Salmeterol + Fluticasone

Indications

Salmeterol + Fluticasone is used for: Chronic Asthma, COPD

Adult Dose

Inhalation Asthma Adult: As combination containing salmeterol 50 mcg and fluticasone propionate 100/250/500 mcg/dose of inhalation powder: 1 inhalation bid. As combination containing salmeterol 25 mcg and fluticasone propionate 50/125/250 mcg/dose of pressurised inhalation: 2 inhalation bid. Chronic obstructive pulmonary disease Adult: As combination containing salmeterol 50 mcg and fluticasone propionate 500 mcg/dose of inhalation powder: 1 inhalation bid.

Child Dose

Inhalation Asthma Child: 4-12 yr: As combination containing salmeterol 50 mcg and fluticasone propionate 100 mcg/ dose of inhalation powder: 1 inhalation bid; As combination containing salmeterol 25 mcg and fluticasone propionate 50 mcg/dose of pressurised inhalation: 2 inhalation bid. >12 yr: As combination containing salmeterol 50 mcg and fluticasone propionate 100/250/500 mcg/dose of inhalation powder: 1 inhalation bid; As combination containing salmeterol 50/125/250 mcg and fluticasone propionate 50 mcg/dose of pressurised inhalation: 2 inhalation bid.

Renal Dose

Administration

Contra Indications

Not for primary treatment of status asthmaticus or other acute attacks of asthma. Severe hypersensitivity to milk proteins.

Precautions

Pulmonary TB, severe cardiovascular disorders, heart rhythm abnormalities, DM, thyrotoxicosis, hypokalaemia. Patients at risk of decreased bone mineral content (e.g. smoking, old age, sedentary lifestyle, poor nutrition, family history of osteoporosis or long term use of drugs that may decrease bone mass (e.g. anticonvulsants and corticosteroids). Do not stop therapy abruptly; therapy should be down titrated. Advise patient to rinse mouth after inhalation. Monitor height of children on prolonged therapy. Pregnancy, lactation.

Pregnancy-Lactation

Pregnancy There are no randomized clinical studies in pregnant women; in women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control of asthma Labor and delivery There are no human studies evaluating effects of therapy during labor and delivery; because of potential for beta-agonist interference with uterine contractility, use of drug during labor should be restricted to those patients in whom benefits clearly outweigh the risks Lactation There are no available data on presence of fluticasone propionate or salmeterol in human milk, effects on breastfed child, or effects on milk production; other corticosteroids have been detected in human milk; however, fluticasone propionate and salmeterol concentrations in plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low; 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 therapy or from underlying maternal condition Measurable levels of salmeterol and fluticasone detected in lactating rats treated with each drug

Interactions

Increased fluticasone levels with CYP 3A4 inhibitors e.g ritonavir, ketoconazole, itraconazole. Additive effects with other beta-agonist.

Side Effects

Side effects of Salmeterol + Fluticasone : >10% Upper respiratory tract infection (21-27%), Headache (12-21%), Pharyngitis (10-13%) 1-10% Candidiasis, nonspecific site (0-10%), Throat irritation (7-9%), Musculoskeletal pain (2-9%), Bronchitis (2-8%), Upper respiratory inflammation (4-7%), Viral respiratory infections (4-6%), Nausea or vomiting (4-6%), Cough (3-6%), Sinusitis (4-5%), Hoarseness or dysphonia (2-5%), Fever (3-4%), Diarrhea (2-4%), Gastrointestinal (GI) discomfort or pain (1-4%), Oral candidiasis (1-4%), Muscle cramps or spasms (3%), Malaise or fatigue (2-3%), Viral GI infections (0-3%) Potentially Fatal: Paradoxical bronchospasm.

Mode of Action

Salmeterol, a long acting beta 2-agonist which acts locally in the lung to mediate bronchodilation. Fluticasone, a corticosteroid with mainly glucocorticoid activity, reduce symptoms and exacerbations of asthma.