IPRASURE Pulmules
Ipratropium Bromide and Levosalbutamol respirator solution [500mcg+
1.25mg]/2.5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each 2.5 mL
unit-dose respule contains Levosalbutamol sulphate 1.25 mg and
Ipratropium Bromide 500 mcg. INDICATION: Indicated in
patients with COPD on a regular aerosol bronchodilator, who continue to
have evidence of bronchospasm and who require a second bronchodilator.
DOSAGE AND METHOD OF ADMINISTRATION: Adults & children
more than 12 years: One respule three times a day [maximum recommended
daily dose], every 6 to 8 hours. IPRASURE respules are for oral
inhalation only. Administer by a standard jet nebulizer.
CONTRAINDICATIONS: contraindicated in patients with a
history of hypersensitivity to any of its components, or to atropine and
its derivatives. Reactions have included urticaria, angio-oedema, rash,
bronchospasm, anaphylaxis, and oropharyngeal oedema.
WARNING AND PRECAUTION: Levosalbutamol Sulphate: Can
cause dangerous bronchospasm. Asthma may deteriorate acutely over a
period of hours or chronically over several days or longer. Not a
replacement for corticosteroids. should be used with caution in patients
with cardiovascular disorders, especially coronary insufficiency,
cardiac arrhythmias, and hypertension. Avoid excessive use. Watch for
hypersensitivity reactions. Ipratropium Bromide: Caution with glaucoma
or prostate hyperplasia or bladder outflow obstructions. Rare
hypersensitivity reactions. Risk of eye complications during therapy.
Seek immediate help for glaucoma symptoms. Administer carefully to avoid
eye contact. UNDESIRABLE EFFECTS: Serious adverse
reactions include paradoxical bronchospasm, cardiovascular effects,
immediate hypersensitivity reactions, and hypokalaemia. Headache, nausea
(with or without vomiting) and dryness of the mouth.
DRUG INTERACTIONS: Levosalbutamol Sulphate: Avoid other
short-acting bronchodilators or epinephrine. Use beta-blockers
cautiously. Monitor potassium and digoxin levels with diuretics and
digoxin. Extreme caution with MAO inhibitors/tricyclic antidepressants.
Ipratropium Bromide: May enhance bronchodilatory effect with
beta-adrenergic drugs/xanthine. Caution in narrow-angle glaucoma; risk
increased with beta2-agonists.
USE IN SPECIAL POPULATION: Pregnancy: Category C;
potential teratogenic effects observed in animals; use only if benefits
outweigh risks. Labour/Delivery: Use cautiously due to potential
interference with uterine contractility. Nursing: Potential
tumorigenicity; consider importance to mother. Ipratropium Bromide
Pregnancy/Lactation: Safety not established; consider risks vs.
benefits. should be used with caution in hepatic impairment. These
highlights do not include all the information needed to use IPRASURE
Pulmules effectively and safely. Please refer to full prescribing
information [available on request].
FOR FURTHER INFORMATION, CONTACT: Medical Affairs;
Alkem House; Senapati Bapat Marg, Lower Parel, Mumbai, Maharashtra: 400
013. Prepared on 7th June 2024. Source: Prescribing Information IPRASURE
Pulmules