The recommended dosage of Budison-FG HFA Inhaler is budesonide 320 mcg, formoterol fumarate 9.6 mcg and glycopyrrolate 18 mcg administered as 2 inhalations (budesonide/formoterol fumarate/glycopyrrolate 160 mcg/4.8 mcg/9 mcg which is equivalent to metered dose (budesonide/formoterol fumarate/glycopyrrolate 182 mcg/5.5 mcg/10.4 mcg) twice daily, once in the morning and again in the evening by oral inhalation. Do not take more than two inhalations twice daily. After inhalation, rinse mouth with water without swallowing.

Contraindicated in patients who have demonstrated hypersensitivity to Budesonide, Formoterol, Glycopyrrolate or any of the excipients.

Budison-FG inhaler is not indicated for the treatment of asthma. Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy [without inhaled corticosteroid (ICS)] for asthma is associated with an increased risk of serious asthma-related events (hospitalizations, intubations, death). Do not initiate in acutely deteriorating COPD. Do not use to relieve acute symptoms. Do not use in combination with an additional therapy containing a LABA because of the risk of overdose. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Candida albicans infection of the mouth and pharynx may occur. Patient should be monitored periodically. Patient should be advised to rinse his/her
mouth with water without swallowing after inhalation to help reduce the risk. Use of Budison-FG inhaler is associated with increased risk of pneumonia in patients with COPD. Patients should be monitored for signs and symptoms of pneumonia. Use with caution in patients with immunosuppressive disease like existing tuberculosis, fungal, viral, bacterial or parasitic infection or ocular herpes simplex. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Caution should be taken when transferring from oral steroids to Budison-FG. In that case taper the systemic corticosteroids when transferring to Budison-FG. Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible
individuals. If such changes occur, appropriate therapy should be considered. If paradoxical bronchospasm occurs, discontinue Budison-FG and institute alternative therapy. Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation. Decreases in bone mineral density (BMD) may occur with long-term administration of products containing ICS. Assess for decrease in bone mineral density initially and periodically thereafter.
Glaucoma and cataract have been reported in patients with COPD following the long-term administration of inhaled corticosteroids or with use of inhaled anticholinergics. Therefore, close monitoring is warranted in patients with a change in vision or with a history glaucoma and/or cataract. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction as worsening of urinary retention may occur. If symptoms occur, patient should be advised to contact a healthcare provider immediately. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.

Common side effects are upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasm, urinary tract infection, cough, sinusitis and diarrhea.

Strong cytochrome P450 3A4 inhibitors like ritonavir, atazanavir,
clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir,
saquinavir, telithromycin etc. may cause increased systemic
corticosteroid effects. Other adrenergic drugs may potentiate
effect. Diuretics, xanthine derivatives or steroids may potentiate
hypokalemia or ECG changes. Monoamine oxidase inhibitors and
tricyclic antidepressants may potentiate effect of Formoterol on
vascular system. ß-blockers may block bronchodilatory effects of
ß-agonists and produces severe bronchospasm. Glycopyrrolate
may interact additively with concomitantly used anticholinergic
medications. Avoid administration of Budison-FG with other
anticholinergic-containing drugs.

USE IN PREGNANCY:
There are no adequate and well-controlled studies with two of its
individual components glycopyrrolate and formoterol in pregnant
women to inform a drug-associated risk; however, studies are
available for the other component, budesonide. This preparation
should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
USE IN LACTATION:
Since there are no data from controlled trials on the use of
Budesonide, Glycopyrrolate & Formoterol by nursing mothers, a
decision should be made whether to discontinue breast feeding or
to continue this preparation, taking into account the importance of
this preparation to the mother.
USE IN ELDERLY PATIENTS:
Based on available data for Budesonide, Glycopyrrolate &
Formoterol no adjustment of dosage is needed in geriatric
patients.
USE IN CHILDREN:
Budesonide, Formoterol & Glycopyrrolate inhaler is not indicated
for use in children. The safety and effectiveness of Budesonide,
Glycopyrrolate & Formoterol inhaler have not been established in
pediatric patients.

Budison-FG HFA inhaler: Each canister contains 120 puffs.