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Nystatin EP5

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Product Description

Nystatin EP5 is a polyene antifungal antibiotic used to treat fungal infections caused primarily by Candida species. It acts by binding to ergosterol in fungal cell membranes, creating pores that lead to cell leakage and death. Nystatin EP5 is widely used in pharmaceutical formulations for topical, oral, and mucosal candidiasis treatment. It is non-absorbable from the gastrointestinal tract, making it effective for treating infections in the mouth, throat, and intestines.

 

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Description

Uses

Primary Uses 

  1. Treatment of Candidiasis

    • Effective against cutaneous, mucocutaneous, and oral thrush infections caused by Candida albicans and related species.

    • Used in treating vaginal candidiasis.

  2. Topical Antifungal

    • Incorporated in creams, ointments, powders, and sprays for skin fungal infections.

  3. Oral Suspension and Lozenge

    • Used for oral candidiasis (thrush), especially in immunocompromised patients such as those with HIV/AIDS or undergoing chemotherapy.

  4. Gastrointestinal Fungal Infections

    • Used orally for intestinal candidiasis, since it is not systemically absorbed.

Secondary Uses 

  1. Prophylactic Use

    • Prevention of fungal infections in patients on prolonged antibiotic or corticosteroid therapy.

  2. Veterinary Applications

    • Used in animals for fungal infections of skin and mucous membranes.

  3. Combination Therapies

    • Sometimes combined with other antifungals or antibiotics in complex infections.

  4. Dental Care

    • Formulated in mouthwashes for managing oral fungal infections after dental procedures or in denture wearers.

 

KEY PRODUCT FEATURES

Key Attributes

Basic Identification Attributes

  • Chemical Name (IUPAC): Polyene macrolide antifungal

  • Common/Trade Name: Nystatin EP5

  • CAS Number: 1400-61-9

  • HS Code: 2941.90.99

  • Synonyms: Nystatin, Nystatin antibiotic

Physical & Chemical Properties

  • Physical State: Off-white to yellowish powder or crystalline form

  • Solubility: Sparingly soluble in water, soluble in organic solvents like DMSO

  • Melting Point: Approximately 120–130°C (decomposes)

  • Stability: Stable under recommended storage conditions

Safety & Hazard Attributes

  • GHS Classification: Not classified as hazardous

  • Toxicity: Low systemic toxicity; avoid inhalation of dust and contact with eyes

  • Exposure Limits: No specific occupational limits

Storage & Handling Attributes

  • Storage Conditions: Store in a cool, dry place protected from light and moisture

  • Container Type: Supplied in sealed bottles or containers

  • Shelf Life: Typically 2–3 years when stored properly

  • Handling Precautions: Use dust mask and gloves to avoid inhalation and skin contact

 

Regulatory & Compliance Attributes

  • Complies with European Pharmacopoeia (EP) standards

  • Registered under relevant pharmaceutical regulations and good manufacturing practices (GMP)

 

Environmental & Health Impact

  • Biodegradability: Expected to biodegrade in the environment

  • Ecotoxicity: Low; avoid large releases into aquatic environments

  • Bioaccumulation: Not expected

  • Carcinogenicity/Mutagenicity: Not classified as carcinogenic or mutagenic

SAFETY HANDLING PRECAUTIONS

Safety Handling Precautions

  • PPE Required: Gloves, dust mask, and eye protection recommended

  • Handling Guidelines: Avoid inhaling dust and prolonged skin exposure

  • Storage Measures: Keep container tightly closed and stored in a dry, ventilated area

 

First Aid Measures

  1. Inhalation: Move to fresh air if irritation occurs; seek medical advice if symptoms persist

  2. Skin Contact: Wash with soap and water; discontinue use if irritation develops

  3. Eye Contact: Rinse immediately with plenty of water; seek medical attention if irritation persists

  4. Ingestion: Rinse mouth; seek medical advice if adverse effects occur

 

Firefighting Measures

  • Fire Hazards: Combustible powder

  • Extinguishing Media: Use water spray, foam, dry chemical, or CO₂ extinguishers

  • Special Precautions: Avoid dust formation; wear protective equipment

  • Hazardous Combustion Products: Carbon oxides and nitrogen oxides may be released

 

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