1-Day (Tioconazole Vaginal) – Side Effects, Interactions, Uses, Dosage, Warnings

Reviewed: June 23, 2020

Tioconazole is an antifungal medication that fights infections caused by fungus.

Tioconazole vaginal (for use in the vagina) is used to treat vaginal Candida (yeast) infections.

Tioconazole vaginal may also be used for other purposes not listed in this medication guide.

uses

What is 1-Day (Vaginal) used for?

• Vaginal Candidiasis

warnings

What is the most important information I should know about 1-Day (Vaginal)?

You should not use tioconazole vaginal if you are allergic to it.

Do not use this medicine if you have never had a vaginal yeast infection that has been confirmed by a doctor.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

• fever, chills, vomiting, pain in your back or shoulder;
• pelvic pain, vaginal discharge with a bad odor;
• if you are having vaginal itching or discomfort for the first time; or
• if you think you may have been exposed to HIV (human immunodeficiency virus).

FDA pregnancy category C. It is not known whether tioconazole vaginal will harm an unborn baby. Do not use this medicine without your doctor’s advice if you are pregnant.

It is not known whether tioconazole vaginal passes into breast milk or if it could harm a nursing baby. Do not use this medicine without your doctor’s advice if you are breast-feeding.

Do not give this medication to anyone under 12 years old without medical advice.

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Side Effects

What are the side effects of 1-Day (Vaginal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening vaginal symptoms.

Common side effects may include:

• vaginal redness or swelling;
• mild stomach pain;
• pain or burning when you urinate;
• headache, runny or stuffy nose; or
• mild vaginal burning, itching or irritation after use.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pregnancy & Breastfeeding

Can I take 1-Day (Vaginal) if I’m pregnant or breastfeeding?

FDA pregnancy category C. It is not known whether tioconazole vaginal will harm an unborn baby. Do not use this medicine without your doctor’s advice if you are pregnant.

It is not known whether tioconazole vaginal passes into breast milk or if it could harm a nursing baby. Do not use this medicine without your doctor’s advice if you are breast-feeding.

Interactions

What drugs and food should I avoid while taking 1-Day (Vaginal)?

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Do not use a tampon, vaginal douche, spermicide, or other vaginal products while you are using tioconazole vaginal. Do not have vaginal intercourse during treatment.

Dosage Guidelines & Tips

How to take 1-Day (Vaginal)?

Use 1-Day (Vaginal) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

What should I do if I missed a dose of 1-Day (Vaginal)?

Since tioconazole vaginal is used as a single dose, it does not have a daily dosing schedule.

Overdose Signs

What happens if I overdose on 1-Day (Vaginal)?

Since tioconazole vaginal is used as a single dose from a prefilled applicator, an overdose is unlikely to occur.

If you think you or someone else may have overdosed on: 1-Day (Vaginal),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn’t breathing after taking 1-Day (Vaginal), call 911

911

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Medical Disclaimer

Drugs A-Z provides drug information from Everyday Health and our partners, as well as ratings from our members, all in one place. Cerner Multum™ provides the data within some of the Overview, Uses, Warnings, Side Effects, Pregnancy, Interactions, Dosage, Overdose, and Images sections. The information within all other sections is proprietary to Everyday Health. 

Tioconazole vaginal Uses, Side Effects & Warnings

Generic name: tioconazole vaginal [ tee-oh-CON-a-zole ]
Brand names: 1-Day, Vagistat-1
Dosage form: vaginal ointment w/applicator (6.5%)
Drug class: Vaginal anti-infectives

Medically reviewed by Drugs.com on Jan 26, 2023. Written by Cerner Multum.

What is tioconazole vaginal?

Tioconazole is an antifungal medication that fights infections caused by fungus.

Tioconazole vaginal (for use in the vagina) is used to treat vaginal Candida (yeast) infections.

Tioconazole vaginal may also be used for other purposes not listed in this medication guide.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use tioconazole vaginal if you are allergic to it.

Do not use tioconazole vaginal if you have never had a vaginal yeast infection that has been confirmed by a doctor.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

• fever, chills, vomiting, pain in your back or shoulder;

• pelvic pain, vaginal discharge with a bad odor;

• if you are having vaginal itching or discomfort for the first time; or

• if you think you may have been exposed to HIV (human immunodeficiency virus).

FDA pregnancy category C. It is not known whether tioconazole vaginal will harm an unborn baby. Do not use this medicine without your doctor’s advice if you are pregnant.

It is not known whether tioconazole vaginal passes into breast milk or if it could harm a nursing baby. Do not use this medicine without your doctor’s advice if you are breast-feeding.

Do not give this medication to anyone under 12 years old without medical advice.

