Drug Interaction:
No interactions with topically applied steroids reported. but alter absorption of other applied drugs.
Indication:
ASMANEX TWISTHALER 110 mcg, 220 mcg (mometasone furoate inhalation
powder)
Initial U.S. Approval: 1987
RECENT MAJOR CHANGES
Indications and Usage (1.1) [1/2008] Dosage and Administration (2) [1/2008]
Warnings and Precautions (5) [1/2008]
Mometasone furoate nasal spray 50mcg/actuation ( Additional Indication)
Indication -
For the treatment nasal symptoms of seasonal allergic and perennial allergic
rhinitis, in adults and pediatric patients 2 years of age and older
Approved by FDA on 21--05-2014 (Ref- FDA approved List- 2014)
Relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Mometasone furoate Anti Depressant 28-07-2000
2.Mometasone 0.1% 25-04-2009
+ Fusisic acid 2% cream/oint
For the treatment of dermatoses where secondary bacterial and/
or candidial infection is present
3.Mometasone Furoate Oct 1990
Topical corticosteroid
4.Mometasone Furoate Nasal spray 21-05-2014
50mcg/actuation
addl.Indcn.
For the treatment of nasal symptoms of seasonal allergic and
perrenial allergic rhinitis and pediatric patients 2 years of age
and older
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Each gm of ointment contains: 24-12-02
Mometasone Furoate 0.1% +
Salicylic Acid 5% ointment
For the treatment of Chronic plaque psoriasis
2.Each gram of ointment contains: 19-02-2014
Mometasone IP 1mg+
Salicylic acid IP 50mg
Addl.Indication
For the treatment of chronic Plaque Psorasis
3. Memetasone Furoate 0.1% w/w + 16-01-2002
Terbinafine Hcl 1% w/w cream
Topical fungal infection associated with inflammation
& Pruritus
Corticosteroids topical include- Alcometasone dipropionate, Amcinonide, Betamethasone benzoate, dipropionate, valerate, Clobetasol propionate, clocortolone pivalate, Desonide, Desoximetasone, Dexamethasone, Diflorasone, Fluocinolone acetonide,Fluocinonide, Flurandrenolide, Fluticasone propionate, Halcinode, Halobetasol Propionate, Hydrocortisone, Methylprednisolone acetate, Mometasone furoate, Prednicarbate, Triamcinolone acetonide Refer - Betamethasone
Adverse Reaction:
Burning,tingling,stinging,pruritus,signs of skin atrophy (rare).
Exacerbation of primary disease if steroids withdrawn.
Systemic absorption with adrenal suppression may occur when applied over large areas over a long time,on broken skin or under occulsive dressing.
Contra-Indications:
History of hypersens to the drug,steroids or any of thecomponents, primary infection (bacterial, viral,fungal).
Special precautions:
Discontinue if irritation or sensitization occurs. In presence of infection,concomittant antibacterial or antifungal therapy to be instituted.
Sytemic absorption increases when area of appliction is extensive or occlusive dressing is used.
Chronic therapy may interfere with growth & development in children.
Pregnancy & lactation- use after weighing risk benefit.
Dosages/ Overdosage Etc:
Initial U.S. Approval: 1987
Indications;
Relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses
Dosage-
Apply sparingly to affected areas 2 to 4 times daily
Patient Information:
Instructions for Use
Patients should be instructed to record the date of pouch opening on the cap label,
and discard the inhaler 45 days after opening the foil pouch or when the dose
counter reads “00”, and the final dose has been inhaled, whichever comes first.
The inhaler should be held upright while removing the cap.
The medication should be taken as directed, breathing rapidly and deeply, and
patients should not breathe out through the inhaler.
The mouthpiece should be wiped dry and the cap replaced immediately following
each inhalation, rotated fully until the click is heard. Rinsing of mouth after inhalation
is advised.
Patients should store the unit as instructed.
The dose counter displays the doses remaining.
When the dose counter indicates zero, the cap will lock and the unit must be discarded
Patients should be advised that if the dose counter is not working correctly, the unit
should not be used and it should be brought to their physician or pharmacist.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Mometasone furoate is a corticosteroid demonstrating potent antiinflammatory
activity. The precise mechanism of corticosteroid action on
asthma is not known.
Inflammation is an important component in the pathogenesis of asthma.
The anti-inflammatory actions of corticosteroids may contribute to their efficacy
in asthma.
2.Pharmacokinetics
Absorption:
Following a 1000 mcg inhaled dose of tritiated mometasone furoate inhalation
powder to 6 healthy human subjects, plasma concentrations of unchanged
mometasone furoate were shown to be very low compared to the total radioactivity
in plasma.
Following an inhaled single 400 mcg dose of ASMANEX TWISTHALER treatment to
24 healthy subjects, plasma concentrations for most subjects were near or below
the lower limit of quantitation for the assay (50 pcg/mL).
The mean absolute systemic bioavailability of the above single inhaled 400 mcg dose
compared to an intravenous 400 mcg dose of mometasone furoate, was determined
to be less than 1%.
Interaction with Food:
Not available
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category C:
There are no adequate and well-controlled studies of ASMANEX TWISTHALER
use in pregnant women. Animal reproduction studies in mice, rats, and rabbits
revealed evidence of teratogenicity.
Asthma is a serious and potentially life-threatening condition. Poorly controlled
asthma during pregnancy is associated with adverse outcomes for mother and fetus.
ASMANEX TWISTHALER should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
2. Geriatric Use
A total of 175 patients 65 years of age and over (23 of whom were 75 years of age
and older) have been treated with ASMANEX TWISTHALER in controlled clinical trials.
No overall differences in safety or effectiveness were observed between these
and younger patients, and other reported clinical experience has not identified
differences in responses between the elderly and younger patients, but greater
sensitivity of some older individuals cannot be ruled out.
Manufacturer Details