Livarol

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Livarol

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Livarol

What is Livarol? Defining the Antifungal Agent

Property Description
Active ingredient Ketoconazole
Form Vaginal Suppositories (Pessaries)
Pharmacological class Azole Antifungal / Antimycotic
Common use Local Fungal Infections
Origin Synthetic Compound

Livarol is a pharmaceutical preparation defined by its sole active substance, the synthetic compound Ketoconazole. It is classified as an Antimycotic agent within the larger group of azole antifungals, a class of drugs designed specifically to eliminate fungal pathogens. This classification dictates its function as a targeted treatment, primarily recognized for addressing local fungal infections.

The active compound, Ketoconazole, is a synthetic Imidazole derivative and a single-compound product. It is structurally similar to other imidazole antifungals, and pharmacological characteristics support its unique position in the treatment of mycoses.

Composition and Pharmaceutical Type

Livarol is presented in the specific dosage form of vaginal suppositories (or pessaries), which are solid forms intended exclusively for the local action of the drug via the intravaginal route. This form differentiates it from oral antifungal therapies by delivering concentrated medication directly to the affected tissue.

The suppository structure comprises the active Ketoconazole dispersed within an inert carrier material known as the suppository base, typically composed of semi-synthetic glycerides. This specialized formulation ensures the precise dose is released at the site of infection. The overall therapeutic purpose of Livarol is the direct, local elimination of susceptible fungal pathogens, assisting in resolving the infection and restoring physiological balance.

What side effects are possible with Livarol?

Possible Side Effects and Safety Information

The safety profile for Livarol (Ketoconazole vaginal suppositories) is characterized primarily by adverse reactions occurring at the application site, consistent with the local route of administration. Due to minimal systemic absorption, the local formulation carries a distinct safety profile from the oral form of ketoconazole, which is associated with serious systemic risks.

Officially Documented Adverse Reactions

The following effects are classified in regulatory documents based on their frequency:

Classification System-Organ Class Examples of Reactions
Common General Disorders and Administration Site Conditions Application site burning sensation and pruritus (itching).
Uncommon Skin and Subcutaneous Tissue Disorders Application site irritation, erythema (redness), and discomfort.
Frequency Not Known Immune System Disorders Hypersensitivity reactions.

Serious Safety Considerations

Official government advisories explicitly state that the severe systemic risks, such as fatal liver injury (hepatotoxicity) and adrenal problems associated with oral ketoconazole, are not associated with the topical or local formulations. However, rare, severe systemic reactions, including anaphylaxis (serious allergic reaction) and Toxic Epidermal Necrolysis (TEN), have been documented in post-marketing experience with topical ketoconazole-containing products.

Population-Specific Notes

Safety and effectiveness are generally not established in children younger than 12 years of age for some local formulations. For use during pregnancy and lactation, official guidance recommends that the potential benefits should be weighed against any potential risk due to limited available data.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

The overdose profile for the active substance, Ketoconazole, primarily addresses the consequences of high systemic exposure, such as through accidental ingestion, which is considered an overdose scenario for this locally acting suppository. The regulatory concern focuses on severe and potentially life-threatening systemic effects.

Overdose may present with signs related to acute liver injury (hepatotoxicity), including jaundice (yellowing of the skin or eyes), fatigue, and nausea.

Life-Threatening Manifestations

High systemic levels of the active ingredient are associated with documented risks of severe outcomes, including fatal liver injury and certain life-threatening ventricular tachyarrhythmias, such as Torsades de pointes, which result from electrical changes in the heart (QT prolongation). Regulator information also notes a risk of adrenal insufficiency.

Emergency Actions Mandated by Authorities

Immediate medical attention is required for a suspected overdose. The official guidance states to call emergency services or contact a poison control center for accidental ingestion or if severe symptoms, such as collapse or trouble breathing, occur.

No specific antidote is known for systemic ketoconazole overdose. Treatment described in regulatory documents consists solely of symptomatic and supportive measures, including close monitoring of the patient's condition, particularly for blood pressure and adrenal function.

