Nadostine Sucrose-Free

Generic Name: nystatin (Oral route)

nye-STAT-in

Commonly used brand name(s)

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

Uses For Nadostine Sucrose-Free

Nystatin belongs to the group of medicines called antifungals. The dry powder, lozenge (pastille), and liquid forms of this medicine are used to treat fungus infections in the mouth.

Nystatin is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for 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)

Before Using Nadostine Sucrose-Free

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and has not been reported to cause different side effects or problems in children than it does in adults. However, since children up to 5 years of age may be too young to use the lozenges (pastilles) or tablets safely, the oral suspension dosage form is best for this age group.

Geriatric

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of nystatin

This section provides information on the proper use of a number of products that contain nystatin. It may not be specific to Nadostine Sucrose-Free. Please read with care.

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 this medicine 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 :

• This medicine 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 this medicine 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 this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.

Dosing

The dose of this medicine 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 this medicine. 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 this medicine, 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.

Nadostine Sucrose-Free Side Effects

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:

Less common

• 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.

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• Nadostine Sucrose-Free Support Group
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