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Antifungals, Azole (Vaginal)

This monograph includes information on the following:

1) Butoconazole 
2) Clotrimazole
3) Econazole *
4) Miconazole
5) Terconazole
6) Tioconazole

VA CLASSIFICATION
Primary: GU302

Commonly used brand name(s): Canesten 1-Day Cream Combi-Pak2; Canesten 1-Day Therapy2; Canesten 3-Day Therapy2; Canesten 6-Day Therapy2; Canesten Combi-Pak 1-Day Therapy2; Canesten Combi-Pak 3-Day Therapy2; Clotrimaderm2; Ecostatin Vaginal Ovules3; FemCare2; Femizol-M4; Femstat 31; Gyne-Lotrimin2; Gyne-Lotrimin Combination Pack2; Gyne-Lotrimin32; Gyne-Lotrimin3 Combination Pack2; GyneCure6; GyneCure Ovules6; GyneCure Vaginal Ointment Tandempak6; GyneCure Vaginal Ovules Tandempak6; Miconazole-74; Micozole4; Monazole 74; Monistat 16; Monistat 34; Monistat 3 Combination Pack4; Monistat 3 Dual-Pak4; Monistat 3 Vaginal Ovules4; Monistat 5 Tampon4; Monistat 74; Monistat 7 Combination Pack4; Monistat 7 Dual-Pak4; Monistat 7 Vaginal Suppositories4; Mycelex Twin Pack2; Mycelex-72; Mycelex-G2; Myclo-Gyne2; Novo-Miconazole Vaginal Ovules4; Terazol 35; Terazol 3 Dual-Pak5; Terazol 3 Vaginal Ovules5; Terazol 75; Vagistat-16.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

*Not commercially available in the U.S.

Not commercially available in Canada.



Category:


Antifungal (vaginal)—

Indications

Accepted

Candidiasis, vulvovaginal (treatment)—Vaginal azoles are indicated in the local treatment of vulvovaginal candidiasis caused by Candida albicans and other species of Candida in pregnant (second and third trimesters only) and nonpregnant women {01} {03} {07} {10} {13} {15} {16} {19} {23} {24}. It is recommended that nonpregnant women self-medicate with nonprescription antifungal vaginal medications only if they have been diagnosed previously with vulvovaginal candidiasis and have the same symptoms {31}. If symptoms recur within 2 months, women should seek professional medical care {31}. Pregnant women treating vulvovaginal candidiasis with antifungal vaginal agents should use at least a 7-day treatment regimen and seek their physician's advice before using medication in the first trimester {31}.

—Not all species or strains of a particular organism may be susceptible to a specific vaginal azole.

Unaccepted
Vaginal azoles are not effective in the treatment of vulvovaginitis caused by other common pathogens such as Trichomonas vaginalis {23}.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:

Chemical group—
    Imidazoles: Butoconazole, clotrimazole, econazole nitrate, miconazole nitrate, tioconazole {23}.
    Triazole: Terconazole {23}.
Molecular weight—
    Butoconazole nitrate: 474.80 {21}
    Clotrimazole: 344.85 {21}
    Econazole nitrate: 444.70 {21}
    Miconazole nitrate: 479.15 {21}
    Terconazole: 532.47 {21}
    Tioconazole: 387.72 {21}

Mechanism of action/Effect:

Fungistatic; may be fungicidal, depending on concentration; exact mechanism of action is unknown {01} {07} {13} {16} {19} {23} {24}. Azoles inhibit biosynthesis of ergosterol or other sterols, damaging the fungal cell membrane and altering its permeability {13} {16} {23} {24}. As a result, loss of essential intracellular elements may occur {07} {15} {16} {19} {24}.

