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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Careone Tioconazole 1
Generic Name
Tioconazole
Active Ingredient
TioconazoleCategory
Azole Antifungal [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 6.5 g/100g | OINTMENT | VAGINAL | 41520-426 |
Detailed information about Careone Tioconazole 1
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Careone Tioconazole 1, you must consult a qualified healthcare professional.
Tioconazole is a potent broad-spectrum imidazole antifungal agent used primarily for the treatment of vulvovaginal candidiasis and various superficial fungal skin infections.
For the treatment of vulvovaginal candidiasis, the standard adult dose is a single application of Tioconazole 6.5% vaginal ointment. This is typically provided in a pre-filled applicator containing approximately 4.6 grams of ointment (300 mg of Tioconazole). This single dose is designed to provide therapeutic levels of the medication for several days.
For topical skin infections (Tinea pedis, Tinea cruris, Tinea corporis), a 1% cream is typically applied to the affected and surrounding skin areas twice daily, usually in the morning and evening. The duration of treatment varies:
For onychomycosis (nail infections), a 28% solution is applied to the affected nails twice daily for 6 to 12 months, depending on the rate of nail growth and the severity of the infection.
Tioconazole is generally not recommended for use in children under the age of 12 for vaginal infections unless directed by a pediatrician. For topical skin infections, safety and efficacy in the pediatric population have not been extensively established in large-scale clinical trials; however, healthcare providers may prescribe it if the benefits outweigh the risks. Always consult a pediatrician before applying any antifungal medication to a child.
Because Tioconazole is applied topically and systemic absorption is negligible, no dosage adjustments are required for patients with renal (kidney) impairment.
Similar to renal impairment, the minimal systemic absorption of Tioconazole means that hepatic (liver) impairment does not necessitate a change in the topical or vaginal dosing regimen.
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, given the local nature of the drug, no specific age-related dosage adjustments are typically recommended.
For the vaginal ointment, a missed dose is unlikely as it is a single-dose treatment. For topical cream applied twice daily, apply the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not apply double the amount to catch up.
An overdose of Tioconazole is highly unlikely when used as directed. If the medication is accidentally swallowed, contact a poison control center or seek emergency medical attention immediately. Symptoms of ingestion might include nausea, vomiting, or gastric upset.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or stop treatment early for topical skin infections without medical guidance, as the fungus may return.
Because Tioconazole is applied locally, the most common side effects are localized to the site of application. Approximately 6% to 10% of patients using the vaginal ointment report some form of local irritation. These symptoms are usually mild and transient (temporary).
While systemic absorption is low, severe allergic reactions can occur.
> Warning: Stop taking Tioconazole and call your doctor immediately if you experience any of these:
Tioconazole is intended for short-term use. There are no documented long-term side effects associated with a single-dose vaginal application. However, chronic, unmonitored use of topical antifungals can lead to:
No FDA black box warnings have been issued for Tioconazole. It is generally considered safe for its intended over-the-counter and prescription uses when used according to the label instructions.
Report any unusual symptoms or symptoms that worsen after application to your healthcare provider. If your yeast infection symptoms do not improve within 3 days, or if they last more than 7 days, you may have a condition other than a yeast infection.
Tioconazole is intended for vaginal or topical use only. It must never be used in the eyes or taken orally. If the product comes into contact with the eyes, rinse thoroughly with cool water. Before using this medication, ensure that you have been previously diagnosed with a yeast infection by a healthcare professional. Self-diagnosis for first-time sufferers is discouraged because symptoms of yeast infections often mimic other conditions like bacterial vaginosis or trichomoniasis, which require different treatments.
No FDA black box warnings for Tioconazole. It has a high safety profile when used as a localized antifungal agent.
Because Tioconazole is not absorbed systemically in significant amounts, routine laboratory monitoring (such as blood counts or liver function tests) is not required for standard use. However, if a patient is using Tioconazole topically over very large surface areas of broken skin for an extended period, a healthcare provider might monitor for systemic azole effects, though this is clinically rare.
Tioconazole does not affect the central nervous system and is not expected to impair a patient's ability to drive or operate heavy machinery.
There are no known direct interactions between alcohol and topically applied Tioconazole. However, alcohol can sometimes exacerbate inflammatory conditions in the body, so moderation is always advised during any infection.
For the single-dose vaginal ointment, there is no tapering requirement. For topical creams, do not stop treatment as soon as the itching stops; continue for the full duration prescribed by your doctor to ensure the fungus is completely eradicated and to prevent recurrence.
> Important: Discuss all your medical conditions, including if you have a fever, foul-smelling discharge, or pain in the back or shoulders, with your healthcare provider before starting Tioconazole, as these may be signs of a more serious infection.
There are currently no documented systemic drug-drug interactions that are strictly contraindicated with the topical or vaginal use of Tioconazole. This is primarily due to the drug's minimal systemic absorption. However, it should not be used concurrently with other vaginal products (such as douches, spermicides, or other antifungal creams) as they may interfere with Tioconazole’s efficacy or increase irritation.
