Dulamet(200 mcg+5 mcg)/puff

Dulamet is indicated for:

FDA-approved indication

• Maintenance treatment of asthma in patients 5 years of age and older whose asthma is not adequately controlled on an inhaled corticosteroid alone, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting beta2-agonist (LABA).

Guideline-supported / regionally approved use

• In some countries (including Bangladesh), fixed-dose ICS/LABA combinations such as Dulamet are also used as maintenance bronchodilator therapy in chronic obstructive pulmonary disease (COPD), per local regulatory labeling; confirm the approved indication on the local product label before use.

Important: Dulamet is not indicated for relief of acute bronchospasm or status asthmaticus and must not be used as a rescue inhaler; a separate short-acting bronchodilator should always be available for acute symptoms.

Each actuation of the Mometasone Furoate + Formoterol Fumarate pressurized inhalation aerosol delivers a fixed-dose combination of mometasone furoate (an inhaled corticosteroid) and formoterol fumarate dihydrate (a long-acting beta2-adrenergic agonist, LABA). It is commonly available in strengths such as 100 mcg/5 mcg and 200 mcg/5 mcg per actuation, delivered via a metered-dose inhaler (MDI) device.

Dulamet is a fixed-dose combination inhaler containing an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA), used for long-term, twice-daily maintenance treatment of asthma. It combines the anti-inflammatory action of mometasone furoate with the bronchodilator action of formoterol fumarate to improve lung function and reduce asthma exacerbations. It is not a rescue inhaler and does not relieve sudden asthma attacks.

Dulamet belongs to the therapeutic class of fixed-dose combination inhaled corticosteroid (ICS) + long-acting beta2-agonist (LABA) bronchodilators used in the maintenance management of asthma.

Pharmacodynamics

Mometasone Furoate + Formoterol Fumarate combines an inhaled corticosteroid and a long-acting beta2-agonist to provide both anti-inflammatory control and sustained bronchodilation; see Mode of Action for mechanistic detail.

Pharmacokinetics

Following inhalation, the mometasone furoate component of Mometasone Furoate + Formoterol Fumarate is largely deposited in the lungs, and the swallowed portion undergoes extensive first-pass hepatic metabolism (via CYP3A4) with low systemic bioavailability. The formoterol fumarate component is absorbed from the lung and gut, metabolized mainly by direct glucuronidation and by O-demethylation via CYP2D6 and CYP2C19, and eliminated primarily in urine and feces as metabolites and unchanged drug.

Dulamet is administered by oral inhalation using the supplied metered-dose inhaler only. Shake the inhaler well before each use, prime it before first use or if not used for more than 5 days, and rinse the mouth with water (without swallowing) after each dose to reduce the risk of oral candidiasis and hoarseness. Do not exceed the prescribed number of inhalations, and do not use this inhaler to treat sudden breathing problems.

Dulamet has the following clinically significant drug interactions:

• Strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin): may increase systemic exposure to the mometasone component of Dulamet, raising the risk of systemic corticosteroid effects including adrenal suppression; concurrent use should be avoided or monitored closely.
• Other long-acting beta2-agonists (LABAs): should not be used concurrently with Dulamet because of additive beta-agonist adverse effects (e.g. tachycardia, tremor).
• Beta-blockers (including ophthalmic): may block the bronchodilator effect of the formoterol component and can produce severe bronchospasm; use only if no alternative is available.
• Monoamine oxidase inhibitors, tricyclic antidepressants, and drugs that prolong the QTc interval: may potentiate the cardiovascular effects of formoterol; use with caution.
• Non-potassium-sparing diuretics (e.g. loop or thiazide diuretics): may worsen ECG changes and/or hypokalemia associated with beta-agonists; monitor potassium levels.

Common side effects of Dulamet include:

• Nasopharyngitis, headache, and upper respiratory tract infection
• Oral candidiasis (thrush) and hoarseness/dysphonia
• Sinusitis and throat irritation
• Back pain and musculoskeletal pain
• Palpitations, tremor, and nervousness (beta-agonist effects)

Less common but serious effects can include paradoxical bronchospasm, hypersensitivity reactions, immunosuppression with increased infection risk, adrenal suppression/hypercorticism, cardiovascular effects (increased heart rate, blood pressure changes, arrhythmia), hypokalemia, hyperglycemia, reduced bone mineral density with long-term use, and effects on growth in children (see Precautions and Warnings, and Use in Special Populations).

Pregnancy: Data on the use of Dulamet in pregnant women are limited. As with other asthma medications, uncontrolled asthma poses risks to both mother and fetus, so Dulamet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under a physician's guidance.