Azoles also inhibit biosynthesis of triglycerides and phospholipids by fungi. In addition, azoles inhibit oxidative and peroxidative enzyme activity, resulting in intracellular buildup of toxic concentrations of hydrogen peroxide, which may contribute to deterioration of subcellular organelles and cellular necrosis {19}. In Candida albicans , azoles inhibit transformation of blastospores into invasive mycelial form. {23}

Terconazole—Triazoles are more slowly metabolized than imidazoles {13} {23}. Triazoles also affect sterol synthesis to a lesser degree {23}.

Absorption:

Butoconazole—Approximately 5.5% absorbed systemically following intravaginal administration. {01} {24}

Clotrimazole—3 to 10% estimated to be absorbed following intravaginal administration. {03} {24}

Econazole; miconazole; tioconazole—Small amounts absorbed systemically following intravaginal administration. {05} {07} {19} {23} {24}

Terconazole—Approximately 5 to 8% absorbed in hysterectomized patients and approximately 12 to 16% absorbed in nonhysterectomized patients with tubal ligations. {08} {09} {13} {24}

Biotransformation:

Clotrimazole—Rapidly metabolized to inactive metabolites. {03} {23}


Precautions to Consider

Carcinogenicity

Butoconazole; miconazole; terconazole; tioconazole—Long-term studies in animals have not been done. {01} {05} {08} {09} {23}

Clotrimazole—Long-term studies of intravaginal clotrimazole in animals have not been done. However, a long-term study of oral clotrimazole in Wistar strains of rats has not shown that clotrimazole is carcinogenic. {03} {04}

Terconazole—Studies have not been done {09}.

Mutagenicity

Butoconazole—Butoconazole has not been shown to be mutagenic in studies in appropriate indicator microorganisms. {01}

Terconazole—Terconazole has not been shown to be mutagenic in studies for induction of microbial point mutations (Ames test), induction of cellular transformation, chromosomal breaks (micronucleus test), or in studies for dominant lethal mutations in mouse germ cells. {08} {09} {13}

Tioconazole—No mutagenic or cytogenic effects were observed. {23}

Pregnancy/Reproduction
Fertility—
Butoconazole: Studies in rabbits or rats, given oral doses of up to 30 or 100 mg per kg of body weight (mg/kg) daily, respectively, have not shown that butoconazole causes impaired fertility. {01}

Terconazole: Terconazole, given orally in doses of up to 40 mg/kg daily, has not been shown to cause impairment of fertility in female rats. {08} {09} {13}

Pregnancy—
Pregnant women treating vulvovaginal candidiasis with antifungal vaginal agents should use at least a 7-day treatment regimen. A decision to use antifungal vaginal agents during the first trimester should be based on risk-benefit status and on advice of the physician {31}.

Butoconazole: Adequate and well-controlled studies in humans have not been done during the first trimester {01}. Clinical studies in over 200 pregnant women, given butoconazole intravaginally for 3 or 6 days during the second and third trimesters, have not shown that butoconazole causes adverse effects on the fetus {01} {14}. Follow-up reports on infants born to these women have not shown that butoconazole causes any adverse effects. {01} {14}

Studies in rats, given intravaginal doses of 6 mg/kg daily (three to seven times the usual human dose) during organogenesis, have shown that butoconazole causes an increase in resorption rate and a decrease in litter size {01} {14}. Butoconazole was not shown to be teratogenic {01} {14}.

Studies in rats, given oral doses of up to 50 mg/kg daily throughout organogenesis, have not shown that butoconazole causes adverse effects on the fetus {01} {14}. The administration of oral doses of 100, 300, or 750 mg/kg daily has resulted in adverse effects (abdominal wall defects, cleft palate) on the fetus, although maternal stress was evident at these higher dosages {01} {14}.

Studies in rabbits, given oral doses (e.g., 150 mg/kg) that caused maternal stress, have not shown that butoconazole causes adverse effects on the fetus {01} {14}.

FDA Pregnancy Category C {01}.


