PULMOSMART Pulmules
Formoterol Fumarate and Budesonide Respirator Suspension (20 mcg +
0.5mg/1mg)/2ml
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each respules
contains Formoterol [20mcg] and Budesonide [0.5mg and 1mg].
INDICATION: For the treatment of asthma where the use
of corticosteroid and long acting beta agonist in combination is
appropriate. DOSAGE AND METHOD OF ADMINISTRATION: 1
mg/0.5 mg Pulmosmart pulmules - One respule twice a day. The contents of
the respules are for inhalation use only, using a standard jet
nebulizer. A total daily dose of formoterol greater than 40 mcg is not
recommended. CONTRAINDICATIONS: Hypersensitivity to any
ingredient of the formulation.
WARNING AND PRECAUTION: The solution should not be
injected or taken orally. Special care is required when transferring
patients from oral corticosteroids to Pulmosmart respules, particularly
those with lung tuberculosis, fungal, or viral infections. Oral
candidiasis and paradoxical bronchospasm may occur with inhaled
corticosteroids. Systemic effects may include adrenal suppression and
growth retardation in children. Use cautiously in patients with
cardiovascular disorders, especially coronary insufficiency,
arrhythmias, and hypertension. Avoid concomitant use with ketoconazole,
HIV protease inhibitors, or other potent CYP3A4 inhibitors. Not for
rapid relief of acute asthma episodes. Use cautiously in patients with
thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated
hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic
subvalvular aortic stenosis, and severe hypertension.
UNDESIRABLE EFFECTS: The most common adverse effects in
adults with formoterol include skeletal muscle tremor, palpitations and
cramps, insomnia, tachycardia, decreases in plasma potassium, and
increases in plasma glucose. Common adverse events with budesonide
include respiratory infection, rhinitis, coughing, otitis media, viral
infection, moniliasis, gastroenteritis, vomiting, diarrhoea, abdominal
pain, ear infection, epistaxis and conjunctivitis and rash.
DRUG INTERACTIONS: CYP3A4 inhibitors (e.g.,
ketoconazole) raise budesonide levels; avoid if possible. PULMOSMART
Respules are not recommended with potent CYP3A4 inhibitors.
Beta-adrenergic drugs can increase effects and arrhythmia risk with
digitalis. Beta-blockers inhibit formoterol; use cardioselective ones if
needed. Some drugs (e.g., quinidine, MAOIs) raise arrhythmia risk.
Non-potassium-sparing diuretics worsen hypokalaemia and ECG changes.
Budesonide and formoterol have no known interactions with other asthma
treatments. USE IN SPECIAL POPULATION: Pregnancy:
Formoterol and Budesonide, category C and B drug respectively. Should
only be used when the benefits outweigh the potential risks. Lactation:
only if the expected benefit to the mother is greater than any possible
risk to the child. Increased exposure can be expected in patients with
severe liver impairment, needs caution.These highlights do not include
all the information needed to use Pulmosmart respules 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 12th June 2024. Source: Prescribing
Information Pulmosmart respules.