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Pevaryl Depot

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Pevaryl Depot

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Treatment option: Balanitis, Vaginitis, Empeines

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.

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Overview of Pevaryl Depot

Quick Facts

Property Description
Active ingredient Econazole nitrate
Form Prolonged-release vaginal ovule (Vaginal pessary)
Pharmacological class Antifungal Agent (Imidazole Derivative)
Common use Local treatment of fungal infections
Origin Synthetic organic compound

Defining Pevaryl Depot: Antifungal Classification and Active Ingredient

Pevaryl Depot is a specialized prescription medicine defined by its active ingredient, econazole nitrate (the International Nonproprietary Name or INN). This synthetic organic compound is classified as an antifungal agent, belonging to the imidazole derivative group within the broader azole antimycotic family. The medicine's general therapeutic purpose is to provide effective local treatment of conditions like vulvovaginal mycoses. The agent is characterized as a broad spectrum antimycotic with action against various pathological fungi and yeasts, including Candida species.

Pevaryl Depot's Unique Form: The Prolonged-Release Vaginal Ovule

The physical structure of Pevaryl Depot is its main distinguishing feature: it is formulated as a prolonged-release vaginal ovule, a specialized dosage form also known as a vaginal pessary or egg, which is designed exclusively for intravaginal use. The ovule’s composition features micronized econazole nitrate integrated into a solid, often lipid-based matrix or vehicle. This formulation is the basis of the "Depot" function, which ensures the single active ingredient is released gradually, or in a sustained manner, over an extended duration. This type of controlled and continuous delivery system maintains a persistent therapeutic concentration of the antifungal agent directly at the site of infection.

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What side effects are possible with Pevaryl Depot?

Possible side effects and safety information

The safety profile of econazole nitrate, the active ingredient in Pevaryl Depot, is documented by regulatory agencies through classification based on frequency and system-organ effects. The most commonly reported adverse reactions are generally localized to the application area.

Adverse Reaction Classification

Frequency Category Officially Documented Adverse Reactions
Common (ge 1/100 to <1/10) Pruritus (Itching), Skin burning sensation
Uncommon (ge 1/1,000 to <1/100) Rash, Erythema (Redness)

Reactions categorized by regulators as having Not Known frequency, meaning they are reported from post-marketing experience and lack reliable frequency estimation, include Hypersensitivity, Angioedema, Urticaria, and application site swelling or irritation. These effects primarily involve the Skin and Subcutaneous Tissue Disorders and General Disorders and Administration Site Conditions system-organ classes, with Hypersensitivity relating to Immune System Disorders.

Population and Safety Constraints

Official labeling includes specific safety considerations and restrictions. The product is contraindicated in individuals with known hypersensitivity to econazole nitrate or any components. Due to potential for damage, the product must not come into contact with latex (rubber) products, such as condoms or contraceptive diaphragms.

Regulatory documents advise caution regarding use during pregnancy, especially in the first trimester, requiring a practitioner's assessment of need due to potential for low-level absorption. Caution is also advised during breastfeeding, as it is not known whether the medicine is excreted in human milk. A high-level safety note states that the concomitant use of econazole and coumarin anticoagulants (like Warfarin) may result in the enhancement of the anticoagulant effect.

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Overdose and Emergency Response

The official regulatory profile for Pevaryl Depot overdose is defined by the absence of reported human cases in official documentation. Consequently, no specific symptoms or severe life-threatening outcomes of overexposure are formally documented in regulatory labels.

This low risk classification is supported by the physiological finding that systemic absorption of econazole nitrate following vaginal application is extremely low, which significantly limits the potential for systemic toxicity.

The context for seeking urgent medical help is centered on the unauthorized route of exposure. Immediate medical attention must be sought if the prolonged-release vaginal ovule is accidentally swallowed (oral ingestion). In such a circumstance, official guidance mandates contacting emergency services or a Poison Control Center for necessary advice.

Management of a suspected overdose is generally defined by regulatory authorities as symptomatic and supportive treatment. Furthermore, official regulatory documents state that no specific antidote is known for econazole nitrate overdose. No specialized monitoring or population-specific risk considerations are formally documented.

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Therapeutic Uses of Pevaryl Depot

What Pevaryl Depot Treats: Main Uses and Benefits

Pevaryl Depot is applied across domains where additional symptomatic support is needed, such as in vulvovaginal mycoses, a condition generally known as a vaginal yeast infection, specifically addressing infections caused by Candida species. The active ingredient, econazole nitrate, is classified as an antifungal agent for this therapeutic use. Pevaryl Depot is used in situations involving certain distressing symptoms, where it may assist with managing the fungal overgrowth.

The medication is considered relevant in conditions associated with acute or disruptive episodes where symptoms create noticeable physiological strain. It is generally used when short-term symptomatic assistance is needed, such as fungal infections that commonly follow a course of broad-spectrum antibiotics, providing supportive relief with the benefit of a single-application, sustained local action.

