nystatin vaginal
30/06/10
Generic Name: nystatin vaginal (nye STAT in)
Brand Names:
What is nystatin vaginal?
Nystatin is an antifungal medication. Nystatin prevents fungus from growing.
Nystatin vaginal is used to treat vaginal candida (yeast) infections.
Nystatin vaginal may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about nystatin vaginal?
Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.
Avoid wearing tight-fitting, synthetic clothing (ej., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.
Avoid getting this medication in your eyes, nose or mouth.
Who should not use nystatin vaginal?
Do not use nystatin vaginal if you have ever had an allergic reaction to it.
Do not use nystatin vaginal if you have a fever, abdominal pain, foul-smelling discharge, diabetes, HIV, or AIDS. Consult your doctor.
Do not use this medication without first talking to your doctor if you are pregnant. Do not use nystatin vaginal without first talking to your doctor if you are breast-feeding a baby.
How should I use nystatin vaginal?
Use nystatin vaginal exactly as directed by your doctor, or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Wash your hands before and after using this medication.
Insert the tablet into the vagina using the applicator as directed.
Use this medication continuously for the prescribed amount of time, even during your menstrual period.
You can use a sanitary napkin to prevent the medication from staining your clothing but do not use a tampon.
If the infection does not clear up after you have finished one course of therapy, or if it appears to get worse, see your doctor. You may have another type of infection.
Avoid getting this medication in your eyes, nose, or mouth. Store nystatin vaginal at room temperature away from moisture and heat.
What happens if I miss a dose?
Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only your next regularly scheduled dose. Do not use a double dose.
What happens if I overdose?
An overdose of nystatin vaginal is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that nystatin vaginal has been ingested, contact an emergency room or a poison control center.
What should I avoid while using nystatin vaginal?
Avoid wearing tight-fitting, synthetic clothing (ej., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.
Avoid sexual intercourse or use a condom to prevent the infection from spreading to your partner.
Nystatin vaginal side effects
Stop using nystatin vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).
Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Nystatin vaginal Dosing Information
Usual Adult Dose for Oral Thrush:
1 to 2 oral lozenges (200,000 to 400,000 units) 4 to 5 times a day or
500,000 units of oral suspension 4 times a day.
Usual Adult Dose for Intestinal Candidiasis:
500,000 to 1,000,000 units orally 3 times a day.
Usual Pediatric Dose for Oral Thrush:
Neonates: 100,000 units of oral suspension 4 times a day.
>1 m <12 m:: 200,000 units of oral suspension 4 times a day.
>=1 year <18 years: 1 to 2 oral lozenges (200,000 to 400,000 units) 4 to 5 times a day or 500,000 units of oral suspension 4 times a day.
What other drugs will affect nystatin vaginal?
Avoid using other vaginal creams or douches at the same time as nystatin unless your doctor approves.
Drugs other than those listed here may also interact with nystatin vaginal. Talk to your doctor and pharmacist before taking any prescription or over the counter medicines.
Where can I get more information?
- Your pharmacist has additional information about nystatin vaginal 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.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 3.04. Revision Date: 4/12/2009 4:39:21 PM.
Nystatin Vaginal Insert
30/06/10
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei.
Nystatin Vaginal Inserts, USP are available as oval-shaped compressed inserts for intravaginal administration, each containing 100,000 units Nystatin, USP. Inactive ingredients include corn starch, ethylcellulose, anhydrous lactose, microcrystalline cellulose, polyethylene glycol and stearic acid.
Nystatin Vaginal Insert – Clinical Pharmacology
Nystatin is both fungi-static and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Nystatin acts by binding to sterols in the cell membrane of sensitive fungi with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, trichomonads or viruses.
Nystatin is not absorbed from intact skin or mucous membranes.
Indications and Usage for Nystatin Vaginal Insert
Nystatin Vaginal Inserts, USP are effective for the local treatment of vulvovaginal candidiasis (moniliasis). The diagnosis should be confirmed, prior to therapy, by KOH smears and/or cultures. Other pathogens commonly associated with vulvovaginitis (Trichomonas and Haemophilus vaginalis) do not respond to nystatin and should be ruled out by appropriate laboratory methods.
Contraindications
This preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
Precautions
General
Discontinue treatment if sensitization or irritation is reported during use.