Therapeutic Uses of Livarol

What Livarol Treats: Main Uses and Benefits

Targeted Resolution of Vulvovaginal Candidiasis (VVC)

The primary therapeutic role of Livarol, containing the antifungal agent Ketoconazole, is the treatment of Vulvovaginal Candidiasis (VVC), commonly associated with the condition known as a vaginal yeast infection. This medication plays a role in managing the fungal infection by addressing the causative Candida organisms. The treatment is relevant for easing symptoms associated with active infection and is commonly used across conditions presenting with acute episodes. It is often used during phases when symptoms become more noticeable due to temporary physiological imbalance.

Relief of Acute Genital Inflammatory Discomfort

The medication is used to help address symptom clusters that interfere with daily comfort. These symptoms cluster into severe pruritus (itching), a persistent burning sensation, and noticeable vulvovaginal swelling or redness. Relevant when supportive symptom management is appropriate, the treatment provides supportive relief when symptoms interfere with routine activities and contributes to easing the overall symptom load.

Support in Managing Recurring Symptom Patterns

Livarol is relevant across conditions characterized by episodic or recurring symptom patterns, including Recurrent Vulvovaginal Candidiasis. It is applied in addressing conditions involving episodic or fluctuating manifestations. This application supports a more manageable experience during symptomatic periods and supports general well-being during symptomatic phases.


Quick Fact: Relief for Intense Genital Discomfort

Regulatory References

  1. ClinicalTrials.gov entry on local Ketoconazole use for VVC

Eligibility and Restrictions for Use

Livarol (Ketoconazole Vaginal Suppositories) eligibility is defined by regulatory agencies based on established contraindications and specific population limitations, reflecting its local route of administration.

Contraindications and Absolute Restrictions

Use of the medicine is contraindicated and formally prohibited for individuals with a known history of Hypersensitivity (an allergy) to the active ingredient, Ketoconazole, or to any other component used in the suppository formulation.

Age and Developmental Eligibility

Livarol is generally established for use in adult women and adolescents aged 12 years and older, who are the primary target population for Vulvovaginal Candidiasis treatment. Safety and efficacy have not been established in pediatric patients under 12 years of age, and use is generally not recommended in this group. No specific restrictions or adjustments are documented for older adults.

Pregnancy and Lactation Status

For Pregnant Individuals and Nursing Mothers, the status is classified as conditional use. The medicine should only be used if the healthcare provider determines that the potential therapeutic benefit outweighs any potential risk, as adequate and well-controlled human studies in these populations are typically limited for local antifungals.

Condition-Based Eligibility

No restrictions regarding severe systemic conditions, such as Hepatic (Liver) or Renal (Kidney) Impairment, are documented for the local vaginal suppository. This exclusion of systemic contraindications is due to the minimal to non-detectable absorption of Ketoconazole into the bloodstream following the intravaginal route.

What should I know about interactions with other medicines?

Interactions with other medicines and products (LIVALO - Pitavastatin)

The official regulatory documents for Livalo (pitavastatin) detail several interactions that can significantly alter the drug's concentration or increase the risk of adverse events, particularly myopathy and rhabdomyolysis.

Contraindicated and Restricted Combinations

Co-administration with Cyclosporine is contraindicated due to a massive increase in pitavastatin exposure (AUC), which substantially raises the risk of severe muscle damage. Co-administration with Gemfibrozil (a fibrate) is not recommended due to a combination of increased pitavastatin concentrations and an additive risk of muscle toxicity.

Pharmacokinetic Interactions

Pitavastatin's primary interactions are mediated by the inhibition of the OATP1B1 drug transporter. Potent inhibitors of this transporter can lead to dramatically increased plasma levels of pitavastatin. For instance, co-administration with Rifampin is documented to increase pitavastatin exposure by over six-fold. Macrolide antibiotics, such as Erythromycin, are also associated with clinically significant increases in pitavastatin concentrations.

Pharmacodynamic and Population Notes

The risk of myopathy is also increased when pitavastatin is combined with other agents that pose a similar risk, such as lipid-modifying dosages of Niacin (greater than 1 gram per day). Furthermore, in patients with moderate or severe renal impairment or those on hemodialysis, the risk profile for interactions and muscle toxicity is heightened, requiring regulatory caution.

