Nebuliser Solution: It is indicated for the treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD). It is also indicated, when used concomitantly with inhaled beta 2-agonists, for treatment of reversible airway obstruction as in acute and chronic ... Read moreNebuliser Solution: It is indicated for the treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD). It is also indicated, when used concomitantly with inhaled beta 2-agonists, for treatment of reversible airway obstruction as in acute and chronic asthma.Inhaler: As bronchodilator in the treatment of chronic reversible airway obstruction as in asthma and chronic obstructive pulmonary disease including chronic bronchitis and emphysema. Treatment of acute reversible airway obstruction.

Anticholinergic bronchodilators

Ipratropium Bromide is a quaternary ammonium compound with anticholinergic properties. It appears to inhibit vagal reflexes by antagonising the action of acetylcholine (the transmitter agent released from the vagus nerve). Anticholinergics prevent the increase in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.

Children over 3 years: The usual dose is 0.4-2.0 ml Ipratropium Bromide Solution (100-500 micrograms) up to three times daily. Adults (including elderly and adolescents) over 12 years of age: The usual dose is 0.4-2.0 ml Ipratropium Bromide Solution (100-500 micrograms) up to four times daily.

Inhaler: Ipratropium has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines, steroids and cromolyn sodium, commonly used in the treatment of chronic obstructive pulmonary disease, without adverse drug reactions. There are no studies fully evaluating the  interaction effects of Ipratropium and these drugs with respect to effectiveness.

Nebuliser Solution: Known hypersensitivity to atropine or its derivatives, or to any other component of the product.Inhaler: Known hypersensitivity to Ipratropium, Atropine or its derivative. Also contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soybean, lecithin and peanut.

Nebuliser Solution: Common: Headache, Dizziness, Cough, Inhalation induced bronchospasm, Dryness of mouth, Vomiting. Uncommon: Urticaria, Tachycardia, Skin rash, Pruritus. Rare: Anaphylactic reaction, Eye pain, Mydriasis, Intraocular pressure increased, Palpitations, Atrial fibrillation, Nausea. Inhaler: Potentially life-threatening effects- Idiosyncratic reactions to Ipratropium bromide are rare. Severe adverse effects due to the inhibition of muscarinic receptors and ganglion blockade are theoretically possible but unlikely with the metered-dose aerosol. Severe/Irreversible adverse effects- No effects of this kind is reported. Symptomatic adverse effects- Regular use of Ipratropium can lead to a dry mouth through inhibition of salivary low. Observed during clinical practice- The most common adverse reactions reported are dryness of the oropharynx (5%); cough, exacerbation of symptoms, & irritation from aerosol (3%); headache (2%); nausea, dizziness, blurred vision/difficulty in accommodation & drying of secretions (1%). Less frequently reported adverse reactions to include tachycardia, nervousness, paresthesias, drowsiness, coordination difficulty, itching, hives, flushing, alopecia, constipation, tremor & mucosal ulceration. Case of precipitation or worsening of narrow-angle glaucoma, acute eye pain & hypotension have been reported. Allergic-type reactions such as skin rash, angioedema of the tongue, lips & face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been also reported; with positive rechallenges in some cases. Ipratropium bromide does not produce adverse effects on mucociliary clearance, in contrast to atropine and other muscarinic antagonists. There is no evidence that in the therapeutic dose range, Ipratropium has any adverse effect on bronchial secretion.

The safety of Ipratropium Bromide during human pregnancy has not been established. The benefits of using Ipratropium Bromide during a confirmed or suspected pregnancy must be weighed against possible hazards to the unborn child. It is not known whether Ipratropium Bromide is excreted into breast milk.

Nebuliser Solution: Use of the nebulizer solution should be subject to close medical supervision during initial dosing. Caution is advocated in the use of anticholinergic agents in patients with narrow-angle glaucoma, or with prostatic hyperplasia or bladder-outflow obstruction or cystic fibrosis. Immediate hypersensitivity reactions have been demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal edema and anaphylaxis. There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular pressure, narrow-angle glaucoma, eye pain) when aerosolized ipratropium bromide has come into contact with the eyes during nebulizer therapy. Patients must be instructed in the correct administration of the Ipratropium Nebulizer Solution. Care must be taken not to allow the solution or mist to enter the eyes. It is recommended that the nebulizer solution is administered via a mouthpiece. If a mouthpiece is not available and a nebulizer mask is used, it must fit properly. Inhaler: Patients should be advised that temporary blurring of vision precipitation or worsening of narrow-angle glaucoma or eye pain may result if the aerosol is sprayed into the eyes. If recommended dosage does not provide relief or symptoms become worse, patients should seek immediate medical attention. While taking Ipratropium inhalation aerosol, other inhaled drugs should not be used unless prescribed.Ipratropium inhalation aerosol is not indicated for the initial treatment of acute episodes of bronchospasm where rapid response is required. Drugs with faster onset may be preferable as initial therapy in this situation. Immediate hypersensitivity reactions may occur after administration of Ipratropium bromide, as demonstrated by rare cases of urticaria, angio-oedema, rash, bronchospasm and oropharyngeal oedema.

Acute overdosage by inhalation is unlikely since Ipratropium bromide is not well absorbed systematically after aerosol administration. Inhaled dosage of 5 mg produces an increase in heart rate and palpitation. Single doses of Ipratropium bromide 30 mg by mouth caused anticholinergic side effects but which were not considered severe enough to require specifc reversal.

As the product contains no preservative, a fresh ampoule should be used for each dose and the ampoule should be opened immediately before administration. Any solution left in the ampoule should be discarded. Do not store above 25°C. Keep the ampoule in the outer carton.

Anticholinergic bronchodilators

Ipratropium Bromide is a quaternary ammonium compound with anticholinergic properties. It appears to inhibit vagal reflexes by antagonising the action of acetylcholine (the transmitter agent released from the vagus nerve). Anticholinergics prevent the increase in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.

The safety of Ipratropium Nebulizer Solution during human pregnancy has not been established. The benefits of using Ipratropium Nebuliser Solution during pregnancy must be weighed against the possible hazards to the fetus. It is not known whether ipratropium bromide is excreted into breast milk. Caution should be exercised when Ipratropium Nebulizer Solution is administered to nursing mothers.