IPRASURE LS
Levosalbutamol 0.63mg and Ipratropium Bromide 500mcg Respirator
Solution
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each 2.5 ml
of unit dose respule contains Levosalbutamol 0.63mg and Ipratropium
Bromide 500mcg. INDICATION: In the treatment of
bronchospasm associated with chronic obstructive pulmonary disease
(COPD) in patients requiring more than one bronchodilator.
DOSAGE AND METHOD OF ADMINISTRATION:
Adults and Adolescents ≥ 12 years old: Administered three times a
day, every 6 to 8 hours, by nebulization.
IPRASURE LS respule is for oral inhalation only.
Administer by nebulization using with a standard jet nebulizer (with a
face mask or mouthpiece) connected to an air compressor. Do not exceed
recommended dose. CONTRAINDICATIONS: Contraindicated in
patients with a history of hypersensitivity to any of its components, or
to atropine and its derivatives. Reactions have included urticaria,
angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
WARNING AND PRECAUTION: Levosalbutamol: May cause
life-threatening paradoxical bronchospasm, should be discontinued if
this occurs. Can produce clinically significant cardiovascular effects
in some patients, as measured by heart rate, blood pressure, and
symptoms. Immediate hypersensitivity reactions may occur including
urticaria, angioedema, rash, bronchospasm, anaphylaxis, and
oropharyngeal edema. Should be used with caution in patients with
cardiovascular disorders, especially coronary insufficiency,
hypertension, and cardiac arrhythmias; in patients with convulsive
disorders, hyperthyroidism, or diabetes mellitus. May produce
significant hypokalemia in some patients, which has the potential to
produce adverse cardiovascular effects. Asthma may deteriorate acutely
over a period of hours or chronically over several days or longer.
Ipratropium: Use anticholinergic agents cautiously in patients with
narrow-angle glaucoma, prostatic hyperplasia, bladder-outflow
obstruction, or cystic fibrosis. Ipratropium bromide may cause immediate
hypersensitivity reactions and rare ocular complications if it contacts
the eyes during nebulizer therapy. UNDESIRABLE EFFECTS:
Serious adverse reactions include with levosalbutamol, paradoxical
bronchospasm, cardiovascular effects, immediate hypersensitivity
reactions, hypokalemia, angioedema, anaphylaxis, arrhythmias (including
atrial fibrillation, supraventricular tachycardia, extra systoles),
asthma, chest pain, cough increased, dysphonia, dyspnea,
gastroesophageal reflux disease (GERD), metabolic acidosis, nausea,
nervousness, rash, tachycardia, tremor, urticaria. Adverse events with
Ipratropium are Headache, cough, local irritation, dry mouth, nausea,
urticaria, narrow-angle glaucoma, tachycardia, laryngeal spasms, skin
rash, anaphylactic reactions, increased intraocular pressure,
palpitations, atrial fibrillation, bronchospasms, urinary retention.
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: Not indicated for pediatric
patients less than 6 years of age. Pregnancy - Levosalbutamol: Category
C drug; 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; Caution should be exercised. Renal Impairment: the risk
of toxic reactions. Monitor renal function. Ipratropium Bromide
Pregnancy/Lactation: Safety not established; consider risks vs.
benefits. Hepatic impairment: Use is not been studied. should be used
with caution in hepatic impairment. These highlights do not include all
the information needed to use IPRASURE LS 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 2nd August 2024. Source: Prescribing
Information IPRASURE LS