Indication:
Chronic obstructive pulmonary disease.
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Ipratropium bromide Anti-cholinergic November 1992
bronchdilator
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Ipratropium Bromide 500mg + 03-04-2001
Salbutamol Sulphate
eq.to Salbutamol 2.5mg per 2.5ml respiratory
solution
For Bronchospasm in patients suffering from
Chronic Pulmonary disorders
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Ipratropium Respiratory Boehringer 09-06-2015
bromide & ingelheim
salbutamol
Adverse Reaction:
Dryness of mouth and pharyneal irritation, cough, headache, dizziness, nausea, gastrointestinal distress, blurred vision, Less frequently palpitation, nervousness, drowsiness difficulty in co-ordination, constipation, rash.
Contra-Indications:
Hypersens to atropine or its cogeners. Treatment of acute episodes of bronchospasm.
Special precaution: Patients with narrow angle glaucoma, prostatic hypertrophy, pregnancy and lactation, children under 3 yrs. Bladder neck obstruction, glaucoma, or patients susceotible to glaucoma, Protect patients eyes from nebulised drug Renal and hepatic impairment Pregnancy, lactation, children
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
IPRATROPIUM - Inhalation
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
ipratropium, atropine, belladonna, hyoscyamine, or scopolamine, or other
inhalational aerosol medicines. Also tell your healthcare care professional
if you are allergic to soya beans, or related foods substances such as
soyabeans or peanuts.
2.Pregnancy-
Ipratropium has not been studied in pregnant women. However, it has not been
shown to cause birth defects or other problems in animal studies
3. Breast-feeding-
It is known whether ipratropium passes into breast milk. Although most medicines pass
into breast milk in small amounts,many of them may be used safely while breast-feeding.
Mothers who are taking this medicine and who wish to breast feed should discuss this
with their doctor.
4.Children-
This medicine has been tested in children, and in effective doses , has not been
shown to cause different side effects or problems than it does in adults.
5.Older adults-
Ipratropium inhalation has been tested in patients 65 years of age or older.
This medicine is not expected to cause different side effects or problems in older
people, than in adults..
6. Other medicines-
Although certain medicines should not be used together at all, in other cases two
different medicines may be used together even if an interaction might occur.
In such cases your doctor may want to change the dose, or other precautions
may be necessary.
Tell your doctor if you are using any other prescription or non-prescription
(Over-the counter) OTC medicine.
7. Other medical problems-
The presence of other medical problems may affect the use of ipratropoim .
Make sure you tell your doctor if you have any other medical problems
especially-
Difficult urination- ipratropium may make the condition worse.
Glaucoma- ipratropium may make the condition worse if it gets into the eyes
Manufacturer Details