SPRAHALER RESPULES

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SPRAHALER RESPULES Product Information Leaflets
Brand Name:
SPRAHALER RESPULES
Generic Name:
Ipratropium Bromide

DESCRIPTION:

SPRAHALER RESPULES is an anticholinergic agent and it is used for the treatment of Asthma and COPD.

COMPOSITION:

Ipratropium Bromide BP equivalent to Ipratropium Bromide (anhydrous)…500mcg
Isotonic solution………q.s.

INDICATIONS:

SPRAHALER RESPULES administered either alone or with other bronchodilators, especially beta-adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.
SPRAHALER RESPULES is indicated, when used concomitantly with inhaled beta2-agonists, for treatment of reversible airways obstruction as in acute and chronic asthma.

DOSAGE & ADMINISTRATION:

Adults:
500 mcg (in 2ml respules) 3 to 4 times daily
Children (6-12 years):
250 (1ml) up to 4 times daily
Children (below 6 years):
125 to 250 mcg (0.5 to 1ml) up to 4 times daily

CONTRAINDICATIONS:

Ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.

UNDESIRABLE EFFECTS:

The most common non-respiratory adverse reactions reported in clinical trials are headache, throat irritation, cough, gastrointestinal motility disorders (including constipation, diarrhoea and vomiting), nausea (with or without vomiting), dizziness and dryness of the mouth.

PRESENTATION:

SPRAHALER RESPULES is available as respule of 2 ml

PREGNANCY & LACTATION:

Pregnancy Category B. No adequate or well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, ipratropium bromide should be used during pregnancy only if clearly needed. It is not known whether ipratropium bromide is excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that the active component, ipratropium bromide, would reach the infant to an important extent, especially when inhaled. However, because many drugs are excreted in human milk, caution should be exercised when ipratropium bromide is administered to a nursing mother.

Patients should consult with their physician before taking any medicine.