Brand name: Ipravent Inhaler
Composition: Ipratropium Bromide
Each actuation delivers:
Ipratropium Bromide ….. 20 mcg
Suspended in CFC-free propellant………….HFA
Dosage form: Inhalation aerosol
Category: Bronchodilator / Anticholinergic (Antimuscarinic) - short acting
Ipravent Inhaler is indicated for the regular treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD) and chronic asthma.
Administration and dosage:
Adults (Including the Elderly):
Usually 1 or 2 puffs, three or four times daily, although some patients may need up to 4 puffs at a time to obtain maximum benefit during early treatment.
Children (6–12 years):
1 or 2 puffs (20 or 40 micrograms) two times daily.
Below 6 Years:
1 puff (20 micrograms) three times daily.
The recommended dose should not be exceeded.
Ipravent Inhaler may be used with a Zerostat/Zerostat VT Spacer device in patients who find it difficult to synchronize aerosol actuation with inspiration of breath.
Ipravent Inhaler should not be taken by patients with known hypersensitivity to atropine or its derivatives, or to ipratropium bromide or to any other component of the product.
Ipratropium HFA inhalation aerosol is a bronchodilator for the maintenance treatment of bronchospasm associated with COPD and is not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response. Inhaled medicines, including ipratropium HFA inhalation aerosol, may cause paradoxical bronchospasm. If this occurs, stop treatment with ipratropium HFA inhalation aerosol and consider other treatments.
Immediate hypersensitivity reactions may occur after administration of ipratropium as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
Use ipratropium with caution in patients with narrowangle glaucoma, prostatic hyperplasia, or bladder-neck obstruction, particularly if they are receiving an anticholinergic by another route. Cases of precipitation or worsening of narrow-angle glaucoma and acute eye pain have been reported with direct eye contact of ipratropium administered by oral inhalation.
Category B. There are, however, no adequate or well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, use ipratropium during pregnancy only if clearly needed.
It is not known whether ipratropium inhalation aerosol is excreted in human milk. Although lipid-soluble quaternary cations pass into breast milk, it is unlikely that the active component, ipratropium, would reach the infant to an important extent, especially when taken by inhalation. Ipratropium is not well absorbed systemically after inhalation or oral administration. However, because many drugs are excreted in human milk, exercise caution when ipratropium is administered to a breastfeeding woman.
Safety and efficacy in children have not been established.
Although Ipratropium is minimally absorbed into the systemic circulation, there is some potential for an additive interaction with concomitantly used anticholinergic medications. Caution is therefore advised in the co-administration of Ipratropium inhalation with other anticholinergic-containing drugs.
The following side effects have been reported. The frequencies given below are based on clinical trials involving patients who have been treated with ipratropium bromide.
1) Ocular complications have been reported when aerolised ipratropium bromide, either alone or in combination with an adrenergic beta2-agonist, has come into contact with the eyes during nebuliser therapy
2) As with other inhalation therapy, inhalation induced bronchoconstriction may occur with an immediate increase in wheezing after dosing. This should be treated straight away with a fast acting inhaled bronchodilator. Ipravent Inhaler should be discontinued immediately, the patient assessed and, if necessary, alternative treatment instituted.
3) The risk of urinary retention may be increased in patients with pre-existing urinary outflow tract obstruction.
Other side-effects include urticaria including giant urticaria, hypotension back pain, headache, influenza-like symptoms, dizziness, dyspepsia, bronchitis, COPD exacerbations, dyspnea, sinusitis and urinary tract infection.
No symptoms specific to overdosage have been encountered. In view of the wide therapeutic window and topical administration of ipratropium bromide, no serious anticholinergic symptoms are to be expected. As with other anticholinergics, dry mouth, visual accommodation disturbances and tachycardia would be the expected symptoms and signs of overdose.
Store below 30oC.
Do not freeze.
Canister containing 200 metered doses.
Manufacturer: Cipla Ltd., India