Clotrimazole: Adequate and well-controlled studies in humans have not been done during the first trimester {25}. Reports on up to 177 pregnant females given clotrimazole intravaginally during the second and third trimesters have not shown that clotrimazole causes adverse effects on the fetus {25}. Follow-up reports on 71 infants born to these females have not shown that clotrimazole causes any adverse effects. {03} {04}

Studies in rats, given repeated intravaginal doses of up to 100 mg/kg daily, have not shown that clotrimazole causes adverse effects on the fetus {15} {16} {25}.

Studies in rats and mice, given repeated oral doses of 50 to 120 mg/kg, have shown that clotrimazole causes embryotoxicity (possibly secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young, and decreased survival to weaning {25}. Studies in mice, rabbits, and rats, given oral doses of up to 200, 180, and 100 mg/kg, respectively, have not shown that clotrimazole is teratogenic {25}.

FDA Pregnancy Category B {25}.


Econazole: Adequate and well-controlled studies have not been performed in humans {07}.


Miconazole: Clinical studies in over 500 pregnant females given miconazole intravaginally for 14 days have not shown that miconazole causes adverse effects on the fetus. Follow-up reports on infants born to these women have not shown that miconazole causes any adverse effects {05}.

Miconazole crosses the placenta in animals. Studies in animals have shown that miconazole, given in oral doses of 80 mg/kg, causes embryotoxicity and fetotoxicity. Studies in rats have shown that miconazole, given orally, causes prolonged gestation, although this was not shown in studies using rabbits.

FDA Pregnancy Category B {05}.


Terconazole: At oral doses less than or equal to 10 mg/kg, no embryotoxicity was seen in rats {13}. Studies in rats given terconazole orally in doses of 10 mg/kg daily have shown that terconazole causes delayed fetal ossification. In studies in rats given 20 to 40 mg/kg orally during organogenesis, terconazole was shown to cause embryotoxicity (e.g., decreased litter size and number of viable young, reduced fetal weight, delayed ossification, and increased incidence of skeletal abnormalities) {13}. The skeletal changes observed (delayed ossification, short wavy ribs) were felt to be secondary to maternal toxicity or stress, which was evident from reduced body weight gain during most of the organogenesis period {13}.

Terconazole has not been shown to be teratogenic in rats given oral doses of up to 40 mg/kg daily or given subcutaneous doses of up to 20 mg/kg daily, or in rabbits given doses of 20 mg/kg daily. {08} {09} {13}

FDA Pregnancy Category C.


Tioconazole: Adequate and well-controlled studies have not been performed in humans. {23}

In limited and uncontrolled clinical use in about 20 patients, a single dose administered at varying stages of pregnancy did not appear to interfere with normal progress of the pregnancy and delivery {23}. However, 1-day treatment may not be effective in pregnant patients and is not recommended {31}.

In studies in rats, adverse effects on parturition and/or fetal development were observed during local and systemic use. {23}

FDA Pregnancy Category C.


Labor—

Vaginal azoles have been shown to cause dystocia in rats when given through parturition {01} {14}.

Butoconazole: Butoconazole has not been shown to cause dystocia in rabbits given oral doses of up to 100 mg/kg. {01} {14}

Terconazole: Terconazole has not been shown to adversely affect parturition in rats given up to 40 mg/kg orally per day during pregnancy, up through 3 weeks of lactation {13}.

Breast-feeding

It is not known whether vaginal azoles are distributed into breast milk. {01} {13} {14} {22} {24} However, problems in humans have not been documented. {01} {05} {08} {09} {24}

Pediatrics

No information is available on the relationship of age to the effects of vaginal azoles {01} {13} {14} {22} in pediatric patients. Safety and efficacy have not been established in children up to 12 years of age {28}.


