Decomit Plus100 mcg+6 mcg

Established / Approved Uses

• Maintenance treatment of asthma in adults and adolescents in whom use of a combination inhaler (inhaled corticosteroid + long-acting beta2-agonist) is appropriate — i.e. patients not adequately controlled on inhaled corticosteroids alone and short-acting bronchodilators "as needed", or patients already adequately controlled on both an inhaled corticosteroid and a long-acting beta2-agonist.
• Maintenance treatment of chronic obstructive pulmonary disease (COPD) for symptomatic relief in patients with severe COPD (FEV1 < 50% predicted) and a history of repeated exacerbations who have significant symptoms despite regular bronchodilator therapy.

Guideline-Supported Use

Some formulations of Decomit Plus are also used as combined maintenance-and-reliever therapy (MART) in asthma, in which the same inhaler is used both for regular daily dosing and for relief of symptoms, under specific physician-directed regimens.

Decomit Plus is not indicated for the initial management of acute asthma exacerbations or as a rescue/reliever inhaler used alone.

Beclometasone Dipropionate + Formoterol Fumarate is a fixed-dose combination inhalation product. It combines beclometasone dipropionate, an inhaled corticosteroid, with formoterol fumarate (dihydrate), a long-acting beta2-adrenergic agonist (LABA), delivered as extrafine particles typically via a pressurised metered-dose inhaler (pMDI) using an HFA propellant, or as a dry-powder inhaler (DPI) in some markets.

Common strengths available include 100 mcg/6 mcg and 200 mcg/6 mcg (beclometasone dipropionate/formoterol fumarate) per actuation/inhalation.

Decomit Plus is a fixed-dose combination inhaler used in the long-term maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). It pairs an inhaled corticosteroid (beclometasone dipropionate), which reduces airway inflammation, with a long-acting beta2-agonist (formoterol fumarate), which relaxes airway smooth muscle to keep the airways open.

Because it contains a long-acting beta2-agonist, Decomit Plus carries the class warning that LABAs, when used alone (without an inhaled corticosteroid), increase the risk of asthma-related death; this risk is mitigated when formoterol is used in a fixed combination with an inhaled corticosteroid, as in this product. Decomit Plus is intended for regular, scheduled use and is not a substitute for a fast-acting rescue inhaler.

Decomit Plus belongs to the therapeutic class of Inhaled Corticosteroid (ICS) + Long-Acting Beta2-Agonist (LABA) combination bronchodilators, used in the respiratory corticosteroid-combination drug category for asthma and COPD maintenance therapy.

Beclometasone Dipropionate + Formoterol Fumarate combines two active substances with complementary mechanisms of action:

• Beclometasone dipropionate is a synthetic glucocorticoid that, after conversion to its active metabolite beclometasone-17-monopropionate in the lung, exerts potent local anti-inflammatory activity — reducing airway mucosal edema, mucus secretion, and bronchial hyperresponsiveness — with relatively low systemic corticosteroid activity at therapeutic inhaled doses.
• Formoterol fumarate is a highly selective, long-acting beta2-adrenergic receptor agonist. It relaxes bronchial smooth muscle by increasing intracellular cyclic AMP, producing bronchodilation that begins within 1–3 minutes and persists for approximately 12 hours.

Used together in Beclometasone Dipropionate + Formoterol Fumarate, the corticosteroid controls the underlying airway inflammation while formoterol provides rapid and sustained bronchodilation, improving lung function and symptom control in asthma and COPD.

Decomit Plus is for oral inhalation only and must not be swallowed or injected.

• Use the inhaler at the same times each day for maintenance dosing.
• Shake before use (pMDI), inhale slowly and deeply while actuating, and hold the breath briefly.
• Clean the mouthpiece regularly as directed in the product leaflet.
• Always rinse the mouth with water after inhalation to reduce local corticosteroid side effects such as oral candidiasis and hoarseness.
• If a spacer device is prescribed with the inhaler, use it as instructed by the physician or pharmacist.

Clinically Significant Interactions

• Beta-blockers (including eye drops): May weaken or antagonize the bronchodilating effect of the formoterol component of Decomit Plus and can provoke severe bronchospasm; concurrent use should generally be avoided in patients with airway disease.
• Strong CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, itraconazole): May increase systemic exposure to the beclometasone component, raising the risk of systemic corticosteroid side effects; use with caution.
• Other beta2-agonists, xanthine derivatives (e.g. theophylline), corticosteroids, or non-potassium-sparing diuretics: May potentiate the hypokalemic effect of formoterol; monitor serum potassium, particularly in severe asthma exacerbations.
• Drugs that prolong the QT interval (e.g. certain antiarrhythmics, antipsychotics, some antibiotics) or monoamine oxidase inhibitors and tricyclic antidepressants: May increase the risk of ventricular arrhythmias when combined with formoterol; use with caution.
• Other sympathomimetic agents: Concomitant use may add to cardiovascular stimulant effects (increased heart rate, tremor).

Common

• Oral/oropharyngeal candidiasis (thrush) and hoarseness/dysphonia — reduced by rinsing the mouth after use
• Headache
• Nasopharyngitis, throat irritation, cough
• Tremor, palpitations, tachycardia
• Hypokalemia (low blood potassium)
• Muscle cramps

Less Common / Serious

• Paradoxical bronchospasm (immediate worsening of wheeze after inhalation) — discontinue immediately if this occurs and seek medical advice
• Hypersensitivity reactions (rash, urticaria, pruritus, angioedema of the face/throat)
• QT-interval prolongation and other cardiac arrhythmias
• Hyperglycemia
• Signs of systemic corticosteroid effect with long-term high-dose use (adrenal suppression, decreased bone mineral density, cataracts, glaucoma) — see Precautions and Warnings
• Increased incidence of pneumonia reported in COPD patients using inhaled corticosteroid combinations

Pregnancy: Data on the use of Decomit Plus in pregnant women are limited. As with other inhaled corticosteroid/LABA combinations, it should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus, and only at the lowest effective dose needed to maintain adequate asthma/COPD control. A physician should always be consulted before use in pregnancy.