Information for Patients
The patient should be informed of symptoms of sensitization or irritation and told to report them promptly.
The patient should be warned against interruption or discontinuation of medication even during menstruation and even though symptomatic relief may occur within a few days.
The patient should be advised that adjunctive measures such as therapeutic douches are unnecessary and sometimes inadvisable, but cleansing douches may be used by nonpregnant women, if desired, for esthetic purposes.
Laboratory Tests
If there is a lack of response to Nystatin Vaginal Inserts, USP, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy (see INDICATIONS AND USAGE).
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenesis, or whether this medication affects fertility in females.
Pregnancy
Teratogenic effects: Pregnancy Category A
There have been no reports that use of Nystatin Vaginal Inserts by pregnant women increases the risk of fetal abnormalities or affects later growth, development and functional maturation of the child. Nevertheless, because the possibility of harm cannot be ruled out, Nystatin Vaginal Inserts should be used during pregnancy only if the physician considers it essential to the welfare of the patient.
Animal reproduction studies have not been conducted with Nystatin Vaginal Inserts.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Adverse Reactions
Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even on prolonged administration. Rarely, irritation or sensitization may occur (see PRECAUTIONS).
Nystatin Vaginal Insert Dosage and Administration
The usual dosage is one insert (100,000 units nystatin) daily for two weeks.
The inserts should be deposited high in the vagina by means of the applicator. “Instructions for the Patient” are enclosed in each package.
How is Nystatin Vaginal Insert Supplied
Nystatin Vaginal Inserts, USP:
Pale yellow mottled oval-shaped, flat face, beveled insert (Debossed ODYSSEY on one side and 705 on the other) are available in packages of 15 individually foil wrapped inserts, with applicator and “Instructions for the Patient”.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
DURAMED PHARMACEUTICALS, INC.
Subsidiary of Barr Pharmaceuticals, Inc. B08 – 0705
Pomona, New York 10970 R8 – 07 (V.2)
15001177
| NYSTATIN nystatin insert |
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Revised: 02/2008Duramed Pharmaceuticals, Inc
Nystatin Ointment
30/06/10
Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows:
Nystatin Ointment – Clinical Pharmacology
Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic that is obtained from Streptomyces noursei, and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida [Monilia]albicans and other Candida species. It exhibits no appreciable activity against bacteria.
Nystatin provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.
Indications and Usage for Nystatin Ointment
Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.
Contraindications
Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of its components.
Precautions
Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.
This preparation is not for ophthalmic use.
Adverse Reactions
Nystatin is virtually non-toxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.
Nystatin Ointment Dosage and Administration
Nystatin Ointment should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to Nystatin Ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder.
This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.
How is Nystatin Ointment Supplied
Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows:
NDC 0168-0007-15 15 gram tube
NDC 0168-0007-30 30 gram tube
Store at controlled room temperature 15°- 30°C (59°-86°F).
E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747
I20715G
R3/08
#21
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER
NDC 0168-0007-15
FOUGERA®
Nystatin Ointment USP
100,000 USP Nystatin Units Per Gram
For Topical Use Only.
Not for Ophthalmic Use.
Rx only
CONTAINS: 100,000 USP
Nystatin Units per gram,
in a polyethylene and
mineral oil base.
NET WT 15 grams
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON
NDC 0168-0007-15
FOUGERA® Rx only
Nystatin Ointment USP
100,000 USP Nystatin Units Per Gram
WARNING: Keep this and all
drugs out of reach of children.
For Topical Use Only.
Not for Ophthalmic Use.
NET WT 15 grams
| NYSTATIN nystatin ointment |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA062124 | 09/23/1982 | |
| Labeler - E. FOUGERA & CO., A division of Nycomed US Inc. (043838424) |
| Registrant - Nycomed US Inc. (043838424) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Nycomed US Inc. | 174491316 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Nycomed US Inc. | 043838424 | ANALYSIS | |
Revised: 11/2009E. FOUGERA & CO., A division of Nycomed US Inc.
Nystatin Oral Suspension
30/06/10
Dosage Form: oral suspension
NYSTATIN ORAL
SUSPENSION, USP
100,000 Units/mL
Rx Only
Nystatin Oral Suspension Description
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:
C47H75NO17 MW 926.13
Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodiumphosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxymethylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP
Nystatin Oral Suspension – Clinical Pharmacology
Pharmacokinetics
Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.