Geriatrics


Appropriate studies on the relationship of age to the effects of vaginal azoles have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


For miconazole
» Warfarin    (concurrent use may cause bleeding and/or bruising{32})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Allergy to azoles


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
    
Vaginal burning, itching, discharge, or other irritation not present before therapy{01}{07}{13}{14}{15}{16}{19}{23}{25}

Incidence rare
    
Hypersensitivity {14}{15}{16}{19}{23}{25}(skin rash or hives)



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent or rare
    
Abdominal or stomach cramps or pain{15}{16}{25}
    
burning or irritation of penis of sexual partner{15}{16}{25}
    
headache{13}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Antifungals, Azole (Vaginal) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Allergy to azoles

Pregnancy—Some animal studies have shown that vaginal azoles may be embryotoxic or fetotoxic; however, problems have not been documented in humans. Use of at least a 7-day treatment regimen is recommended for pregnant patients in the second and third trimesters instead of regimens of shorter duration; use of the medication in the first trimester should be based on risk-benefit status and on the advice of a physician

Labor—Vaginal azoles have been shown in some studies to cause dystocia when given through labor
Other medications, especially warfarin

Proper use of this medication
Reading patient instructions before using medication

Using at bedtime, unless otherwise directed by physician; retaining miconazole vaginal tampons overnight and removing them the following morning

Checking with physician before using applicator if pregnant {07} {13} {14} {15} {16} {19}

Using cream, which is packaged with some of the vaginal suppositories or tablets, by applying it externally to genitalia to treat genital itching

» Compliance with full course of therapy, even if menstruation begins

» Proper dosing
Inserting as soon as possible; not inserting if almost time for next dose

» Proper storage

Precautions while using this medication
Checking with physician if no improvement within 3 days, if symptoms do not disappear within 7 days, or if symptoms worsen during use of 1-, 3-, and 7-day treatment regimens; also, checking with physician if symptoms return within 2 months or if exposure to human immunodeficiency virus (HIV) occurs

Protecting clothing because of possible soiling with vaginal azoles; avoiding the use of unmedicated tampons
»
Using hygienic measures to cure infection and prevent reinfection
Wearing cotton panties instead of synthetic underclothes

Wearing only freshly washed underclothes
» Routine treatment of sexual partner is unnecessary unless male partner is experiencing symptoms of local itching or skin irritation of the penis

» Understanding that some vaginal products may contain oils that damage latex; avoiding concurrent use of latex products, such as condoms, diaphragms, and cervical caps, during treatment and for 3 days after discontinuing medication

» Checking with doctor before douching between doses to obtain recommendation for use and advice for proper procedure


Side/adverse effects
Signs of potential side effects, especially vaginal burning, itching, discharge, or other irritation not present before therapy, and hypersensitivity


General Dosing Information
Diagnosis of first-time users of vaginal azole antifungal agents should be made by physicians. Patients should consult a physician if symptoms return within 2 months or if exposure to HIV occurs. Recurring yeast infections may be a sign of other conditions, such as diabetes or impaired immune function. {28} Recurring conditions or severe local vaginal infections may benefit from vaginal treatments of longer duration, such as 10 to 14 days, or from the use of appropriate oral medications instead {31}.

If there is no response to therapy, the course of therapy may be repeated after other pathogens have been ruled out by potassium hydroxide (KOH) smears and cultures. {01} {05} {13} {19} {22} {25}

If sensitization or irritation occurs, treatment with vaginal azoles should be discontinued. {01} {13} {14} {19} {22}

It is recommended that the patient wait 3 days after treatment with azole antifungal agents to resume using latex barrier devices such as condoms or diaphragms {28}. The vehicles for some vaginal azole products contain lipid-based components. It is likely that many of these products affect the performance of latex contraceptive devices, such as cervical caps, condoms, or diaphragms {03} {13} {22}.

Unmedicated tampons may absorb vaginal creams, ointments, or suppositories and are not recommended for use concurrently with vaginal azole antifungal agents {28}.

For tioconazole ointment
Symptomatic relief following one dose of tioconazole ointment may take up to 7 days to achieve {28}.

