Nebulizer solution: 500 mcg/2ml
Indication & Usage
Ipravent Respules is an anticholinergic agent indicated for treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD).
Ipravent Respules is indicated, when used concomitantly with inhaled beta2-agonists, for treatment of reversible airways obstruction as in acute and chronic asthma.
Dosage & Administration
The dosage should be adapted to the individual needs of the patient. In children aged 12 years and under, only Ipratropium bromide respirator solution 1 ml should be used.
The following doses are recommended:
Adults (including the elderly) and children over 12 years of age:
250 - 500 micrograms 3 to 4 times daily 3 to 4 times daily.
For treatment of acute bronchospasm, 500 micrograms.
Repeated doses can be administered until the patient is stable. The time interval between the doses may be determined by the physician.
It is advisable not to exceed the recommended daily dose during either acute or maintenance treatment. Daily doses exceeding 2 mg in adults and children over 12 years of age should only be given under medical supervision.
Children 6 - 12 years of age:
250 micrograms up to a total daily dose of 1mg.
The time interval between doses may be determined by the physician.
Children 0 – 5 years of age (for treatment of acute asthma only):
125 – 250 micrograms up to a total daily dose of 1 mg.
Ipratropium bromide should be administered no more frequently than 6 hourly in children under 5 years of age.
For acute bronchospasm, repeated doses may be administered until the patient is stable.
If therapy does not produce a significant improvement or if the patient's condition gets worse, medical advice must be sought. In the case of acute or rapidly worsening dyspnea (difficulty in breathing) a doctor should be consulted immediately.
Ipravent Respules may be combined with a short-acting beta2-agonist in the same nebulizer chamber, for simultaneous administration where co-administration is required. The solution should be used as soon as possible after mixing and any unused solution should be discarded.
Ipravent Respules can be administered using a range of commercially available nebulizing devices. The dose of nebulizer solution may need to be diluted in order to obtain a final volume suitable for the particular nebulizer being used (usually 2 – 4 ml); if dilution is necessary use only sterile sodium chloride 0.9% solution.
The unit dose vials are intended only for inhalation with suitable nebulizing devices and should not be taken orally or administered parenterally.
Many of the listed undesirable effects can be assigned to the anticholinergic properties of Ipratropium Nebulizer Solution. As with all inhalation therapy Ipratropium Nebulizer Solution may show symptoms of local irritation. Adverse drug reactions were identified from data obtained in clinical trials and pharmacovigilance during post approval use of the drug.
The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastro-intestinal motility disorders (including constipation, diarrhea and vomiting), nausea, and dizziness.
Known hypersensitivity to atropine or its derivatives, or to any other component of the product.
There is evidence that the administration of Ipratropium Nebulizer Solution with beta-adrenergic drugs and xanthine preparations may produce an additive bronchodilatory effect.
The risk of acute glaucoma in patients with a history of narrow-angle glaucoma (see Special Warnings and Precautions for Use) may be increased when nebulized ipratropium bromide and beta2-agonists are administered simultaneously.
Warnings & Precautions
Use of the nebulizer solution should be subject to close 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 edema 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 colored images in association with red eyes from conjunctival congestion and corneal edema 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 the 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.
Pregnancy & Lactation
The safety of Ipratropium Nebulizer Solution during human pregnancy has not been established. The benefits of using Ipratropium Nebulizer Solution during a confirmed or suspected pregnancy must be weighed against the possible hazards to the unborn child. Preclinical studies have shown no embryo-toxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.
It is not known whether ipratropium bromide is excreted into breast milk. It is unlikely that ipratropium bromide would reach the infant to an important extent, however caution should be exercised when Ipratropium Nebulizer Solution is administered to nursing mothers.
Store below 25°C.
Keep vials in the outer carton in order to protect from light.
Keep out of the sight and reach of children.
Each pack contains 4 combipacks having 5 respules of 2ml, totally 20 Respules as single dose unit.
CIPLA Ltd/ India
Marketing Authorization Holder in IRAN