Microbiology
Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
Indications and Usage for Nystatin Oral Suspension
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
Contraindications
The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
Precautions
General
This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.
Pregnancy
Category C
Animal reproduction studies have not been conducted with Nystatin Oral Suspension. It is also not known whether Nystatin Oral Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin Oral Suspension should be given to a pregnant woman only if clearly needed.
Nursing Mothers
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.
Pediatric Use
See DOSAGE AND ADMINISTRATION.
Adverse Reactions
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 non-specific myalgia have also been rarely reported.
Overdosage
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 of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
Nystatin Oral Suspension Dosage and Administration
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).
NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.
CHILDREN AND ADULTS
4–6 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.
How is Nystatin Oral Suspension Supplied
Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a cherry flavored, light creamy yellow, ready-to-use suspension. It is supplied as follows:
NDC 66689-037-01. 5 mL unit dose cup.
NDC 66689-037-50. Case contains 50 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 5 trays of 10 unit dose cups each.
NDC 66689-037-99. Case contains 100 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 10 trays of 10 unit dose cups each.
Storage
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Avoid freezing.
Rx Only
Manufactured by:
VistaPharm®
Largo, FL 33771
VP2053
04/10
PRINCIPAL DISPLAY PANEL – 100,000 units/mL cup label
Xact DOSE™
NYSTATIN
ORAL SUSPENSION, USP
100,000 units/mL
NDC 66689-037-01
Alcohol not more than 1% v/v
SHAKE WELL BEFORE USING
Protect from freezing
Store at 20°–25°C (68°–77°F)
[See USP CONTROLLED RM TEMP]
Rx Only This cup delivers 5 mL VP2052
Manufactured by VistaPharm, Inc.
Largo, FL 33771
| NYSTATIN nystatin suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA064142 | 05/10/2010 | |
| Labeler - VistaPharm, Inc (048458728) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| VistaPharm, Inc | 048458728 | MANUFACTURE, REPACK | |
Revised: 04/2010VistaPharm, Inc
nystatin and triamcinolone
30/06/10
Generic Name: nystatin and triamcinolone (topical) (nye STAT in and TRYE am SIN o lone)
Brand names: Mycogen II, Mytrex, …show all 10 brand names.
What is nystatin and triamcinolone?
Nystatin is an antibiotic medication that prevents fungus from growing on your skin.
Triamcinolone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.
The combination of nystatin and triamcinolone topical (for the skin) is used to treat skin infections caused by fungus or yeast.
Nystatin and triamcinolone may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about nystatin and triamcinolone?
You should not use this medication if you are allergic to nystatin or triamcinolone.
Before using nystatin and triamcinolone, tell your doctor if you have any type of skin infection (especially tuberculosis infection of the skin), or if you have chicken pox or herpes infection (including cold sores).
Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.
Use this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.
What should I discuss with my health care provider before using nystatin and triamcinolone?
You should not use this medication if you are allergic to nystatin or triamcinolone.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
-
any type of skin infection, especially tuberculosis infection of the skin; or
-
chicken pox or herpes infection (including cold sores).
Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.
FDA pregnancy category C. It is not known whether nystatin and triamcinolone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether nystatin and triamcinolone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I use nystatin and triamcinolone?
Use this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.
Apply a thin layer of nystatin and triamcinolone to your skin and rub in gently.
Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. Covering the skin that is treated with nystatin and triamcinolone can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions.
Avoid tight-fitting clothes over treated skin areas. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers.
Call your doctor if your symptoms do not improve, or if they get worse after using this medication.
Do not use nystatin and triamcinolone for any other skin conditions your doctor has not prescribed the medication to treat.
Store this medicine at room temperature away from moisture and heat. Keep the tube or bottle tightly closed when not in use.
What happens if I miss a dose?
Apply the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may result if you absorb this medicine through your skin by applying too much of it.
An overdose of nystatin and triamcinolone is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.
What should I avoid while using nystatin and triamcinolone?
Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use nystatin and triamcinolone on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.
Nystatin and triamcinolone side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing triamcinolone through your skin:
-
blurred vision, or seeing halos around lights;
-
uneven heartbeats;
-
mood changes;
-
sleep problems (insomnia);
-
weight gain, puffiness in your face; or
-
feeling tired.