The treatment helps address symptom clusters that may become intense or disruptive, including symptoms related to inflammatory or irritative states (pruritus), a pronounced burning sensation, and local signs of inflammation. The treatment supports general well-being during symptomatic phases.


Quick Fact: Relief for Acute Discomfort

Property Description
Primary Indication Conditions presenting with acute episodes of Vulvovaginal mycoses
Symptom Focus Symptoms that create noticeable physiological strain (itching, burning, inflammation)
Clinical Context Applied in clinical settings that involve acute symptom patterns (e.g., post-antibiotics)
Patient Benefit Supports easing the overall symptom load and contributes to improved day-to-day comfort

Regulatory References

  1. NIH DailyMed drug documentation
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Eligibility and Restrictions for Use

Who Can and Cannot Use Pevaryl Depot?

Pevaryl Depot's eligibility is strictly defined by regulatory documentation, identifying groups for whom use is prohibited, restricted, or requires special caution.

Absolute Contraindications (Must Not Use)

The medicine is strictly contraindicated for individuals with a known hypersensitivity to the active ingredient, econazole nitrate, to any related imidazole antifungal preparations, or to any excipients in the vaginal ovule.

Age-Related Eligibility

Pevaryl Depot is intended for use in adult females. Use is not indicated or not established in the pediatric population, specifically children under the age of 16 years. No specific precautions are required solely for older adults.

Populations Requiring Conditional Use

  • Pregnancy and Lactation: Use during the first trimester of pregnancy is avoided; use in later trimesters and during lactation requires caution and a determination of clear need.
  • Concomitant Medication: Patients using oral anticoagulants (such as Warfarin) must use this medicine with caution, as increased monitoring of anticoagulant effects is necessary.
  • Product Compatibility: Use is restricted with latex barrier contraceptives (condoms or diaphragms) due to the risk of the ovule's excipients damaging the latex material.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for econazole nitrate (the active ingredient in Pevaryl Depot) focuses on two primary areas: potential systemic interactions with certain medicines and local restrictions involving other vaginal products and contraceptives.


Systemic Drug Interaction Potential

Econazole is officially noted as a known inhibitor of the metabolic isoenzymes CYP3A4 and CYP2C9. This pharmacokinetic profile indicates a risk of systemic interaction with other medicines metabolized by these enzymes. Specifically, co-administration with Oral Anticoagulants, such as Warfarin or Acenocoumarol, has resulted in the enhancement of the anticoagulant effect. This is measured as an increase in the International Normalized Ratio (INR) or prothrombin time. Regulatory documentation indicates that the risk of this systemic interaction is heightened when conditions favor higher absorption, such as application to large body surface areas, the genital area, or under occlusion.


Local Restrictions and Non-Medicinal Interactions

Strict limitations exist concerning local co-administration. The product must not be used in conjunction with other internal or external treatment of the genitalia. Furthermore, the product’s components are documented to potentially damage the latex material used in contraceptive diaphragms or condoms, requiring their avoidance. Similarly, the local treatment may inactivate the intended efficacy of spermicidal contraceptives. No interactions with food, alcohol, supplements, or herbal products are explicitly documented in the official prescribing information for this dosage form.

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Mechanism of Action

How Pevaryl Depot Works

The action of Econazole Nitrate involves the disruption of fungal structural and physiological processes.


Blocking the Fungal Structural Pathway

This mechanism describes the drug's role as an inhibitor of the fungal enzyme 14-alpha demethylase (CYP51). By inhibiting this enzyme, the drug prevents the fungus from synthesizing ergosterol, the primary sterol essential for cell membrane structure. This blockage results in the accumulation of toxic precursor molecules, weakening the cellular boundary, and initiating a cascade of events that compromise cell viability.


Destabilizing the Fungal Cell Membrane

Beyond enzymatic inhibition, the molecule exerts a direct physical action on the existing fungal cell membrane lipids. This interaction disorganizes the membrane, significantly increasing its permeability. The physical destabilization and subsequent leakage of essential intracellular components leads to cellular functional impairment, resulting in the cessation of fungal growth or cellular destruction.

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Dosage and Administration Information

Official Administration and Dosing for Pevaryl Depot

The usage of Pevaryl Depot is based on established routes, dosing schedules, and administration procedures for the 150 mg econazole nitrate vaginal pessary. The administration is via the intravaginal route only.

Standard Adult Regimens

The use of the vaginal pessary typically involves two primary approaches. Dosing parameters generally include the following regimens:

Regimen Type Dosage and Frequency Duration
Prolonged-Release (Depot) One 150 mg pessary Single application
Multi-Dose Course One 150 mg pessary once daily Three consecutive days

Procedural Instructions and Timing

For proper local application, the pessary is inserted high into the vagina. The application typically occurs at night (before retiring/bedtime) to facilitate maximum action while the patient is recumbent.

Population and Co-Administration Rules

Use is not indicated for pediatric patients under 16 years of age. No specific dosage adjustments are typically stipulated for older adults. Furthermore, the product is characterized by the requirement that it should not be used in conjunction with other internal or external treatments applied to the genitalia.

