Ascon-F

• Approved Indications:
• Maintenance treatment of asthma in adults and children 12 years and older, where use of a combination of inhaled corticosteroid and long-acting β2-agonist is appropriate.
• Treatment of chronic obstructive pulmonary disease (COPD) to reduce exacerbations in adults with a history of exacerbations and persistent symptoms despite long-acting bronchodilator therapy.
• Off-label Uses:
• Occasionally used in pediatric asthma under specialist supervision for children younger than 12 years.
• May be used off-label in severe asthma requiring combination therapy.

• Route: Inhalation via metered-dose inhaler (MDI) or dry powder inhaler (DPI), depending on formulation.
• Adults:
• Usual dosage ranges from 1 to 2 inhalations twice daily (dose dependent on severity and product strength).
• Max dose depends on specific product and patient tolerance; typical total daily dose of beclomethasone is 200–800 mcg, and formoterol 12–24 mcg daily.
• Pediatrics (≥12 years): Same as adults.
• Elderly: No specific dose adjustment; monitor for side effects.
• Renal/Hepatic Impairment: No dose adjustment recommended.
• Administration Notes:
• Shake inhaler before use (for MDI).
• Rinse mouth after inhalation to reduce risk of oral candidiasis.
• Use regularly for maintenance; not intended for relief of acute bronchospasm.
• Patients should be trained on proper inhaler technique.

Beclomethasone dipropionate is an inhaled corticosteroid (ICS) that exerts anti-inflammatory effects by binding to glucocorticoid receptors, modulating gene expression to reduce airway inflammation, mucus production, and hyperresponsiveness. Formoterol fumarate is a long-acting β2-adrenergic receptor agonist (LABA) that relaxes bronchial smooth muscle via activation of adenylate cyclase and increased cyclic AMP, leading to sustained bronchodilation. The combination provides complementary control of airway inflammation and bronchoconstriction, improving respiratory function and symptom control.

• Absorption:
• Beclomethasone dipropionate is rapidly hydrolyzed to active metabolite beclomethasone-17-monopropionate after inhalation.
• Formoterol is well absorbed from the lungs.
• Distribution:
• Beclomethasone metabolites are widely distributed, with high plasma protein binding (~87%).
• Formoterol is highly protein bound (~61%).
• Metabolism:
• Beclomethasone is metabolized primarily in the liver by esterases.
• Formoterol is metabolized mainly via direct conjugation and O-demethylation by CYP2D6.
• Elimination:
• Beclomethasone metabolites eliminated mainly via urine.
• Formoterol eliminated via urine and feces.
• Half-life:
• Beclomethasone active metabolite: approx. 2.7 hours.
• Formoterol: approx. 10 hours.

• Pregnancy:
• FDA Category C. Use only if potential benefits justify potential risks.
• Animal studies show adverse effects at high doses; limited human data available.
• Lactation:
• Beclomethasone and formoterol may be excreted in breast milk in small amounts.
• Use with caution; monitor infant for adverse effects.

• Primary Therapeutic Class: Respiratory inhalant combination therapy
• Subclass: Inhaled corticosteroid (ICS) + Long-acting beta-2 adrenergic agonist (LABA)

• Known hypersensitivity to beclomethasone dipropionate, formoterol fumarate, or any excipients.
• Primary treatment of status asthmaticus or acute episodes of bronchospasm requiring urgent intervention.
• Patients with severe hypersensitivity to milk proteins (for DPI formulations containing lactose).

• Not indicated for relief of acute bronchospasm; always have a short-acting bronchodilator available.
• Risk of paradoxical bronchospasm; discontinue if it occurs.
• Prolonged use may cause systemic corticosteroid effects such as adrenal suppression, osteoporosis, cataracts, and glaucoma.
• Monitor for worsening asthma symptoms and airway infections (including pneumonia in COPD patients).
• Use caution in patients with cardiovascular disorders; may cause tachycardia or arrhythmias.
• Monitor growth in pediatric patients regularly.

• Common:
• Hoarseness, throat irritation, oral candidiasis (thrush), cough.
• Headache, tremor, palpitations, nervousness.
• Serious but Rare:
• Paradoxical bronchospasm, hypersensitivity reactions (rash, angioedema).
• Adrenal suppression, osteoporosis, glaucoma, cataracts.

• Concomitant use with other LABAs or long-acting sympathomimetics increases risk of cardiovascular side effects.
• CYP3A4 inhibitors (e.g., ketoconazole) may increase systemic corticosteroid effects.
• Beta-blockers may reduce bronchodilator efficacy and should be used with caution.
• Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants may potentiate cardiovascular effects of formoterol.

• Current asthma and COPD guidelines recommend combination ICS/LABA inhalers like beclomethasone + formoterol for maintenance therapy to reduce exacerbations and improve lung function.
• Emphasis on using lowest effective corticosteroid dose to minimize systemic side effects.
• Recent approvals include maintenance and reliever therapy (MART) regimens using formoterol-containing combinations for asthma.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and heat.
• Do not freeze.
• Keep inhaler cap tightly closed when not in use.
• Keep out of reach of children.