Dulera

Dulera (mometasone furoate 100 mcg/200 mcg and formoterol fumarate dihydrate 5 mcg) is a long-acting beta agonist and inhaled corticosteroid used to treat asthma. Common side effects of Dulera include:

•  stuffy nose
• hoarseness or deepened voice
• dry mouth
• sore throat headache
• sinus pain
• changes in menstrual periods
• dizziness
• anxiety
• headache
• sleep problems (insomnia)
• back pain
• muscle cramps
• cough
• skin rash, or
• itching

The recommended daily dosage of Dulera is two inhalations twice a day. Talk to your doctor about your individual dosage amount. Aldesleukin, beta blockers, azole antifungals, macrolide antibiotics, and HIV protease inhibitors may interact with Dulera. Tell your doctor if you have serious side effects of Dulera including sores or white patches in your mouth or throat; wheezing, choking, or other breathing problems after using this medication; blurred vision, eye pain, or seeing halos around lights; changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist); low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; chest pain, fast or pounding heartbeats, tremors, restless feeling, seizures; increased thirst or hunger, urinating more than usual; or worsening asthma symptoms.

Our Dulera (mometasone furoate 100 mcg/200 mcg and formoterol fumarate dihydrate 5 mcg) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Dulera Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening asthma symptoms;
• tremors, nervousness, chest pain, fast or pounding heartbeats;
• fever, chills, cough with mucus, feeling short of breath;
• wheezing, choking, or other breathing problems after using this medication;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• signs of thrush (a fungal infection)--sores or white patches in your mouth or throat, trouble swallowing;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder--tiredness or weakness, feeling light-headed, nausea, vomiting.

Mometasone can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• runny or stuffy nose, sinus pain;
• headache; or
• cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Dulera (Mometasone Furoate, Formoterol Fumarate Dihydrate Inhalation)

 

Dulera Professional Information

SIDE EFFECTS

LABA use may result in the following:

• Serious asthma-related events - hospitalizations, intubations, and death [see WARNINGS AND PRECAUTIONS].
• Cardiovascular and central nervous system effects [see WARNINGS AND PRECAUTIONS].

Systemic and local corticosteroid use may result in the following:

• Candida albicans infection [see WARNINGS AND PRECAUTIONS]
• Immunosuppression [see WARNINGS AND PRECAUTIONS]
• Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
• Growth effects in pediatrics [see WARNINGS AND PRECAUTIONS]
• Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

The safety data described below is based on 3 clinical trials which randomized 1913 patients 12 years of age and older with asthma, including 679 patients exposed to DULERA for 12 to 26 weeks and 271 patients exposed for 1 year. DULERA was studied in two placebo-and active-controlled trials (n=781 and n=728, respectively) and in a long-term 52-week safety trial (n=404). In the 12 to 26week clinical trials, the population was 12 to 84 years of age, 41% male and 59% female, 73% Caucasians, 27% non-Caucasians. Patients received two inhalations twice daily of DULERA (100 mcg/5 mcg or 200 mcg/5 mcg), mometasone furoate MDI (100 mcg or 200 mcg), formoterol MDI (5 mcg) or placebo. In the long-term 52-week active-comparator safety trial, the population was 12 years to 75 years of age with asthma, 37% male and 63% female, 47% Caucasians, 53% non-Caucasians and received two inhalations twice daily of DULERA 100 mcg/5 mcg or 200 mcg/5 mcg, or an active comparator.

The incidence of treatment emergent adverse reactions associated with DULERA in Table 2 below is based upon pooled data from 2 clinical trials 12 to 26 weeks in duration in patients 12 years and older treated with two inhalations twice daily of DULERA (100 mcg/5 mcg or 200 mcg/5 mcg), mometasone furoate MDI (100 mcg or 200 mcg), formoterol MDI (5mcg) or placebo.

Table 2: Treatment-Emergent Adverse Reactions in DULERA Groups Occurring at an Incidence of ≥3% and More Commonly than Placebo

Adverse Reactions	DULERA*		Mometasone Furoate*		Formoterol*	Placebo* n=196 n (%)
	100 mcg/5 mcg n=424 n (%)	200 mcg/5 mcg n=255 n (%)	100 mcg n=192 n (%)	200 mcg n=240 n (%)	5 mcg n=202 n (%)
Nasopharyngitis	20 (4.7)	12 (4.7)	15 (7.8)	13 (5.4)	13 (6.4)	7 (3.6)
Sinusitis	14 (3.3)	5 (2.0)	6 (3.1)	4 (1.7)	7 (3.5)	2 (1.0)
Headache	19 (4.5)	5 (2.0)	10 (5.2)	8 (3.3)	6 (3.0)	7 (3.6)
Average Duration of Exposure (days)	116	81	165	79	131	138
*All treatments were administered as two inhalations twice daily.

Oral candidiasis has been reported in clinical trials at an incidence of 0.7% in patients using DULERA 100 mcg/5 mcg, 0.8% in patients using DULERA 200 mcg/5 mcg and 0.5% in the placebo group.

Long-Term Clinical Trial Experience

In a long-term safety trial in patients 12 years and older treated for 52 weeks with DULERA 100 mcg/5 mcg (n=141), DULERA 200 mcg/5 mcg (n=130) or an active comparator (n=133), safety outcomes in general were similar to those observed in the shorter 12 to 26 week controlled trials. No asthma-related deaths were observed. Dysphonia was observed at a higher frequency in the longer term treatment trial at a reported incidence of 7/141 (5%) patients receiving DULERA 100 mcg/5 mcg and 5/130 (3.8%) patients receiving DULERA 200 mcg/5 mcg. No clinically significant changes in blood chemistry, hematology, or ECG were observed.

Postmarketing Experience

The following adverse reactions have been reported during post-approval use of DULERA or post-approval use with inhaled mometasone furoate or inhaled formoterol fumarate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac disorders: angina pectoris, cardiac arrhythmias, e.g., atrial fibrillation, ventricular extrasystoles, tachyarrhythmia Immune system disorders: immediate and delayed hypersensitivity reactions including anaphylactic reaction, angioedema, severe hypotension, rash, pruritus

Investigations: electrocardiogram QT prolonged, blood pressure increased (including hypertension)

Metabolism and nutrition disorders: hypokalemia, hyperglycemia

Respiratory, thoracic and mediastinal disorders: asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm

Read the entire FDA prescribing information for Dulera (Mometasone Furoate, Formoterol Fumarate Dihydrate Inhalation)