Nystatin

What is Nystatin?

• Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei used as a topical and oral antifungal agent with activity against many species of yeast and candida albicans, which is used largely to treat skin and oropharyngeal candidiasis.

Nystatin

Nystatin ball-and-stick

Nystatin

What are the uses of this medicine?

• Nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis (fungal infections of the inside of the mouth and lining of the stomach and intestines).
• Nystatin Oral Suspension, USP, is used for the treatment of candidiasis in the oral cavity.

How does this medicine work?

• Nystatin (nye stat' in) is a polyene macrolide antibiotic that acts by binding to sterols in the plasma membranes of fungi causing the cells to leak, eventually leading to fungal cell death.
• Nystatin is indicated for the treatment of yeast and candidal infections of the skin, mucous membranes and gastrointestinal tract.
• It is not absorbed orally and thus not indicated for invasive fungal infections.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a history of hypersensitivity to any of its components.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Nystatin was approved by the FDA in 1971 and is currently widely used in the treatment of superficial yeast infections and candida infections of the skin, mucous membranes and gastrointestinal tract, including oropharyngeal candidiasis.

How should this medicine be used?

Recommended dosage: Nystatin tablets:

• The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily.
• Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

Nystatin suspension: Infants:

• 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes).

Children and Adults:

• 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth).
• The preparation should be retained in the mouth as long as possible before swallowing.
• Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.

Administration:

• Nystatin comes as a tablet and a suspension (liquid) to take by mouth.
• For the treatment of fungal infections of the lining of the stomach and intestines, nystatin tablets are usually taken three times a day.
• For the treatment of fungal infections of the mouth, nystatin suspension is usually used four times a day.
• Shake the suspension well before each use to mix the medication evenly. Place half of the dose in each side of the mouth and hold it there as long as possible before swallowing.
• Use nystatin as long as instructed by your doctor, even if you feel better.
• If you stop using nystatin too soon or skip doses, your infection may not be completely treated.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Nystatin tablets are provided for oral administration as coated tablets containing 500,000 units nystatin.
• As Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL.

This medicine is available in fallowing brand namesː

• Mycostatin Oral Tablets
• Nilstat Oral Tablets
• Nilstat Suspension
• Nystex Suspension

What side effects can this medication cause?

Nystatin is well tolerated even with prolonged therapy.

The most common side effects of this medicine include:

• Oral irritation and sensitization
• Diarrhea
• nausea
• vomiting
• gastrointestinal upset/disturbances
• Rash, including urticaria
• Stevens-Johnson syndrome
• Tachycardia
• bronchospasm
• facial swelling
• nonspecific myalgia

What special precautions should I follow?

• This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.
• It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.
• Nystatin is not absorbed orally and has not been linked to drug induced liver injury.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• nausea
• gastrointestinal upset

• There have been no reports of serious toxic effects of superinfections

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Category C.
• It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• Nystatin should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Safety and efficacy have been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active Ingredients:

• nystatin

Inactive Ingredients:

• anhydrous lactose, carnauba wax, corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, and titanium dioxide.

Who manufactures and distributes this medicine?

Nystatin tablets: Distributed by:

• Sun Pharmaceutical Industries, Inc.
• Cranbury, NJ

Nystatin Oral Suspension: Manufactured by:

• Vista pharma
• Largo, FL

What should I know about storage and disposal of this medication?

Nystatin tablets:

• Store at 20° to 25°C (68° to 77°F).
• DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Nystatin Oral Suspension:

• Store at 20° to 25°C (68° to 77°F).
• AVOID FREEZING.

• Dailymed label info on Nystatin
• FDA Nystatin