Mycostatin (Nystatin)

MYCOSTATIN® Preparations

Squibb

Nystatin

Antifungal Antibiotic

Indications And Clinical Uses: Oral: Prevention and treatment of fun of the oral cavity and esophagus, for intestinal candidiasis and for protection against candidal overgrowth during antimicrobial or corticosteroid therapy.

Topical: Treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) species.

Vaginal: Local treatment of vaginal mycotic infections caused by C. albicans (Monilia) and other Candida species and treatment of pregnant patients to prevent thrush in the newborn.

Contra-Indications: Hypersensitivity to nystatin or any components of Mycostatin products.

Precautions: Nystatin oral preparations are not indicated for the treatment of systemic mycoses.

It is recommended that appropriate microbiological studies (e.g. KOH smears and/or cultures) be used to confirm the diagnosis of candidiasis and rule out other pathogens. If there is a lack of therapeutic response, appropriate microbiological studies should be repeated. Discontinue medication if irritation occurs with topical or intravaginal use.

Pregnancy: Use of the vaginal applicator may not be considered desirable during pregnancy. Appropriate measures should be taken to avoid possible reinfection during sexual intercourse.

Animal reproduction studies have not been conducted with nystatin oral preparations. It is also not known whether these preparations can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Nystatin oral preparations should be administered to a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Lactation: It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed to a nursing woman.

Mycostatin oral tablets contain tartrazine which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Information for the Patient: Patients taking the oral medication should receive the following information and instructions:

1. The patient should be instructed to use the medication as directed (including the replacement of missed doses). The medication is not for any disorder other than that for which it is prescribed. 2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue the medication until the prescribed course of treatment is completed. 3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly. 4. When prescribing nystatin oral suspension, advise the patient of the importance of good oral hygiene, including the proper care (where applicable) of dentures.

Adverse Reactions: Nystatin is well tolerated by all age groups including debilitated infants, even on prolonged administration. Rarely, oral irritation or sensitization may occur.

The following adverse reactions have been reported with nystatin oral dosage forms: Gastrointestinal: diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic: rash

In addition, rarely reported cases of: tachycardia, bronchospasm, facial swelling, urticaria and nonspecific myalgia.

Stevens-Johnson syndrome has been reported very rarely.

There have been no reports of serious toxic effects or superinfections.

Local or intravaginal irritation occurs rarely.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Large oral doses (in excess of 5 million units daily) have caused nausea and gastrointestinal upset.

Dosage And Administration: Oral Suspension: Infants: Usual prophylactic and therapeutic dosage is 100 000 units 4 times daily, dropped into the side of the mouth and swallowed. Dosage may be increased if necessary.

For prophylaxis in the newborn, 100 000 units once daily may be given by dropper directly into the mouth.

Children and adults: Usual therapeutic dose is 100 000 units 4 times daily, dropped into the mouth and held for some time before swallowing. Dosage may be doubled for those occasional infections which are severe or difficult to treat, if necessary.

Note: When candidal lesions of the skin and/or nasal, vaginal or rectal mucosae are present in addition to intestinal infection, these should be treated concomitantly with a topical anticandidal preparation.

Oral Tablets: Usual prophylactic and therapeutic dose is 500 000 units 3 times daily. Dosage may be increased to 1 000 000 units 3 times daily if intestinal fungi are not adequately suppressed.

Topical: Apply cream or ointment liberally to affected areas 1 to 4 times daily or as indicated until healing is complete. The cream is usually preferred to the ointment in candidiasis involving intertriginous areas. Apply powder to candidal lesions 2 or 3 times daily until lesions have healed. For fungal infection of the feet caused by Candida species, dust the powder freely on the feet and in the shoes and socks.

Vaginal Cream: Usual dosage is 4 g (100 000 units) once or twice (100 000 or 200 000 units) daily deposited high in the vagina by means of the applicator.

In most cases, 2 weeks of therapy will be sufficient, but more prolonged treatment may be necessary. Administration should generally be continued for at least 48 hours after clinical cure to prevent relapse. It is important that therapy be continued during menstruation. Adjunctive measures such as therapeutic douches are unnecessary and sometimes inadvisable. Cleansing douches may be used by nonpregnant women, if desired, for esthetic purposes.

Pregnant patients with monilial infections should receive a dosage of 4 g vaginal cream once or twice daily for 3 to 6 weeks before term to prevent thrush in the newborn.

Nystatin therapeutic administration should generally be continued for at least 48 hours after clinical cure to prevent relapse. If signs and symptoms worsen or persist beyond 14 days of treatment, the patient should be reevaluated, and alternate therapy considered. When oral nystatin is given concomitantly with an oral antibacterial agent, oral nystatin should be continued at least as long as the antibacterial agent. Local treatment of chronic or resistant vaginal, oral or cutaneous moniliasis with nystatin may be supplemented with oral nystatin administration.

Availability And Storage: Oral Suspension

Each mL of pale yellow, cherry-mint-flavored suspension contains: nystatin 100 000 units. Nonmedicinal ingredients: carboxymethylcellulose, cinnamaldehyde, dibasic sodium phosphate, ethyl alcohol 1% (v/v), flavor, glycerin, methylparaben, propylparaben, sodium saccharin, sucrose and water. Hydrochloric acid and sodium hydroxide for pH adjustments. Bottles of 24 and 48 mL with calibrated dropper. Store at room temperature. Avoid freezing.

Oral Tablets

Each brown, coated tablet contains: nystatin 500 000 units. Nonmedicinal ingredients: cornstarch, FD&C red No. 3, blue No. 2 and yellow No. 6, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, povidone, printing ink, stearic acid, talc, tartrazine and titanium dioxide and triacetin. Bottles of 100. Store at room temperature.

Topical Cream: Each g of aqueous, perfumed vanishing cream base contains: nystatin 100 000 units. Nonmedicinal ingredients: aluminum hydroxide gel, glyceryl monostearate, perfume, polyethylene glycol monostearate, polyoxyethylene fatty alcohol ether, propylene glycol, simethicone, sorbic acid, sorbitol solution, titanium dioxide, water and white petrolatum. Tubes of 15 and 30 g.

Topical Ointment: Each g contains: nystatin 100 000 units in Plastibase (plasticized hydrocarbon gel), a polyethylene and mineral oil gel base. Nonmedicinal ingredients: mineral oil heavy and polyethylene. Tubes of 30 g.

Topical Powder: Each g contains: nystatin 100 000 units dispersed in talc. Nonmedicinal ingredients: talc. Bottles of 15 g.

Vaginal Cream

Each g contains: nystatin 25 000 units in a cream base. Nonmedicinal ingredients: aluminum hydroxide gel, methylparaben, polyoxyethylene fatty alcohol ether, propylene glycol, propylparaben, simethicone, water and white petrolatum. Hydrochloric acid or sodium hydroxide (for pH adjustments). Tubes of 120 g with applicator designed to deliver a 4 g dose (100 000 units). (Shown in Product Recognition Section)

MYCOSTATIN® Preparations Squibb Nystatin Antifungal Antibiotic

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