BUTOCONAZOLE


Vaginal Dosage Forms

BUTOCONAZOLE NITRATE CREAM (VAGINAL) USP

Usual adult and adolescent dose
Antifungal (vaginal)
Nonpregnant patients: Intravaginal, 100 mg (1 applicatorful of a 2% cream) once a day at bedtime for three days {01} {14}. May be repeated for an additional three days if needed {01} {14} {24}.

Pregnant patients (second and third trimesters only): Intravaginal, 100 mg (1 applicatorful of a 2% cream) once a day at bedtime for six days {01} {24}.


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {01}.

Strength(s) usually available
U.S.—


2% (100 mg per applicatorful) (OTC) [Femstat 3{01}]

Note: Packaging may include either three prefilled applicators or three cardboard applicators plus tube of cream {01}.


Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For vaginal use only.
   • Continue medicine for full time of treatment.

Note: Include patient instructions when dispensing.



BUTOCONAZOLE NITRATE VAGINAL SUPPOSITORIES

Usual adult and adolescent dose
Antifungal (vaginal)
Nonpregnant patients: Intravaginal, 100 mg once a day at bedtime for three days {14}. May be repeated for an additional three days if needed {14}.


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {01}.

Strength(s) usually available
U.S.—
Not commercially available.

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a well-closed container.

Auxiliary labeling:
   • For vaginal use only.
   • Continue medicine for full time of treatment.

Note: Include patient instructions when dispensing.



CLOTRIMAZOLE


Vaginal Dosage Forms

CLOTRIMAZOLE CREAM (VAGINAL) USP

Usual adult and adolescent dose
Antifungal (vaginal)
Intravaginal, 50 mg (1 applicatorful of a 1% vaginal cream) once a day, preferably at bedtime, for six to fourteen consecutive days; or {03} {15} {16} {24}

Intravaginal, 100 mg (1 applicatorful of a 2% vaginal cream) once a day, preferably at bedtime, for three days; or {15}

Intravaginal, 500 mg (1 applicatorful of a 10% vaginal cream) as a single dose, preferably at bedtime. {10} {15}


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {12}.

Strength(s) usually available
U.S.—


1% (50 mg per applicatorful) (OTC) [FemCare{12}] [Gyne-Lotrimin{03}] [Mycelex-7{02}{12}][Generic]{12}

Canada—


1% (50 mg per applicatorful) (OTC) [Canesten 6-Day Therapy{15}] [Clotrimaderm{11}] [Myclo-Gyne{16}]


2% (100 mg per applicatorful) (OTC) [Canesten 3-Day Therapy{15}] [Clotrimaderm{11}]


10% (500 mg per applicatorful) (OTC) [Canesten 1-Day Therapy{15}] [Canesten 1-Day Cream Combi-Pak{15}]

Note: Many of these products are packaged with one reusable vaginal applicator or more than one single-use vaginal applicator, or as prefilled vaginal applicators.
Combi-paks also contain a small tube of 1% clotrimazole cream for external application to genitals for treatment of itching.


Packaging and storage:
Store between 2 and 30 °C (36 and 86 °F). Store in a collapsible tube or in a tight container.

Auxiliary labeling:
   • For vaginal use only.
   • Continue medicine for full time of treatment.

Note: Include patient instructions when dispensing.



CLOTRIMAZOLE VAGINAL TABLETS USP

Usual adult and adolescent dose
Antifungal (vaginal)
Nonpregnant patients: Intravaginal, 500 mg as a single dose, preferably at bedtime {15} {25}; 200 mg once a day, preferably at bedtime, for three consecutive days {15} {16}; or 100 mg once a day, preferably at bedtime, for six or seven consecutive days. {03} {15} {16} {24}

Pregnant patients: Intravaginal, 100 mg once a day, preferably at bedtime, for seven consecutive days. {24}


Note: The three-day regimen is not effective in pregnant women {24}.
In severe vulvovaginal candidiasis, single-dose treatment with clotrimazole 500-mg vaginal tablets may not be effective. Longer treatment with the 100- or 200-mg vaginal tablets or vaginal cream is recommended. {04}


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {12}.

