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 beta₂-agonists, for the treatment of reversible airway obstruction as in acute and chronic asthma.

Inhaler: As a bronchodilator in the treatment of chronic reversible airway obstruction as in asthma and chronic obstructive pulmonary disease including chronic bronchitis and emphysema. Also for the treatment of acute reversible airway obstruction.

Ipratropium Bromide is a quaternary ammonium compound with anticholinergic properties. It appears to inhibit vagal reflexes by antagonizing 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 the interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.

Nebuliser Solution-

Adults (including the elderly) and children over 12 years of age: 250-500 micrograms (i.e. 1 ml or 2 ml) 3 to 4 times daily.

For treatment of acute bronchospasm: 500 micrograms/2 ml. 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 (i.e. 1 ml) up to a total daily dose of 1 mg (4 ml). 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 (i.e. 0.5 ml-1 ml) up to a total daily dose of 1 mg (4 ml). Ipratropium bromide should be administered no more frequently than 6 hourly in children under 5 years of age. Repeated doses can be administered until the patient is stable. The time interval between the doses may be determined by the physician.

Ipratropium Nebuliser Solution may be combined with a short-acting beta 2-agonist in the same nebulizer chamber. The solution should be used as soon as possible after mixing and any unused solution should be discarded. Ipratropium Nebuliser Solution 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 Ipratropium Nebulizer Solution is intended only for inhalation with suitable nebulizing devices and should not be taken orally or administered parenterally.

Inhaler-

Adults: The usual dose is 1-2 puffs (20 gm/spray) three or four times daily. Single dose upto 80 gm (4 puffs) may be required to obtain maximum benefit during early treatment. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours.

Children: 

• 6-12 years: Usually 1-2 puffs two to three times daily.
• Below 6 years: The usual dose is 1 puff (20 gm) three times daily.
• In order to ensure that the inhaler is used correctly, the administration should be supervised by an adult.
• No specific information on the use of the product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group has been reported.

Administration

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

• Take off the cap.
• Shake the inhaler (at least six times) vigorously before each use.
• If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
• Breathe out as full as comfortably possible & hold the inhaler upright.
• Place the actuator into mouth between the teeth and close lips around the mouthpiece.
• While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
• Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
• If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
• After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
• Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

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 derivatives. 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, increased intraocular pressure, 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 have been reported.
• Symptomatic adverse effects: Regular use of Ipratropium can lead to dry mouth through inhibition of salivary flow.
• Observed during clinical practice: The most common adverse reactions reported are dryness of the oropharynx (5%); cough, exacerbation of symptoms, and irritation from aerosol (3%); headache (2%); nausea, dizziness, blurred vision/difficulty in accommodation, and drying of secretions (1%). Less frequently reported adverse reactions include tachycardia, nervousness, paresthesias, drowsiness, coordination difficulty, itching, hives, flushing, alopecia, constipation, tremor, and mucosal ulceration. Cases of precipitation or worsening of narrow-angle glaucoma, acute eye pain, and hypotension have been reported. Allergic-type reactions such as skin rash, angioedema of the tongue, lips and face, urticaria (including giant urticaria), laryngospasm, and anaphylactic reactions have also been 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 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.

Nebuliser Solution: Use of the nebulizer solution should be subject to close medical supervision during initial dosing. Caution is advised 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 be 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 the 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, angioedema, rash, bronchospasm and oropharyngeal edema.

Acute overdosage by inhalation is unlikely since Ipratropium bromide is not well absorbed systemically 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 specific reversal.

Anticholinergic bronchodilators

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.