FLUTICASONE PROPIONATE + SALMETEROL XINAFOATE DPI CAPSULES
FLUTICASONE PROPIONATE + SALMETEROL XINAFOATE DPI CAPSULES - Image 2
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FLUTICASONE PROPIONATE + SALMETEROL XINAFOATE DPI CAPSULES

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Description

PRODUCT DESCRIPTION:

 

Fluticasone Propionate + Salmeterol Xinafoate DPI Capsules combine the potent anti-inflammatory effects of Fluticasone Propionate (an inhaled corticosteroid) with the long-acting bronchodilator properties of Salmeterol Xinafoate (a β2-agonist), providing comprehensive control of asthma and chronic obstructive pulmonary disease (COPD).

Packaged in 30 capsule units, this dry powder inhalation format ensures targeted delivery deep into the lungs with every actuation using a compatible DPI device.

The three strengths support a tiered treatment approach as per disease severity and clinical judgment.

Formulation & Presentation:

  • Dosage Form: Dry Powder Inhaler Capsules (for use with a compatible inhalation device)
  • Presentation: Blister packs of 30 capsules each for use with compatible DPI device (Customizable as per market demand)
  • Available Strengths: Available in 3 Strengths
  • 100 MCG Fluticasone + 50 MCG Salmeterol
  • 250 MCG Fluticasone + 50 MCG Salmeterol
  • 500 MCG Fluticasone + 50 MCG Salmeterol
  • Route of Administration: Inhalation (via Dry Powder Inhaler), as per clinical indication and severity (As per physician’s discretion or decision)

Therapeutic Indications:

  • Long-term maintenance treatment of persistent asthma in patients requiring combination therapy
  • Management of moderate to severe COPD including chronic bronchitis and emphysema
  • Reduction of exacerbations and improvement of pulmonary function over time

Side Effects:

  • COMMON:
    • Hoarseness or throat irritation
    • Oral thrush (candidiasis)
    • Headache
    • Mild tremors
  • SERIOUS (RARE):
    • Paradoxical bronchospasm
    • Hypokalemia
    • Adrenal suppression with long-term use
    • Increased risk of pneumonia (in COPD patients)
  • PRECAUTIONS:
    • Not indicated for acute bronchospasm relief
    • Rinse mouth after each use to reduce risk of oral candidiasis
    • Use with caution in patients with cardiovascular disease, diabetes, thyroid disorders
    • Monitor potassium levels and signs of systemic corticosteroid effects with prolonged therapy

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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: (15x1x8 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: Non-Pressurized Non-metered-dose inhaler (DPI). May not require cold-chain logistics (if specified by packaging). Protect from moisture and direct sunlight. The capsules should be used strictly as per label guidelines.

Regulatory Status & Supply Information:

  • Regulatory Status: WHO-GMP Complaint 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?

  • Pulmonologists and Specialist Clinics managing chronic respiratory conditions
  • Hospitals & Healthcare Institutions focused on step-up therapy for asthma and COPD
  • Pharmaceutical Distributors & Importers seeking dossier-ready DPI products for regulated and semi-regulated markets
  • Government Tender Authorities & NGOs offering evidence-based respiratory care solutions

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable documentation support for effective registration
  • Trusted consortium network simplifying India’s complex pharma supply chain
  • Multiple approved manufacturers for best regional fit
  • Audited and compliant manufacturing network across India
  • Customizable branding, packaging, and formulation flexibility
  • End-to-end logistics coordination and support
  • Deep expertise in exporting specialty injectables and DPI products

Contact Details:

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