NYSTATIN (Oral)

Some commonly used brand names are:

In the U.S.?

• Mycostatin
• Nilstat
• Nystex

In Canada?

• Mycostatin
• Nadostine
• Nilstat
• PMS Nystatin

Generic name product may be available in the U.S.

Category

• Antifungal, oral-local

Description

Nystatin (nye-STAT-in) belongs to the group ofmedicines called antifungals. The dry powder, lozenge (pastille), and liquidforms of this medicine are used to treat fungus infections in the mouth.

Nystatin is available only with your doctor's prescription, in the followingdosage forms:

Oral
• Lozenges (Pastilles) (U.S.)
• Oral suspension (U.S. and Canada)
• Powder for oral suspension (U.S. and Canada)
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For nystatin, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to nystatin. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Studies in humans have not shown that oral nystatincauses birth defects or other problems.

Breast-feeding?Oral nystatin has not been reported to cause problemsin nursing babies.

Children?This medicine has been tested in children and hasnot been reported to cause different side effects or problems in childrenthan it does in adults. However, since children up to 5 years of age may betoo young to use the lozenges (pastilles) or tablets safely, the oral suspensiondosage form is best for this age group.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof oral nystatin in the elderly with use in other age groups.

Proper Use of This Medicine

For patients taking the dry powder form of nystatin:

• Add about 1/8 teaspoonful of dry powder to about 4 ounces ofwater immediately before taking. Stir well.
• After it is mixed, take this medicine by dividing the whole amount(4 ounces) into several portions. Hold each portion of the medicine in yourmouth or swish it around in your mouth for as long as possible, gargle, andswallow. Be sure to use all the liquid to get the full dose of medicine.

For patients taking the lozenge (pastille) form ofnystatin:

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

For patients taking the oral liquid form of nystatin:

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

Patients with full or partial dentures may need to soak their denturesnightly 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 necessaryto have new dentures made.

To help clear up your infection completely, keep takingthis medicine for the full time of treatment, even if your conditionhas improved. Do not miss any doses.

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

The number of lozenges, tablets, or milliliters (mL) of suspension thatyou take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, andthe length of time you take the medicine depend on the medical problem forwhich you are taking nystatin.

• For the lozenge (pastille) and tabletdosage forms:
  • Adults and children 5 years of age and older: 1 or 2 lozenges ortablets three to five times a day for up to fourteen days.
  • Children up to 5 years of age: Children this young may not be ableto use the lozenges or tablets safely. The oral suspension is better for thisage 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 do miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet or dry powder form of this medicine in thebathroom, near the kitchen sink, or in other damp places. Heat or moisturemay cause the medicine to break down.
• Store the lozenge (pastille) form in the refrigerator. Heat willcause this medicine to break down.
• Keep the oral liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Side Effects of This Medicine

Alongwith its needed effects, a medicine may cause some unwanted effects. The followingside effects may go away during treatment as your body adjusts to the medicine.However, check with your doctor if any of the following side effects continueor are bothersome:

Less common

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although this use is not included in product labeling,nystatin is used in certain patients with the following medical condition:

• Candidiasis, oral (fungus infection of the mouth) (prevention)

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.