Formoterol Mometasone

Formoterol Mometasone Brand Name– Dulera

What is Formoterol Mometasone

Formoterol mometasone is a combination of an inhaled corticosteroid (ICS) (mometasone) and a long-acting beta-2 agonist (LABA) (formoterol) administered by oral inhalation.

The combination is indicated for the maintenance treatment of asthma in adult and pediatric patients 5 years and older.

This product is not used for acute bronchospasm or acute asthmatic attacks; a short-acting beta-2 agonist (SABA) should be available for acute bronchospasm.

Formoterol mometasone is not a first-line agent in the treatment of asthma. Orally inhaled corticosteroids (ICSs) such as budesonide are considered a preferred pharmacologic treatment in the long-term management of persistent asthma of various severities according to the Expert Panel of the National Asthma Education and Prevention Program (NAEPP).

NAEPP concluded that ICSs are the most potent and consistently effective class of medications for the long-term control of asthma in both adults and children.

LABAs, such as formoterol, are an acceptable adjunct maintenance treatment with an ICS for persistent asthma inadequately controlled with a low-dose ICS (step 3 care).

NAEPP recommends that equal consideration be given to increasing the ICS dose versus adding a LABA.

The preferred treatments in steps 4 to 6 care include the combined use of a LABA and ICS.

The use of LABAs alone to treat asthma, without an ICS to treat lung inflammation, is associated with an increased risk of asthma-related death; therefore, LABAs are contraindicated in patients with asthma without the use of an asthma controller medication (i.e. ICS).

Formoterol mometasone is used off-label for the maintenance treatment of adults with chronic obstructive pulmonary disease (COPD).

According to the Global Initiative for Chronic Lung Disease (GOLD) guidelines for COPD, a combination of a LABA and ICS, such as formoterol; mometasone, may be used as initial therapy in group D (those with a high risk of exacerbation).

Combination of a LABA with an ICS has the greatest likelihood of reducing exacerbations in patients with blood eosinophil counts of 200 cells/microL and higher.

An ICS combined with a LABA is more effective than the individual components in improving lung function and health status and reducing exacerbations in patients with exacerbations and moderate to very severe COPD; however, clinical trials failed to demonstrate a statistically significant effect on survival.

At follow-up, if the patient is still experiencing dyspnea, consider switching inhaler device and investigate for other causes of dyspnea.

If the patient has COPD exacerbations, consider triple therapy with a long-acting muscarinic antagonist (LAMA), a LABA, and ICS

Indications

  1. asthma
  2. chronic bronchitis
  3. chronic obstructive pulmonary disease (COPD)
  4. emphysema

For the maintenance treatment of asthma

Side Effects

  1. adrenocortical insufficiency
  2. anaphylactoid reactions
  3. angina
  4. angioedema
  5. asthma-related death
  6. atrial fibrillation
  7. blurred vision
  8. bronchospasm
  9. candidiasis
  10. cataracts
  11. cough
  12. dysphonia
  13. dyspnea
  14. flushing
  15. growth inhibition
  16. headache
  17. hyperglycemia
  18. hypertension
  19. hypokalemia
  20. hypotension
  21. hypothalamic-pituitary-adrenal (HPA) suppression
  22. immunosuppression
  23. increased intracranial pressure
  24. infection
  25. influenza
  26. ocular hypertension
  27. osteopenia
  28. osteoporosis
  29. palpitations
  30. pharyngitis
  31. premature ventricular contractions (PVCs)
  32. pruritus
  33. QT prolongation
  34. rash
  35. sinus tachycardia
  36. sinusitis
  37. urticaria
  38. wheezing

Monitoring Parameters

  • blood glucose
  • growth rate
  • pulmonary function tests (PFTs)
  • serum potassium

Contraindications

  • acute bronchospasm
  • alcoholism
  • aneurysm
  • asthma-related death
  • bradycardia
  • breast-feeding
  • cardiac arrhythmias
  • cardiac disease
  • cataracts
  • children
  • coronary artery disease
  • corticosteroid hypersensitivity
  • corticosteroid therapy
  • corticosteroid withdrawal
  • diabetes mellitus
  • diabetic ketoacidosis
  • females
  • fungal infection
  • geriatric
  • glaucoma
  • growth inhibition
  • heart failure
  • hepatic disease
  • herpes infection
  • hypertension
  • hyperthyroidism
  • hypocalcemia
  • hypokalemia
  • hypomagnesemia
  • hypotension
  • hypothalamic-pituitary-adrenal (HPA) suppression
  • increased intracranial pressure
  • increased intraocular pressure
  • infants
  • infection
  • labor
  • long QT syndrome
  • malnutrition
  • MAOI therapy
  • measles
  • myocardial infarction
  • neonates
  • osteoporosis
  • paradoxical bronchospasm
  • pheochromocytoma
  • potential for overdose or poisoning
  • pregnancy
  • QT prolongation
  • seizure disorder
  • seizures
  • status asthmaticus
  • thyroid disease
  • thyrotoxicosis
  • tobacco smoking
  • tuberculosis
  • varicella
  • viral infection
  • visual impairment

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