Less serious side effects may include:
-
stinging, burning, itching, or skin irritation;
-
acne;
-
dry skin; or
-
changes in skin color.
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.
Nystatin and triamcinolone Dosing Information
Usual Adult Dose for Cutaneous Candidiasis:
Cream: Apply to affected area(s) 2 times daily.
Ointment: Apply to affected area(s) 3 times daily.
Usual Pediatric Dose for Cutaneous Candidiasis:
<2 months: Safety and efficacy have not been established.
2 months-18 years:
Cream: Apply to affected area(s) 2 times daily.
Ointment: Apply to affected area(s) 3 times daily.
What other drugs will affect nystatin and triamcinolone?
It is not likely that other drugs you take orally or inject will have an effect on topically applied nystatin and triamcinolone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
Where can I get more information?
- Your pharmacist can provide more information about nystatin and triamcinolone topical.
- 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.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.05. Revision Date: 10/16/2009 1:06:23 PM.
nye-STAT-in, trye-am-SIN-oh-lone a-SEET-oh-nide
Commonly used brand name(s):
In the U.S.
- Mycolog-II
- Mytrex
- Quenalog
Available Dosage Forms:
- Ointment
- Cream
Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination
Pharmacologic Class: Triamcinolone
Chemical Class: Polyene
Uses For nystatin and triamcinolone
Nystatin and triamcinolone combination contains an antifungal and a corticosteroid (cortisone-like medicine).
Antifungals are used to treat infections caused by a fungus. They work by killing the fungus or preventing its growth. nystatin and triamcinolone will not work for other kinds of infections. Corticosteroids belong to the family of medicines called steroids. They are used to help relieve redness, swelling, itching, and other discomfort of many skin problems.
nystatin and triamcinolone is used to treat certain fungus infections, such as Candida (Monilia), and to help relieve the discomfort of the infection.
Topical corticosteroids may rarely cause some serious side effects. Some of the side effects may be more likely to occur in children. Before using nystatin and triamcinolone in children, be sure to talk to your doctor about these problems, as well as the good nystatin and triamcinolone may do.
Nystatin and triamcinolone combination is available only with your doctor’s prescription.
Before Using nystatin and triamcinolone
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 nystatin and triamcinolone, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to nystatin and triamcinolone 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
Children may be especially sensitive to the effects of topical nystatin and triamcinolone combination. This may increase the chance of side effects during treatment. Therefore, it is especially important that you discuss with your child’s doctor the good that nystatin and triamcinolone may do as well as the risks of using it.
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. Although there is no specific information comparing use of topical nystatin and triamcinolone combination in the elderly with use in other age groups, nystatin and triamcinolone is not expected to cause different side effects or problems in older people than it does in younger adults.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Using nystatin and triamcinolone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Rotavirus Vaccine, Live
Using nystatin and triamcinolone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aldesleukin
- Quetiapine
Using nystatin and triamcinolone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alatrofloxacin
- Alcuronium
- Aspirin
- Atracurium
- Balofloxacin
- Cinoxacin
- Ciprofloxacin
- Clinafloxacin
- Enoxacin
- Fleroxacin
- Flumequine
- Gallamine
- Gemifloxacin
- Grepafloxacin
- Hexafluorenium
- Itraconazole
- Levofloxacin
- Licorice
- Lomefloxacin
- Metocurine
- Moxifloxacin
- Norfloxacin
- Ofloxacin
- Pefloxacin
- Phenytoin
- Primidone
- Prulifloxacin
- Rosoxacin
- Rufloxacin
- Saiboku-To
- Sparfloxacin
- Temafloxacin
- Tosufloxacin
- Trovafloxacin Mesylate
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.
Other Medical Problems
The presence of other medical problems may affect the use of nystatin and triamcinolone. Make sure you tell your doctor if you have any other medical problems, especially:
- Herpes
- Vaccinia (cowpox)
- Varicella (chickenpox)
- Other virus infections of the skin—Triamcinolone may speed up the spread of virus infections
- Tuberculosis (TB) of the skin—Triamcinolone may make a TB infection worse
Proper Use of nystatin and triamcinolone
Do not use nystatin and triamcinolone in or around the eyes.
Check with your doctor before using nystatin and triamcinolone on any other skin problems. It should not be used on bacterial or virus infections. Also, it should only be used on certain fungus infections of the skin.
