PULMOSMART Inhaler
Formoterol Fumarate and Budesonide Inhalation (6mcg and 200 or
400mcg/actuation)
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each
actuation delivers Formoterol [6mcg] and Budesonide [200/400mcg].
INDICATION: Asthma - Pulmosmart Inhaler is indicated in
the regular treatment of asthma, where the use of a combination (LABA &
ICS) has been found to be appropriate.
DOSAGE AND METHOD OF ADMINISTRATION: Asthma -
Maintenance Therapy: Pulmosmart Inhaler is taken as regular maintenance
treatment with a separate rapid acting bronchodilator as rescue. Single
maintenance and reliever therapy: Pulmosmart Inhaler are taken as
regular maintenance and as needed in response to symptoms. Maintenance
Therapy: Patients should be advised to have their separate rapid acting
bronchodilator available for rescue use at all times. Recommended Dosage
Adults (18 Years and Older) Pulmosmart-200 Inhaler: 1–2 inhalations,
twice daily. Maximum dose is 4 inhalations, twice daily. Pulmosmart- 400
Inhaler - 1 inhalation, twice daily. Maximum dose is 2 inhalations,
twice daily. Adolescents (12-17 Years) - Pulmosmart-200 Inhaler, 1–2
inhalations, twice daily. Pulmosmart- 400 Inhaler - 1 inhalation, twice
daily. Children (6-11 Years) - Pulmosmart-100 Inhaler, 2 inhalations,
twice daily. Single Maintenance and Reliever Therapy (For Pulmosmart
-100 and 200 only) - Adults (18 years and older). The recommended
maintenance dosage is 2 inhalations per day as maintenance therapy
(either one inhalation twice daily, or two inhalations in either the
morning or the evening), although some patients may require two
inhalations twice daily. Not more than 6 inhalations should be taken on
any single occasion. A total daily dose of more than 8 inhalations is
not normally needed; however, a total daily dose of up of 12 inhalations
could be used for a limited period. Patients using more than 8
inhalations daily should be strongly recommended to seek medical advice.
Pulmosmart- 400 Inhaler should not be used for single maintenance and
reliever therapy. 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 Inhaler 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 Inhaler.