PULMOSMART Pulmicaps
Formoterol Fumarate and Budesonide Powder for Inhalation (6mcg and
200/400mcg)
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each
Pulmicaps contains Formoterol [6mcg] and Budesonide [200 & 400mcg].
INDICATION: ASTHMA - Where use of combination of
inhaled regular corticosteroid and Long acting beta 2 agonist is
appropriate.
DOSAGE AND METHOD OF ADMINISTRATION: Asthma - A.
Maintenance Therapy: Keep a rapid-acting bronchodilator available for
rescue use at all times. B. Single Maintenance and Reliever Therapy: Use
Pulmosmart Pulmicaps regularly and as needed for symptoms. Recommended
Dosage: Adults (18 Years and Older): Pulmosmart-200 Pulmicaps: 1–2
pulmicaps, twice daily (Max: 4 pulmicaps, twice daily), Pulmosmart-400
Pulmicaps: 1 pulmicap, twice daily (Max: 2 pulmicaps, twice daily).
Adolescents (12-17 Years): Pulmosmart-200 Pulmicaps: 1–2 pulmicaps,
twice daily, Pulmosmart-400 Pulmicaps: 1 pulmicap, twice daily. Children
(6-11 Years): Pulmosmart-200 Pulmicaps: 2 pulmicaps, twice daily. Single
Maintenance and Reliever Therapy (Pulmosmart-200 Pulmicaps only): Adults
(18 years and older): 2 pulmicaps per day as maintenance (1 pulmicap
twice daily, or 2 pulmicaps once daily). Use 1 additional pulmicap as
needed. If symptoms persist, take another pulmicap. Do not exceed 6
pulmicaps on a single occasion or 12 pulmicaps per day. Seek medical
advice if using more than 8 pulmicaps daily. Note: Single inhaler
therapy is not recommended for children and adolescents. Pulmosmart-400
Pulmicaps are not for single maintenance and reliever therapy.
Pulmosmart Pulmicaps should only be used with ALKEM’s Innohaler device
only. CONTRAINDICATIONS: For patients with a history of
hypersensitivity to the drug's components, it is not suitable for
primary treatment of status asthmaticus, acute asthma/COPD episodes
requiring intensive measures, or relief of acute bronchospasm.
WARNING AND PRECAUTION: Seek medical attention if
Pulmosmart Pulmicaps is ineffective or dosage exceeds recommendations.
Have a rescue inhaler available at all times. Avoid excessive use or
combination with other LABAs; monitor for pneumonia, immunosuppression,
hypersentivity reaction, glaucoma, cataract, systemic eosinophilic
conditions, cardiovascular effects, Hypokalemia and Hyperglycemia and
growth in children. Serious asthma-related adverse events and
exacerbations may occur during treatment. Patients using
formoterol/budesonide combination should not use an additional LABA
(e.g., salmeterol, formoterol fumarate, arformoterol tartrate) for any
reason, including prevention of exercise-induced bronchospasm (EIB) or
the treatment of asthma. UNDESIRABLE EFFECTS: Common:
Candida infections in the oropharynx, Headache, tremor, Palpitations.
Possible systemic effects include Cushing's syndrome, Cushingoid
features, adrenal suppression, growth retardation in children and
adolescents, decrease in bone mineral density, cataract and glaucoma.
DRUG INTERACTIONS: Co-administration of
formoterol/budesonide with potent CYP3A4 inhibitors (e.g., ritonavir,
atazanavir, clarithromycin, indinavir, itraconazole, nefazodone,
nelfinavir, saquinavir, telithromycin)can increase systemic exposure to
budesonide, leading to potential adverse effects. Formoterol's efficacy
is weakened by beta blockers. MAOIs may trigger hypertensive reactions.
Hypokalemia, worsened by non-potassium-sparing diuretics, warrants
caution with formoterol/budesonide.
USE IN SPECIAL POPULATION: In renal impairment: No
specific data. Hepatic impairment: patients with hepatic disease should
be closely monitored due to risk of accumulation. 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. These highlights do not include all the information needed to use
Pulmosmart 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 10th June 2024. Source: Prescribing Information
Pulmosmart Pulmicaps.