Mechanism of Action

How Livarol Works


Inhibition of Fungal Sterol Synthesis

The mechanism of Livarol is initiated by the active ingredient, Ketoconazole, binding to and inhibiting the fungal cytochrome P45014alpha-demethylase enzyme. This molecular action fundamentally blocks the ergosterol biosynthesis pathway, preventing the fungus from converting lanosterol into ergosterol, the key sterol component required for its cell membrane structure and function. This domain describes the biochemical interference that impairs critical metabolic processes within the pathogen.


️ Compromise of Pathogen Cell Membrane Integrity

The result of blocking ergosterol production is the incorporation of abnormal, toxic sterols into the fungal membrane, leading to its structural failure. This physiological consequence increases membrane permeability and fragility, resulting in impaired transmembrane gradient maintenance and inhibition of essential membrane-bound functions. This cascade of damage leads to the fungicidal or fungistatic effect on the susceptible fungal organism, which is the final mechanistic step at the application site.

Dosage and Administration Information

Livarol administration is defined by a specific, standardized protocol for the Ketoconazole vaginal suppository formulation. The approved route of administration is exclusively intravaginal, ensuring the local delivery of the antifungal agent.

The standard adult dosing schedule requires the application of one suppository unit per day (400 mg Ketoconazole). This dosing is performed once daily, with specific timing instructions emphasizing use before bedtime to promote optimal localized absorption and retention.

Proper administration technique is detailed in the product instructions. The suppository must be fully released from its packaging and inserted deep into the vagina while the patient is in a reclined position. A key procedural restriction is that the suppository must not be cut into pieces, which preserves the proper distribution of the active substance within the unit.

The total course duration is conditional based on the nature of the application. The standard short-course length is typically 3 to 5 consecutive days. For instances characterized as chronic or recurrent, a longer, standardized course of 10 days is stipulated. There are no high-level dosage adjustments provided for special populations, such as older adults, within the labeling for this local form.


Instruction Entity Specification
Administration Route Intravaginal route only.
Dosing Schedule One suppository unit per day.
Frequency/Timing Once daily, before bedtime.
Standard Duration 3 to 5 days, or 10 days for recurrence.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Livarol

This overview summarizes the formal research studies that have been conducted to evaluate Livarol (Ketoconazole vaginal suppositories), describing what outcomes the trials explored and what the current scientific evidence indicates, based on official research and scientific sources.


Evidence for Use in Vulvovaginal Candidiasis (VVC)

Research examining the use of local antifungals, including this formulation, was conducted for conditions characterized by acute or disruptive episodes like VVC, commonly associated with a vaginal yeast infection. The evidence base includes randomized controlled trials (RCTs), where subjects were assigned by chance to receive either the medicine or a comparison treatment.

Studies monitored two main areas: outcomes related to physical discomfort and mycological outcomes (the presence of the Candida fungus). Findings describe patterns observed in patient-reported outcomes describing perceived discomfort and fungal presence in patients with VVC. Research provides insight into short-term changes during periods of increased symptom activity. However, researchers observed that follow-up durations were limited to short-term intervals (typically around 10 days post-treatment) for the primary assessment.


Evidence for Recurrent VVC Patterns and Extended Follow-up

Studies were conducted for conditions characterized by fluctuating or episodic manifestations, specifically in the context of Recurrent Vulvovaginal Candidiasis (RVVC). Research explored how symptoms were measured during the study period, including subsequent relapse, often involving observational settings evaluating daily-life functioning.

Studies monitored outcomes reflecting the long-term course of the condition, particularly the rate at which symptoms returned. Findings contribute to the broader evidence landscape describing how patients reported their experience over time intervals. However, long-term outcomes are not fully established for the specific suppository formulation. Data for long-term outcomes for this local formulation, therefore, remain limited, as most extensive studies on recurrence prevention involve oral antifungal agents.


Areas of Uncertainty and Research Gaps

Research contributes to the context but not individual predictions, and findings highlight what is known and what is still uncertain about this medicine. One key limitation is that follow-up durations were limited in many of the primary efficacy trials; therefore, long-term outcomes are not well characterized. Comparative evidence is lacking against every newer topical agent now available. The results apply only to the populations studied, and information for certain complex groups, such as those with underlying systemic conditions, remains insufficient for evidence specific to this local formulation.

