In the pharmaceutical industry, Nystatin tablets (typically 500,000 units) are a potent polyene antifungal medication. As a pharmacist and manufacturer, I categorize this as a “non-absorbable” antifungal, meaning it stays in the digestive tract to treat infections locally without entering the bloodstream.
Primary Clinical Indications
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Intestinal Candidiasis: The primary use for the tablet form is treating fungal infections (yeast) in the stomach and intestines.
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Oral Thrush (Off-label): While a liquid “swish and swallow” is preferred, tablets are sometimes used to treat refractory cases of oral candidiasis.
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Prophylaxis: Often prescribed to patients with weakened immune systems (e.g., those on chemotherapy or with HIV) to prevent fungal overgrowth in the gut.
Mechanism: Ergosterol Binding
Nystatin works by physically “poking holes” in the fungal cell wall.
Targeting Ergosterol: It binds to ergosterol, a key component of the fungal cell membrane (similar to cholesterol in humans).
Pore Formation: This binding creates pores or channels in the cell membrane.
Lethal Leakage: Essential cellular components like potassium leak out through these holes, leading to the rapid death of the fungus.
The Pharmacist’s “Technical Warning”
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No Systemic Use: Nystatin tablets are not effective for fungal infections in the blood, lungs, or skin. It must make direct contact with the fungus in the gut to work.
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Finish the Course: Symptoms may disappear in 24–72 hours, but the medication must be continued for at least 48 hours after clinical cure to prevent a relapse.
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Minimal Side Effects: Because it isn’t absorbed into the blood, systemic side effects are rare. However, high doses can cause nausea, vomiting, or diarrhea.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Non-Absorbable” USP: On your marketplace, highlight that Nystatin has zero systemic absorption, making it an exceptionally safe antifungal for patients who cannot tolerate systemic drugs like Fluconazole due to liver concerns.
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Stability for Export: Nystatin is sensitive to heat, light, and moisture. Utilizing Alu-Alu blister packaging is the gold standard for maintaining a 24-month shelf life in Zone IVb tropical regions.
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Dossier Support: We provide full CTD/eCTD Dossiers for Nystatin 500,000 IU tablets to support your firm’s registration in international health tenders and regulated markets.