Volusol

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Volusol

Medically reviewed

Marina Burgos

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 Volusol

What Type of Medicine is Volusol?

Volusol is a prescription-only medication containing the active ingredient Butoconazole, typically prepared as butoconazole nitrate. It is formally classified as a synthetic azole antifungal agent, placing it within the specialized imidazole derivative subclass. This classification confirms the product is chemically manufactured and intended to combat fungal pathogens.

Butoconazole's inclusion in the azole antifungal class is based on its primary mechanism of action. As an imidazole derivative, this agent is characterized by its ability to selectively inhibit the synthesis of ergosterol in fungal cells. This classification defines the product's function as a targeted anti-infective agent.


Composition and Pharmaceutical Form

Volusol is supplied as a vaginal cream, which is the designated dosage form for this topical preparation. This semi-solid form is intended for localized application via the intravaginal route, ensuring the medication's effect is concentrated at the site of infection.

The product is a single-agent product, containing only Butoconazole suspended within a specialized cream base, which serves as the vehicle for effective delivery and sustained contact with the target tissue. Topical azoles are utilized for localized fungal conditions to maintain a high concentration at the site of application. The cream formulation is a distinguishing feature, differentiating it from oral or alternative topical forms.


General Therapeutic Purpose of Butoconazole

The general therapeutic purpose of Butoconazole is the eradication or inhibition of growth of the fungal pathogens responsible for the localized condition. The substance works by interfering with the synthesis of key molecules necessary for the fungus to maintain its structure. This mechanism is essential in clearing the infection, which is the foundational goal of this type of antifungal therapy.

Regulatory References

  1. Butoconazole Vaginal Cream: MedlinePlus Drug Information

What side effects are possible with Volusol?

Possible Side Effects and Safety Information

The safety profile for Volusol (Butoconazole Nitrate Vaginal Cream) is established by government regulatory agencies and centers on local application-site reactions and specific safety constraints. The medication is for topical use, and its officially documented adverse effects reflect this characteristic.


Documented Adverse Reactions and Frequency

Clinical trials have classified certain adverse reactions as common, reported by 5.7% of patients. These effects primarily involve the application site and may include both local and systemic symptoms:

System-Organ Class Common Adverse Reactions
Application Site Vulvar/vaginal burning, itching, soreness, and swelling
Gastrointestinal Pelvic pain or abdominal pain/cramping

Official Safety Constraints

A critical safety restriction documented in the regulatory labeling relates to the cream's composition. Volusol contains mineral oil, which can potentially weaken materials made of latex or rubber, such as condoms or vaginal contraceptive diaphragms. Because of this material interaction, the use of such barrier products is not recommended for up to 72 hours following treatment.

Population-Specific Safety

Regulatory documents also define safety characteristics for specific populations:

  • Pregnancy: The medication holds a Pregnancy Category C classification. This designation indicates that it should be used only if the potential benefit is deemed to justify the potential risk, as adequate and well-controlled studies in pregnant women are not available.
  • Pediatric Use: The safety and effectiveness of the cream have not been established in pediatric patients.

The medication is contraindicated in any individual with a documented history of hypersensitivity to butoconazole or any other component of the cream.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Volusol (Butoconazole Nitrate Vaginal Cream) confirms that acute overdose is considered unlikely to lead to serious adverse effects. This determination is based on the drug's topical route of administration, which results in minimal systemic absorption (approximately 1.7% of the dose is typically absorbed), thus substantially limiting the potential for severe systemic toxicity.

Overdose Scenarios and Required Actions

The primary overdose scenario identified in regulatory documents is accidental oral ingestion of the vaginal cream, as the product is not intended for non-vaginal administration.

Overdose Context Required Action
Accidental Oral Ingestion Contact their physician or local poison control center immediately is the mandated action by official instructions.
Systemic Risk Serious systemic effects are unlikely to occur due to the minimal rate of drug absorption.

Management and Antidote Information

For the management of overdose, official prescribing information directs that treatment should consist solely of symptomatic and supportive therapy. This approach is required because regulatory documents explicitly state that no specific treatment or antidote is known for butoconazole overdose. The requirement to seek immediate medical attention is strictly based on the event of accidental ingestion of the cream.

Therapeutic Uses of Volusol

Targeted Support for Vulvovaginal Candidiasis

Volusol is primarily used in the therapeutic domain of localized antifungal support, applied across conditions presenting with acute episodes of symptomatic vulvovaginal candidiasis (VVC). It is commonly used to help with symptom clusters that are characteristic of this condition.

