Drug Guide
Fluticasone Propionate and Salmeterol Xinafoate
Classification
Therapeutic: Bronchodilator and Anti-inflammatory for asthma/COPD
Pharmacological: Corticosteroid and Long-acting Beta-2 adrenergic agonist
FDA Approved Indications
- Maintenance treatment of asthma in patients 4 years and older
- Prevention of exercise-induced bronchospasm in patients 4 years and older
- Maintenance treatment of airflow obstruction in patients with COPD
Mechanism of Action
Fluticasone propionate reduces inflammation by inhibiting multiple cell types and mediator substances; salmeterol stimulates beta-2 adrenergic receptors leading to bronchodilation.
Dosage and Administration
Adult: Inhalation twice daily, as prescribed by physician, using the specific device and dose.
Pediatric: Typically starting at the lowest dose, titrated based on response; consult specific product labeling.
Geriatric: Adjust doses cautiously, considering potential for increased systemic effects and comorbidities.
Renal Impairment: No specific dosage adjustment needed.
Hepatic Impairment: No specific dosage adjustment needed.
Pharmacokinetics
Absorption: Rapid absorption through pulmonary tissue.
Distribution: Extensively bound to plasma proteins, predominantly to albumin.
Metabolism: Fluticasone is metabolized in the liver via CYP3A4, salmeterol is metabolized by CYP3A4.
Excretion: Metabolites excreted primarily in feces and urine.
Half Life: Fluticasone: approx. 7.8 hours; Salmeterol: approx. 5.5 hours.
Contraindications
- Hypersensitivity to glucocorticoids or salmeterol.
- Acute episodes of asthma or COPD exacerbation requiring oral or IV corticosteroids.
Precautions
- Use with caution in patients with infections, ocular herpes simplex, or osteoporosis.
- Monitor for systemic corticosteroid effects, such as adrenal suppression, especially in long-term use.
Adverse Reactions - Common
- Oral candidiasis (Common)
- Headache (Common)
- Throat irritation (Common)
- Rhinitis (Common)
Adverse Reactions - Serious
- Paradoxical bronchospasm (Rare)
- Immunosuppression leading to infections (Rare)
- Cardiovascular effects (tachycardia, hypertension) (Rare)
- Bone fractures (Rare)
- Ocular effects (glaucoma, cataracts) (Rare)
Drug-Drug Interactions
- Other beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, CYP3A4 inhibitors (e.g., ketoconazole)
Drug-Food Interactions
- Avoid concurrent use with grapefruit juice (due to CYP3A4 inhibition).
Drug-Herb Interactions
N/ANursing Implications
Assessment: Monitor respiratory status, lung sounds, and peak expiratory flow rate.
Diagnoses:
- Impaired gas exchange
- Risk for infection
- Ineffective airway clearance
Implementation: Administer inhaler/device properly, educate patient on inhalation technique, rinse mouth after use.
Evaluation: Assess symptom control, lung function tests, and side effects.
Patient/Family Teaching
- Use inhaler/device as prescribed, do not stop medication abruptly.
- Rinse mouth to prevent oral thrush.
- Report any signs of paradoxical bronchospasm or systemic effects.
Special Considerations
Black Box Warnings:
- Severe asthma episodes if used for acute symptoms.
- Potential risk of asthma-related death with long-term use if not properly managed.
Genetic Factors: Genetic variations in CYP3A4 may affect drug metabolism.
Lab Test Interference: May cause false decrease in serum cortisol levels.
Overdose Management
Signs/Symptoms: Severe systemic corticosteroid effects, such as hyperglycemia, hypertension, or adrenal suppression.
Treatment: Discontinue medication, supportive measures, systemic corticosteroids if necessary.
Storage and Handling
Storage: Store at room temperature, away from moisture, heat, and light.
Stability: Stable under recommended storage conditions for the duration specified on the label.