Budison-FG HFA Inhaler

Budison-FG HFA Inhaler is used for: Chronic Obstructive Pulmonary Disease (COPD)

Inhalation Chronic Obstructive Pulmonary Disease Indicated for maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) 2 oral inhalations twice daily. Max 2 inhalations twice daily. Hepatic impairment Formal pharmacokinetic studies not conducted; however, budesonide and formoterol fumarate are predominantly cleared by hepatic metabolism Severe hepatic disease: Closely monitor

Renal impairment Formal pharmacokinetic studies not conducted; however, glycopyrronium systemic exposure increased with moderate renal impairment (ie, eGFR 45 mL/min) Severe (CrCl ?30 mL/min/1.73m2) or end-stage renal disease requiring dialysis: Use if expected benefit outweighs potential risk

Shake well before oral inhalation Exhale fully through mouth, close lips around mouthpiece and tilt head back, keeping tongue below the mouthpiece, while breathing in deeply and slowly, release puff of medication by pressing on actuator; repeat for second inhalation Rinse mouth with water and spit out water after each dose (2 inhalations) to reduce risk of thrush Avoid spraying in eyes

Hypersensitivity. Not indicated for relief of acute bronchospasm or treatment of asthma.

Safety and efficacy not established for asthma; use of long-acting beta2-adrenergic agonists (LABAs) as monotherapy (ie, without inhaled corticosteroids) for asthma is associated with increased risk asthma-related death; data do not suggest an increased risk of death with LABAs in patients with COPD Do not initiate in patients with acutely deteriorating COPD, which may be a life-threatening condition; use only for maintenance and not as a rescue therapy Patients who have been taking inhaled, short-acting beta2 agonists on a regular basis should discontinue these drugs when budesonide/formoterol/glycopyrrolate inhaled is initiated Oropharyngeal candidiasis is associated with orally inhaled corticosteroids; advised patients to rinse mouth with water and without swallowing Lower respiratory tract infections, including pneumonia, reported following inhaled corticosteroids Immunosuppressive drugs (eg, corticosteroids) use increases susceptibility to infection; some infections may be more serious or fatal compared with others not taking corticosteroids Caution if patients are being transferred from systemic corticosteroids; monitor for adrenal insufficiency, particularly for patients maintained on physiologic doses (eg, ≥20 mg/day of prednisone, or equivalent) Hypercorticism and adrenal suppression may occur if dose is exceeded Oral inhaled therapies can produce paradoxical bronchospasm, which may be life-threatening; if this occurs, permanently discontinue and treat immediately with inhaled, short-acting bronchodilator Beta2 agonists can produce clinically significant cardiovascular effects (eg, increased heart rate and blood pressure, arrhythmias, ECG changes) Decreased bone mineral density observed with long-term administration of corticosteroids Use of long-term corticosteroids or inhaled anticholinergics associated with glaucoma, cataracts, or worsening of narrow-angle glaucoma Caution in patients with urinary retention (eg, prostatic hyperplasia, bladder-neck obstruction) Caution with sympathomimetic use in patients with convulsive disorders or thyrotoxicosis; beta2 agonists may aggravate preexisting diabetes mellitus and ketoacidosis Beta agonists may produce significant hypokalemia and transient hyperglycemia