Lactation: It is not known whether beclometasone dipropionate or formoterol fumarate (or their metabolites) are excreted in human breast milk in clinically significant amounts. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue Decomit Plus should be made by a physician, weighing the benefit of treatment to the mother against any potential risk to the infant.

LABA Class Warning

Long-acting beta2-agonists (LABAs) such as the formoterol component of Decomit Plus may increase the risk of asthma-related death when used as monotherapy without an inhaled corticosteroid. This risk is mitigated when formoterol is used only as part of a fixed-dose combination with an inhaled corticosteroid, as in Decomit Plus; the product should never be used as, or substituted with, a formoterol-only inhaler in asthma.

Not for Acute Symptoms

Decomit Plus should not be used to treat acute asthma symptoms or exacerbations. Patients should be given a separate rapid-acting rescue inhaler for immediate relief and instructed to seek medical attention if reliever use increases.

Other Precautions

• Cardiovascular disease: Use with caution in patients with cardiac arrhythmias, coronary artery disease, cardiomyopathy, or QT-interval prolongation, due to the cardiac stimulant effects of formoterol.
• Untreated infections: Use with caution in patients with active or quiescent pulmonary tuberculosis, or untreated fungal, bacterial, or viral respiratory infections, due to the local immunosuppressive effect of the inhaled corticosteroid.
• Adrenal suppression: Prolonged use, especially at higher doses, may cause features of systemic corticosteroid effect, including adrenal suppression; caution is needed when transferring from oral corticosteroids and during periods of stress (e.g. surgery).
• Bone density: Long-term inhaled corticosteroid use may be associated with a decrease in bone mineral density.
• Diabetes and hypokalemia: Use with caution in patients with diabetes mellitus (may raise blood glucose) or conditions predisposing to low potassium.
• Paradoxical bronchospasm: If wheezing worsens immediately after use, discontinue and seek alternative therapy.
• Not for abrupt discontinuation: Treatment should not be stopped suddenly; dose should be reduced gradually under medical supervision.

Overdose of Decomit Plus is likely to produce effects related mainly to the formoterol (LABA) component, including tachycardia, tremor, palpitations, headache, nausea, hyperglycemia, and hypokalemia; QT-interval prolongation and arrhythmias may occur. Overdose of the inhaled corticosteroid component alone is unlikely to cause acute symptoms but chronic excessive use may suppress adrenal function.

If an overdose of Decomit Plus is suspected, seek immediate medical attention or contact emergency services/a poison control center. Management is supportive and symptomatic; serum potassium and cardiac status should be monitored by medical professionals. Do not attempt home treatment beyond seeking urgent care.

Store the inhaler below 25°C to 30°C (do not refrigerate or freeze) and protect from direct sunlight. Do not puncture, break, or expose the canister to heat or flame, even when it appears empty, as it is pressurised. Keep out of the reach and sight of children.

• Pediatric: Safety and efficacy of Decomit Plus in children under 18 years have not been established for routine use; it is generally not recommended in this age group outside specific specialist-directed regimens. See Pediatric Uses.
• Elderly: No specific dose adjustment is required based on age alone, but elderly patients, especially those with cardiovascular disease, should be monitored for cardiac effects of the formoterol component.
• Hepatic impairment: Limited data; systemic exposure is low with inhaled use, but caution is advised in severe hepatic disease.
• Renal impairment: No specific dose adjustment is established as the drug is not significantly renally cleared at therapeutic inhaled doses.
• Pregnant and breastfeeding women: See Pregnancy and Lactation — use only if clearly needed, under physician guidance.

Decomit Plus is intended for long-term, regular maintenance treatment of asthma and COPD, not for short-term or occasional use. The prescribing physician should reassess the patient's condition periodically (e.g. every 3–6 months) to determine whether the dose can be reduced to the lowest effective maintenance dose, or whether treatment needs to be intensified. Treatment should not be stopped abruptly; any change in dose or discontinuation should be done gradually under medical supervision.

Beclometasone Dipropionate + Formoterol Fumarate is classified as an Inhaled Corticosteroid (ICS) + Long-Acting Beta2-Agonist (LABA) fixed-dose combination, within the broader respiratory corticosteroid-combination drug class used for asthma and COPD.

Beclometasone Dipropionate + Formoterol Fumarate acts through two complementary mechanisms: beclometasone dipropionate binds to glucocorticoid receptors in airway tissue, suppressing the inflammatory cascade (reducing cytokine release, mucosal edema, and airway hyperresponsiveness), while formoterol fumarate stimulates beta2-adrenergic receptors on bronchial smooth muscle, activating adenylate cyclase to increase intracellular cyclic AMP and produce rapid, sustained relaxation of the airway smooth muscle (bronchodilation).

The safety and efficacy of Decomit Plus in children and adolescents under 18 years of age have not been established for general clinical use, and it is generally not recommended in this population outside specialist respiratory care. Limited clinical data exist for adolescents in certain age ranges under specific regulatory approvals in some countries, but this varies by market and formulation. Where use in a minor is being considered, it should only be initiated and monitored by a pediatric respiratory specialist, with close attention to growth, adrenal function, and bone health during long-term inhaled corticosteroid therapy.