This medication helps address symptom clusters that may become intense or disruptive, including severe local pruritus (itching), burning, and associated soreness. It is also relevant for managing secondary discomfort, such as painful urination (dysuria) and painful intercourse (dyspareunia).

“The medication is considered relevant in contexts marked by increased discomfort where short-term symptomatic assistance is needed.”

Applied during phases of increased distress, Volusol contributes to easing discomfort during symptomatic periods and may be part of symptomatic management in the affected therapeutic area. This provides supportive relief when symptoms create noticeable physiological strain.

Focus: Symptomatic Support Volusol is typically used to help ease the symptoms related to inflammatory or irritative states, and supports general well-being during acute symptomatic phases.

Regulatory References

  1. NIH DailyMed Label for Butoconazole Nitrate Cream

Eligibility and Restrictions for Use

Who Can and Cannot Use Volusol?

The eligibility for Volusol (Butoconazole Nitrate Vaginal Cream) is strictly defined by official regulatory documentation and is based on specific population restrictions and contraindications.

Contraindications and Restrictions

Absolute Contraindication:

  • Volusol is contraindicated and must not be used by individuals with a known history of hypersensitivity or allergic reaction to butoconazole nitrate or to any component of the cream formulation.

Age-Related Eligibility:

  • Use is established for non-pregnant adult and adolescent females.
  • Safety and effectiveness in children (pediatric population) have not been established.
  • Older adults do not have specific restrictions documented based on age alone.

Reproductive Status:

  • Pregnancy (US FDA Category C): Safety has not been established in pregnant women. Use is restricted and should occur only if the potential benefit justifies the potential risk to the fetus.
  • Lactation: Caution is required for nursing mothers as it is not known whether the drug is excreted in human milk.

Conditional Use:

  • Individuals presenting with severe symptoms such as fever or abdominal pain must avoid use. Patients with recurrent infections, diabetes mellitus, or HIV should undergo clinical re-evaluation before continued treatment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Volusol (butoconazole nitrate vaginal cream) is a topical antifungal product, and the official regulatory profile is defined by an interaction involving the cream's excipients rather than systemic drug-drug interactions. Because of the medication's minimal systemic absorption, no clinically significant interactions with oral prescription medicines, over-the-counter drugs, or herbal products are documented in regulatory labeling.

Interaction scope

Property Documented Regulatory Information
Medicinal product categories with documented interactions: None documented in the official regulatory label.
Product categories with documented interactions: Latex or rubber products (specifically condoms or vaginal contraceptive diaphragms).
Mechanistic basis of interactions (only if stated in label): Excipient-mediated physical degradation: The mineral oil in the cream may weaken the latex or rubber material.
Timing-based interaction rules (if applicable): Use of the identified products is not recommended within 72 hours (3 days) following treatment with the cream.
Interaction-related restrictions: Prohibition of co-use of the vaginal cream with latex/rubber barrier contraceptives for a specific duration.

Interaction classifications (high-level)

The official labeling documents this material incompatibility as an interaction with a risk of product failure. This restriction is formally classified as a timing-based constraint and is based on regulatory information from the U.S. Food and Drug Administration (FDA) Prescribing Information. The restriction applies solely to latex or rubber barrier contraceptives.

Resulting interaction structure

The regulatory interaction profile for Volusol is defined by a specific excipient-mediated product incompatibility rather than systemic drug-drug interactions. The constraint is formally documented as a timing-based restriction due to the mineral oil content in the cream potentially compromising the integrity of latex or rubber products. The absence of listed pharmacokinetic or pharmacodynamic interactions is consistent with the topical application and minimal systemic absorption profile noted in official government information.

Mechanism of Action

Butoconazole Mechanism of Action

Butoconazole's mechanism involves direct intervention in the core metabolic processes of fungal cells. The action focuses specifically on metabolic pathways unique to these pathogens.

Targeted Inhibition of Fungal Ergosterol Production

The active molecule selectively binds to and inhibits the fungal enzyme lanosterol 14-alpha demethylase ( CYP51) . This enzyme is essential for synthesizing ergosterol, a sterol component required for the structural integrity and function of the fungal cell membrane. The drug's action rapidly blocks this key step, which is unique to the fungal life cycle.

Disruption of Fungal Cell Membrane Integrity

By preventing ergosterol formation, the mechanism leads to the accumulation of toxic, methylated sterol precursors within the membrane. This substitution fundamentally disrupts the membrane's physical structure, causing a critical loss of stability and function. This structural failure results in the leakage of vital cellular components, which functionally arrests fungal cell proliferation and reproduction, and results in cell lysis.

