Composition: Each applicator of UNITOL provides approximately 4.6 grams of ointment containing 300mg of tioconazole.

Properties:

Tioconazole is a member of the imidazole class of antifungal agents. Several studies have demonstrated that the imidazoles inhibit ergosterol synthesis in fungi.
Indications:
This product used in the local treatment of vaginal mycosis, especially candidiasis.

Contraindications:
This medication should not be used in case of hypersensitivity to an imidazole antifungal or to any component of the preparation.

If the patient has diabetes, a positive HIV test, or AIDS.

Warnings:

• The oily nature of the excipients in this preparation may deteriorate the rubber of male condoms or diaphragms; therefore, it should not be used during treatment.
• If the infection does not resolve after a few days, the doctor should be consulted.
• Skin and mucosal sensitization may occur. It should be discontinued if such reaction occurs, and appropriate therapy instituted.
• The diagnosis of vulvo-vaginal candidiasis should be confirmed by KOH smears and/or cultures before initiating therapy.
• Acid soaps should be avoided as they promote the multiplication of fungi.
• The patient partner may be infected with no symptoms. If they are not treated together, recontamination is possible.

Drug Interactions:

This product may be used in patients taking oral contraceptives

Spermicides: Like any local vaginal treatment, this drug may decrease the contraceptive effectiveness of local Spermicides.
Pregnancy and breastfeeding:
There are no adequate and well controlled studies which establish the safety of tioconazole ointment, ovule and cream in pregnant women. Accordingly, the ointment, ovule or cream should be used during pregnancy only if in the opinion of the physician the potential benefit outweighs the potential risk to the fetus.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, nursing should be temporarily discontinued while tioconazole preparations are administered. Tioconazole should not be used by nursing women unless, in the judgment of a physician, the potential benefit outweighs the possible risk.

Undesirable effects:
Some signs of local irritation (pruritus, burning sensation, vulvar edema) have been reported, mostly moderate and transient.

Aggravation of burns and itching at the beginning of treatment: these symptoms reflect the destruction of the microscopic fungi that release an irritating substance. These manifestations do not usually recur in later applications. Otherwise, it may be intolerance or an allergy to the medication so it should contact the doctor.
Dosage and administration:
1 ovule or 1 applicator full of ointment in the evening at bedtime. The ovule must be inserted deep into the vagina.

Introduce the ovule and the applicator in the lying position and then lie down for 5 to 10 minutes. By melting in the vagina, the ovule can be the cause of an inconvenient discharge; it is advisable to wear a protection.

Storage conditions: Store at controlled room temperature 15^o – 30^o C.

How supplied:

UNITOL is supplied in a ready – to- use, prefilled, single-dose vaginal applicator. Each applicator will deliver approximately 4.6 grams of UNITOL containing 65 mg of tioconazole per gram of ointment.