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Recent Clinical Evidence

Evidence for use in Vulvovaginal Mycoses (VVC)

The core research for Pevaryl Depot, which contains the active ingredient econazole nitrate, examined conditions such as acute or disruptive episodes, specifically vulvovaginal mycoses. The ovule formulation was evaluated in numerous Randomized Controlled Trials (RCTs) and comparative studies. These studies often explored the compound against an inactive substance (vehicle) or against other antifungal treatments used in comparison. This research was studied for its application in short-term or episodic symptom patterns and was observed in clinical settings evaluating daily-life functioning related to the infection.


Study Outcomes: Cure and Symptom Endpoints

Researchers in these trials established key measurement points, or outcomes, to assess the measures defined for the study. One primary measure used was Composite Cure, defined as the simultaneous observation of both fungal clearance and the measured change in physical signs of infection. Studies also closely monitored Mycological Cure, which is based on laboratory results indicating the absence of the specific fungal species. Furthermore, studies examined changes in measures of patient-reported discomfort, tracking outcomes such as the intensity of pruritus (itching) and the presence of a burning sensation.


Long-Term Follow-up and Evidence in Specific Populations

Research studies primarily used short-term or intermediate-term follow-up durations, assessing outcomes up to approximately four to six weeks post-treatment. Studies explored the relapse or recurrence rate during this defined time interval. Separately, research was evaluated in specific sub-groups, such as women with recurrent candidal infections. Population-based case-control studies and some clinical trials also examined the use of the ovules in pregnant women, primarily in the second and third trimesters.


What is Still Uncertain About the Research Record

The research record identifies evidence gaps and limitations. Follow-up durations were limited in many studies of this specific formulation, and there is limited information for long-term outcomes regarding the ovule’s effect on preventing infection recurrence beyond the intermediate-term window. Comparative evidence with certain newer topical treatments is also limited, and results apply only to the populations studied in the trials. These limitations indicate that the long-term effects are not fully established on the cycle of conditions characterized by fluctuating or episodic manifestations.

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Frequently Asked Questions (FAQ)

Common questions about Pevaryl Depot (FAQ)


Q: What specific type of fungal infections is Pevaryl Depot intended to treat?

According to official product information, this medicine is indicated for the local treatment of infections caused by fungi and yeasts. This primarily includes vulvovaginal candidiasis, which is caused by Candida species such as Candida albicans.


Q: How long does the single-dose 150 mg pessary continue to release the medicine for?

Pevaryl Depot is specially designed as a prolonged-release ovule, which means it provides a sustained and continuous delivery of the active ingredient at the site of infection. While the specific quantifiable duration of the release is not published in the patient-facing regulatory summaries, the formulation is designed to maintain therapeutic concentration for an extended period from a single application.


Q: When should I start to feel relief from my symptoms after using Pevaryl Depot?

Studies and official information for topical products containing the active ingredient, econazole nitrate, indicate that some patients may experience relief of their symptoms soon after treatment is started. Individual responses and relief timelines can vary.


Q: Can I have sex while I am using Pevaryl Depot?

Regulatory guidance and patient leaflets often note that, to avoid potential re-infection or risk of damage to latex contraceptives, a pause in intercourse during the treatment course may be advised. The ovule’s components are known to potentially damage or reduce the effectiveness of latex-based barrier contraceptives (condoms/diaphragms), which is a key reason for the restriction.


Q: Do I need a prescription from a doctor to buy Pevaryl Depot?

Official regulatory documents indicate that this medication is typically dispensed as a prescription-only product. This requires that a healthcare practitioner determine the appropriate course of treatment and authorize its use.


Q: What is the difference between Pevaryl Depot and the cream formulation?

Pevaryl Depot is a specialized prolonged-release vaginal ovule (pessary) designed for single or short-course intravaginal use. The cream formulation, where available, is a different dosage form applied using an applicator, and is often used for a longer course of treatment that may cover both internal and external fungal infections.


Q: Can Pevaryl Depot be used while menstruating?

Some official Patient Information Leaflets advise that patients do not interrupt or stop the treatment course if their menstrual period begins. The recommended course of treatment should be completed.

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How should Pevaryl Depot be stored and disposed of?

Storage Conditions

Official regulatory labeling for Pevaryl Depot (Econazole Nitrate Ovule) defines precise storage constraints to maintain product stability.

Storage Requirement Specification
Temperature Limit Do not store above 30 C (86 F).
Protection Keep away from heat and sunlight.
Container Rule Store in the original container.
Stability Check Do not use if the plastic packet is broken or if the ovule is not white to off-white.

Disposal Instructions

Disposal must align with official protocols for pharmaceutical waste:

  • Prohibited Disposal: Do not discard the medicine via wastewater or standard household waste.
  • Required Procedure: Ask a pharmacist how to properly throw away unused or expired product. This measure is required to help protect the environment.
  • Child Safety: Keep the medicine out of the sight and reach of children.

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

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