Nilstat (Nystatin)

NILSTATĀ®

Technilab

Nystatin

Antifungal Antibiotic

Indications And Clinical Uses: Oral Drops: Monilial infections of the mouth (thrush) and intestinal moniliasis in infants and children.

Oral Tablets: Prevention and treatment of intestinal moniliasis. Prevention or treatment of lower intestinal and anal infections caused by Candida albicans (monilia).

Powder: For the treatment of infections of the oral cavity by C. albicans (monilia).

Cream and Ointment: Treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (monilia) species.

Vaginal Cream, Tablets: Local treatment of vaginal mycotic infections caused by Candida albicans.

Precautions: Little activity against bacteria, protozoa and viruses. Discontinue medication if irritation should occur from topical or intravaginal use.

Pregnancy: During pregnancy, the vaginal applicators should be used only on the advice of a physician.

Appropriate measures should be taken to avoid reinfection during sexual intercourse.

Adverse Reactions: High oral dosage may produce nausea, vomiting and diarrhea.

Tachycardia, bronchospasm, facial swelling, urticaria and nonspecific myalgia have been reported rarely.

Dosage And Administration: Therapy should generally be continued for at least 48 hours after clinical cure to prevent relapse. 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.

Oral Drops: Infants and children: 100 000 units 3 to 4 times daily for oral (thrush) and intestinal moniliasis. For treatment of infections of the oral cavity, the medication should be dropped directly on the tongue by means of the calibrated dropper and retained in the mouth for as long as possible before swallowing. For treatment of intestinal infections, may be dropped directly on the tongue by means of the calibrated dropper, or may be mixed with milk, lukewarm formula, or other nonacid vehicles, or incorporated in honey, jelly or peanut butter.

Oral Tablets: 500 000 units 3 times daily. Double dosage, if necessary, for adults.

Powder: Children and adults: Oral suspension: 400 000 to 600 000 units 4 times daily.

Topical Cream and Ointment: Apply cream or ointment liberally to affected areas twice daily or as prescribed by the physician.

Vaginal Cream: 1 applicatorful (500 000 units) daily. In cases of severe infection, repeat application every 12 hours. Generally 2 weeks therapy will be sufficient; however, more prolonged therapy may be necessary. Therapy should be continued during menstruation.

Vaginal Tablets: 1 tablet inserted high in the vagina by means of the applicator once or twice daily for 2 weeks or as required. Therapy should be continued during menstruation.

Availability And Storage:

Oral: Drops

Each mL contains: nystatin 100 000 units. Nonmedicinal ingredients: artificial flavoring, calcium disodium EDTA, D&C Yellow #10, magnesium aluminum silicate, methylparaben, polysorbate 80, propylparaben, purified water and sucrose.

Tablets

Each round, film-coated, pink tablet, engraved “LL” and “N5”, contains: nystatin 500 000 units. Nonmedicinal ingredients: cornstarch, ethylcellulose, hydroxypropyl methylcellulose, isopropyl alcohol, light mineral oil, magnesium stearate, stearic acid and titanium dioxide. Bottles of 100.

Powder

For use only in extemporaneous prescription compounding of oral and topical preparations. Nonmedicinal ingredients: talc. Bottles of 1 billion units.

Topical: Cream: Each g contains: nystatin 100 000 units. Nonmedicinal ingredients: emulsifying wax, glycerin, isopropyl myristate, lactic acid, purified water, sodium hydroxide and sorbic acid. Tubes of 15 and 30 g. Jars of 450 mg.

Ointment

Each g contains: nystatin 100 000 units. Nonmedicinal ingredients: light mineral oil and polyethylene. Tubes of 30 g.

Vaginal Cream

Each g contains: nystatin 100 000 units. Nonmedicinal ingredients: emulsifying wax, glycerin, isopropyl myristate, lactic acid, purified water, sodium hydroxide and sorbic acid. Tubes of 75 g with re-usable applicator.

Tablets

Each oval, pale yellow tablet, engraved “LL” and “N6”, contains: nystatin 100 000 units. Nonmedicinal ingredients: isopropyl alcohol, lactose, magnesium stearate, povidone, sorbitol and starch. Boxes of 15 with applicator.

NILSTATĀ® Technilab Nystatin Antifungal Antibiotic

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