Key Studies & References

  1. Impact of vaginal microbiota on the clinical efficacy and long-term recurrence of ketoconazole suppositories in treating severe vulvovaginal candidiasis: a secondary analysis of a multicentre randomised trial
  2. Antifungal (oral and vaginal) therapy for recurrent vulvovaginal candidiasis: a systematic review and meta-analysis
  3. Efficacy of antifungal drugs in the treatment of vulvovaginal candidiasis: a Bayesian network meta-analysis

Frequently Asked Questions (FAQ)

Common questions about Livarol (FAQ)

Q: What is Livarol used to treat?

According to the official regulatory indications, Livarol is used for the local treatment of fungal infections of the vagina. This specifically addresses conditions like vulvovaginal candidiasis, which is commonly known as a vaginal yeast infection.

Q: Is Livarol considered an antibiotic, an antifungal, or an antiviral medicine?

Livarol, which contains the active ingredient Ketoconazole, is classified as an imidazole antifungal agent. This means the medicine is designed to target and treat infections caused by various types of fungi by interfering with their cell structure.

Q: What are the main goals of treatment with Livarol?

Studies and official information indicate that the main goals of treatment include achieving mycological outcomes, which means reducing the fungal organism at the site of application. Another goal is the reduction of patient-reported outcomes related to physical discomfort and symptoms.

Q: Are there any long-term side effects associated with Livarol use?

The severe systemic risks associated with the oral form of Ketoconazole, such as fatal liver injury, are explicitly stated in official advisories as not associated with the local vaginal suppository formulation. Due to minimal systemic absorption, the safety profile of the local form is distinct and primarily involves site-specific reactions.

Q: How quickly does Livarol typically start working?

While an exact onset time is not consistently published in patient information, pharmacokinetic research indicates that the active ingredient is released and retained on vaginal tissue for an extended period. This suggests a mechanism of local action where the ingredient is retained quickly upon administration.

Q: Can Livarol cause drowsiness or affect my ability to drive?

Drowsiness and nervousness are documented side effects associated with the systemic (oral) form of Ketoconazole. Since the vaginal suppository has minimal systemic absorption, these effects are generally less frequently reported or associated with the local formulation.

Q: Does Livarol interact with common over-the-counter pain relievers like ibuprofen?

Official drug interaction resources note that the co-administration of Ketoconazole with some pain relievers may increase the potential risk of adverse events, particularly related to liver injury. Official guidance indicates that simultaneous use may require supervision by a healthcare professional.

Q: What generally happens if a dose of Livarol is missed?

Patient information generally describes using the missed dose as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose is described as being skipped entirely. The documentation describes returning to the regular schedule and avoiding a double dose.

Q: Are there any specific foods or supplements that should be avoided while taking Livarol?

Regulatory information describes that the consumption of grapefruit or grapefruit juice may be avoided when using Ketoconazole. This is because grapefruit may increase the systemic blood levels of the active ingredient and could potentially increase the risk of side effects.

Q: Is Livarol approved by major regulatory bodies like the FDA or EMA?

Ketoconazole formulations, in general, are approved by major regulatory authorities like the FDA and EMA for use in treating fungal infections. The specific vaginal suppository formulation is based on this established regulatory foundation.

Q: Does Livarol interact with or reduce the effectiveness of birth control pills?

Drug interaction resources indicate that Ketoconazole may potentially alter the blood levels of hormonal birth control, such as pills containing levonorgestrel. Official resources describe that any such combination may require close supervision by a healthcare professional.

Q: Is Livarol available over-the-counter, or is a prescription required?

Ketoconazole is available in various formulations with different access categories. While some topical forms may be sold over-the-counter (OTC), the vaginal suppository formulation is typically available only by prescription (Rx).

Q: Is it safe to consume alcohol while undergoing treatment with Livarol?

Official advisories generally recommend that alcohol consumption may be avoided while using Ketoconazole. This is due to the potential for an increased risk of liver damage and the possibility of a severe, unpleasant reaction (such as flushing or nausea).

