Bio-Statin

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fast heart rate;

• trouble breathing; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• mouth irritation;

• upset stomach, nausea, vomiting, diarrhea; or

• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 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.

• If you have an allergy to nystatin or any other part of Bio-Statin (nystatin powder for oral suspension).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Store in a refrigerator.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to nystatin: compounding powder, oral capsule, oral lozenge, oral suspension, oral tablet, topical cream, topical ointment, topical powder, vaginal tablet

General

The most commonly reported side effects include oral irritation and sensitization.[Ref]

Gastrointestinal

Frequency not reported: Diarrhea, bloody diarrhea, nausea, vomiting, gastrointestinal upset/disturbances, oral irritation and sensitization[Ref]

Dermatologic

Frequency not reported: Rash, urticaria, Sevens-Johnson syndrome, generalized pustular eruptions[Ref]

Immunologic

Frequency not reported: Delayed (type IV) hypersensitivity reactions[Ref]

Cardiovascular

Frequency not reported: Tachycardia[Ref]

Other

Frequency not reported: Facial swelling[Ref]

Respiratory

Frequency not reported: Bronchospasm[Ref]

Musculoskeletal

Frequency not reported: Non-specific myalgia[Ref]

Some side effects of Bio-Statin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Consult WARNINGS section for additional precautions.

Administration advice:
-Patients should shake the oral suspension well prior to use, and the suspension should be administered by placing half of the dose in each side of the mouth with a dropper.

Storage requirements:
-The manufacturer product information should be consulted.

General:
-This drug is fungistatic and fungicidal in yeasts and yeast-like fungi; it is not active against organisms lacking sterols in their cell membranes.

Monitoring:
-Signs/symptoms of candidiasis (e.g., cultures)
-Hypersensitivity reactions

Patient advice:
-Patients should continue treatment for at least 48 hours after symptoms disappear and/or cultures are negative for Candida albicans.
-Patients should be instructed to report signs/symptoms of hypersensitivity reactions.
-Patients should be told to immediately contact their healthcare providers if symptoms worsen and/or are not improved after 14 days.

Caution is recommended. Excreted into human milk: Data not available Excreted into animal milk: Unknown