Components:
Tioconazole
Tioconazole
Method of action:
Antifungal Broad Spectrum, Antiprotozoal, Gynecological Antiinfectives And Antiseptics
Antifungal Broad Spectrum, Antiprotozoal, Gynecological Antiinfectives And Antiseptics
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Name of the medicinal product

1-Day

Qualitative and quantitative composition

Tioconazole

Therapeutic indications

The information provided in Therapeutic indications of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
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VAGISTAT-1 (tioconazole) is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As VAGISTAT-1 (tioconazole) has been shown to be effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smears and/or cultures. Other pathogens commonly associated with vulvovaginitis should be ruled out by appropriate methods.

Studies have shown that women taking oral contraceptives have a cure rate similar to those not taking such agents when treated with VAGISTAT-1 (tioconazole) .

Safety and effectiveness in pregnant and diabetic patients have not been established (see PRECAUTIONS).

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
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VAGISTAT-1 (tioconazole) has been found to be effective as a single- dose treatment for vulvovaginal candidiasis. Using the prefilled applicator, insert one applicator- full intravaginally. Administration of VAGISTAT-1 (tioconazole) just prior to bedtime may be preferred.

Contraindications

The information provided in Contraindications of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
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VAGISTAT-1 (tioconazole) is contraindicated in individuals who have been shown to be sensitive to imidazole antifungal agents or to other components of the ointment.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
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WARNINGS

No information provided.

PRECAUTIONS

General

VAGISTAT-1 (tioconazole) is intended for intravaginal administration only. Applicators should be opened just prior to administration to prevent contamination. Administration of VAGISTAT-1 (tioconazole) just prior to bedtime may be preferred. The VAGISTAT-1 (tioconazole) ointment base may interact with rubber or latex products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment is not recommended.

If clinical symptoms persist, appropriate microbiological tests should be repeated to rule out other pathogens and to confirm the diagnosis.

Carcinogenesis

No long-term studies in animals have been performed to evaluate the carcinogenic potential of tioconazole.

Mutagenesis

Tioconazole did not demonstrate mutagenic activity at the levels examined in tests at either the chromosomal or subchromosomal level.

Impairment of Fertility

No impairment of fertility was seen in male rats administered tioconazole hydrochloride in oral doses up to 150 mg/kg/day. However, there was evidence of preimplantation loss in female rats at oral dose levels above 35 mg/kg/day.

Pregnancy

Pregnancy Category C: Tioconazole hydrochloride had no adverse effects on fetal viability or growth when administered orally to pregnant rats at doses of 55, 110, and 165 mg/kg/day during the period of organogenesis. A drug- related increase in the incidence of dilated ureters, hydroureters, and hydronephrosis observed in the fetuses of this study was transient and no longer evident in pigs raised to 21 days of age. These effects did not occur following intravaginal administration of approximately 10 mg/kg/day in a 2% cream. There was no evidence of major structural anomalies. No embryotoxic or teratogenic effects were observed in rabbits receiving oral dose levels as high as 165 mg/kg/day or daily intravaginal application of approximately 2-3 mg/kg in a 2% tioconazole cream during organogenesis. Tioconazole hydrochloride, like other azole antimycotic agents, causes dystocia in rats when treatment is extended through parturition. Associated effects in rats include prolongation of pregnancy, in utero deaths, and impaired pup survival. The ''no-effect'' level for this phenomenon is 20 mg/kg/day orally and approximately 9 mg/kg/day intravaginally. No effect on parturition occurred in rabbits at 50 mg/kg/day orally.

There are no adequate and well-controlled studies in pregnant women. VAGISTAT® -1 (tioconazole 6.5%) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

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 VAGISTAT-1 (tioconazole) is administered.

Pediatric Use

Safety and effectiveness in children have not been established.

Undesirable effects

The information provided in Undesirable effects of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
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The incidence of adverse reactions to VAGISTAT-1 (tioconazole) is based on clinical trials involving 1000 patients. Burning and itching were the most frequent side effects occurring in approximately 6% and 5% of the patients, respectively. In most instances these did not interfere with the course of therapy.

There were occasional reports (less than 1%) of other side effects including irritation, discharge, vulvar edema and swelling, vaginal pain, dysuria, nocturia, dyspareunia, dryness of vaginal secretions, desquamation, and burning sensation.

Overdose

The information provided in Overdose of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
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Pharmacokinetic properties

The information provided in Pharmacokinetic properties of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
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Systemic absorption of tioconazole after a single intravaginal application of VAGISTAT-1 (tioconazole) in nonpregnant patients is negligible.