Q: How long does Livarol typically stay in the body after the treatment course is completed?

Pharmacokinetic studies on the local formulation show that the active ingredient is released and retained on vaginal tissue. Research indicates that the medicine can be retained locally for at least 24 hours following the administration of the suppository.

Q: Are there specific lab tests required before beginning treatment with Livarol?

Intensive monitoring, such as frequent liver function tests, is required by regulators for patients on the oral systemic form of Ketoconazole. This level of monitoring is not specifically required in labeling for the local vaginal suppository due to its minimal systemic absorption.

Q: Does Livarol have a widely available generic version?

The active ingredient, Ketoconazole, is an established medicine in the market. It is widely available and tracked in drug statistics, meaning it can be found in lower-cost generic forms.

Q: Can Livarol affect mood or cause psychological side effects, according to studies?

Changes in mood or depression are serious side effects listed in the regulatory documents for the systemic (oral) form of Ketoconazole. These psychological effects are generally considered less likely with the local vaginal formulation due to minimal systemic absorption.

Q: Does Livarol interfere with normal sleep patterns?

Difficulty falling asleep or staying asleep (insomnia) is associated with the systemic (oral) use of Ketoconazole. These effects are not typically associated with the local suppository formulation.

Q: Is it a common expectation to feel tired during the first few days of Livarol treatment?

Extreme tiredness or weakness is a symptom associated with the systemic (oral) use of Ketoconazole. Because the vaginal suppository is a local treatment, this type of systemic effect is generally not expected during the first few days.

Q: What is the difference between a caution and a contraindication for Livarol?

In official documents, a contraindication defines a condition under which the drug must never be used due to a known, high risk. A caution, conversely, indicates that the drug can be used but requires specific monitoring or a careful benefit-risk assessment, according to the official label.

Q: Does Livarol have potential drug interactions with herbal or vitamin supplements?

Official advisories recommend providing information to a healthcare professional about all other medications, including vitamins and herbal supplements. This is because Ketoconazole may interact with some of these products, potentially altering the levels or effects of either substance.

Q: What is the recommended storage temperature and shelf life for Livarol?

The official product information specifies that Livarol should be stored at room temperature, typically ranging from 15^circC to 30^circC (59^circF to 86^circF). It is described as being important to keep the medication protected from light and moisture to maintain its stability. The exact shelf life is designated by the manufacturer and can be found printed on the packaging.

Q: Are there any published studies on Livarol's long-term safety beyond the clinical trial period?

While the primary efficacy trials for local formulations often have limited follow-up durations, regulatory bodies continue to monitor for rare and serious adverse reactions. This ongoing monitoring is done through mandatory post-marketing surveillance of all approved topical and local medications.

Q: Why do official documents list 'hepatic impairment' as a restriction for Livarol use?

The severe warning regarding liver impairment (hepatotoxicity) is specifically directed at the oral form of Ketoconazole due to the high risk of liver injury. The local suppository formulation has minimal systemic absorption, and official advisories state that the severe liver risks associated with the systemic oral form are generally not associated with this local use.

Q: Has Livarol been studied in individuals with chronic kidney disease?

Manufacturer labeling for Ketoconazole generally provides no specific dosage modifications for patients with renal impairment. This suggests that, for the local formulation, standard use is generally described without specific dose adjustments related to kidney status.

How should Livarol be stored and disposed of?

How to Store and Dispose of Livarol (Ketoconazole)

Official regulatory documents define strict environmental controls to preserve Livarol (Ketoconazole vaginal suppositories).

Storage Requirements

The medication must be stored below a specific temperature limit, typically 25 C or 30 C (77 F or 86 F), and must be protected from heat, light, and moisture. It is explicitly required that the product not be refrigerated or frozen, as temperature extremes can compromise the suppository base. Livarol must remain in its original, sealed packaging until use.

Child Safety and Disposal

All medicines must be stored out of the sight and reach of children.

When disposing of unused or expired Livarol, the official guidance requires adherence to local pharmaceutical waste regulations. The medicine must not be discarded via wastewater (flushing) or placed into general household waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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