Nystatin

Nystatin belongs to the pharmacological class of Polyene Antifungal.

Nystatin has been approved to relieve symptoms and also for the treatment and maintenance of Candidiasis ,Prevention of secondary fungal infection in peritoneal dialysis-associated infection, Fungal Infections.

Nystatin exhibits minimal systemic absorption when administered orally, resulting in undetectable plasma concentrations. Similarly, topical or vaginal administration does not lead to detectable plasma concentrations. Due to its limited systemic absorption, nystatin does not undergo distribution in the body. Since nystatin is not absorbed into the systemic circulation, it is not subject to plasma protein binding. Furthermore, nystatin undergoes minimal metabolism due to its limited systemic absorption. The primary route of elimination for orally administered nystatin is through the feces, where the majority of the drug is excreted unchanged.

The common side effects involved in using Nystatin are Oral irritation., Diarrhea, Nausea, Vomiting, Stomach upset, Ras, and Hives, Skin irritation, Allergic reaction, Bradycardia (slow heart rate), Bronchospasm, Facial swelling, Muscle pain

Nystatin is available in the form of Oral powder, Oral Suspension, Capsules, and Oral Tablets.

Nystatin is approved in Germany, Japan, Malaysia, India, the U.K., the U.S., and China.

Nystatin belongs to the pharmacological class of Polyene Antifungal.

Nystatin acts as a channel-forming ionophore, which means it works by creating a pore in the fungal plasma membrane. This pore spans the membrane and leads to an alteration in its permeability. As a result, intracellular contents leak out, and the electrochemical gradients necessary for normal cell function are disrupted. This mechanism of action is specific to fungal cells and not mammalian cells due to nystatin's higher affinity for binding to ergosterol, a crucial sterol present in fungal cell walls, compared to its mammalian equivalent, cholesterol. By selectively targeting fungal cells, nystatin effectively disrupts their structure and function, providing its therapeutic effect.

Nystatin has been approved to relieve symptoms and also for the treatment and maintenance of Candidiasis ,Prevention of secondary fungal infection in peritoneal dialysis-associated infection, Fungal Infections.

In HIV-infected patients, when administered at dosages ranging from 2 to 7 mg/kg every other day for a maximum of 15 days, Nystatin exhibits linear pharmacokinetics. It demonstrates rapid clearance from the blood initially, with a terminal half-life of approximately 5 to 7 hours.

Nystatin is found to be available in the form of Oral powder, Oral Suspension, Capsules, and Oral Tablets.

Nystatin can be used in the following treatment:

• Candidiasis
• Prevention of secondary fungal infection in peritoneal dialysis-associated infection
• Fungal Infections.

Nystatin can help to relieve symptoms and also for the treatment and maintenance of Candidiasis ,Prevention of secondary fungal infection in peritoneal dialysis-associated infection, Fungal Infections.

Nystatin is approved for use in the following clinical indications:

• Candidiasis
• Prevention of secondary fungal infection in peritoneal dialysis-associated infection
• Fungal Infections.

• Candidiasis, mild oropharyngeal disease

For the treatment of mild oropharyngeal candidiasis, an alternative agent can be used. The recommended oral dosage is a suspension that should be swished in the mouth and swallowed. The recommended dose is 400,000 to 600,000 units, to be taken 4 times daily. It is advised to retain the suspension in the mouth for several minutes before swallowing. The duration of treatment is typically 7 to 14 days.

Note: For compounding purposes, a powder form is available. Approximately 1/8 teaspoon (equivalent to 500,000 units) of the powder can be mixed with approximately 1/2 cup of water. This mixture should be given 4 times a day.

• Prevention of secondary fungal infection in peritoneal dialysis-associated infection:

When peritoneal dialysis-associated infection is being concurrently treated with antibacterials, nystatin can be used to prevent secondary fungal infections. The recommended oral dosage is 500,000 units, to be taken 3 or 4 times daily. The treatment should continue for the duration of antibacterial therapy. Additionally, nystatin therapy may be extended for an additional 3 days after the last dose of an aminoglycoside or 7 days after the last dose of vancomycin.

• Fungal infections, including cutaneous and mucocutaneous infections:

For the treatment of fungal infections, topical formulations are commonly used. It is important to note that cream is generally preferred over ointment for areas of skin folds or moisture-prone regions. In cases of very moist lesions, the use of topical powder is recommended.

For cream and ointment formulations, they should be applied twice daily or as directed until complete healing is achieved. The affected areas should be covered with a thin layer of cream or ointment.

In the case of topical powder, it should be applied to the affected areas 2 to 3 times daily until complete healing is achieved.

It is essential to follow the recommended treatment regimen and continue using the topical medication until the infection is fully resolved.