Name of the medicinal product
1-Day
Qualitative and quantitative composition
Tioconazole
Therapeutic indications
The information provided in Therapeutic indications of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
more... close

VAGISTAT-1 (tioconazole) is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As VAGISTAT-1 (tioconazole) has been shown to be effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smears and/or cultures. Other pathogens commonly associated with vulvovaginitis should be ruled out by appropriate methods.

Studies have shown that women taking oral contraceptives have a cure rate similar to those not taking such agents when treated with VAGISTAT-1 (tioconazole) .

Safety and effectiveness in pregnant and diabetic patients have not been established (see PRECAUTIONS).

Dosage (Posology) and method of administration
The information provided in Dosage (Posology) and method of administration of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
more... close

VAGISTAT-1 (tioconazole) has been found to be effective as a single- dose treatment for vulvovaginal candidiasis. Using the prefilled applicator, insert one applicator- full intravaginally. Administration of VAGISTAT-1 (tioconazole) just prior to bedtime may be preferred.

Contraindications
The information provided in Contraindications of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
more... close

VAGISTAT-1 (tioconazole) is contraindicated in individuals who have been shown to be sensitive to imidazole antifungal agents or to other components of the ointment.

Special warnings and precautions for use
The information provided in Special warnings and precautions for use of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
more... close

WARNINGS

No information provided.

PRECAUTIONS

General

VAGISTAT-1 (tioconazole) is intended for intravaginal administration only. Applicators should be opened just prior to administration to prevent contamination. Administration of VAGISTAT-1 (tioconazole) just prior to bedtime may be preferred. The VAGISTAT-1 (tioconazole) ointment base may interact with rubber or latex products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment is not recommended.

If clinical symptoms persist, appropriate microbiological tests should be repeated to rule out other pathogens and to confirm the diagnosis.

Carcinogenesis

No long-term studies in animals have been performed to evaluate the carcinogenic potential of tioconazole.

Mutagenesis

Tioconazole did not demonstrate mutagenic activity at the levels examined in tests at either the chromosomal or subchromosomal level.

Impairment of Fertility

No impairment of fertility was seen in male rats administered tioconazole hydrochloride in oral doses up to 150 mg/kg/day. However, there was evidence of preimplantation loss in female rats at oral dose levels above 35 mg/kg/day.

Pregnancy

Pregnancy Category C: Tioconazole hydrochloride had no adverse effects on fetal viability or growth when administered orally to pregnant rats at doses of 55, 110, and 165 mg/kg/day during the period of organogenesis. A drug- related increase in the incidence of dilated ureters, hydroureters, and hydronephrosis observed in the fetuses of this study was transient and no longer evident in pigs raised to 21 days of age. These effects did not occur following intravaginal administration of approximately 10 mg/kg/day in a 2% cream. There was no evidence of major structural anomalies. No embryotoxic or teratogenic effects were observed in rabbits receiving oral dose levels as high as 165 mg/kg/day or daily intravaginal application of approximately 2-3 mg/kg in a 2% tioconazole cream during organogenesis. Tioconazole hydrochloride, like other azole antimycotic agents, causes dystocia in rats when treatment is extended through parturition. Associated effects in rats include prolongation of pregnancy, in utero deaths, and impaired pup survival. The ''no-effect'' level for this phenomenon is 20 mg/kg/day orally and approximately 9 mg/kg/day intravaginally. No effect on parturition occurred in rabbits at 50 mg/kg/day orally.

There are no adequate and well-controlled studies in pregnant women. VAGISTAT® -1 (tioconazole 6.5%) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

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 VAGISTAT-1 (tioconazole) is administered.

Pediatric Use

Safety and effectiveness in children have not been established.

Undesirable effects
The information provided in Undesirable effects of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
more... close

The incidence of adverse reactions to VAGISTAT-1 (tioconazole) is based on clinical trials involving 1000 patients. Burning and itching were the most frequent side effects occurring in approximately 6% and 5% of the patients, respectively. In most instances these did not interfere with the course of therapy.

There were occasional reports (less than 1%) of other side effects including irritation, discharge, vulvar edema and swelling, vaginal pain, dysuria, nocturia, dyspareunia, dryness of vaginal secretions, desquamation, and burning sensation.

Overdose
The information provided in Overdose of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
more... close

Pharmacokinetic properties
The information provided in Pharmacokinetic properties of 1-Day is based on data of another medicine with exactly the same composition as the 1-Day of the medicine (Tioconazole). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug 1-Day directly from the package or from the pharmacist at the pharmacy.
more... close

Systemic absorption of tioconazole after a single intravaginal application of VAGISTAT-1 (tioconazole) in nonpregnant patients is negligible.

Available in countries
See all
close