Nystat

 100000 Unit/ml Oral Suspension
ACME Laboratories Ltd.

30 ml bottle: ৳ 46.84

Indications

Approved Indications:

  • Oropharyngeal Candidiasis (Thrush): Treatment and prevention of Candida infections in the mouth and throat.
  • Cutaneous Candidiasis: Treatment of superficial Candida infections of the skin folds, diaper area, and intertriginous regions.
  • Vaginal Candidiasis (Candidal Vaginitis): Treatment of mucosal Candida infections of the vagina.
  • Gastrointestinal Candidiasis: Adjunctive treatment for Candida infections of the intestinal tract, especially in immunocompromised patients.

Clinically Accepted Off-label Uses:

  • Prophylaxis of fungal infections in immunocompromised patients (e.g., during chemotherapy).
  • Prevention of candidiasis in denture wearers.
  • Adjunct in treatment of esophageal candidiasis (less common, other systemic agents preferred).
Dosage & Administration

Oropharyngeal Candidiasis (Adults and Children):

  • Oral suspension 400,000 to 600,000 units four times daily (swish and swallow or spit as directed) for 7 to 14 days.

Cutaneous Candidiasis:

  • Apply topical cream, ointment, or powder 2 to 3 times daily for 2 weeks or until symptoms resolve.

Vaginal Candidiasis:

  • Vaginal tablets or suppositories, 100,000 units once to twice daily for 7 to 14 days.

Gastrointestinal Candidiasis:

  • Oral suspension, 500,000 units 4 times daily for 2 weeks (adjust duration based on clinical response).

Special Populations:

  • Pediatrics: Same doses as adults for oral and topical use; dose by weight for oral suspension may be adjusted in infants.
  • Elderly: No specific dose adjustment; monitor for efficacy and tolerance.
  • Renal/Hepatic Impairment: No dose adjustment necessary; poor systemic absorption limits systemic toxicity.

Administration Notes:

  • For oral suspension, swish in mouth thoroughly before swallowing.
  • For vaginal administration, insert at bedtime.
  • Avoid ingestion of food or drink immediately after oral administration for optimal mucosal contact.
Mechanism of Action (MOA)

Nystatin is a polyene antifungal that binds to ergosterol, a key component of fungal cell membranes. This binding disrupts membrane integrity, creating pores that increase membrane permeability. The resultant leakage of intracellular ions and molecules leads to fungal cell death. Nystatin’s selective affinity for ergosterol over cholesterol makes it effective against Candida species while minimally affecting human cells.

Pharmacokinetics
  • Absorption: Negligible systemic absorption from the gastrointestinal tract, skin, or mucous membranes.
  • Distribution: Acts locally at the site of application or infection.
  • Metabolism: Not metabolized systemically due to lack of absorption.
  • Elimination: Eliminated unchanged in feces after oral administration.
  • Onset: Rapid local antifungal activity after topical or oral application.
Pregnancy Category & Lactation
  • Pregnancy: Category C – Animal studies show no teratogenic effects; human data limited. Use only if clearly needed.
  • Lactation: Limited systemic absorption; considered safe during breastfeeding.
Therapeutic Class
  • Polyene antifungal agent
Contraindications
  • Known hypersensitivity to nystatin or any formulation excipients
  • Not for systemic fungal infections requiring systemic antifungals
Warnings & Precautions
  • Use caution in patients with known hypersensitivity to polyene antifungals.
  • Monitor for allergic reactions (rare).
  • Avoid contact with eyes; if contact occurs, rinse thoroughly with water.
  • Not effective for systemic fungal infections due to poor absorption.
  • Prolonged use of topical formulations may lead to superinfection with non-susceptible organisms.
Side Effects

Common:

  • Topical: Skin irritation, redness, burning, itching, rash
  • Oral: Nausea, diarrhea, gastrointestinal discomfort (rare)

Rare:

  • Hypersensitivity reactions including rash, urticaria, and anaphylaxis
  • Local irritation or hypersensitivity with vaginal use
Drug Interactions
  • No significant drug-drug interactions due to negligible systemic absorption.
  • No known food or alcohol interactions.
Recent Updates or Guidelines
  • Nystatin remains recommended as a first-line topical agent for mucocutaneous candidiasis due to efficacy and safety.
  • Newer systemic antifungals preferred for invasive or esophageal candidiasis.
  • Guidelines emphasize its role in prophylaxis in immunocompromised patients for oropharyngeal candidiasis.
Storage Conditions
  • Store at 20°C to 25°C (68°F to 77°F).
  • Protect from moisture and light.
  • Keep container tightly closed.
  • No refrigeration needed.
  • Shake oral suspension well before use.
Available Brand Names