PULMOSMART G® Pulmicaps
Glycopyrronium, Formoterol Fumarate and Budesonide Powder for
Inhalation (25mcg, 12mcg and 400mcg)
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each
Pulmicaps contains Glycopyrronium [25mcg], Formoterol [12mcg] and
Budesonide [400mcg]. INDICATION: As maintenance
treatment for patients with chronic obstructive pulmonary disease.
DOSAGE AND METHOD OF ADMINISTRATION: The recommended
dose is the inhalation of the contents of one capsule of PULMOSMART G -
twice daily using the Alkem’s Innohaler device only. Pulmicaps for
inhalation only and must not be swallowed.
CONTRAINDICATIONS: Patients who have demonstrated
hypersensitivity to glycopyrronium, formoterol, budesonide lactose or
any other component of the product.
WARNING AND PRECAUTION: PULMOSMART-G Pulmicaps is not
indicated for the treatment of asthma. Not to be initiated in patients
with acutely deteriorating COPD. Should not be used for the relief of
acute symptoms. Patients may develop Oropharyngeal Candidiasis and
pneumonia. Patients requiring oral corticosteroids should be weaned
slowly from systemic corticosteroid use after transferring to
PULMOSMART-G Pulmicaps. Caution should be exercised when considering the
co-administration of known strong CYP3A4 inhibitors. Should be
administered with extreme caution to patients being treated with
monoamine oxidase inhibitors or tricyclic antidepressants. Can produce
paradoxical bronchospasm which may be life-threatening, reduction in
bone density, cataract, hypokalemia and glaucoma. Immediate
hypersensitivity reactions have been reported after administration of
budesonide, glycopyrronium or formoterol fumarate. Should be used with
caution in patients with severe hypersensitivity to lactose, urinary
retention. Formoterol fumarate, like other beta2-agonists, can produce a
clinically significant cardiovascular effect in some patients as
measured by increases in pulse rate, systolic or diastolic blood
pressure, and also cardiac arrhythmias, such as supraventricular
tachycardia and extrasystoles. Hence shall not be used with others
LABAs. UNDESIRABLE EFFECTS: Hospitalizations,
intubations, death, Candida albicans infection, Increased risk of
pneumonia in COPD, immunosuppression and risk of infections,
hypercorticism and adrenal suppression, paradoxical bronchospasm,
hypersensitivity reactions including anaphylaxis, cardiovascular
effects, reduction in bone mineral density, worsening of narrow-angle
glaucoma and cataracts, worsening of urinary retention.
DRUG INTERACTIONS: Specific drug interaction studies of
budesonide/glycopyrronium/formoterol with other co-administered drugs
have not been performed. Ketoconazole and itraconazole, strong
inhibitors of CYP3A4, the main metabolic enzyme for corticosteroids,
increased plasma levels of orally ingested budesonide and orally inhaled
budesonide, respectively.
USE IN SPECIAL POPULATION: Use with caution and close
monitoring in patients with renal and hepatic impairment. (Analyze
risk-benefit ratio) No adequate information in pregnant women and on
breastfed infants. These highlights do not include all the information
needed to use Pulmosmart G Pulmicaps 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 Aug 2024. Source: Prescribing Information
Pulmosmart Pulmicaps.