Apply a thin layer of nystatin and triamcinolone to the affected area and rub in gently and thoroughly.
The use of any kind of airtight covering over nystatin and triamcinolone may increase absorption of the medicine and the chance of irritation and other side effects. Therefore, do not bandage, wrap, or apply any airtight covering or other occlusive dressing (for example, kitchen plastic wrap) over nystatin and triamcinolone unless directed to do so by your doctor. Also, wear loose-fitting clothing when using nystatin and triamcinolone on the groin area. When using nystatin and triamcinolone on the diaper area of children, avoid tight-fitting diapers and plastic pants.
To help clear up your infection completely, keep using nystatin and triamcinolone for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses. However, do not use nystatin and triamcinolone more often or for a longer time than your doctor ordered. To do so may increase absorption through your skin and the chance of side effects. In addition, too much use, especially on thin skin areas (for example, face, armpits, groin), may result in thinning of the skin and stretch marks.
Dosing
The dose of nystatin and triamcinolone 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 and triamcinolone. 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 fungus infections:
- For cream dosage form:
- Adults and children—Apply to the affected area(s) of the skin two times a day, morning and evening
- For ointment dosage form:
- Adults and children—Apply to the affected area(s) of the skin two or three times a day.
- For cream dosage form:
Missed Dose
If you miss a dose of nystatin and triamcinolone, apply 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.
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.
Precautions While Using nystatin and triamcinolone
To help clear up your infection completely and to help make sure it does not return, good health habits are also required. Keep the affected area as cool and dry as possible.
If your skin problem does not improve within 2 or 3 weeks, or if it becomes worse, check with your doctor.
The corticosteroid in nystatin and triamcinolone may be absorbed through the skin and may be more likely to cause side effects in children. Long-term use may affect growth and development as well. Children who must use nystatin and triamcinolone should be followed closely by their doctor.
For diabetic patients:
- Although rare, the corticosteroid in nystatin and triamcinolone may cause higher blood and urine sugar levels, especially if you have severe diabetes and are using large amounts of nystatin and triamcinolone. Check with your doctor before changing your diet or the dosage of your diabetes medicine.
nystatin and triamcinolone 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.
Check with your doctor immediately if any of the following side effects occur:
Rare
- Blistering, burning, dryness, itching, peeling, or other sign of irritation not present before use of nystatin and triamcinolone
Check with your doctor as soon as possible if any of the following side effects occur:
Many of the above side effects are more likely to occur in children, who may absorb greater amounts of nystatin and triamcinolone.
- Acne or oily skin
- increased hair growth, especially on the face
- increased loss of hair, especially on the scalp
- reddish purple lines on arms, face, legs, trunk, or groin
- thinning of skin with easy bruising
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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Nystatin and Triamcinolone Ointment
30/06/10
Generic Name: nystatin and triamcinolone acetonide
Dosage Form: ointment
NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT USP
For Dermatologic Use Only
Not For Ophthalmic Use
Rx only
Nystatin and Triamcinolone Ointment Description
Nystatin and triamcinolone acetonide ointment, USP for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide.
Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. It has a molecular formula of C47H75NO17 and a molecular weight of 926.13.
Triamcinolone acetonide is designated chemically as Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α-). The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. It has a molecular formula of C24H31FO6 and a molecular weight of 434.50.
Each gram of nystatin and triamcinolone acetonide ointment contains 100,000 USP nystatin units and 1 mg of triamcinolone acetonide in a base of polyethylene and mineral oil.
Nystatin and Triamcinolone Ointment – Clinical Pharmacology
NYSTATIN
Nystatin exerts its antifungal activity against a variety of pathogenic and nonpathogenic yeasts and fungi by binding to sterols in the cell membrane. The binding process renders the cell membrane incapable of functioning as a selective barrier. Nystatin provides specific anticandidal activity to Candida (Monilia) albicans and other Candida species, but is not active against bacteria, protozoa, trichomonads, or viruses. Nystatin is not absorbed from intact skin or mucous membranes.
TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide is primarily effective because of it’s anti-inflammatory, anti-pruritic and vasoconstrictive actions, characteristic of the topical corticosteroid class of drugs. The pharmacological effects of the topical corticosteroids are well known, however, the mechanisms of their dermatologic actions are unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Pharmacokinetics:
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION).
