasone Dipropionate 0.25% + Apr-1974

Neomycin Sulphate 0.5% Ointment and Cream

3.Beclomethasone Dipropionate ).25% + 30-01-2008

Econazole 10mg +

Neomycin 5mg per cream

For the topical treatment of bacterial and fungal infections

4.Beclomethasone Dipropionate IP 0.25mg w/w + 15-09-2010

Neomycin Sulphate IP 0.5% w/w cream

Addl/Lower stgth

5. Beclomethasone Dipropionate IP 100mcg + 05-01-1998

Formoterol Fumarate Dihydrate BP eq, to

Formoterol Fumarate 6mcg Metered dose Inhaler

For the treatment of bronchial asthma where use of inhaled

Corticosteroid therapy found appropiate

Adverse Reaction:

Risk of additsonian crisis if oral steroids suddenly replaced by inhaled preparation. Hoarseness(occassionally).

Monilia infection of throat and mouth (occassional) HPA axis supression, pulmonary infiltrates, suppress bone metabolism.

Topical use:

Dermal thinning, telengectasia and striae (espl face, eyelids & flexures). Perioral dermatitis. Systemic absorption on prolonged use over large area.

Topical appln to eye:

increased intraocular pressure,glaucoma, and catarat.

Contra-Indications:

Primary treatment of status asthmaticus or other acute asthmatic episodes requiring intensive measures. Hypersens to ingredients.

Special precautions:
In patients transferred from systemic corticosteroids to beclomethasone & patients suffering from adrenal insuffciency, localised fungal infections of allergic conditions.

Dosages/ Overdosage Etc:

Date of Approval 1974

Indications:

Inflammatory disorders Asthma prophylaxis

Dosage:

Adults inhalation- 2 inhalations (84mcg) 3 or 4 times daily

Children(6 to 12 years) 1 or 2 inhalations(42 to 84mcg) 3 or 4 times a day..

Patient Information:

Corticosteroids Inhalational - Includes - Beclomethasone,Budesonide , Dexamethasone, Flunisolide, Triamcinolone

Refer - Beclomethasone

1. Do not exceed the recommended dosage

2. May cause irritation and drying of nasal mucosa. Contact physician if symptoms do not improve, if the condition worsens or if sneezing or nasal irritation occurs.

3. Clear nasal pasage of secretions prior to use. If nasal passages are blocked, use a decongestant just before administration to ensure adequate penetration of the spray.

4. Effects are not immediate.benefits requires regular use and usually occurs within a few days.

5.Allergy- Tell your doctor if you are allergic or unusual reactions to corticosteroids or any food substances such as preservatives, dyestuffs etc.

6.Pregnancy- When used in regular daily doses during pregnancy to keep mothers asthma under control, these medicines have not been repored to cause breathing defects or birth defects in the baby.

7. Breast feeding- . Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

8. Children- Inhalation corticosteroids have been tested in children in low effective doses and have not be shown to cause different side effects or problems than they do in adults. Children who are using ihaled steroids in large does should notbe exposed tochicken pox or measles. .

9. Older adults- Although there is no specific information comparing use of inhaled corticosteroids in the elderly, with use in other age groups, this medicine is not expected to cause different side effects than they do youger adults.

10. Other medicines- Tell your doctor if you are taking any other OTC medicines

11. Other medical problems- Tell your doctor if you are having any other medical problems especialy - Osteoporsis- inhaled steroids in high doses may make this condition worse in women who are past menopause and who are not receiving an estrogen replacement. 12. Dosing- Follow the instructions of your doctor

13. Missed dose- If you miss your dose take it as soon as possible. Then use any remaining dose for the day at regularly spaced intervals.

14.Storage- Keep out of reach of children Store away from direct sunlght Do not store the capsule form of this medicine in the bath room, under the kitchen sink or in any damp places Moisture may cause the medicine to break down Keep the aerosol or suspesioform from getting too cold or freezing Do not puncture , break or burn the aerosol container even after it is empty.

Pharmacology/ Pharmacokinetics:

Ref- Drug Facts And comparisons (2010)

Corticosteroids Inhalational -

Includes - Beclomethasone,Budesonide , Dexamethasone, Flunisolide, Triamcinolone

Refer - Beclomethasone

Pharmacology:

For sytemic use of corticosteroids, refer Glucocorticoids- Dexamethasone

These drugs are also classified as Intranasal Steroids

These drugs have the potent glucocorticoid and weak mineralcorticoid activity. The mechanisms responsible for the anti-inflammatory action of corticosteroids on the mucosa are unknown.

However, glucocorticoids have a wide range of inhibitory activities against multiple cell types(eg. mast cells, eosinophilis, neutrophils, macrophages, lymphocytes) and mediators(eg. histamine., eicosanoids, leukotrienes, cytrokines) involved in allergic and nonallergic/irritant-mediated inflammation. These agents when administred topically in recommended doses, exert direct local anti-inflammatory effects with minimal systemic effects. Exceeding the recommended dose may result in systemic effects, including hypothalmic-pituiary-adrenal(HPA) function suppression

Pharmacokinetics:

The amount of an intranasal dose that reaches systemic circulation is generally low, metabolism is rapid.

Pharmacokinetics of Inhaled Corticosteroids

Parameter

Absoption Distribution Metabolism Metabolites Excretion T 1/2

systemic Vd(L/kg) Protein Site Activity

bioavailibity binding

from

lungs

Beclomethasone

~20% NA 87% liver Beclomethasone feces,urine 2.8hr

(CYP3A) 17mono proponate (less than

(active), free 10%)

beclomethasone

(very weak anti-

inflammatory

Budesonide

25% 4.3 85-90% liver 16a-hydroxy urine 2.8hr

(CYP3A) prednisolone (~60%)

and 6b-hydroxy feces

budesonide

(<1% of parent)

Flunisolide

40% 1.8 NA liver 6b-OH (low renal 1.8hr

corticosteroid (50%)

potency) feces

(40%)

Fluticasone

20% 3.5 91% Liver) 17-B-carboxylic feces 3.1hr

(CYP3A) acid(negligable urine

in animal studies less

than

(0.02%)

Triamcinolone

21.5% 1.4 ~68% mostly from liver 6B-hydroxy- urine 1.5hr

liver extensively triamcinolone (40%)

from the acetonide,21- feces

kidneys carboxy-traim (~60%)

cinoline aceto

nide, and 21-

carboxy-6B-

hydroxytriam

cinoline aceto

nide (less active

than parent)

Pregnancy and lactation:

Pregnancy:

Topical application of recommended dose is unlikely to acheive significant systemic levels: however, use these agents during prenancy only if potential benefits outweigh the potential hazards to the fetus.

Carefully observe infants born of mothers who have received substantial doses of corticosteroids during prenancy for signs of adrenal insufficiency.

Lactation:

Advise mothers taking pharmacologic doses not to nurse. Dexamethsone appears in breast milk and could suppress growth.

Beclomethasone, budesonide, flunisolide, triamcinolone- not known whether these drugs are excreted in breast milk.

Use caution while administering to nursing mothers.

PROCTOSEDYL- BD

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation