Aroneb Nebuliser Solution
Arformoterol
15 mcg/2 ml
Incepta Pharmaceuticals Ltd.
| Pack size | 5's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 40.00 AED |
Indications
Aroneb Nebuliser Solution is used for:
Chronic Obstructive Pulmonary Disease (COPD)
Adult Dose
Maintenance Treatment of Chronic Obstructive Pulmonary Disease, including chronic bronchitis and emphysema.
15 mcg (1 ampoule) inhaled via nebulization twice daily (morning and evening).
A total daily dose of greater than 30 mcg is not recommended.
Child Dose
Renal Dose
Renal Impairment
Dose adjustment not necessary
Administration
For oral inhalation only.
One 15 mcg/2 mL vial every 12 hours.
For use with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor.
Contra Indications
Hypersensitivity to arformoterol or formoterol, or any ingredients
Treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid
Precautions
LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events.
Do not initiate Arformoterol Inhalation Solution in acutely deteriorating patients.
Do not use for relief of acute symptoms. Concomitant short-acting beta2- agonists can be used as needed for acute relief.
Do not exceed the recommended dose. Excessive use of Arformoterol Inhalation Solution, or use in conjunction with other medications containing long-acting beta2-agonists, can result in clinically significant cardiovascular effects, and may be fatal.
Life-threatening paradoxical bronchospasm can occur. Discontinue Arformoterol Inhalation Solution immediately.
Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or with sensitivity to sympathomimetic drugs.
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; drug should only be used during pregnancy if expected benefit outweighs potential risk to fetus; women should be advised to contact their physician if they become pregnant while receiving therapy
The potential effect of therapy on labor and delivery is unknown; because of potential for beta-agonists interference with uterine contractility, use of inhalation solution during labor should be restricted to whom benefits clearly outweigh risk
Animal data
In animal reproduction studies with rats and rabbits at exposures approximately 370 and 8,400 times adult exposure at maximum recommended human daily inhalation dose (MRHDID) of 15 mcg every 12 hours, respectively, there were findings of structural abnormalities, embryofetal and infant mortality, and alterations of growth
Adverse effects generally occurred at large multiples of the MRHDID when drug was administered by oral route to achieve high systemic exposures; no evidence of fetal harm was observed in rabbits at an exposure approximately 4,900 times the MRHDID
Lactation
There are no data on presence of arformoterol or its metabolites in human milk, effects on breastfed infant, or on milk production; however, arformoterol was excreted in milk of lactating rats; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Interactions
Other adrenergic drugs may potentiate the effect. Use with caution.
Xanthine derivatives, steroids, diuretics, or non-potassium-sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution.
MAO inhibitors, tricyclic antidepressants, and drugs that prolong the QTc interval may potentiate effects on the cardiovascular system. Use with extreme caution.
Beta-blockers may decrease effectiveness. May block the bronchodilatory effects of beta-agonists. Use with caution and only when medically necessary.
Contraindicated (2)
cisapride
thioridazine
Serious - Use Alternative (35)
adagrasib
amisulpride
amitriptyline
amoxapine
clomipramine
desipramine
doxepin
fexinidazole
formoterol
foscarnet
glasdegib
hydroxychloroquine sulfate
imipramine
indacaterol, inhaled
inotuzumab
isocarboxazid
ivosidenib
lefamulin
linezolid
lofepramine
lopinavir
macimorelin
maprotiline
mobocertinib
nortriptyline
ondansetron
panobinostat
phenelzine
pimozide
protriptyline
tranylcypromine
trazodone
trimipramine
umeclidinium bromide/vilanterol inhaled
vilanterol/fluticasone furoate inhaled
Adverse Effects
Side effects of Arformoterol :
1-10%
Back pain (6%)
Chest pain (7%)
Diarrhea (6%)
Dyspnea (4%)
Flu syndrome (3%)
Leg cramps (4%)
Lung disorder (2%)
Pain (8%)
Peripheral edema (3%)
Rash (4%)
Sinusitis (5%)
Mechanism of Action
Long-acting beta2-agonist, R, R-enantiomer of racemic formoterol; relaxes bronchial smooth muscle by acting selectively on beta2-receptors.
The pharmacologic effects of beta2-adrenoceptor agonist drugs, including arformoterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cyclic AMP). Increased intracellular cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Note
Aroneb 15 mcg/2 ml Nebuliser Solution manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Arformoterol. Aroneb is availble in Bangladesh.
Farmaco BD drug index information on Aroneb Nebuliser Solution is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.