Strength(s) usually available
U.S.—


100 mg (OTC) [FemCare{12}] [Gyne-Lotrimin{03}] [Gyne-Lotrimin Combination Pack{03}] [Mycelex-7{02}{12}][Generic]{12}


200 mg (OTC) [Gyne-Lotrimin3{03}{12}] [Gyne-Lotrimin3 Combination Pack{12}]


500 mg (Rx) [Mycelex-G{04}] [Mycelex Twin Pack{12}]

Canada—


100 mg (OTC) [Myclo-Gyne{16}]


200 mg (OTC) [Canesten Combi-Pak 3-Day Therapy{15}]


500 mg (OTC) [Canesten Combi-Pak 1-Day Therapy{15}]

Note: Twin and combination packs and combi-paks also contain a small tube of 1% clotrimazole cream for external application to genitals for treatment of itching.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a well-closed container.

Auxiliary labeling:
   • For vaginal use only.
   • Continue medicine for full time of treatment.

Note: Include patient instructions when dispensing.



ECONAZOLE


Vaginal Dosage Forms

ECONAZOLE NITRATE VAGINAL SUPPOSITORIES

Usual adult and adolescent dose
Antifungal (vaginal)
Intravaginal, 150 mg once a day at bedtime for three days {07}. May be repeated if needed. {07}


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {07}.

Strength(s) usually available
U.S.—
Not commercially available.

Canada—


150 mg (Rx) [Ecostatin Vaginal Ovules{07}]

Packaging and storage:
Store below 30 °C (86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For vaginal use only.
   • Continue medicine for full time of treatment.

Note: Include patient instructions when dispensing.



MICONAZOLE


Vaginal Dosage Forms

MICONAZOLE NITRATE VAGINAL CREAM

Usual adult and adolescent dose
Antifungal (vaginal)
Intravaginal, 20 mg (one applicatorful) once a day at bedtime for seven days {05} {19} {24}. May be repeated if needed {19}.


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {19}.

Strength(s) usually available
U.S.—


2% (OTC) [Femizol-M{12}] [Miconazole-7{12}] [Monistat 7{05}][Generic]{12}

Canada—


2% (OTC) [Micozole{30}] [Monazole 7{29}] [Monistat 7{19}]

Note: Many of these products are packaged with one reusable vaginal applicator or more than one single-use vaginal applicator, or as prefilled vaginal applicators.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For vaginal use only.
   • Continue medicine for full time of treatment.

Note: Include patient instructions when dispensing.



MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP

Usual adult and adolescent dose
Antifungal (vaginal)
Intravaginal, 100 mg once a day at bedtime for seven days {19}. May be repeated for seven days if needed {19}; or

Intravaginal, 200 or 400 mg once a day at bedtime for three days. {05} {19} {24} May be repeated if needed {19}.


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {05}.

Strength(s) usually available
U.S.—


100 mg (OTC) [Monistat 7{05}] [Monistat 7 Combination Pack{12}][Generic]


200 mg (OTC) [Monistat 3 Combination Pack{20}]


200 mg (Rx) [Monistat 3{27}]

Canada—


100 mg (OTC) [Monistat 7 Vaginal Suppositories{15}{19}] [Monistat 7 Dual-Pak{19}]


400 mg (OTC) [Monistat 3 Vaginal Ovules{15}{19}] [Monistat 3 Dual-Pak{19}] [Novo-Miconazole Vaginal Ovules{26}]

Note: Dual-paks and combination packs also contain a small tube of 2% miconazole cream for external application to genitals for treatment of itching. {19}


Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F). Store in a tight container.

Auxiliary labeling:
   • For vaginal use only.
   • Continue medicine for full time of treatment.

Note: Include patient instructions when dispensing.