Oral powder: 100,000 units/g

Oral suspension: 100,000 units/mL

Oral tablet: 500,000 units

Capsule: 500,000 units, 1,000,000 units

Oral powder, Oral Suspension, Capsules, Oral Tablet.

Dosage Adjustments in Pediatric Patients:

• Diaper dermatitis, candidal:

Limited information is available regarding the treatment of candidal diaper dermatitis in infants. For topical application, ointment or cream should be applied to the affected area 2 to 4 times daily. Most studies have utilized a dosing frequency of 4 times daily .

• Mucocutaneous candidal infection:

For infants, children, and adolescents with mucocutaneous candidal infection, the recommended dosing is as follows according to the manufacturer's labeling: Apply cream or ointment topically to the affected area twice daily. Additionally, a powder formulation can be applied 2 to 3 times daily. Limited data is available for alternate dosing regimens, but for cream, ointment, or powder, applying to the affected area 2 to 4 times daily has been suggested.

• Candidiasis, oropharyngeal treatment:

Mild cases of oropharyngeal candidiasis should be treated for a duration of 7 to 14 days. In infants, oral suspension should be administered orally at a dose of 200,000 units 4 times daily. The dose should be divided equally and given to each side of the mouth. For children and adolescents, the recommended oral suspension dose is 400,000 to 600,000 units 4 times daily. Similar to infants, the dose should be divided between both sides of the mouth, and the suspension should be swished and retained in the mouth for as long as possible before swallowing.

• Peritonitis, prophylaxis for high-risk situations:

To prevent peritonitis in high-risk situations, such as during antibiotic therapy or percutaneous endoscopic gastrostomy (PEG) placement in infants, children, and adolescents, oral suspension is recommended. The oral suspension should be administered orally at a dose of 10,000 units/kg once daily.

There are no specific dietary restrictions associated with the use of Nystatin. However, it is always advisable to follow a balanced and healthy diet while taking any medication to support overall well-being and optimize the body's response to treatment.

Nystatin may be contraindicated under the following conditions:

• Patients who have previously shown hypersensitivity to any of the components of the preparation should not use it due to contraindications.

The adverse reactions related to Nystatin can be categorized as follows:

Common:

• Oral irritation
• Diarrhea
• Nausea
• Vomiting
• Stomach upset
• Rash
• Hives
• Skin irritation
• Allergic reaction
• Bradycardia (slow heart rate)
• Bronchospasm
• Facial swelling
• Muscle pain

The following are the side effects involving Nystatin:

• Oral irritation
• Diarrhea
• Nausea
• Vomiting
• Stomach upset
• Rash
• Hives
• Skin irritation
• Allergic reaction
• Bradycardia (slow heart rate)
• Bronchospasm
• Facial swelling
• Muscle pain

Pregnancy:

Teratogenic Effects - Category C

The teratogenic effects of nystatin oral suspension have not been studied in animals. Its potential to cause fetal harm or affect reproductive capacity in pregnant women is unknown. Therefore, nystatin oral suspension should only be administered to pregnant women if it is clearly necessary.

Lactation:

The excretion of nystatin in human milk has not been established. Since many drugs are excreted in human milk, caution should be exercised when administering nystatin to nursing women.

Physicians should be knowledgeable as well as vigilant about the treatment and identification of overdosage of Nystatin.

Nausea and gastrointestinal discomfort have been reported, with oral doses of nystatin exceeding five million units per day. However, there have been no documented cases of severe toxic effects resulting from superinfections.

Pharmacodynamics

Nystatin is an antifungal agent that exhibits both fungistatic and fungicidal properties in vitro against a broad range of yeasts and yeast-like fungi. Its antifungal effects are achieved by disrupting the cell membrane of the fungal organisms. While resistance to nystatin is minimal in Candida albicans, it has been observed to develop in other Candida species. It is important to note that nystatin does not possess significant activity against bacteria, protozoa, or viruses. Due to its considerable systemic toxicity, nystatin is currently not available in a formulation suitable for systemic use. As a result, its effectiveness is primarily limited to topical, oral, and gastrointestinal infections.

Pharmacokinetics

● Absorption:

When administered orally, nystatin is minimally absorbed systemically, and topical or vaginal administration does not result in detectable plasma concentrations.

● The volume of distribution:

Nystatin does not undergo distribution as it is not absorbed into the systemic circulation.

● Protein binding:

Since nystatin is not absorbed into the systemic circulation, it is not subject to plasma protein binding.

● Metabolism:

Nystatin undergoes little-to-no systemic absorption, and therefore it is not significantly metabolized.

● Route of elimination:

The majority of orally administered nystatin is excreted unchanged in the feces.

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