Azbec Inhaler
Beclomethasone Dipropionate
250mcg
Eskayef Pharmaceuticals Ltd.
| Pack size | 200 puffs |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 320.00 AED |
Available as:
Indications
Azbec Inhaler is used for:
Asthma, Chronic obstructive pulmonary disease (COPD)
Adult Dose
Management of chronic asthma
Adults: 100-400 mcg twice daily.
Prophylaxis of asthma
Adults: 50-200 mcg twice daily. Increased if necessary to maximum 400 mcg twice daily.
When patient's symptoms remain under satisfactory control, the dose should be titrated to the lowest dose at which effective control of asthma is maintained.
Child Dose
Management of chronic asthma
Children over 12 years: 100-400 mcg twice daily.
Children (5-12 years): 100-200 mcg twice daily. Maximum 200-400 mcg twice daily.
Prophylaxis of asthma
Children over 12 years: 50-200 mcg twice daily. Increased if necessary to maximum 400 mcg twice daily.
Children (5-12 years): The usual starting dose is 100 mcg twice daily. Depending on the severity of asthma, the daily dose may be increased up to 400 mcg administered in 2-4 divided doses.
When patient's symptoms remain under satisfactory control, the dose should be titrated to the lowest dose at which effective control of asthma is maintained.
Renal Dose
Administration
Prime inhaler (2 actuations into air) before first use and after prolonged idleness (>10 days)
Contra Indications
Hypersensitivity to any of the ingredients of this preparation contraindicates its use.
Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Precautions
Localized infections: Candida albicans infection of the mouth and throat may occur. Advise patients to rinse their mouth with water without swallowing after inhalation.
Deterioration of asthma and acute episodes: Do not use QVAR for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma.
Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to QVAR.
Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections. More serious or even fatal courses of chickenpox or measles can occur in susceptible patients. Use with caution in patients with these infections because of the potential for worsening of these infections.
Paradoxical Bronchospasm: Bronchospasm, with an immediate increase in wheezing, may occur after dosing. Treat bronchospasm immediately with an inhaled, short-acting bronchodilator and discontinue QVAR.
Hypersensitivity Reactions: Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm may occur. Discontinue QVAR if such reactions occur.
Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue QVAR slowly.
Monitoring Parameters
Monitor patients periodically for signs of adverse effects on the oral cavity.
Monitor patients with major risk factors for decreased bone mineral content.
Monitor the growth of pediatric patients.
Monitor patients with changes in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts closely.
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled in pregnant women; there are clinical considerations with use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women; available human data do not establish presence or absence of drug- associated risk to fetus; in animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 0.75 times maximum recommended human daily inhalation dose (MRHDID) in adults (0.64 mg/day); in rats exposed to beclomethasone dipropionate by inhalation, dose-related gross injury to fetal adrenal glands was observed at doses greater than 180 times the MRHDID, but there was no evidence of external or skeletal malformations or embryo lethality at inhalation doses up to 440 times the MRHDID
The risk of complications to mother and developing fetus from inadequate control of asthma must be balanced against risks from exposure to beclomethasone dipropionate
Labor or delivery
There are no specific human data regarding any adverse effects of inhaled beclomethasone dipropionate on labor and delivery
Fertility
Impairment of fertility was observed in rats and dogs at oral doses corresponding to 250 and 25 times the MRHDID for adults on a mg/ m² basis, respectively
Lactation
There are no data available on presence in human milk, effects on breastfed child, or on milk production; however, other inhaled corticosteroids have been detected in human milk
The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from beclomethasone dipropionate or from underlying maternal condition
Interactions
Inhibitors of CYP3A4: potential pharmacokinetic interaction (increased plasma beclomethasone dipropionate concentrations).
Inducers of CYP3A4: potential pharmacokinetic interaction (decreased plasma beclomethasone dipropionate concentrations).
Antidiabetic agents
May increase blood glucose concentrations in patients with diabetes mellitus.
NSAIDs
Possible increased risk of GI ulceration
Decreased serum salicylate concentrations. When corticosteroids are discontinued, serum salicylate concentration may increase possibly resulting in salicylate intoxication
Vaccines and Toxoids
May cause a diminished response to toxoids and live or inactivated vaccines.
May potentiate the replication of some organisms contained in live, attenuated vaccines.
Can aggravate neurologic reactions to some vaccines (supraphysiologic dosages).
Contraindicated (0)
Serious - Use Alternative (10)
aldesleukin
BCG intravesical live
BCG vaccine live
echinacea
hyaluronidase
leflunomide
macimorelin
natalizumab
pimecrolimus
tacrolimus ointment
Adverse Effects
Side effects of Beclomethasone Dipropionate :
>10%
Pharyngitis (5-27%),Headache (8-25%),URI (5-11%)
1-10%
Rhinitis (3-7%),Pain (1-5%),Increased asthma symptoms (2-4%),Dysphonia (1-4%),Sinusitis (3%),Oral symptoms (2-3%),Nausea (1-2%)
Mechanism of Action
Beclometasone controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes, fibroblasts, reverses capillary permeability and lysosomal stabilisation at the cellular level to prevent or control inflammation.
Note
Azbec 250mcg Inhaler manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Beclomethasone Dipropionate. Azbec is availble in Bangladesh.
Farmaco BD drug index information on Azbec Inhaler is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.