How should I use tioconazole vaginal?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take tioconazole vaginal by mouth. It is for use only in your vagina.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is usually given as a single dose. You should notice some improvement in your symptoms after the 1-day treatment. It may take up to 7 days after using the 1-day dose before your symptoms go away completely.

Call your doctor if your symptoms do not improve after 3 days, or if you still have symptoms for longer than 7 days. Frequent vaginal yeast infections that do not clear up with treatment may be a sign of a more serious condition.

The single-use applicator is for one use only. Throw the applicator away after one use, even if there is still some medicine left in it after inserting your dose.

Tioconazole vaginal contains mineral oil or petrolatum, which can weaken the latex rubber in a condom or diaphragm. These forms of birth control may be less effective if you use them during your treatment with tioconazole vaginal. Use another form of birth control while you are using tioconazole and for at least 3 full days after your treatment ends.

Store at room temperature away from moisture and heat. Do not warm the medicine applicator before using tioconazole vaginal.

What happens if I miss a dose?

Since tioconazole vaginal is used as a single dose, it does not have a daily dosing schedule.

What happens if I overdose?

Since tioconazole vaginal is used as a single dose from a prefilled applicator, an overdose is unlikely to occur.

What should I avoid while using tioconazole vaginal?

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Do not use a tampon, vaginal douche, spermicide, or other vaginal products while you are using tioconazole vaginal. Do not have vaginal intercourse during treatment.

Tioconazole vaginal side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening vaginal symptoms.

Common side effects of tioconazole vaginal may include:

• vaginal redness or swelling;

• mild stomach pain;

• pain or burning when you urinate;

• headache, runny or stuffy nose; or

• mild vaginal burning, itching or irritation after use.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tioconazole vaginal dosing information

Usual Adult Dose for Vaginal Candidiasis:

Insert 1 applicatorful intravaginally once at bedtime.

Use: For the treatment of vaginal yeast infections

Usual Pediatric Dose for Vaginal Candidiasis:

12 years or older: Insert 1 applicatorful intravaginally once at bedtime.

Use: For the treatment of vaginal yeast infections

What other drugs will affect tioconazole vaginal?

It is not likely that other drugs you take orally or inject will have an effect on tioconazole used in the vagina. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

More about tioconazole topical

• Compare alternatives
• Pricing & coupons
• Reviews (1,695)
• Side effects
• Dosage information
• During pregnancy
• Drug class: vaginal anti-infectives
• Breastfeeding
• En español

Patient resources

• Advanced Reading
• Tioconazole

Other brands

Tioconazole 1 Day, Vagistat-1

Professional resources

• Prescribing Information

Related treatment guides

• Vaginal Yeast Infection

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 6.03.

Active substance KETOCONAZOL (KETOCONAZOLUM) | Compendium – drug reference book

• Pharmacological properties
• Indications KETOCONAZOL
• Application of KETOCONAZOL
• Contraindications
• Side effects
• Special instructions
• Interactions
• Overdose
• Diagnosis
• Recommended alternatives
• Trade names

Medicinal preparations containing the active substance KETOCONAZOL

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Ketoconazole is a synthetic derivative of imidazoledioxolane. It has a fungicidal and fungistatic effect on dermatophytes, yeast (genus Candida , Pityrosporum , Torulopsis , Cryptococcus ), dimorphic and higher fungi (eumycetes). Less sensitive to ketoconazole Aspergillus spp ., Sporothrix schenckii , some Dermatiaceae , Mucor spp . and other fucomycetes except Entomophthrales . Pharmacological properties are due to the ability to have a damaging effect on the cell membrane of fungi. Through interaction with the enzyme 14-α demethylase, ketoconazole inhibits the biosynthesis of ergosterol, an essential component of the membrane, from lanosterol. Like other azole compounds, the mechanisms of the antifungal action of ketoconazole include inhibition of cellular respiration processes, interaction with membrane phospholipids, impaired transformation of yeast fungi into mycelial forms, suppression of purine uptake, and impaired TG and/or phospholipid biosynthesis. In high concentrations, ketoconazole can have a direct physicochemical effect on fungal membranes, showing a fungicidal effect. Secondary resistance to ketoconazole does not develop.

