Salmeterol Xinafoate + Fluticasone Propionate Inhaler (120 Metered Doses)
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Salmeterol Xinafoate + Fluticasone Propionate Inhaler (120 Metered Doses)

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Description

PRODUCT DESCRIPTION:

 

This dual-action inhaler combines Salmeterol Xinafoate, a long-acting beta2-agonist (LABA), with Fluticasone Propionate, a potent inhaled corticosteroid (ICS), offering both bronchodilation and anti-inflammatory control in a single device.

It is formulated for chronic asthma and moderate to severe COPD, ensuring long-term symptom management and reduced exacerbation risks.

Each pressurized metered-dose inhaler (pMDI) delivers 120 metered doses with three available strength variants, allowing for personalized treatment across disease severity stages.

Formulation & Presentation:

  • Dosage Form: Inhaler Device
  • Presentation: Sterile, Multi-use Metered Dose Inhaler (customizable as per market demand)
  • Available Strengths: 3 Strengths with 120 Metered Doses
    • 25 MCG Salmeterol + 50 MCG Fluticasone
    • 25 MCG Salmeterol + 125 MCG Fluticasone
    • 25 MCG Salmeterol + 250 MCG Fluticasone
  • Route of Administration: Inhalation via pressurized metered-dose inhaler (pMDI), as per clinical indication and severity (As per physician’s discretion or decision)

Therapeutic Indications:

  • Maintenance therapy for chronic asthma not adequately controlled with inhaled corticosteroids alone
  • Management of moderate to severe COPD including chronic bronchitis and emphysema
  • Prevention of exercise-induced bronchospasm (under medical advice)

Side Effects:

  • COMMON:
    • Hoarseness or throat irritation
    • Cough or oral thrush (candidiasis)
    • Headache
    • Tremors
  • SERIOUS (RARE):
    • Paradoxical bronchospasm
    • Adrenal suppression with long-term use
    • Hypokalemia
    • Increased risk of pneumonia in COPD patients
  • PRECAUTIONS:
    • Rinse mouth after use to reduce the risk of oropharyngeal candidiasis
    • Not to be used for acute bronchospasm or as a rescue inhaler
    • Caution in patients with cardiovascular disorders, thyroid dysfunction, or diabetes
    • Dose adjustment may be necessary in hepatic impairment

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TECHNICAL INFORMATION

Product Specifications:

  • HSN Code: To be assigned per international classification standards & import jurisdiction
  • Weight: Approx. 40g per Carton (With Packaging)
  • Dimensions: (15 x 1 x 8 CMS)
  • Shelf Life: 24 to 36 months under recommended storage conditions from date of manufacture or as per label specifications. Cold chain not mandatory.
  • Storage: Pressurized metered-dose inhaler (pMDI). May not require cold-chain logistics (if specified by packaging). Protect from moisture and direct sunlight. Highly pressurized—use strictly as per label guidelines.

Regulatory Status & Supply Information:

  • Regulatory Status: WHO-GMP Compliant Manufacturing. Further certifications available on request
  • Exports Ready Dossiers: Dossier Available (CTD/eCTD formats)
  • Stability: Compliant
  • MOQ: Negotiable based on market & registration status
  • Export Options: Available for private label, institutional supply, or branded export

Who Should Source This Product?

  • Hospital Chains & Pulmonary Clinics managing long-term respiratory care
  • Government & Institutional Buyers requiring ICS+LABA combination therapy under essential drug programs
  • Respiratory Product Distributors catering to asthma and COPD specialists
  • International Buyers seeking high-quality, dossier-ready respiratory products for regulated and semi-regulated markets

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable documentation for effective registration in target markets
  • Trusted consortium network simplifying India’s complex pharma supply chain
  • Multiple approved manufacturers suited to import country needs
  • Network of audited, compliant manufacturers across India
  • Customizable branding, packaging & formulation flexibility
  • End-to-end logistics coordination & support
  • Expertise in exporting specialty injectables & respiratory products

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