Decomit

 100 mcg/puff Metered-Dose Inhaler (MDI)
Beximco Pharmaceuticals Ltd.

200 metered doses: ৳ 270.00

Indications

Beclomethasone Dipropionate is a high-potency corticosteroid with strong anti-inflammatory properties. It is used in various inhaled, intranasal, and topical forms for a wide range of conditions:

A. Respiratory (Inhalation)

  • Asthma (mild to severe persistent) – for maintenance therapy and prevention of bronchospasm
  • Chronic Obstructive Pulmonary Disease (COPD) – as part of combination therapy in selected patients (moderate to severe)
  • Exercise-induced bronchospasm – prophylactic use in asthma patients

B. Nasal (Intranasal Formulations)

  • Allergic Rhinitis (seasonal and perennial)
  • Non-allergic rhinitis
  • Nasal polyps – prevention of recurrence post-surgical removal
  • Rhinosinusitis (chronic) – as adjunctive therapy

C. Dermatologic (Topical Cream or Ointment)

  • Inflammatory skin conditions including:
    • Eczema
    • Psoriasis (limited, non-exfoliative)
    • Contact dermatitis (allergic/irritant)
    • Atopic dermatitis
    • Seborrheic dermatitis
    • Lichen planus
    • Discoid lupus erythematosus
    • Insect bites with inflammation
Dosage & Administration

A. Inhalation (Asthma, COPD)

  • Adults:
    • Initial: 200–400 mcg twice daily via inhaler or nebulizer
    • Maximum: Up to 1000 mcg/day in divided doses (based on severity)
  • Pediatrics (6–12 years):
    • 100–200 mcg twice daily
  • Children (≤5 years):
    • Nebulized solution preferred: 100 mcg twice daily (under supervision)
  • Elderly: No routine dose adjustment; monitor response closely

B. Intranasal

  • Adults & Children ≥12 years:
    • 1–2 sprays (50 mcg/spray) in each nostril once or twice daily
    • Max: 400 mcg/day
  • Children 6–11 years:
    • 1 spray in each nostril once daily

C. Topical (Skin Application)

  • Apply a thin film to the affected area once or twice daily
  • Avoid prolonged use (>2 weeks) or use under occlusive dressings unless directed

Special Populations

  • Renal/Hepatic Impairment: No dosage adjustment typically required
  • Avoid sudden discontinuation in long-term users; tapering may be needed
Mechanism of Action (MOA)

Beclomethasone Dipropionate is a synthetic glucocorticoid prodrug that is converted in vivo to its active form, beclomethasone-17-monopropionate (B-17-MP). It binds to intracellular glucocorticoid receptors, modulating gene transcription and suppressing the production of pro-inflammatory mediators such as prostaglandins, leukotrienes, interleukins, and tumor necrosis factor-α. This results in reduced vascular permeability, leukocyte migration, and inflammatory cytokine expression, producing potent anti-inflammatory and anti-allergic effects in the lungs, nasal mucosa, or skin depending on the route.

Pharmacokinetics
  • Absorption:
    • Inhaled: 10–25% reaches lungs; rest is swallowed and undergoes first-pass metabolism
    • Topical: Minimal systemic absorption with intact skin
    • Intranasal: Absorbed through nasal mucosa; minimal systemic exposure
  • Distribution:
    • Plasma protein binding ~87%
    • Peak plasma levels reached in ~0.5–2 hours (inhaled)
  • Metabolism:
    • Rapidly converted by esterase enzymes to B-17-MP (active metabolite)
    • Further metabolism occurs in the liver
  • Excretion:
    • Primarily via feces (as metabolites)
    • Small amount in urine
  • Half-life: ~2.8 hours (B-17-MP)
  • Bioavailability:
    • Inhaled: ~20–30%
    • Intranasal: <44%
    • Topical: Negligible systemic bioavailability
Pregnancy Category & Lactation
  • Pregnancy:
    • Category C (FDA) – No adequate human studies; animal studies show possible fetal risks.
    • Inhaled and topical forms should be used only if clearly needed and for short durations.
    • Avoid prolonged or high-dose use during pregnancy.
  • Lactation:
    • Excretion into breast milk is not well studied, but systemic exposure is low.
    • Use with caution; avoid topical application to the breast area.
    • Inhaled and nasal use unlikely to harm a breastfed infant.
Therapeutic Class
  • Primary Class: Corticosteroid (Glucocorticoid)
  • Subclasses:
    • Inhaled Corticosteroid (ICS) – for asthma, COPD
    • Topical Corticosteroid – dermatologic
    • Intranasal Corticosteroid – for rhinitis and polyps
Contraindications
  • Hypersensitivity to beclomethasone or any formulation components
  • Untreated fungal, bacterial, or viral infections at the site of application
  • Active or latent tuberculosis involving the respiratory tract (for inhaled use)
  • Ocular herpes simplex
  • Children <6 years (intranasal use) – unless directed by physician
Warnings & Precautions
  • Local Immunosuppression: May mask or exacerbate infections
  • Systemic Effects: With high doses or prolonged use, adrenal suppression, Cushing’s syndrome, or growth retardation in children may occur
  • Paradoxical bronchospasm: Rare with inhaled use; discontinue if occurs
  • Nasal Septum Perforation: Reported with long-term nasal use
  • Skin Thinning and Striae: Possible with long-term topical use
  • Monitor: Children’s growth (with prolonged use), signs of systemic corticosteroid effects
Side Effects

Inhaled/Nasal Use

  • Common: Hoarseness, cough, sore throat, nasal irritation, epistaxis
  • Less Common: Oral candidiasis, dysphonia
  • Serious: Adrenal suppression, growth retardation (in children), glaucoma, cataracts

Topical Use

  • Common: Burning, itching, dryness, erythema
  • Prolonged Use: Skin atrophy, telangiectasia, striae, acneiform eruptions
  • Rare: Allergic contact dermatitis, secondary infections
Drug Interactions
  • CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir): May increase systemic levels of beclomethasone, increasing risk of adrenal suppression
  • Systemic corticosteroids: Risk of additive effects
  • Live vaccines: May reduce immune response (if systemic exposure occurs)

Note: No significant drug-food or drug-alcohol interactions reported.

Recent Updates or Guidelines
  • GINA 2024 guidelines recommend low-dose inhaled corticosteroids like Beclomethasone as the cornerstone of long-term asthma control.
  • FDA recently emphasized the importance of rinsing the mouth after inhaled use to prevent oral candidiasis.
  • Increasing preference for low-dose inhaled steroids in pediatric asthma to reduce long-term risks.
Storage Conditions
  • Inhalers: Store at 20°C to 25°C; protect from heat and freezing. Avoid puncturing or burning the canister.
  • Nasal Sprays: Store between 15°C to 30°C; do not freeze.
  • Topical Cream/Ointment: Store below 25°C; protect from light and moisture.
  • Handling: Shake well before use (inhalers); keep container tightly closed; discard after expiry or 3 months after opening (for nasal sprays).