Dissolves rapidly in the acidic environment of the stomach to form hydrochloride, which is rapidly absorbed. The bioavailability of ketoconazole depends on the acid-producing function of the stomach. Co-administration with food may increase the absorption of ketoconazole. C _{max in blood plasma is achieved 1-4 hours after ingestion. Widely distributed in most body fluids. Plasma protein binding – 84-99%, mainly with albumin. Elimination from blood plasma has a two-phase character. T ½ in the first phase is about 2 hours, in the terminal phase – about 8 hours. Partially metabolized by oxidation, dealkylation and aromatic hydroxylation. Most of ketoconazole and its metabolites are excreted in the bile and then excreted in the feces (57% within 4 days, of which 20–65% are unchanged), the remainder is excreted in the urine (13% within 4 days, of which 2–4% are unchanged).}

When applied externally, it does not undergo significant resorption. Systematic topical application in the form of a 2% shampoo leads to the accumulation of ketoconazole in the hair keratin. With intravaginal application, small amounts of ketoconazole enter the systemic circulation. C _{max in the blood plasma of women after intravaginal use of 400 mg of ketoconazole ranges from 0-20.7 ng / ml.}

treatment of skin and hair infections caused by dermatophytes: epidermophytosis of the body, limbs, feet, inguinal athlete caused by Trichophyton rubrum , Trichophyton mentagrophytes , Microsporum canis and Epidermo phyton floccosum , as well as treatment of skin candidiasis and pityriasis versicolor, dandruff, seborrheic dermatitis caused by Malassezia furfur . Treatment of acute and chronic recurrent vaginal mycosis. Prevention of fungal infections of the vagina with reduced body resistance and against the background of treatment with drugs that disrupt the normal microflora of the vagina.

cream . Candidiasis of the skin, epidermophytosis of the body, hands, feet, inguinal athlete and pityriasis versicolor: it is recommended to apply the cream to the affected skin and surrounding areas 1 time per day.

Seborrheic dermatitis: it is recommended to apply the cream to the affected skin 1 or 2 times a day, depending on the severity of the infection.

The duration of treatment is: pityriasis versicolor – 2-3 weeks, yeast infections – 2-3 weeks, athlete’s groin – 2-4 weeks, athlete’s foot – 3-4 weeks, athlete’s foot – 4-6 weeks.

The duration of treatment for seborrheic dermatitis is 2 to 4 weeks. For maintenance therapy for seborrheic dermatitis, the cream is applied 1 or 2 times a week.

Shampoo . Apply shampoo to the affected areas for 3-5 minutes, then rinse with water.

Treatment of dandruff and seborrheic dermatitis (seborrheic eczema): shampoo is applied 2 times a week for 2-4 weeks. Pityriasis versicolor: apply daily for 5 days.

Prevention of dandruff and seborrheic dermatitis (seborrheic eczema): every week or once every 2 weeks. Prevention of pityriasis versicolor: daily for 3 days (single course) before the start of the summer season.

Pessaries, suppositories . Intravaginally. Apply 1 pessary (suppository) per day for 3-5 days, depending on the course of the disease. If necessary, the course of treatment is repeated until clinical recovery, confirmed by laboratory tests. In chronic candidiasis, 1 pessary (suppository) is used for 10 days.

hypersensitivity to ketoconazole; inside is not prescribed for liver diseases, during pregnancy and lactation, with mycotic meningitis (poorly penetrates through the BBB).

when applied topically, burning sensation, itching are possible, especially in the first days of treatment. When ingested, in some cases, diarrhea, nausea, headache, dizziness, photophobia, paresthesia, thrombocytopenia, exanthema, itching may occur, very rarely – alopecia, urticaria, rash and other manifestations of allergic reactions. When using ketoconazole in doses exceeding those recommended, in rare cases, reversible gynecomastia and oligospermia were observed. At a daily therapeutic dose of 200 mg (in 1 dose), a transient decrease in plasma testosterone levels may develop; normalization of the level occurs less than 24 hours after taking ketoconazole. Patients with liver disease or hypersensitivity to ketoconazole very rarely develop hepatitis. In this case, ketoconazole is immediately canceled. The risk of this complication is increased in women over the age of 50 years, as well as after treatment with griseofulvin or hepatotoxic drugs. Sometimes there is a slight increase in the activity of transaminases or alkaline phosphatase, which does not require discontinuation of treatment with ketoconazole.

When using the cream immediately after long-term treatment with topical corticosteroids, skin irritation may occur. It is recommended to continue topical corticosteroid therapy in the morning and take ketoconazole in the evening. Then gradually reduce the dose of the steroid over 2-3 weeks until it is completely canceled. If you have previously used a potent steroid drug, then it should be replaced with a drug with a weaker effect and reduce doses according to the same scheme.

Ketoconazole reduces the cortisol response to ACTH, so it is necessary to monitor adrenal function in patients with insufficiency of these glands, as well as in patients undergoing prolonged stress (complex surgical interventions, intensive care). When taking ketoconazole > 2 weeks in a row, it is necessary to monitor liver function (before treatment, 2 weeks after the start of treatment and then monthly).

When taking alcohol during ketoconazole therapy, in exceptional cases, a disulfiram-like reaction to alcohol is observed, characterized by hyperemia, rash, peripheral edema, nausea and headache.

