Nystatin

Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset.

There have been no reports of serious toxic effects or superinfections (See CLINICAL PHARMACOLOGY: Pharmacokinetics ).

Your pharmacist has additional information about nystatin written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (See PRECAUTIONS: General).

Gastrointestinal

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other

Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been reported.

Read the entire FDA prescribing information for Nystatin Oral Suspension (Nystatin (oral))

Nystatin is used in the treatment of:

• Candidiasis, Chronic Mucocutaneous
• Candidiasis, Oral
• Candidiasis, Vulvovaginal

Nystatin is used in the prevention of:

• AIDS-Related Opportunistic Infections
• Candidiasis, Cutaneous

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nystatin falls into category C:

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

OR

There are no well-controlled studies that have been done in pregnant women. Nystatin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

OR

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Nystatin should be given to a pregnant woman only if clearly needed.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Other drugs may interact with nystatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

In the U.S.

• Bio-Statin

In Canada

• Mycostatin Suspension
• Nadostine
• Nadostine Sucrose-Free
• Nilstat Drops
• Nilstat Powder
• Nyaderm
• Pms-Nystatin

Available Dosage Forms:

• Capsule
• Tablet
• Suspension

Therapeutic Class: Antifungal

Chemical Class: Polyene

For patients taking the dry powder form of nystatin:

• Add about ⅛ teaspoonful of dry powder to about 4 ounces of water immediately before taking. Stir well.
• After it is mixed, take nystatin by dividing the whole amount (4 ounces) into several portions. Hold each portion of the medicine in your mouth or swish it around in your mouth for as long as possible, gargle, and swallow. Be sure to use all the liquid to get the full dose of medicine.

For patients taking the lozenge (pastille) form of nystatin:

• Nystatin lozenges (pastilles) should be held in the mouth and allowed to dissolve slowly and completely. This may take 15 to 30 minutes. Also, the saliva should be swallowed during this time. Do not chew or swallow the lozenges whole.
• Do not give nystatin lozenges (pastilles) to infants or children up to 5 years of age. They may be too young to use the lozenges safely.

For patients taking the oral liquid form of nystatin :

• nystatin is to be taken by mouth even if it comes in a dropper bottle. If it does come in a dropper bottle, use the specially marked dropper to measure each dose accurately.
• Take nystatin by placing one-half of the dose in each side of your mouth. Hold the medicine in your mouth or swish it around in your mouth for as long as possible, then gargle and swallow.

Patients with full or partial dentures may need to soak their dentures nightly in nystatin for oral suspension to eliminate the fungus from the dentures. In rare cases when this does not eliminate the fungus, it may be necessary to have new dentures made.

To help clear up your infection completely, keep taking nystatin for the full time of treatment, even if your condition has improved. Do not miss any doses.

Dosing

The dose of nystatin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of nystatin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For the lozenge (pastille) and tablet dosage forms:
  • Adults and children 5 years of age and older: 1 or 2 lozenges or tablets three to five times a day for up to fourteen days.
  • Children up to 5 years of age: Children this young may not be able to use the lozenges or tablets safely. The oral suspension is better for this age group.
• For the suspension dosage form:
  • Adults and children 5 years of age and older: 4 to 6 milliliters (mL) (about 1 teaspoonful) four times a day.
  • For older infants: 2 mL four times a day.
  • For premature and low-birth-weight infants: 1 mL four times a day.

Missed Dose

If you miss a dose of nystatin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the lozenge (pastille) form in the refrigerator.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• nausea or vomiting
• stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.