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
NYSTATIN and TRIAMCINOLONE ACETONIDE
Patients having mild to severe manifestations of cutaneous candidiasis treated with combined nystatin and triamcinolone acetonide show a faster and more pronounced clearing of erythema and pruritis than patients treated with nystatin or triamcinolone acetonide alone.
Indications and Usage for Nystatin and Triamcinolone Ointment
Nystatin and triamcinolone acetonide ointment is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment .
Contraindications
This preparation is contraindicated in those patients with a history of hypersensitivity to any of its components.
Precautions
General:
Systemic absorption of topical corticosteroids has produced reversible hypothalmic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.
Conditions that augment systemic absorption include application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings (see DOSAGE AND ADMINISTRATION).
Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use).
If irritation or hypersensitivity develops with the combination nystatin and triamcinolone acetonide, treatment should be discontinued and appropriate therapy instituted.
Information for the Patient: Patients using this medication should receive the following information and instructions.
- This medication is to be used as directed by the physician. It is for dermatological use only.
Avoid contact with eyes. - Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
- The treated skin area should not be bandaged or otherwise covered or wrapped as to be occluded (see DOSAGE AND ADMINISTRATION).
- Patients should report any signs of local adverse reactions.
- When using this medication in the inguinal area, patients should be advised to apply ointment sparingly and to wear loose fitting clothing.
- Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
- Patients should be advised on preventative measures to avoid reinfection.
Laboratory Tests: If there is a lack of therapeutic response, appropriate microbiological studies (e.g. KOH smears and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens, before instituting another course of therapy.
A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating hypothalmic-pituitary-adrenal (HPA) axis suppression due to corticosteroid.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic or mutagenic potential or possible impairment of fertility in males or females.
Pregnancy Category C: There are no teratogenic studies with combined nystatin and triamcinolone acetonide. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Therefore, any topical corticosteroid preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Topical preparations containing corticosteroids should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers: It is not known whether any component of this preparation is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised during use of this preparation by a nursing woman.
Pediatric Use: In clinical studies of nystatin and triamcinolone acetonide cream formulation on a limited number of pediatric patients ranging in age from 2 months through 12 years, the combination cleared or significantly ameliorated the diseased state in most patients.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalmic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papiledema.
Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Adverse Reactions
Acneiform eruption has been reported to occur in approximately one percent of patients with the use of combined nystatin and triamcinolone acetonide.
Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even during prolonged use. Rarely, irritation may occur.
The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS: General). However, acute overdosage and serious adverse effects with dermatologic use are unlikely.
DOSAGE AND ADMINISTRATION:
A thin film of nystatin and triamcinolone acetonide ointment, USP is usually applied to the affected areas twice daily in the morning and evening.
The ointment should be discontinued if symptoms persist after 25 days of therapy. (See PRECAUTIONS: Laboratory Tests.)
Nystatin and triamcinolone acetonide ointment should not be used with occlusive dressings.
How is Nystatin and Triamcinolone Ointment Supplied
Nystatin and triamcinolone acetonide ointment, USP, a yellow ointment, is supplied as follows:
15 Gram Tube – NDC 0168-0089-15
30 Gram Tube – NDC 0168-0089-30
60 Gram Tube – NDC 0168-0089-60
Store at controlled room temperature 15°-30°C (59°-86°). Avoid freezing.
E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747
I28915E
R3/08
#272
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER
NDC 0168-0089-15
Fougera®
NYSTATIN and
TRIAMCINOLONE
ACETONIDE
OINTMENT USP
Rx only
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Each gram contains 100,000 USP
Nystatin Units and 1 mg of
triamcinolone acetonide in a
polyethylene and mineral oil base.
NET WT 15 grams
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON
NDC 0168-0089-15
Fougera® Rx only
NYSTATIN and
TRIAMCINOLONE
ACETONIDE OINTMENT USP
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
WARNING: Keep out of
the reach of children.
NET WT 15 grams
| NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin and triamcinolone acetonide ointment |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA062602 | 10/09/1985 | |
| Labeler - E. FOUGERA & CO., A division of Nycomed US Inc. (043838424) |
| Registrant - Nycomed US Inc. (043838424) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Nycomed US Inc. | 174491316 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Nycomed US Inc. | 043838424 | ANALYSIS | |
Revised: 11/2009E. FOUGERA & CO., A division of Nycomed US Inc.