MICONAZOLE NITRATE VAGINAL TAMPONS

Usual adult and adolescent dose
Antifungal (vaginal)
Intravaginal, 100 mg (1 tampon) once a day at bedtime for five consecutive days; retain vaginally overnight and remove tampon the following morning. {06}


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {08}.

Strength(s) usually available
U.S.—


5% (Rx) [Monistat 5 Tampon]{06}

Note: Available in California only {06}.


Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For vaginal use only.
   • Continue medicine for full time of treatment.

Note: Include patient instructions when dispensing.



TERCONAZOLE


Vaginal Dosage Forms

TERCONAZOLE VAGINAL CREAM

Usual adult and adolescent dose
Antifungal (vaginal)
Intravaginal, 20 mg (1 applicatorful of a 0.4% cream) once a day at bedtime for seven days; or {08} {13} {24}

Intravaginal, 40 mg (1 applicatorful of a 0.8% cream) once a day at bedtime for three days.


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {08}.

Strength(s) usually available
U.S.—


0.4% (20 mg per applicatorful) (Rx) [Terazol 7{08}]


0.8% (40 mg per applicatorful) (Rx) [Terazol 3{08}]

Canada—


0.4% (20 mg per applicatorful) (Rx) [Terazol 7{13}]


0.8% (40 mg per applicatorful) (Rx) [Terazol 3{13}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For vaginal use only.
   • Continue medicine for full time of treatment.

Note: Include patient instructions when dispensing.



TERCONAZOLE VAGINAL SUPPOSITORIES

Usual adult and adolescent dose
Antifungal (vaginal)
Intravaginal, 80 mg once a day at bedtime for three days. {09} {13} {24}


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {09}.

Strength(s) usually available
U.S.—


80 mg (Rx) [Terazol 3{09}]

Canada—


80 mg (Rx) [Terazol 3 Dual-Pak{13}] [Terazol 3 Vaginal Ovules{13}]

Note: Dual-paks also contain a small tube of 0.8% terconazole cream for external application to genitals for treatment of itching. {19}


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For vaginal use only.
   • Continue medicine for full time of treatment.

Note: Include patient instructions when dispensing.



TIOCONAZOLE


Vaginal Dosage Forms

TIOCONAZOLE VAGINAL OINTMENT

Usual adult and adolescent dose
Antifungal (vaginal)
Intravaginal, 300 mg (1 applicatorful of a 6.5% vaginal ointment) as a single dose, preferably at bedtime. {22}


Note: Limited data suggest that a second dose one or two weeks later may be effective for those patients with residual symptoms after one dose. {22}


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {22}.

Strength(s) usually available
U.S.—


6.5% (OTC) [Monistat 1{28}] [Vagistat-1{22}]

Canada—


6.5% (OTC) [GyneCure{22}] [GyneCure Vaginal Ointment Tandempak{22}]

Note: Tandempaks also contain a small tube of 1% tioconazole cream for external application to genitals for treatment of itching {22}.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For vaginal use only.


TIOCONAZOLE VAGINAL SUPPOSITORIES

Usual adult and adolescent dose
Antifungal (vaginal)
Intravaginal, 300 mg, as a single dose, preferably at bedtime. {22}


Note: Limited data suggest that a second dose one or two weeks later may be effective for those patients with residual symptoms after one dose. {22}


Usual pediatric dose
Children up to 12 years of age: Safety and efficacy have not been established {22}.

Strength(s) usually available
U.S.—
Not commercially available.

Canada—


300 mg (OTC) [GyneCure Ovules{22}] [GyneCure Vaginal Ovules Tandempak{22}]

Note: Tandempaks also contain a small tube of 1% tioconazole cream for external application to genitals for treatment of itching {22}.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For vaginal use only.

Note: Include patient instructions when dispensing.