There are no known food interactions with Tioconazole. Because it is not taken orally, its absorption is not affected by grapefruit juice, dairy, or high-fat meals.
There are no well-documented interactions between Tioconazole and herbal supplements like St. John's Wort or Ginkgo Biloba. However, patients should always inform their doctor of all supplements they are taking.
Tioconazole is not known to interfere with standard blood or urine laboratory tests. It may, however, interfere with the results of vaginal cultures if the sample is taken too soon after application, as the medication will still be present in the vaginal vault and may inhibit the growth of the fungus in the lab dish.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including those applied to the skin.
Tioconazole is absolutely contraindicated in the following individuals:
These are conditions where the drug should be used with caution and only after a risk-benefit analysis by a physician:
As a member of the imidazole family, Tioconazole shares a common nitrogen-containing five-membered ring. Patients who experience contact dermatitis or systemic reactions to one azole are at an increased risk of reacting to others. If you have ever had a reaction to 'Monistat' (miconazole) or 'Lotrimin' (clotrimazole), you should consult an allergist before using Tioconazole.
> Important: Your healthcare provider will evaluate your complete medical history, including any previous reactions to antifungal creams, before prescribing or recommending Tioconazole.
Tioconazole is classified by the FDA as Pregnancy Category C. This means that animal reproduction studies have shown an adverse effect on the fetus (when given orally at high doses), but there are no adequate and well-controlled studies in humans. Because systemic absorption from the 6.5% vaginal ointment is negligible, the risk to the developing fetus is considered low. However, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Many doctors prefer using 7-day topical azole treatments in pregnant women rather than 1-day treatments, as the lower concentration may be gentler, though Tioconazole remains an option.
It is not known whether Tioconazole is excreted in human milk. However, because systemic absorption is so low, it is unlikely that significant amounts would reach the breast milk or affect a nursing infant. As a precaution, if applying Tioconazole cream to the skin, avoid applying it to the breast or nipple area to prevent the infant from accidentally ingesting the medication during feeding.
Safety and effectiveness in children below the age of 12 have not been established. Vaginal yeast infections are rare in pre-pubertal girls; if symptoms occur, they should be evaluated by a pediatrician to rule out other causes or potential hygiene issues.
Clinical studies of Tioconazole did not include enough patients aged 65 and older to determine if they respond differently than younger patients. In general, elderly patients may have thinner, more sensitive skin or vaginal mucosa, which could increase the sensation of burning or irritation. No specific dosage adjustments are required, but caution regarding skin integrity is advised.
Renal impairment does not affect the pharmacokinetics of topically applied Tioconazole. No dose adjustment is necessary for patients with kidney disease or those on dialysis.
Since Tioconazole does not reach significant levels in the systemic circulation, hepatic impairment (liver disease) does not interfere with the safety or efficacy of the drug. No adjustments based on Child-Pugh classification are required.
> Important: Special populations, particularly pregnant women and the elderly, require individualized medical assessment to ensure the most appropriate antifungal therapy is selected.
Tioconazole is an imidazole antifungal agent. Its primary mechanism of action is the inhibition of the enzyme 14-alpha-demethylase, a cytochrome P450 enzyme found in fungal cells. This enzyme is responsible for the demethylation of lanosterol into ergosterol. Ergosterol is a vital component of the fungal cell membrane, providing structural integrity and fluidity. By blocking its synthesis, Tioconazole causes a buildup of toxic sterol intermediates and a depletion of ergosterol, leading to 'leaky' membranes. This results in the loss of essential intracellular electrolytes and eventually causes cell death. Additionally, Tioconazole may inhibit fungal peroxidases, leading to the accumulation of toxic concentrations of hydrogen peroxide within the fungal cell.
The pharmacodynamics of Tioconazole are characterized by its broad spectrum of activity. It is effective against Candida albicans, Candida glabrata, and other Candida species, as well as dermatophytes like Trichophyton rubrum. The onset of symptomatic relief (reduction in itching and burning) typically occurs within 24 to 48 hours of the single vaginal application, although the medication continues to work for several days as it remains in the vaginal tissue.
| Parameter | Value |
|---|---|
| Bioavailability | Negligible (Topical/Vaginal) |
| Protein Binding | Highly bound (if systemic) |
| Half-life | ~72 hours (local persistence) |
| Tmax | N/A (Local action) |
| Metabolism | Hepatic (minimal systemic portion) |
| Excretion | Fecal/Urinary (minimal systemic portion) |
Tioconazole is classified as an imidazole antifungal. Related medications in this class include miconazole (Monistat), clotrimazole (Lotrimin), and ketoconazole (Nizoral). It is distinguished from the triazole class (like fluconazole) by its chemical structure, though they share a similar mechanism of action.