Pregnancy Data are not available for glycopyrrolate or formoterol fumarate in pregnant women; however, studies are available for budesonide Studies (Swedish registries) of pregnant women who received inhaled budesonide alone during pregnancy did not show increased risk of abnormalities Clinical considerations Labor or delivery: No well-controlled human trials; because of potential for beta agonists interfering with uterine contractility, restrict use during labor to patients in whom benefits clearly outweigh risks Animal studies Budesonide SC administration caused structural abnormalities, was embryocidal, and reduced fetal weights in rats and rabbits at 0.3 and 0.75 times the maximum recommended human daily inhaled dose (MRHDID), but these effects were not seen in rats that received inhaled doses up to 4 times the MRHDID Experience with PO corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans Formoterol Oral administration in rats and rabbits caused structural abnormalities at 1,500 and 61,000 times the MRHDID It was also embryocidal, increased pup lost at birth and during lactation, and decreased pup weight in rats at 110 times the MRHDID No structural abnormalities, embryocidal, or developmental effects observed in rats that received inhalation doses up to 350 times the MRHDID Glycopyrrolate SC administration in rats and rabbits did not cause structural abnormalities or affect fetal survival at 2,700-5,400 times MRHDID It also had no effects on physical, functional, and behavioral development of rat pups up to 2,700 times the MRHDID Lactation Data are not available for glycopyrrolate or formoterol fumarate in lactating women; however, studies are available for budesonide Budesonide dry powder inhalation shows the total daily oral dose of budesonide available in breast milk to the infant is ~0.3-1% of the maternal inhaled dose

Strong CYP3A4 inhibitors Exercise caution Coadministration with strong CYP3A4 inhibitors may increase budesonide systemic exposure Adrenergic drugs Exercise caution Coadministration of formoterol with other adrenergic drugs may cause additive sympathetic effects Xanthine derivatives, corticosteroids, or diuretics Monitor for hypokalemia Coadministration of beta2 agonists (eg, formoterol) with xanthine derivatives, corticosteroids, or diuretics may potentiate risk of hypokalemia The hypokalemia and/or ECG changes that may result from nonpotassium sparing diuretics may be worsened by beta2 agonists, especially if beta2 agonist dose exceeded MAOIs, TCAs, or QTc prolonging drugs Use extreme caution with beta2 agonists in patients treated with MAOIs, TCAs, or other drugs known to prolong QTc interval owing to additive action of adrenergic agonists on the cardiovascular system Beta blockers Beta blockers inhibit the therapeutic effect of beta2 agonists and may also produce severe bronchospasm Patients with COPD should normally not use beta blockers, excepts under certain circumstances (eg, prophylaxis after MI); consider cardioselective beta blockers when necessary Anticholinergics Monitor Coadministration of glycopyrrolate with anticholinergic medications may cause additive effects

Side effects of Formoterol Fumarate + Glycopyrrolate + Budesonide inhaler : 1-10% Upper respiratory tract infection (5.7%) Pneumonia (4.6%) Dysphonia (3.3%) Muscle spasms (2.8-3.3%) Back pain (3.1%) Oral candidiasis (3%) Influenza (2.9%) Urinary tract infection (2.7%) Cough (2.7%) Sinusitis (2.6%) Diarrhea (2.1%) <1% Cataracts Frequency Not Defined Other adverse effects associated ≥1 of the individual components Hyperglycemia Anxiety Insomnia Headache Palpitations Nausea Hypersensitivity Depression Agitation Restlessness Nervousness Tremor Dizziness Angina pectoris Tachycardia Arrhythmias (eg, atrial fibrillation, supraventricular tachycardia, extrasystoles) Throat irritation Bronchospasm Dry mouth Bruising Urinary retention Chest pain Sign or symptoms of systemic glucocorticoid steroid effects (eg, hypofunctional adrenal gland) Abnormal behavior

Formoterol: Long-acting selective beta-2 agonist with rapid onset of action; acts locally as bronchodilator; stimulates intracellular adenyl cyclase, which results in increased cyclic adenosine monophosphate levels, causing relaxation of bronchial smooth muscle and inhibition of release of mast cell mediators Glycopyrrolate: Long-acting muscarinic antagonist; often referred to as an anticholinergic; produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle Budesonide: Anti-inflammatory corticosteroid; has potent glucocorticoid activity and weak mineralocorticoid activity

Budison-FG (4.8 mcg+9 mcg+160 mcg)/a HFA Inhaler generic name is Formoterol Fumarate + Glycopyrrolate + Budesonide inhaler. Budison-FG (4.8 mcg+9 mcg+160 mcg)/a HFA Inhaler is manufactured by Aristopharma LimitedBudison-FG is availble in all over Bangladesh. Mes BD drug index information on Budison-FG HFA Inhaler is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.