The cream can be used during pregnancy and lactation. Ingestion is contraindicated.

concomitant use of drugs that reduce the acidity of gastric contents (anticholinergics and antacids, H 9 blockers) should be avoided.0141 2 receptors). If such drugs are indicated, they should be taken no earlier than 2 hours after taking ketoconazole.

Co-administration of rifampicin and ketoconazole reduces the concentration of the latter in the blood, and therefore these two drugs should not be taken simultaneously.

Ketoconazole inhibits the activity of several hepatic oxidases and may delay the inactivation of drugs whose metabolism depends on the action of these enzymes. An increased level of drugs prescribed in parallel with ketoconazole may increase the incidence of side effects. This applies to agents such as cyclosporine, terfenadine, anticoagulants, methylprednisolone, and possibly busulfan. With simultaneous use with ketoconazole, the doses of these drugs should be reduced. Ketoconazole should not be administered simultaneously with astemizole.

After treatment with griseofulvin, it is recommended to take a break for 1 month, and then start treatment with ketoconazole.

in case of oral overdose, the stomach is washed with sodium bicarbonate solution, symptomatic treatment is carried out.

instructions for use, price, analogues, composition, indications

1 g of cream contains:

Active substance: ketoconazole 20 mg.

Excipients: propylene glycol, cetostearyl alcohol, octyldodecanol,

glycerin, anhydrous sodium sulfite, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Uniform white or almost white cream.

Antifungal. It has a fungicidal or fungistatic effect. The mechanism of action is to inhibit the synthesis of ergosterol and change the lipid composition of the membrane. It is active against the causative agent of multi-colored lichen Malassezia furfur, pathogens of some dermatomycosis (Trichophyton sp., Epidermophyton floccosum, Microsporum sp.), Candidiasis pathogens (Candida sp.), and Pityrosporum sp. Ketoconazole cream acts quickly on itching in dermatophyte and yeast infections, as well as in rut lesions caused by Pityrosporum sp. In this case, symptomatic improvement is observed even before the first signs of recovery appear.

When applied topically, ketoconazole is not absorbed.

Dermatophyte infections of the skin caused by Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis and Epidermophyton floccosum: ringworm of the smooth rut, inguinal athlete, epidermophytosis of the hands and feet. Skin candidiasis. Pityriasis versicolor. Seborrheic dermatitis caused by Pityrosporum ovale.

Hypersensitivity to ketoconazole or any of the excipients of the formulation.

Well-controlled safety studies of ketoconazole 2% cream have not been conducted in pregnant and lactating women. The limited data available indicate that there are no adverse effects of the use of the cream on the course of pregnancy or on the health of the fetus / newborn. Animal studies have shown reproductive toxicity at doses not related to topical ketoconazole.

There are currently no known risks associated with the use of Ketoconazole 2% cream during pregnancy or breastfeeding.

Skin candidiasis, ringworm, jock itch, athlete’s foot and hands, pityriasis versicolor: apply the cream once a day to the affected skin and immediately adjacent area.

Seborrheic dermatitis: the cream is applied to the affected area once or twice a day, depending on the severity of the lesion.

Treatment should be continued for a sufficient interval: for several days after the disappearance of all symptoms of the disease. The diagnosis should be re-evaluated if there is no clinical improvement after 4 weeks of treatment.

The usual duration of treatment is as follows: pityriasis versicolor – 2-3 weeks, skin candidiasis – 2-3 weeks, athlete’s groin – 2-4 weeks, ringworm of smooth skin – 3-4 weeks, athlete’s foot – 4-6 weeks.

The usual duration of treatment for seborrheic dermatitis is 2-4 weeks. For maintenance therapy for seborrheic dermatitis, the cream is applied once or twice a week.

Side effects that occur during treatment with ketoconazole are classified depending on the frequency of occurrence in the appropriate groups: very often (> 1/10), often (> 1/100 to 1/1000 to 1/10000 to

Immune system disorders Uncommon: hypersensitivity.

Skin and subcutaneous tissue disorders Common: burning sensation.

Uncommon: bullous rash, contact dermatitis, rash, skin desquamation, oily/dry skin.

Frequency not known: urticaria.

Systemic disorders and complications at the injection site Common: erythema and itching at the injection site.

Uncommon: bleeding, discomfort, dryness, burning, irritation, paresthesia at the site of application.

The use of the cream in excessive amounts may lead to erythema, edema and burning sensation, which usually disappear after therapy is discontinued.

If the cream is accidentally swallowed by children, no special measures are required.

Interaction with other medicinal products has not been observed.

The cream is for external use only. In case of contact with eyes, rinse thoroughly with water. The use of the cream is not contraindicated during pregnancy and lactation.

To prevent withdrawal after discontinuation of long-term treatment with topical corticosteroids, it is recommended that topical corticosteroids be continued in the morning and ketoconazole cream in the evening, followed by gradual withdrawal of steroids over 2-3 weeks.