Common questions about Careone Tioconazole 1
Tioconazole is primarily used to treat vulvovaginal candidiasis, commonly known as a vaginal yeast infection. It is an antifungal medication that works by stopping the growth of the fungus causing the infection. It is often available as a 'one-dose' treatment, making it a convenient option for many women. In addition to vaginal use, certain formulations of Tioconazole are used to treat fungal skin infections like athlete's foot, jock itch, and ringworm. It is also used in some countries as a nail lacquer to treat fungal nail infections (onychomycosis). Always ensure a doctor has confirmed your symptoms are due to a fungal infection before use.
The most common side effects of Tioconazole are localized to the area where the medication is applied. Many women report a temporary increase in vaginal burning, itching, or irritation immediately after inserting the vaginal ointment. These symptoms are usually mild and tend to disappear as the body adjusts to the medication or as the infection clears. Some may also notice an increase in vaginal discharge as the ointment base melts. Because the drug is not absorbed significantly into the bloodstream, systemic side effects like headache or nausea are very rare. If you experience severe blistering or an allergic reaction, stop use and contact a doctor.
There is no known direct interaction between alcohol and Tioconazole when it is used as a vaginal ointment or topical cream. Unlike some oral antifungal medications, Tioconazole does not enter the bloodstream in significant amounts, so it does not interfere with the way your liver processes alcohol. However, it is important to remember that alcohol can sometimes affect your immune system's ability to fight off infections. While a moderate drink is unlikely to cause issues, focusing on hydration and rest is generally recommended when treating any infection. Always check with your healthcare provider if you have specific concerns about alcohol and your medications.
Tioconazole is classified as Pregnancy Category C, meaning it should only be used if the potential benefits outweigh the risks. While animal studies have shown some risks at high oral doses, the amount of Tioconazole absorbed into the blood from a vaginal application is extremely low. Many healthcare providers consider it safe for use in the second and third trimesters, but caution is often advised during the first trimester. It is essential to consult your obstetrician before using any antifungal medication while pregnant. They may recommend a different treatment duration or a specific application method to ensure the safety of both the mother and the baby.
Although Tioconazole is often a 'one-dose' treatment, it does not cure the infection instantly. The medication remains active in the vaginal tissues for several days after the initial application. Most women begin to feel significant relief from itching and burning within 24 to 48 hours. However, it can take up to 3 to 7 days for the symptoms to completely resolve. If your symptoms do not improve within three days, or if they persist for more than a week, you should contact your healthcare provider. It is possible that the infection is not fungal or that it is a resistant strain of yeast.
For the vaginal ointment, there is no 'stopping' the treatment because it is a single-dose application that continues to work over several days. For topical creams used for skin infections, you should not stop the treatment suddenly just because the symptoms have disappeared. Fungal infections can be persistent, and stopping the medication too early can allow the remaining fungus to regrow, leading to a relapse. Always complete the full course of treatment as directed by your doctor or the product packaging. This usually ranges from two to four weeks for skin infections like athlete's foot or ringworm.
If you are using the single-dose vaginal ointment, a missed dose is not applicable as it is only applied once. However, if you are using a Tioconazole topical cream or nail solution and miss a scheduled application, apply it as soon as you remember. If it is nearly time for your next scheduled dose, skip the missed one and continue with your regular routine. Do not apply extra cream to make up for the missed dose, as this may increase the risk of skin irritation. Consistency is key to successfully treating fungal infections, so try to keep a regular schedule.
There is no evidence to suggest that Tioconazole causes weight gain. Weight gain is typically a systemic side effect associated with medications that affect metabolism, hormones, or appetite, such as certain steroids or antidepressants. Because Tioconazole is applied topically or vaginally and has negligible systemic absorption, it does not enter the bloodstream in amounts that could influence body weight. If you experience unexpected weight gain while using this medication, it is likely due to other factors and should be discussed with your healthcare provider to determine the underlying cause.
Tioconazole generally has a low risk of interacting with other medications because it acts locally at the site of application. However, you should avoid using other vaginal products, such as douches, spermicides, or other antifungal creams, at the same time as Tioconazole, as they may interfere with its effectiveness. There is a very slight theoretical risk that it could increase the effects of blood thinners like Warfarin, so patients on such medications should be monitored. Always provide your doctor or pharmacist with a full list of all medications, including over-the-counter drugs and supplements, that you are currently using.
Yes, Tioconazole is available as a generic medication and is also sold under various brand names, the most common being Vagistat-1 in the United States. Generic versions contain the same active ingredient and are required by the FDA to be just as safe and effective as the brand-name product. You can find generic Tioconazole 6.5% vaginal ointment in most pharmacies and retail stores in the feminine hygiene or antifungal section. Choosing a generic version can often be a more cost-effective way to treat a yeast infection while receiving the same clinical benefits as the brand-name equivalent.
Other drugs with the same active ingredient (Tioconazole)