Ipravent Solution 15Ml

COMPOSITION

Each ml contains, Ipratropium Bromide BP 250 mcg.

INDICATIONS

Ipratropium Nebulizer Solution is indicated for treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD). Ipratropium Nebulizer Solution is indicated, when used concomitantly with inhaled beta 2-agonists. for treatment of reversible airways obstruction as in acute and chronic asthma.

CONTRAINDICATIONS

Known hypersensitivity to atropine or its derivatives or to any other component of the product.

WARNING & PRECAUTIONS

Use nebulizer solution should be subject to dose medical supervision during initial dosing. Immediate hypersensitivity reactions following the use of ipratropium nebulizer solution have been demonstrated by cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis. Caution is advocated in the use of anticholinergic agents in patients predisposed to or with narrow-angle glaucoma, or with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder-outflow obstruction). As patients with cystic fibrosis may be prone to gastro-intestinal motility disturbances, Ipratropium Nebulizer Solution, as with other anticholinergics, should be used with caution in these patients. There have been isolated reports of ocular complications (i.e. mydriasis, increased intra-ocular pressure, narrow-angle glaucoma, eye pain) when aerosolized ipratropium bromide, either alone or in combination with an adrenergic beta2 agonist has come into contact with the eyes during nebulizer therapy. Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately. Patients must be instructed in correct administration of Ipratropium Nebulizer Solution. Care must be taken not to allow the solution or mist to enter the eyes. It is recommended that the nebulized solution is administered via a mouthpiece. If this is not available and a nebulizer mask is used, it must fit properly. Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes. 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. Ipratropium nebulizer solution should be discontinued immediately, the patient assessed and, if necessary, alternative treatment instituted.

OVERDOSE

No symptoms specific to overdosage have been encountered. In view of the wide therapeutic window and topical administration of Ipratropium Nebulizer Solution, 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.

CIPLA LTD