Product image of Nystatin Orifarm (Nystatin) supplied by GNH India

Nystatin Orifarm

Active Ingredient:
Nystatin
Origin:
EU

Nystatin Orifarm (Nystatin)

Nystatin, the active ingredient in Nystatin Orifarm, is a polyene antifungal presented as a 100,000 IU/mL oral suspension for oral use. It treats Candida infections of the mouth, throat, gastrointestinal tract and skin, primarily in infants, children and immunocompromised adults.

GNH India supplies Nystatin Orifarm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Orifarm Generics A/S

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Indications & Clinical Uses

Nystatin is used to treat fungal infections caused by Candida species affecting various mucosal and cutaneous sites.

  • Oral thrush (candidiasis): reduces fungal load and relieves symptoms in the mouth and throat.
  • Esophageal candidiasis: eradicates Candida overgrowth in the esophagus, improving swallowing and pain.
  • Intestinal candidiasis: clears Candida from the gastrointestinal tract, helping prevent diarrhea and abdominal discomfort.

How It Works

  • Nystatin binds selectively to ergosterol, a key sterol in fungal cell membranes, forming pores that increase membrane permeability. This leads to leakage of intracellular electrolytes and macromolecules, causing rapid fungal cell death without significant absorption into systemic circulation.

Side Effects

Nystatin may cause a range of adverse reactions, most of which are mild and reversible.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Vomiting: occasional episodes after oral administration.
  • Diarrhea: loose stools during treatment.
  • Abdominal pain: cramping or discomfort.
  • Taste alteration: temporary change in taste perception.
  • Mild oral irritation: transient burning or soreness.

Serious or Rare Side Effects

  • Severe allergic reaction: rash, itching, swelling, or difficulty breathing.
  • Hepatotoxicity: abnormal liver function tests in rare cases.
  • Neutropenia: low white‑blood‑cell count, increasing infection risk.
  • Stevens‑Johnson syndrome: rare severe skin reaction.
  • Anaphylaxis: life‑threatening hypersensitivity.
  • Persistent gastrointestinal ulceration: very uncommon prolonged use.

Precautions & Warnings

Before prescribing Nystatin, clinicians should consider several safety measures.

  • Assess hypersensitivity: avoid use in patients with known allergy to polyene antifungals.
  • Monitor renal function: adjust therapy if severe renal impairment is present.
  • Evaluate hepatic status: caution in patients with liver disease, although systemic absorption is minimal.
  • Use in immunocompromised patients: monitor closely for breakthrough infections.
  • Concomitant antibiotics: be aware of potential overgrowth of resistant organisms.
  • Store below 25°C: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Nystatin has limited systemic absorption, but certain drug combinations may require attention.

Major Interactions (Avoid)

  • Systemic azole antifungals (e.g., fluconazole): increased risk of hepatotoxicity when used together.
  • Nephrotoxic agents (e.g., amphotericin B): additive renal toxicity in rare cases.

Moderate Interactions (Monitor Closely)

  • Antacids containing aluminum or magnesium: may reduce oral suspension absorption.
  • Broad‑spectrum antibiotics: can alter normal flora, potentially affecting fungal colonisation.
  • Immunosuppressants (e.g., cyclosporine): heightened risk of opportunistic infections.
  • Probiotic supplements: may interfere with intended antifungal activity.
  • Oral corticosteroids: increased susceptibility to oral candidiasis, requiring careful monitoring.

Frequently Asked Questions

Nystatin Orifarm is indicated for the treatment of Candida infections such as oral thrush, esophageal candidiasis, and intestinal candidiasis. It works locally in the mouth, throat, and gastrointestinal tract to eliminate fungal overgrowth and relieve associated symptoms.

Nystatin binds to ergosterol, a sterol unique to fungal cell membranes, creating pores that disrupt membrane integrity. This causes leakage of essential intracellular components, leading to rapid fungal cell death while having minimal systemic absorption.

The dosage of Nystatin Orifarm is determined by the prescribing clinician based on the patient’s age, weight, infection site and severity. Healthcare professionals tailor the regimen to achieve optimal therapeutic effect while minimizing adverse reactions.

Nystatin is poorly absorbed from the gastrointestinal tract, so systemic exposure is minimal. It is generally considered low risk during pregnancy and lactation, but clinicians should evaluate each case individually and use the medication only if the potential benefit outweighs any theoretical risk.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Nystatin is a polyene antifungal that acts locally with minimal systemic absorption, making it ideal for mucosal Candida infections. Unlike systemic azoles, it does not inhibit cytochrome P450 enzymes, reducing the likelihood of drug‑drug interactions, but it is not suitable for deep‑tissue or systemic candidiasis.

Store Nystatin Orifarm below 25 °C in its original container, protecting it from moisture, heat and direct sunlight. Do not freeze the product, and keep the lid tightly closed to maintain stability and potency.

Nystatin Orifarm is administered orally as a suspension. The prescribed volume is measured with a calibrated syringe or dosing cup and swished in the mouth before swallowing, or taken directly for gastrointestinal indications, following the healthcare provider’s instructions.

Serious risks, though rare, include severe allergic reactions such as anaphylaxis, hepatotoxicity, neutropenia, and severe skin reactions like Stevens‑Johnson syndrome. Patients should seek immediate medical attention if they experience rash, swelling, breathing difficulty, or unexplained liver‑related symptoms.

Nystatin Orifarm should be avoided in individuals with a documented hypersensitivity to nystatin or other polyene antifungals. Caution is also advised for patients with severe renal or hepatic impairment, and it is not indicated for systemic or deep‑tissue candidiasis.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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