Revised: 03/16/2001



References
  1. Butoconazole nitrate patient information (Femstat 3, Procter & Gamble—US), Developed 1996, Rec 4/96.
  1. Clotrimazole (Mycelex-7, Miles). In: PDR Physicians' desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company; 1994. p. 1566.
  1. Clotrimazole package insert (Gyne-Lotrimin, Schering-Plough—US), Rec 7/1/97.
  1. Clotrimazole (Mycelex-G, Miles). In: PDR Physicians' desk reference. 41st ed. 1987. Oradell, NJ: Medical Economics Company; 1987. p. 1393-4.
  1. Miconazole nitrate (Monistat, Ortho). In: PDR Physicians' desk reference. 41st ed. 1987. Oradell, NJ: Medical Economics Company; 1987. p. 1432-3.
  1. Miconazole nitrate package insert (Monistat 5 Vaginal Tampon, Advanced Care Products—US), Rev 3/94, Rec 5/95.
  1. Econazole nitrate (Ecostatin Vaginal Ovules, Westwood-Squibb). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 545.
  1. Terconazole vaginal cream package insert (Terazol 7, Ortho—US), Rev 6/92, Rec 6/96.
  1. Terconazole vaginal suppositories package insert (Terazol 3, Ortho—US), Rec 5/88, Rec 7/2/88.
  1. Panel comments, 5/18/88.
  1. Clotrimazole (Clotrimaderm, Taro). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 336.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1994 May: 529a.
  1. Terconazole product monograph (Terazol, Janssen-Ortho). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 1655-6.
  1. Butoconazole nitrate product monograph (Femstat, Syntex—Canada), Rev 12/5/88, Rec 7/6/89.
  1. Clotrimazole (Canesten, Bayer Canada). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 253-4.
  1. Clotrimazole package insert (Myclo-Gyne, Boehringer Ingelheim—Canada), Rev 9/94, Rec 5/95.
  1. Miconazole nitrate package insert (Monistat 3, Advanced Care Products—US), Rev 3/96, Rec 5/97.
  1. Miconazole nitrate package insert (Monistat 7, Advanced Care Products—US), Rev 5/96, Rec 5/97.
  1. Miconazole nitrate product monograph (Monistat, McNeil Consumer Products—Canada), Rev 4/97, Rec 4/97.
  1. Miconazole nitrate package insert (Monistat Combination Pack, Advanced Care Products—US), Rev 11/95, Rec 5/97.
  1. Canada JR, editor. The USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention Inc; 1997. p. 119, 186, 263, 473, 718, 738.
  1. Tioconazole product monograph (GyneCure, Pfizer Consumer). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 678-9.
  1. Bennett JE. Antimicrobial agents. In: Hardman JG, Limbird LE, editors. Goodman and Gilman's the pharmacological basis of therapeutics. 9th ed. New York: McGraw Hill; 1996. p. 1175-90.
  1. Doering PL, Santiago TM. Drugs for treatment of vulvovaginal candidiasis: comparative efficacy of agents and regimens [review]. Drug Intell Clin Pharm 1990; 24: 1078-83.
  1. Tioconazole package insert (Vagistat-1, Bristol-Myers Squibb—US), Developed 1997, Rec 5/97.
  1. Miconazole product monograph (Novo-Miconazole Vaginal Ovules, Novopharm—Canada), Rev 10/94, Rec 7/95.
  1. Manufacturer's letter, 4/8/97.
  1. Tioconazole package insert (Monistat 1, Advanced Care Products—US), Developed 1998, Rec 5/97.
  1. Miconazole (Monazole 7, Technilab). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmaceutical Association; 1998. p. 1025.
  1. Miconazole (Micozole, Taro). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmaceutical Association; 1998. p. 992.
  1. Centers for Disease Control and Prevention. 1998 guidelines for treatment of sexually transmitted diseases. MMWR Morb Mortal Wkly Rep 1998 Jan; 47 (No. RR-1): 1-118.
  1. FDA Talk Paper: FDA Updates Safety Information for Miconazole Vaginal Cream and Suppositories. United States Food and Drug Administration, U.S. Department of Health and Human Services, Rockville, MD, 3/2001.
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