Indications
Bexitrol Inhalation is used for:
Chronic asthma, COPD
Adult Dose
Inhalation
Asthma Prevention and Maintenance, COPD Maintenance
Adult: As inhaler:
2 puffs (50 mcg) twice daily; up to 100 mcg twice daily if needed.
Prevention of Exercise-Induced Asthma
2 puffs (50 mcg) at least 30 min prior to exercise.
Child Dose
Inhalation
Child > 4 years
Asthma Prevention and Maintenance, COPD Maintenance
As inhaler:
2 puffs (50 mcg) twice daily; up to 100 mcg twice daily if needed.
Prevention of Exercise-Induced Asthma
2 puffs (50 mcg) at least 30 min prior to exercise.
Renal Dose
Administration
Contra Indications
Contraindicated in patients with hypersensitivity to Salmeterol or to the any excipient of this preparation. Monotherapy in the treatment of asthma. Treatment of status asthmaticus, other acute episodes of asthma or COPD.
Precautions
Patient w/ CV disease, CNS disorders, DM, hyperthyroidism, hypokalaemia, seizure disorders, ketoacidosis. Not intended for the relief of acute bronchospasm. Hepatic impairment. Pregnancy and lactation. Monitoring Parameters Monitor pulmonary function, BP, heart rate, CNS stimulation, hepatic function; glucose and K levels..
Pregnancy-Lactation
Pregnancy
Available data from published epidemiological studies and case reports in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Beta-agonists may interfere with uterine contractility
There are clinical considerations in pregnant women with asthma
In women with poorly or moderately controlled asthma, there is increased risk of pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate
Severe asthma during pregnancy has been associated with maternal mortality, fetal mortality, or both
Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control
Animal data
Oral administration of salmeterol to pregnant rabbits caused teratogenicity characteristic of beta-adrenoceptor stimulation at maternal doses approximately 50 times maximum recommended human daily inhaled dose (MRHDID) on an AUC basis
Labor and delivery
There are no adequate and well-controlled human studies that have evaluated effects of therapy during labor and delivery; because of potential for beta-agonist interference with uterine contractility, use during labor should be restricted to those patients in whom the benefits clearly outweigh the risks
Lactation
There is no information regarding presence of salmeterol in human milk, effects on breastfed child, or on milk production
Drug is detected in rat milk; drug concentrations in human plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be low
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 child from treatment or from underlying maternal condition
Interactions
Diuretics, corticosteroids and xanthines may augment hypokalaemia. Risk of severe hypertension when used with MAOIs, TCAs and other sympathomimetics. Increased susceptibility to cardiac arrhythmias caused by digoxin and other cardiac glycosides.
Side Effects
Side effects of Salmeterol :
>10%
Headache (13-17%), Pain (1-12%)
1-10%
Nasal congestion (9%), Hypertension (4%), Edema (1-3%), Dizziness (4%), Sleep disturbance (1-3%), Migraine (1-3%), Contact dermatitis (1-3%), Urticaria (3%), Hyperglycemia (1-3%), Articular rheumatism (1-3%), Paresthesia (1-3%), Muscular stiffness (1-3%), Photodermatitis (1-2%), Bronchitis (7%), Influenza (5%), Rigidity (1-3%), Rhinitis (5%), Asthma (3%)
Frequency Not Defined
Conjunctivitis, Hyperglycemia, Keratitis, Oral candidiasis, Chest tightness, Cataracts, Hypokalemia, Myositis
Mode of Action
Salmeterol is a direct-acting sympathomimetic which relaxes bronchial smooth muscle by its selective action on beta 2 receptors with little effect on heart rate.
Note
Bexitrol 25mcg Inhalation generic name is Salmeterol. Bexitrol 25mcg Inhalation is manufactured by Beximco Pharmaceuticals Ltd.Bexitrol is availble in all over Bangladesh.
Mes BD drug index information on Bexitrol Inhalation is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.