Beviprex HFA Inhaler
Glycopyrronium Bromide + Formoterol Fumarate
9mcg + 4.8mcg
Square Pharmaceuticals PLC.
| Pack size | 1’s(120 puffs) |
|---|---|
| Unite Price | 450.00 BDT |
Indications
Beviprex HFA Inhaler is used for:
Chronic Obstructive Pulmonary Disease (COPD)
Adult Dose
Chronic Obstructive Pulmonary Disease (COPD)
maintenance treatment of airflow obstruction with COPD, including chronic bronchitis and/or emphysema
2 inhalations/puffs twice daily (morning and evening)
Do not exceed 2 inhalations BID
Hepatic impairment
Studies not conducted
Since formoterol fumarate is predominantly cleared by hepatic metabolism, impairment may lead to plasma formoterol accumulation; monitor closely
Child Dose
Renal Dose
Renal impairment
Studies not conducted
Severe (CrCl <30 mL/min/1.73 m²) or end-stage renal disease requiring dialysis: Use only if expected benefit outweighs the potential risk
Administration
Orally Inhaled Administration
Shake well before each use
Do not exceed 2 inhalations twice daily
Prime device
Prime the inhaler to ensure appropriate drug content in each actuation
Prime before using for the first time
To prime, release 4 sprays into the air away from the face, shaking well before each spray
Must be reprimed when the inhaler has not been used for >7 days; to reprime, release 2 sprays into the air away from the face; shake canister well before each spray
Contra Indications
Hypersensitivity
All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication; not indicated for the treatment of asthma
Precautions
Data from a large placebo-controlled US study in asthma patients showed that LABAs may increase the risk of asthma-related death (see Black Box Warnings)
Should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD; also do not use for the relief of acute symptoms (ie, as rescue therapy) for treating acute episodes of bronchospasm
Do not use more often than recommended, at higher doses than recommended, or in combination with additional therapy containing a LABA because of risk of overdose; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic medicines; patients using drug should not use another medicine containing a LABA for any reason
Can produce paradoxical bronchospasm that may be life-threatening; treat immediately with an inhaled, short-acting bronchodilator, discontinue therapy, and institute alternative therapy
Immediate hypersensitivity reactions have been reported after administration of formoterol or glycopyrrolate
LABAs can produce clinically significant cardiovascular effects, including increases in pulse rate or systolic or diastolic blood pressure; if such effects occur, discontinue therapy
Caution with convulsive disorders, thyrotoxicosis, patients who are unusually responsive to sympathomimetic amines, narrow-angle glaucoma (may worsen), or urinary retention (eg, prostatic hyperplasia, bladder-neck obstruction); instruct patients to contact their physician immediately with worsening disease symptoms
Pregnancy-Lactation
Pregnancy
There are no well-controlled human trials that have investigated the effects on preterm labor or labor at term; because beta 2 agonists may potentially interfere with uterine contractility, drug should be used during labor only if potential benefit justifies potential risk
Single-dose studies in humans found that a very small amount of glycopyrrolate passed the placental barrier
Animal studies
Glycopyrronium
Administered by the subcutaneous route in rats and rabbits, there were no structural abnormalities or a decrease in fetal survival at exposures approximately 2700 and 5400 times from the maximum recommended human daily inhalation dose (MRHDID), respectively; it had no effects on physical, functional, and behavioral development of rat pups with exposures up to 2700 times the MRHDID
Formoterol fumarate
Formoterol fumarate alone, administered by the oral route in rats and rabbits, caused structural abnormalities at 1500 and 61,000 times the MRHDID, respectively
Formoterol fumarate was also embryocidal, increased pup loss at birth and during lactation, and decreased pup weight in rats at 110 times the MRHDID
The adverse effects generally occurred at large multiples of the MRHDID when formoterol fumarate was administered by oral route to achieve high systemic exposures
No structural abnormalities, embryocidal, or developmental effects were seen in rats that received inhalation doses up to 350 times the MRHDID
Lactation
There are no available data on effects of glycopyrrolate, or formoterol fumarate on breastfed child or milk production
There are no available data on presence of glycopyrrolate or formoterol fumarate in human milk
Formoterol fumarate and glycopyrrolate have been detected in plasma of undosed rat pups suckling from exposed dams; the developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breast-fed child from drug or from underlying maternal condition
Interactions
Side Effects
Side effects of Glycopyrronium Bromide + Formoterol Fumarate :
1-10%
Cough (4%)
Urinary tract infection (2.6%)
Arthralgia (<2%)
Chest pain (<2%)
Tooth abscess (<2%)
Muscle spasms (<2%)
Headache (<2%)
Oropharyngeal pain (<2%)
Vomiting (<2%)
Pain in extremity (<2%)
Dizziness (<2%)
Anxiety (<2%)
Dry mouth (<2%)
Fall (<2%)
Influenza (<2%)
Fatigue (<2%)
Acute sinusitis (<2%)
Contusion (<2%)
Frequency Not Defined
Formoterol
Hypersensitivity reactions
Hyperglycemia
Sleep disturbance
Agitation
Restlessness
Tremor
Nausea
Tachycardia
Palpitations
Cardiac arrhythmias
Mode of Action
Glycopyrronium: Long-acting muscarinic antagonist (LAMA); often referred to as an anticholinergic; produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle
Formoterol: Long-acting beta2-agonist (LABA) with a rapid onset of action; stimulates intracellular adenyl cyclase, causing conversion of ATP to cyclic AMP; increased cyclic AMP levels cause relaxation of bronchial smooth muscle
Note
Beviprex 9mcg + 4.8mcg HFA Inhaler generic name is Glycopyrronium Bromide + Formoterol Fumarate. Beviprex 9mcg + 4.8mcg HFA Inhaler is manufactured by Square Pharmaceuticals PLC.Beviprex is availble in all over Bangladesh.
Mes BD drug index information on Beviprex HFA Inhaler is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.