Salmeterol

Indications

Salmeterol 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.