Protide 25/125 HFA

Protide 25/125 HFA25mcg+125mcg

Type:120 Doses Unit

Generic Name:Salmeterol + Fluticasone

Manufacturer:Unimed Unihealth Pharmaceuticals Ltd.

Price:595.00

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Indication

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.

Contraindication

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

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.

Precaution

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.

Side Effect

>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.

Interaction

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

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