Dosage and Administration Information

Official Administration Guidelines for Volusol

The use of Volusol, which contains butoconazole nitrate, is strictly defined by specific instructions regarding its method, dose, and timing.

Feature Guideline Overview
Route of administration The product is restricted to intravaginal administration only, utilizing the dedicated applicator.
Dosing schedule and duration For non-pregnant patients, the approved regimen is a single-dose application, delivering approximately 100 mg of the active ingredient.
Special procedural conditions The application is typically performed once, at bedtime, to ensure the longest duration of contact with the affected area.

Population-Specific Patterns and Constraints

The standard single-day course is the typical usage pattern. However, prescribing information indicates that for specific patient populations, such as pregnant patients in the second or third trimesters, a distinct regimen of once daily for 7 days may be used. Furthermore, documentation states that the safety and effectiveness of this medicine have not been established in the pediatric population.

A critical administration constraint relates to the cream's composition. The product contains mineral oil which has been shown to potentially weaken latex or rubber. Consequently, the use of latex or rubber barrier products, such as condoms or diaphragms, is not recommended for 72 hours following the single treatment.

This instruction map defines the official usage protocol, ensuring standardized administration and adherence to defined conditions.

Recent Clinical Evidence

This is a summary of the research evidence and studies conducted on Volusol (Butoconazole). This information is descriptive only and does not offer clinical advice or personal recommendations.

Evidence for Use in Symptomatic Vulvovaginal Candidiasis (VVC)

The core evidence for Volusol comes from short-term Randomized Controlled Trials (RCTs) focusing on Adult Female Patients with confirmed Symptomatic Vulvovaginal Candidiasis (VVC). These studies explored observed patterns when the product was compared against either a placebo or another active treatment. The research primarily examined conditions characterized by fluctuating or episodic manifestations.

Researchers defined the study's Primary Therapeutic Endpoint by measuring two crucial, related outcomes simultaneously: Clinical Cure and Mycological Cure. Clinical Cure involved tracking symptom changes, such as vulvovaginal irritation and burning. Mycological Cure involved confirming the absence of the causative Candida organism using laboratory indicators. The combination of these endpoints defined the Therapeutic Cure Rate endpoint for the study.


Long-Term Data and Research Gaps

The majority of the evidence comes from research exploring short-term symptom changes, with follow-up durations typically limited to between one and four weeks. Consequently, long-term effects are not fully established, and there is limited information regarding the potential for relapse or the durability of the initial response over several months.

Evidence is also limited for certain groups, specifically patients with recurrent VVC (defined as four or more episodes per year) or those with infections caused by fungal species other than Candida albicans. Scientific reviews also note some methodological heterogeneity in the earlier foundational trials. The research highlights what is known—and what is still uncertain—about Volusol's profile in the broader evidence landscape.

Key Studies & References GYNAZOLE 1- butoconazole nitrate cream Official Labeling (Indications, Clinical Studies, Contraindications)

Frequently Asked Questions (FAQ)

Common questions about Volusol (FAQ)

Q: Is Volusol commonly prescribed for [mentioning a general condition the drug might treat]?

A: Volusol is officially indicated for the local treatment of vulvovaginal candidiasis, which is a common fungal infection often referred to as a yeast infection. This is the main use for the medication as defined in its regulatory documentation.

Q: How quickly does Volusol start to work after taking it?

A: The onset of full symptom relief can vary for each individual. Clinical studies have measured the time until patients first notice an improvement in their symptoms, which for some may occur within a day of beginning treatment. Complete therapeutic cure is typically observed over a slightly longer period.

Q: How long do the effects of a dose of Volusol typically last?

A: Volusol is formulated to provide localized and sustained activity. Official pharmacokinetic data indicates that the measured half-life of the drug in the bloodstream is approximately 21 to 24 hours. This suggests the medication remains present in the body for a certain length of time following administration.

Q: What happens if I accidentally miss a dose of Volusol?

A: For the less common multi-day course, product information typically suggests applying the dose as soon as it is remembered. If it is already close to the time for the next scheduled dose, the missed dose is usually skipped. Regulatory guidance advises against doubling up or using extra cream to compensate for a missed dose.

Q: What should I avoid eating or drinking while I'm on Volusol?

A: Regulatory documents do not note any specific dietary or food restrictions that need to be followed while using Volusol. The primary regulatory constraint relates to material incompatibility, which requires temporary avoidance of certain products containing latex or rubber after use.

