Salmeflo Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per 25 mcg/125 mcg MDI Salmeterol xinafoate 25 mcg, fluticasone propionate 125 mcg. Per 25 mcg/250 mcg MDI Salmeterol xinafoate 25 mcg, fluticasone propionate 250 mcg. Per 50 mcg/250 mcg DPI Salmeterol xinafoate 50 mcg, fluticasone propionate 250 mcg. Per 50 mcg/500 mcg DPI Salmeterol xinafoate 50 mcg, fluticasone propionate 500 mcg

Indications/Uses

MDI: Reversible obstructive airways disease including asthma where use of combination therapy is appropriate. Maintenance treatment of COPD including chronic bronchitis & emphysema. DPI: Maintenance & treatment of mild, moderate & severe persistent asthma in patients >5 yr & w/ COPD.

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Dosage/Direction for Use

MDI Adult & adolescent ≥12 yr 2 inhalations bid. Childn ≥4 yr 2 inhalations bid. DPI Adult & adolescent ≥12 yr 1 cap bid.

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Contraindications

Hypersensitivity. DPI: History of paradoxical bronchospasm.

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Special Precautions

MDI: Risk of exacerbation when therapy in patients w/ asthma is stopped abruptly. Cessation of therapy in patients w/ COPD may be associated w/ symptomatic decompensation. Patients w/ active or quiescent pulmonary TB, thyrotoxicosis, systemic effects including adrenal suppression, growth retardation (childn & adolescents) decrease in bone mineral density, cataract, glaucoma. Regularly monitor height in childn w/ prolonged treatment. DPI: Discontinue use then shift to short acting selective β₂-agonist if breakthrough asthma symptoms or acute asthma exacerbations occur. Avoid use during pregnancy.

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Adverse Reactions

Tachycardia, palpitations, cardiac arrhythmias, precipitation of angina pectoris, CNS stimulation, dry mouth, sweating, headache, dizziness, nausea, vomiting, nervousness, anxiety & tremor, hypersensitivity reactions. DPI: Salmeterol: Peripheral vasodilatation; muscle cramps; potentially serious hypokalemia w/ large doses; paradoxical bronchospasm, angioedema, urticaria, hypotension, collapse. Fluticasone: Churg-Strauss syndrome.

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Drug Interactions

MDI: Nonselective & selective β-blockers. Fluticasone: Potential increased systemic exposure when co-administered w/ strong CYP3A4 inhibitors eg, ketoconazole, ritonavir. DPI: Salmeterol: Increased risk of hypokalaemia w/ corticosteroids, diuretics, or xanthines. Fluticasone: Enhanced metabolism & reduced systemic effects w/ barbiturates, carbamazepine, phenytoin, primidone, rifampicin. Increased plasma conc w/ OCs, ritonavir. Excessive K loss w/ K-depleting diuretics eg, thiazides or frusemide.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Salmeflo detailed prescribing information

Storage

View Salmeflo storage conditions for details to ensure optimal shelf-life.

Description

View Salmeflo description for details of the chemical structure and excipients (inactive components).

Action

View Salmeflo mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Antiasthmatic & COPD Preparations

ATC Classification

R03AK06 - salmeterol and fluticasone ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.

Regulatory Classification

Presentation/Packing

Form

Salmeflo MDI 25 mcg/125 mcg

Packing/Price

1's (P440/canister)

Form

Salmeflo MDI 25 mcg/250 mcg

Packing/Price

1's (P619/canister)

Form

Salmeflo DPI 50 mcg/250 mcg

Packing/Price

(w/ Innohaler) 40 × 1's (P494/box)

Form

Salmeflo DPI 50 mcg/500 mcg

Packing/Price

(w/ Innohaler) 40 × 1's (P688/box)

Salmeflo

salmeterol + fluticasone

Manufacturer:

Lloyd

Distributor:

InnoGen Pharmaceuticals