- Long-acting beta2-adrenergic agonists (LABAs) may increase the risk of asthma-related death [US Black Box Warning]
- When treating patients with asthma, prescribe this drug only for patients not adequately controlled with other asthma-controller medications or whose disease severity clearly warrants initiation of treatment with two maintenance therapies [US Black Box Warning]
- Do not use in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids [US Black Box Warning]
- As therapy has not been studied in patients with acutely deteriorating asthma or COPD, do not initiate in acutely deteriorating asthma or to treat acute symptoms
- Do not use in combination with other inhaled drugs containing beta2-adrenergic agents because of risk of overdose
- Monitor patients periodically for signs of adverse effects on the oral cavity because Candida albicans infection of the mouth and throat may occur during therapy. Advise patients to rinse the mouth following inhalation
- Monitor patients with COPD for signs and symptoms of pneumonia and other lung infections during therapy
- Patients who are on immunosuppressant drugs may experience potential worsening of infections e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex. Use with caution in patients with these infections. More serious or even fatal courses of chickenpox or measles can occur in susceptible patients
- Carefully monitor patients who have been transferred from systemically active corticosteroids to inhaled corticosteroid therapy because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to inhaled corticosteroids
- Discontinue therapy if hypercorticism and adrenal suppression occur with very high dosages or at the regular dosage in susceptible individuals
- Discontinue therapy and institute alternative therapy if paradoxical bronchospasm occurs
- Use with caution in patients with cardiovascular or central nervous system disorders because of beta-adrenergic stimulation
- Assess bone mineral density initially and periodically thereafter because decreases in bone mineral density (BMD) have been observed with long-term administration of therapy
- Monitor growth of pediatric patients because orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients
- Long-term administration of therapy may cause glaucoma, increased intraocular pressure, and cataracts
- Monitor for metabolic effects like eosinophilic conditions, hypokalemia, and hyperglycemia during therapy
- Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis
Cautions: Use cautiously in
- Hepatic impairment
- Arrhythmias
- Seizure disorder
- Measles or varicella exposure
- TB infection
- HTN
- Systemic steroid use
- Elderly patients
- Pediatric or adolescent patients
- Cardiovascular disease
- Hypokalemia
- Diabetes mellitus
- Hyperthyroidism
- Ocular HSV
- Increased IOP
- Glaucoma
- Untreated infections
- Cataracts
Pregnancy Category:C
Breastfeeding: No published data exist on the use of formoterol by inhaler during lactation. Very little formoterol is expected to be excreted into breastmilk. Therefore it is acceptable during breastfeeding because of the low bioavailability and maternal serum levels after use. Safety of inhaled mometasone is unknown. Very little inhaled mometasone is expected to be excreted into breastmilk. Therefore it is acceptable during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 23 May 2011). Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of therapy, taking into account the importance of the therapy to the mother.
US Trade Name(s)
US Availability
Dulera (formoterol/mometasone)
- MDI
- 5 mcg/100 mcg/INH
- 5 mcg/200 mcg/INH
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Dulera 200-5 MCG/ACT AERO [Inhaler] (SCHERING)
13 act = $229.99
39 act = $659.98 - Dulera 100-5 MCG/ACT AERO [Inhaler] (SCHERING)
13 act = $222.98
39 act = $648.96
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