Nystatin Powder
30/06/10
Generic Name: Nystatin (nye-STAT-in)
Brand Name: Nystop
Nystatin Powder is used for:
Treating certain fungal infections. It may also be used for other conditions as determined by your doctor.
Nystatin Powder is an antifungal. It works by killing sensitive fungi.
Do NOT use Nystatin Powder if:
- you are allergic to any ingredient in Nystatin Powder
Contact your doctor or health care provider right away if any of these apply to you.
Before using Nystatin Powder:
Some medical conditions may interact with Nystatin Powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
Some MEDICINES MAY INTERACT with Nystatin Powder. However, no specific interactions with Nystatin Powder are known at this time.
Ask your health care provider if Nystatin Powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Nystatin Powder:
Use Nystatin Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Clean the affected area with soap and water and dry thoroughly. Sprinkle enough powder to cover the affected area.
- If Nystatin Powder is used on the feet, sprinkle Nystatin Powder freely on the feet and in shoes and socks.
- Do not cover with a bandage or dressing unless directed otherwise by your doctor.
- Wash your hands immediately after using Nystatin Powder.
- To clear up your infection completely, use Nystatin Powder for the full course of treatment. Keep using it even if you feel better in a few days.
- Nystatin Powder works best if it is used at the same times each day.
- If you miss a dose of Nystatin Powder, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Nystatin Powder.
Important safety information:
- Nystatin Powder is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse them right away with cool tap water.
- Be sure to use Nystatin Powder for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nystatin Powder while you are pregnant. It is not known if Nystatin Powder is found in breast milk. If you are or will be breast-feeding while you use Nystatin Powder, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Nystatin Powder:
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Nystatin Powder. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, pain, or irritation of the affected area.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Nystatin Powder may be harmful if swallowed.
Proper storage of Nystatin Powder:
Store Nystatin Powder at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Avoid temperatures above 104 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nystatin Powder out of the reach of children and away from pets.
General information:
- If you have any questions about Nystatin Powder, please talk with your doctor, pharmacist, or other health care provider.
- Nystatin Powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Nystatin Powder. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
nystatin (Oral route)
30/06/10
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 nystatin
Nystatin belongs to the group of medicines called antifungals. The dry powder, lozenge (pastille), and liquid forms of nystatin 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 nystatin
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 nystatin, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to nystatin 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
nystatin 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
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.
nystatin 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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Nystatin Cream
30/06/10
Generic Name: Nystatin (nye-STA-tin)
Brand Name: Mycostatin
Nystatin Cream is used for:
Treatment of fungal infections, including jock itch, athlete’s foot, and ringworm. It may be used for other conditions as determined by your doctor.
Nystatin Cream is an antifungal. It works by weakening cell membranes of the sensitive fungus. This allows the cell contents to leak out and results in death of the fungus.
Do NOT use Nystatin Cream if:
- you are allergic to any ingredient in Nystatin Cream
Contact your doctor or health care provider right away if any of these apply to you.
Before using Nystatin Cream:
Some medical conditions may interact with Nystatin Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
Some MEDICINES MAY INTERACT with Nystatin Cream. However, no specific interactions with Nystatin Cream are known at this time.
Ask your health care provider if Nystatin Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Nystatin Cream:
Use Nystatin Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Clean the affected area with soap and water and dry thoroughly. Apply enough medicine to cover the affected area. Rub in gently.
- Wash your hands immediately after using Nystatin Cream, unless your hands are part of the treated area.
- Nystatin Cream works best if it is used at the same time every day.
- To clear up your infection completely, use Nystatin Cream for the full course of treatment. Keep using it even if you feel better in a few days.
- If you miss a dose of Nystatin Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Nystatin Cream.
Important safety information:
- Nystatin Cream is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse right away with cool tap water.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nystatin Cream while you are pregnant. It is not known if Nystatin Cream is found in breast milk. If you are or will be breast-feeding while you use Nystatin Cream, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Nystatin Cream:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Skin irritation.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Nystatin Cream may be harmful if swallowed.
Proper storage of Nystatin Cream:
Store Nystatin Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Nystatin Cream out of the reach of children and away from pets.
General information:
- If you have any questions about Nystatin Cream, please talk with your doctor, pharmacist, or other health care provider.
- Nystatin Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Nystatin Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.