Q: Is it normal to feel a bit nauseous when first starting Volusol?

A: Nausea, pelvic pain, or abdominal cramping have been noted in clinical data as possible side effects reported by some patients. Since Volusol is a topical treatment, most side effects are localized, but mild systemic effects like nausea can occasionally occur.

Q: Why do some people experience headaches when they take Volusol?

A: Headaches are not listed among the most common adverse reactions, but they may be experienced by some patients as a systemic side effect. Because the cream is absorbed minimally into the body, the occurrence of systemic issues like headaches is generally uncommon.

Q: Do alcohol and Volusol mix, and what are the risks?

A: According to the official product information, Volusol has minimal systemic absorption after application. As a result, no clinically significant interactions with oral substances, including alcohol or other oral prescription medicines, are documented in regulatory labeling.

Q: Can people with kidney issues safely take Volusol?

A: Due to the minimal amount of the drug absorbed into the body after local application, specific regulatory dose adjustments are generally not required for patients who have impaired kidney or liver function. All use of the medication by patients with pre-existing health conditions should be done under the direction of a healthcare professional.

Q: Are there specific tests that need to be done before starting Volusol?

A: Official guidelines recommend that a diagnosis of vulvovaginal candidiasis be confirmed by a healthcare professional prior to initiating treatment with Volusol. This is typically done through laboratory indicators such as a KOH smear or a fungal culture.

Q: What is the typical duration of treatment with Volusol?

A: For most non-pregnant patients, the approved regimen is typically a single-dose application. However, a healthcare provider may prescribe a different course, such as once daily for seven days, for specific patient groups, like pregnant patients in their second or third trimester.

Q: Can Volusol be crushed or chewed if someone has difficulty swallowing pills?

A: Volusol is formulated as a cream that is applied locally using an applicator. It is not a tablet or capsule, and product information strictly prohibits swallowing, crushing, or chewing the product. Its use is restricted to intravaginal administration only.

Q: Are there certain medical conditions that would make Volusol unsuitable for a patient?

A: Yes, Volusol is formally contraindicated for anyone with a known history of an allergic reaction or hypersensitivity to the active ingredient or any of the cream’s components. Official documentation notes that patients with conditions such as recurrent infections, diabetes, or HIV are specific populations that may need clinical re-evaluation.

Q: How is Volusol eliminated or processed by the body?

A: Following local application, only a small portion (around 1.7%) of the dose is absorbed systemically. This small absorbed amount is processed in the liver before being eliminated from the body through the body's normal waste processes.

Q: Is there any evidence that Volusol is effective for treating [mentioning a specific symptom]?

A: The effectiveness of Volusol was established by clinical trials that simultaneously measured clinical cure and mycological cure. Clinical cure involved tracking symptom changes such as the improvement of vulvovaginal irritation, itching, and burning.

Q: What is the difference between Volusol and a placebo in clinical trials?

A: Volusol was compared against a placebo (an inactive substance) in clinical trials as part of the process to establish its effectiveness and safety. These studies help establish the therapeutic cure rate compared to an inactive substance for its intended use.

Q: Is the liquid form of Volusol as effective as the tablet form?

A: Volusol is available only as a vaginal cream for topical use, which is its officially designated dosage form. No oral tablet or liquid form of this medication is officially indicated or approved for the treatment of vulvovaginal candidiasis.

Q: Unused or expired Volusol must not be flushed down a toilet or poured into a drain.

A: Proper disposal of unused or expired medication is important for safety and environmental protection. Regulatory guidelines instruct that Volusol should not be disposed of by flushing it down a toilet or pouring it into a drain. Patients are directed to consult a pharmacist or local waste disposal service for guidance on the correct method to discard the medicine.

How should Volusol be stored and disposed of?

How to Store and Dispose of Volusol

Official regulatory documents define strict storage and disposal requirements for Volusol (Butoconazole Nitrate Vaginal Cream) to ensure product stability and safety.


Storage Requirements

Volusol must be stored at controlled room temperature, specifically between 20 C to 25 C (68 F to 77 F). The product must be protected from freezing and temperatures should not exceed the permitted excursion range of 15 C to 30 C (59 F to 86 F). For safety, the medicine must be kept out of reach of children.


Disposal Instructions

Unused or expired Volusol must not be flushed down a toilet or poured into a drain. Disposal must follow local guidelines; consult a pharmacist or local waste disposal company for proper instructions on discarding the medication.

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

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