Lactation: It is not known whether the components of Dulamet are excreted in human milk in clinically significant amounts. Caution should be exercised, and a physician should be consulted, when considering use of Dulamet in a breastfeeding woman.

Boxed warning: LABA-associated risk

Long-acting beta2-agonists (LABA) such as the formoterol component of Dulamet may increase the risk of asthma-related death. Available data show that this risk is reduced when a LABA is used in a fixed-dose combination with an inhaled corticosteroid, as in Dulamet, compared with LABA monotherapy; however, this product should be used only in patients whose asthma is not adequately controlled on an inhaled corticosteroid alone or whose severity clearly warrants combination therapy.

Not for acute symptoms

Dulamet is not a rescue inhaler and must not be used to treat acute bronchospasm; patients should have a separate fast-acting bronchodilator available at all times.

Local and systemic corticosteroid effects

Use of Dulamet can cause oropharyngeal candidiasis (rinse mouth after each use), increased susceptibility to infections (chickenpox, measles) especially in unvaccinated or immunosuppressed individuals, and, with prolonged use, hypothalamic-pituitary-adrenal (HPA) axis suppression, reduced bone mineral density, and effects on growth velocity in children.

Cardiovascular caution

The formoterol component of Dulamet can produce clinically significant cardiovascular effects (increased heart rate, blood pressure, ECG changes) in some patients; use with caution in patients with cardiovascular disease, convulsive disorders, thyrotoxicosis, or diabetes mellitus.

Do not stop abruptly

Dulamet should not be stopped abruptly without medical advice, even if symptoms improve, as this may worsen asthma control.

Overdose of Dulamet is likely to produce exaggerated beta-agonist effects (from the formoterol component), such as tachycardia, tremor, headache, nervousness, palpitations, nausea, dizziness, fatigue, insomnia, hypokalemia, hyperglycemia, and metabolic acidosis; seizures and cardiac arrhythmias may occur in severe cases. There is no specific antidote. Anyone who has taken more than the prescribed dose of Dulamet should seek immediate medical attention or contact a poison control center/emergency services; cardiac and electrolyte monitoring is recommended, and supportive care should be provided under medical supervision.

Store the Dulamet inhaler at room temperature (below 30°C), away from direct sunlight, heat, and moisture. Do not puncture, break, or throw the pressurized canister into a fire or incinerator, even when apparently empty. Keep out of reach and sight of children.

Pediatric

Safety and efficacy of Dulamet have been established for the lower approved strength in children 5 years and older; the higher strength is approved only from 12 years of age. See Pediatric Uses.

Geriatric

Clinical studies of Dulamet have not identified differences in response between elderly and younger patients; use with the usual caution given the increased likelihood of comorbid cardiovascular disease.

Hepatic/renal impairment

No specific dose adjustment of Dulamet has been established; use with caution and monitoring, particularly in significant hepatic impairment.

Immunosuppressed patients

Because of the corticosteroid component, Dulamet should be used with particular caution in patients with active or quiescent tuberculosis, untreated fungal/bacterial/viral/parasitic infections, or ocular herpes simplex.

Dulamet is intended for long-term, regular maintenance use, not intermittent or short-course therapy. Treatment duration should be determined by a physician based on asthma control, with periodic reassessment (e.g. every 3-6 months) to step down to the lowest effective dose or step up therapy if control is inadequate; abrupt discontinuation should be avoided.

Mometasone Furoate + Formoterol Fumarate is classified as an Inhaled Corticosteroid (ICS) + Long-Acting Beta2-Adrenergic Agonist (LABA) fixed-dose combination respiratory/anti-asthmatic agent.

Mometasone Furoate + Formoterol Fumarate works through two complementary mechanisms. Mometasone furoate is a synthetic corticosteroid with potent local anti-inflammatory activity; it binds to glucocorticoid receptors in airway tissue, reducing production of pro-inflammatory mediators, cytokines, and inflammatory cell infiltration, thereby decreasing airway hyperresponsiveness and mucosal edema. Formoterol fumarate is a long-acting, selective beta2-adrenergic receptor agonist; it stimulates intracellular adenylate cyclase, increasing cyclic AMP and producing relaxation of bronchial smooth muscle, with an onset of bronchodilation within minutes and a duration of effect of approximately 12 hours.

C (legacy FDA pregnancy category)

Safety and efficacy of Dulamet (100 mcg/5 mcg strength) have been established in children 5 years of age and older for maintenance treatment of asthma; the 200 mcg/5 mcg strength is approved only for patients 12 years of age and older. Safety and efficacy in children younger than 5 years have not been established. Long-term use of inhaled corticosteroid-containing products such as Dulamet may cause a small reduction in growth velocity in children; growth should be monitored routinely, and the lowest effective dose should be used.