Fluticasone propionate + Formoterol fumarate inhaler

Introduction: Fluticasone propionate + Formoterol fumarate inhaler is used in the treatment of asthma (wheezing and shortness of breath) and chronic obstructive pulmonary disorder (a lung disorder in which the flow of air to the lungs is blocked).

How it works: Formoterol is a long-acting bronchodilator which works by relaxing the muscles in the airways and widens the airways. Fluticasone Propionate is a steroid that works by stopping the release of certain chemical messengers that cause inflammation of the airways.

Important Information: This inhaler should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (reliever). Use at the same time each day.

• Asthma: where use of a combination product is appropriate - patients not adequately controlled with inhaled corticosteroids and 'as needed' short-acting β₂-agonist, or patients already adequately controlled on both.
• COPD: where a long-acting β₂-agonist/inhaled corticosteroid is indicated and patients are unable to use other long-acting β₂-agonist/inhaled corticosteroid.

Respiratory corticosteroids

Long-acting β₂-agonist + Inhaled corticosteroid

Fluticasone propionate is a synthetic, trifluorinated glucocorticoid with potent anti-inflammatory activity in the lungs when given by inhalation. Fluticasone propionate reduces symptoms and exacerbations of asthma. Formoterol fumarate is a long-acting selective β₂ adrenergic receptor agonist. Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. The onset of bronchodilating effect is rapid, within 1-3 minutes, and the duration of effect is at least 12 hours after a single dose.

Formoterol relaxes bronchial smooth muscles to improve airflow. Fluticasone reduces lung inflammation by decreasing inflammatory cell activity.

Adult Dose (250/10 mcg):

• 2 inhalations (puffs) twice daily - morning and evening.

Adult Dose (50/5 mcg):

• 2 inhalations (puffs) twice daily - morning and evening.

Adult Dose (125/5 mcg):

• 2 inhalations (puffs) twice daily - morning and evening.

Adolescents (12+ years):

• 50/5 mcg or 125/5 mcg - 2 puffs twice daily.

Under 12 years: Not recommended.

* Use as directed by the registered physician

Instructions for using the inhaler:

• Remove the cap.
• Shake the inhaler vigorously (at least 6 times).
• Breathe out fully.
• Place mouthpiece in mouth and close lips around it.
• While breathing in deeply and slowly, press down firmly on the canister to release the medicine.
• Hold breath for 10 seconds.
• Rinse mouth with water after each use.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and follow your regular schedule.

Common Side Effects:

• Nausea
• Vomiting
• Respiratory tract infection
• Fungal infection of mouth
• Sore throat
• Headache
• Hoarseness of voice
• Cough
• Musculoskeletal pain
• Increased heart rate

Precautions:

• Do not use in acute asthma attacks (fast-acting reliever inhaler needed).
• Seek medical advice if asthma symptoms remain uncontrolled or worsen.
• Paradoxical bronchospasm may occur - use bronchodilator immediately and discontinue.
• Use with caution in tuberculosis, diabetes, hypertension, heart disease.
• Avoid during pregnancy and lactation.

Contraindications:

• Hypersensitivity to active substances or excipients
• Not for first-line treatment of asthma

Drug Interactions:

• Long-term treatment & co-administration with CYP3A4 inhibitors (ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, ketoconazole, telithromycin) requires caution.
• Non-K sparing diuretics, xanthine derivatives, glucocorticosteroids.
• Concomitant use with MAOIs, furazolidone & procarbazine may precipitate hypertensive reactions.

Food Interactions:

• Unsafe to consume alcohol.

Use in Pregnancy: May be unsafe during pregnancy. Animal studies have shown harmful effects. Your doctor will weigh the benefits and risks.

Use in Lactation: Probably safe during breastfeeding. Limited data suggests the drug does not represent any significant risk to the baby.

Pediatric Use: Not recommended for children under 12 years.

Geriatric Use: No dose adjustment is needed for elderly patients.

Renal Impairment: No data available for use in patients with renal impairment.

Hepatic Impairment: No data available for use in patients with hepatic impairment.

Overdose:

• Formoterol: Angina, hypertension/hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, hypokalemia, hyperglycemia.
• Fluticasone: Temporary suppression of HPA axis function.

Storage: Store in a cool and dry place, protected from light.

Fluticasone propionate + Formoterol fumarate Inhaler