BUFOMIX Easyhaler 160/4.5 Inhalation
Budesonide + Formoterol Fumarate
"160mcg, 4.5mcg/dose "
Hikma Pharmaceuticals
| Pack size | 1 Metered dose inhaler (120 Inhalation doses) |
|---|---|
| Dispensing mode | POM |
| Source | JORDAN |
| Agent | Gulf Drug LLC |
| Retail Price | 163.50 AED |
Available as:
Indications
BUFOMIX Easyhaler 160/4.5 Inhalation is used for:
Asthma, COPD
Adult Dose
Asthma Maintenance and reliever therapy: Adults and adolescents (12 years and older) -
As both maintenance and reliever therapy:
Adults and adolescents (12 years and older): The recommended maintenance dose is 1 puff twice daily or 2 puffs once daily. For some patients a maintenance dose of 2 puffs twice daily may be appropriate (for 160/4.5 mcg/inhalation only). Patients should take 1 additional puff as needed in response to symptoms. If symptoms persist after a few minutes, the additional puff should be taken. Not more than 6 puffs should be taken on any single occasion.
Convicap/cozycap: Maintenance dose: 100 Convicap twice daily. 200 Convicap twice daily. Reliever dose: 1 additional Convicap as needed in response to symptoms. If symptoms persist after a few minutes, an additional Convicap should be taken.
COPD 200 Convicap: 2 Convicaps twice daily. 400 Convicap: 1 Convicap twice daily
Child Dose
<12 years: Safety and efficacy not established
Renal Dose
Administration
Contra Indications
Primary treatment of status asthmaticus or other acute episodes of asthma. Hypersensitivity to Budesonide, Formoterol or to Lactose.
Precautions
Treatment with Budesonide and Formoterol combination should not be initiated to treat a severe exacerbation or if patients have significantly worsening or acutely deteriorating asthma. May produce paradoxical bronchospasm which is life-threatening. Caution when used in patients with CV diseases, especially coronary insufficiency, cardiac arrhythmias and hypertension. Chronic use may further decrease bone mineral content when used in patients with advanced age, osteoporosis, poor nutrition, sedentary lifestyle or tobacco use. May reduce growth velocity when used in paediatric patients. Caution when used in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral or parasitic infections, or ocular herpes simplex. Pregnancy and lactation.
Lactation: No data; weigh risks of therapy against benefits, and either discontinue drug or do not nurse
Pregnancy-Lactation
Pregnancy
In women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control
There are no well-controlled human studies that have investigated the effects of therapy during labor and delivery; because of potential for beta-agonist interference with uterine contractility, use of therapy during labor should be restricted to those patients in whom the benefits clearly outweigh risk
Lactation
There are no available data on the breastfed child or on milk production; budesonide, like other inhaled corticosteroids, is present in human milk; there are no available data on the presence of formoterol fumarate in human milk; formoterol fumarate is present in rat milk; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or from underlying maternal condition
Interactions
Concomitant admin with CYP3A4 inhibitor e.g. itraconazole, clarithromycin, erythromycin may inhibit the metabolism of budesonide. Concurrent use with nonpotassium-sparing diuretics may lead to ECG changes and/or hypokalaemia.
Adverse Effects
Side effects of Budesonide + Formoterol Fumarate :
>10%
Upper respiratory tract infection (URTI) (8-11%), Headache (7-11%), Nasopharyngitis (7-11%)
1-10%
Pharyngolaryngeal pain (6-9%), Stomach discomfort (1-7%), Sinusitis (5-6%), Oral candidiasis (1-6%), Bronchitis (5%), Viral URTI (4%), Backache (2-3%), Influenza (2-3%), Nasal congestion (2-3%), Vomiting (1- 3%)
Mechanism of Action
Budesonide is a corticosteroid that has mainly glucocorticoid activity. It prevents and controls inflammation by controlling the rate of protein syntheis, decreasing the migration of polymorphonuclear leucocytes/fibroblasts and reversing capillary permeability.
Formoterol fumarate is a selective beta2-adrenergic agonist. It causes bronchodilation by catalysing the conversion of adenosine triphosphate to cyclic-3', 5'-adenosine monophosphate (cyclic AMP) resulting in bronchial smooth muscle relaxation.
Note
BUFOMIX Easyhaler 160/4.5 "160mcg, 4.5mcg/dose " Inhalation manufactured by Hikma Pharmaceuticals. Its generic name is Budesonide + Formoterol Fumarate. BUFOMIX Easyhaler 160/4.5 is availble in United Arab Emirates.
Farmaco UAE drug index information on BUFOMIX Easyhaler 160/4.5 Inhalation is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
Some other brands of Budesonide + Formoterol Fumarate :
Inhaler / Dry Powder
Symbicort Turbuhale
"80mcg, 4.5mcg/dose"
ASTRAZENECA AB
Inhaler / Dry Powder
Symbicort Turbuhler
"160mcg, 4.5mcg/dose "
ASTRAZENECA AB
Inhaler / Dry Powder
Symbicort Turbuhaler
"320mcg, 9mcg/dose"
ASTRAZENECA AB
Inhalation
BUFOMIX Easyhaler 320/9
"320mcg, 9mcg/dose"
Hikma Pharmaceuticals