Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
46. Tiotropium 30-01-08
(as Tiotropium Bromide Monohydrate) 18mcg
+ Formoterol Fumarate Dihydy 12mcg
+ Ciclesomide 400mcg per capsules
As 3rd line treatment of severe cases of COPD
when monotherapy and second line therapy with
two drugs do not respond adequately
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Tiotropin as Monohydrate 18mcg 31-01-2008
+ Formoterol Fumarate Dihydro 12mcg
+ Ciclesomide 400mcg per capsules
As 3rd line treatment of Severe cases of COPD when Monotherapy and
Second Line Therapy with Two drugs do not Respond Adequately
2.Tiotropium Bromide 16-04-2003
Anti-asthmatic
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Tiotropin Br 18mcg + 22.04-2004
Formoterol 12mcg Rotacap
For treatment of COPD
2.Tiotropin Br 9mcg + 26-04-2004
Fomoterol 12mcg inhaler
For treatment of COPD
3.Tiotropium Bromide Monohydrate eq.to 22-11-2004
Tiotropin 18mcg +
Formoterol Fumarate 12mcg dry powder inhaler
For treatment of Chronic Obstructive Pulmonary
Disease - COPD
4.Tiotropium Brimide monohydrate eq.to 24-12-2004
Tiotropin 9mcg +
Formoterol Fumarate dehydrate eq.to
Formoterol Fumerate 6mcg meter dose inhaler
For the treatment of chronic Obstructive pulmonary
Disease - COPD
Maintenance treatment of COPD
Adverse Reaction:
Constipation, candidiasis, cough , sinusitis, pharynigitis, Dry mouth, Increased heart rate, angioedema, flu-likev symptoms Dizziness, dysphasia, hoarseness, intestinal obstruction including ileus paralytic Increased risk of stroke, Mouth ulceration, New onset or worsening of glaucoma, itching, rash
Contra-Indications:
Hypersensitivity to atropine or any of its derivative. Not for primary treatment of acute attacks Lactation Special precautions- Glaucoma, prostatic hypertrophy, Hepatic- moderate to severe renal mpairment Excess use- Elderly Not for acute bronchospasm Avoid contact with the eyes Discontinue if hypersensitivity reactions eg, angioedema, or paradoxical bronchospasms occurs Labour and delivery, Pregnancy
Manufacturer Details